KPCO Pharmacy Authorization Guidelines

COLORADO - MEDICATION AUTHORIZATION GUIDELINES DROXIDOPA

Generic Brand HICL GCN Exception/Other DROXIDOPA NORTHERA 40936

INITIAL CRITERIA (NOTE: FOR RENEWAL CRITERIA SEE BELOW)

1. Is this being prescribed by a neurologist or cardiologist?

If yes, continue to #2. If no, do not approve.

2. Is the patient 18 years of age or older?

If yes, continue to #3. If no, do not approve.

3. Does the patient have a confirmed diagnosis of neurogenic hypotension due to Parkinson’s disease, pure autonomic failure, multisystem atrophy, non-diabetic autonomic neuropathy, or dopamine-β-hydroxylase deficiency?

If yes, continue to #4. If no, do not approve.

4. Does the patient have ischemic heart disease, arrhythmias, congestive heart failure, or sustained, severe hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg sitting or supine)?

If yes, do not approve. If no, continue to #5.

5. Does the patient have aspirin hypersensitivity or a yellow dye allergy?

If yes, do not approve. If no, continue to #6.

6. Does the patient have severe renal impairment (CrCl less than 30 mL/min)?

If yes, do not approve. If no, continue to #7.

7. Is the patient currently breastfeeding?

If yes, do not approve. If no, continue to #8.

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES 8. Is the patient currently utilizing a non-selective MAO inhibitor, linezolid, or tedizolid*?

If yes, do not approve. If no, continue to #9.

9. Is the patient symptomatic despite using non-pharmacological interventions (getting up slowly, wearing elastic stockings, adequate salt and fluid intake, elevating the head of the bed, leg-crossing, thigh contraction, etc.)?

If yes, continue to #10. If no, do not approve.

10. Has the patient tried and failed fludrocortisone and midodrine individually and as a combination?

If yes, approve GENERIC only x3 months, max daily dose #6. If no, do not approve.

RENEWAL CRITERIA

1. Has the patient developed symptoms of neuroleptic malignant syndrome; ischemic heart disease; arrhythmias; congestive heart failure; sustained, severe hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg sitting or supine); severe renal impairment (CrCl less than 30 mL/min); or has the patient started a non-selective MAO inhibitor, linezolid, tedizolid*, or breast-feeding?

If yes, do not approve. If no, continue to #2.

2. Have the patient’s symptoms improved?

If yes, approve GENERIC Only x6 months, max daily dose #6. If no, do not approve.

*Possible theoretical interaction for tedizolid.

Creation date: 11/16/2016 Effective date: 1/1/2017 Reviewed date: 7/1/2020 Revised date: 11/1/2016

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES BECAPLERMIN

Generic Brand HICL GCN Exception/Other BECAPLERMIN REGRANEX 17028

Becaplermin will be provided as a plan benefit within the following guidelines:

1. Is the patient diagnosed with diabetes mellitus?

If yes, continue to #2. If no, continue to #4.

2. Is the prescription written by a vascular surgeon, podiatrist, or endocrinologist?

If yes, continue to #3. If no, continue to #4.

3. Is there a diagnosed neoplasm (i.e., cancer), necrotic tissue, infection, or osteomyelitis at site of application?

If yes, continue to #4. If no, approve for 3 months for two (2) tubes per month maximum.

4. Is the prescription a hospital discharge prescription per the member, prescriber, or pharmacy?

If yes, approve for 3 months for two (2) tubes per month maximum. If no, do not approve.

RENEWAL CRITERIA

1. Has there been at least a 30% decrease in wound size?

If yes, approve for a period of time necessry to complete a 20 week course, including the previous approvals, for two (2) tubes per month maximum If no, do not approve

Creation date: 11/16/2016 Effective date: 1/1/2017 Reviewed date: 9/1/2020 Revised date: 11/1/2017

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES INSULIN GLARGINE (VIALS)

Generic Brand HICL GCN Exception/Other INSULIN LANTUS (VIALS) 13072 GLARGINE

Approval for the use of insulin glargine vials is based upon meeting one of the following criteria:

• Patient has type 1 diabetes.

• Prescription is written by CPMG affiliated Endocrinology (Pediatric or Adult) specialist.

• Patient has type 2 diabetes with severe hypoglycemia despite appropriate insulin management (i.e., basal insulin, bolus/mealtime insulin, hypoglycemia management). Severe hypoglycemia can be defined as: o 2-3 episodes <70 mg/dl on separate days in a week o Any event resulting in coma/seizure o Any event requiring the assistance of another person with glucagon or emergency services.

Creation date: 5/25/2018 Effective date: 6/11/2018 Reviewed date: 5/1/2020 Revised date: 5/1/2018

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES LAMOTRIGINE, EXTENDED-RELEASE

Generic Brand HICL GCN Exception/Other LAMOTRIGINE, LAMICTAL XR 24703, EXTENDED- 24739, RELEASE 24693, 30787, 29725, 24697, 24851, 24856, 24869

GUIDELINES FOR USE Note: The 200 mg and 300 mg strength are formulary. All other strengths are nonformulary.

INITIAL CRITERIA 1. Is this being prescribed by a neurologist, in consultation with a neurologist, or was this formulation originally started by a neurologist?

If yes, continue to #2. If no, do not approve.

2. Does the patient have a diagnosis of epilepsy or a history of seizures?

If yes, continue to #3. If no, do not approve.

3. Has the patient tried and failed immediate-release (IR) lamotrigine?

If yes, continue to #4. If no, do not approve.

4. Is the patient at risk for breakthrough seizures because of missed doses or the drug not lasting long enough during the day (i.e., having early morning seizure breakthrough)?

If yes, continue to #5. If no, do not approve.

5. Is the request for a formulary strength of lamotrigine XR/SR?

If yes, approve open-ended. If no, go to #6.

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES 6. Can the patient’s daily dose be achieved by a formulary strength of lamotrigine XR/SR?

If yes, approve the appropriate formulary strength of lamotrigine open-ended. If no, approve the non-formulary strength of lamotrigine x 1 year.

RENEWAL CRITERIA 1. Can the patient’s daily dose be achieved by a formulary strength of lamotrigine XR/SR?

If yes, approve the appropriate formulary strength of lamotrigine open-ended. If no, approve the non-formulary strength of lamotrigine x 1 year.

Creation date: 7/25/2018 Effective date: 8/15/2018 Reviewed date: 7/1/2020 Revised date: 7/1/2018

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES LUMACAFTOR/IVACAFTOR

Generic Brand HICL GCN Exception/Other LUMACAFTOR/IVACAFTOR ORKAMBI 42235

GUIDELINES FOR USE (RENEWAL CRITERIA BELOW) 1. Is the patient 2 years old or older?

If yes, continue to #2. If no, do not approve.

2. Is this medication prescribed by a pulmonologist?

If yes, continue to #3. If no, do not approve.

3. Does the patient have a diagnosis of cystic fibrosis, and is the patient homozygous for the F508del mutation (as verified by testing)?

If yes, continue to #4 If no, do not approve.

4. Is the patient of age 6 years or older?

If yes, continue to #5. If no, approve x12 months at HICL, maximum daily dose of two.

5. Does the patient have a baseline FEV1 of at least 40% as documented by lab report or chart notes (not required for patients younger than 6 years of age)?

If yes, approve x1 fourteen-day fill (#56 tablets). Also, enter an approval x1 year @ HICL, max daily dose #4 to start the day the fourteen-day supply ends. If no, do not approve.

RENEWAL CRITERIA 1. Is there documentation of improvement in the patient’s CF as indicated by a maintained or improved FEV1 or BMI, reductions in pulmonary exacerbations, or improved quality of life as demonstrated by Cystic Fibrosis Questionnaire-Revised (CFQ-R) respiratory domain score?

If yes, approve x 2 years at HICL. If no, do not approve.

Creation date: 9/15/2018 Effective date: 10/12/2018

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES Reviewed date: 7/1/2020 Revised date: 9/1/2018

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES IVACAFTOR

Generic Brand HICL GCN Exception/Other IVACAFTOR KALYDECO 38461

GUIDELINES FOR USE INITIAL CRITERIA (see below for renewal criteria) 1. Is this medication prescribed by a pulmonologist?

If yes, continue to #2. If no, do not approve.

2. Is the patient 6 months old?

If yes, continue to #3. If no, do not approve.

3. Does the patient have a diagnosis of cystic fibrosis (CF) with documentation of at least one of the following mutations in the CFTR gene that is responsive to ivacaftor (Kalydeco)? E56K, P67L, R74W, D579G, G1069R, D1270N, G178R, E193K, L206W, A1067T, S1255P, R117H, S549R, G551D, G551S, S1251N, R117C, S549N, 711+3A→G, F1052V, K1060T, D110H, A455E, S945L, 3272-26A→G, D1152H, G1244E, R352Q, E831X, R1070W, 2789+5G→A, D110E, R347H, G1349D, R1070Q, S977F, 3849+10kbC→T, F1074L

If yes, continue to #4. If no, do not approve.

4. Is the patient homozygous for the F508del-CFTR mutation?

If yes, do not approve. If no, continue to #5.

5. Is the patient of age 6 years or older?

If yes, continue to #6. If no, approve for 12 months at HICL with a quantity limit of #2 per day.

6. Does the patient have a baseline FEV1 of at least 40% as documented by lab report or chart notes (not required for patients younger than 6 years of age)?

If yes, approve for 12 months at HICL with a quantity limit of #2 per day. If no, do not approve.

RENEWAL CRITERIA

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES 1. Is there documentation of improvement in the patient’s CF as indicated by a maintained or improved FEV1 or BMI, reductions in pulmonary exacerbations, or improved quality of life as demonstrated by Cystic Fibrosis Questionnaire-Revised (CFQ-R) respiratory domain score?

If yes, approve x 2 years at HICL with a quantity limit of #4 tablets per day. If no, do not approve.

Creation date: 7/25/2019 Effective date: 8/14/2019 Reviewed date: 7/1/2020 Revised date: 7/1/2019

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES DENOSUMAB

Generic Brand HICL GCN Exception/Other DENOSUMAB XGEVA, PROLIA 37012

1. Is the request for Xgeva or Prolia?

If yes, do not approve. Prolia and Xgeva are not for self-administration (forward for medical benefit review).

Creation date: 11/16/2016 Effective date: 10/17/2019 Reviewed date: 3/1/2019 Revised date: 3/1/2018

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES TAFAMIDIS

Generic Brand HICL GCN Exception/Other TAFAMIDIS VYNDAMAX 45729 46258 TAFAMIDIS VYNDAQEL 37584 41631 MEGLUMINE

GUIDELINES

Tafamidis will be approved if ALL the following are met: 1. Age > 18 years 2. Cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) documented by patient with positive biopsy demonstrating transthyretin (TTR)-amyloid deposition OR meeting all three of the following: a. Diagnosis of heart failure (defined as stage C hear failure (HF) plus New York Heart Association (NYHA class I, II or III), AND either: i. Echocardiogram with end-diastolic interventricular septal wall thickness ≥12mm OR ii. Cardiac MRI consistent with, or suggestive of, amyloidosis b. Pyrophosphate (PYP) scintigraphy cardiac uptake visual score of either: i. Grade 2 or 3 using the Perugini Grade 1-3 scoring system OR ii. Calculated heart-to-contralateral lung (H/CL) ratio > 1.5 c. Absence of a monoclonal gammopathy to rule out light-chain (AL) amyloidosis as determined by meeting the following: i. Serum protein electrophoresis (SPEP): no M spike detected, AND ii. Kappa/lambda serum free light chains: kappa/lambda free ration within normal limits iii. If SPEP and/or kappa lambda serum free light chains are abnormal, serum immunofixation (IFE) is required to be negative (“No monoclonal proteins detected”) iv. If results of any of these are unclear such that criteria is not met, a consultation by the Oncology Dept determining that patient does not have AL amyloidosis is adequate to meet this criterion. 3. Medical history of heart failure (HF) with at least 1 of the following: a. Prior hospitalization for HF b. Clinical evidence of HF (without hospitalization) manifested by signs or symptoms of volume overload or elevated intracardiac pressures that required diuretic 4. Glomerular filtration rate > 25mL/min and is not requiring dialysis 5. Not currently taking inotersen or patisiran 6. No history of heart or liver transplantation 7. No implanted cardiac mechanical assist devices 8. Life expectancy is > 1 year

If all the above are met, approve x 1 year

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES If any of the above are NOT met, do not approve

Creation date: 3/25/2020 Effective date: 3/30/2020 Reviewed date: 3/1/2021 Revised date:

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES WEIGHT LOSS MEDICATIONS

Generic Brand HICL GCN Exception/Other PHENTERMINE- QSYMIA 39347 FORMULARY WITH TOPIRAMATE PA FOR BENEFITS WITH COVERAGE NALTREXONE- CONTRAVE 41389 NONFORMULARY BUPROPION FOR BENEFITS WITH COVERAGE LIRAGLUTIDE SAXENDA 36436 NONFORMULARY FOR BENEFITS WITH COVERAGE LORCASERIN BELVIQ 40373 WITHDRAWN FROM MARKET 2/13/2020

GUIDELINES FOR USE

Must meet all the following: 1. Patient must have benefit plan with coverage for weight loss medications 2. Patient must have an initial body mass index (BMI) of > 30 kg/m2 OR an initial BMI of >27 kg/m2 AND at least one weight-related comorbid condition, such as hypertension, dyslipidemia, type 2 diabetes. AND must meet medication specific criteria: QSYMIA will be approved if phentermine has been tried and failed CONTRAVE will be approved if phentermine and Qsymia have been tried and failed SAXENDA will be approved if phentermine, Qsymia and Contrave have been tried and failed

If above is met, then approve x 1 year If above is not met, then do not approve

Creation date: 3/31/2020 Effective date: 1/1/2020 Reviewed date: Revised date:

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES INTERFERON BETA-1A

Generic Brand HICL GCN Exception/Other INTERFERON AVONEX 11253 20147, BETA-1A 20908, 30222

GUIDELINES FOR USE INITIAL CRITERIA (NOTE: FOR RENEWAL CRITERIA SEE BELOW)

1. Is the requesting physician a CPMG neurologist or an affiliated network neurologist with appropriate referral, if needed?

If yes, continue to #2 If no, do not approve.

2. Does the patient have a diagnosis of a relapsing or active form of multiple sclerosis? (This does not include non-active secondary-progressive MS or primary-progressive MS)

If yes, continue to #3 If no, do not approve

3. Is the patient currently using or will the patient be using Avonex with another disease modifying treatment (see table below)?

If yes, do not approve. If no, continue to #4

4. Is the patient being prescribed Avonex because of significant medication adherence issues or significant intolerances with a current or previous disease modifying therapy requiring multiple injections throughout the week (such as Glatopa/Copaxone, Rebif or Extavia/Betaseron)?

If yes, approve x 2 years If no, go to #5

5. Is there a contraindication or serious precaution to Extavia or Glatopa 20mg/mL?

If yes, go to #6 If no, do not approve and recommend Extavia or Glatopa 20mg/mL

6. Does the patient have high-risk features* for early progression to non-relapsing progressive MS, or has the patient had any of these high-risk features while on disease modifying treatment?

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES If yes, do not approve (Suggest Tysabri, or preferred rituximab biosimilar or Rituxan and determine response. If unwilling to change or unresponsive, approve Avonex x 2 years) If no, approve x 2 years

RENEWAL CRITERIA

1. Is the requesting physician a CPMG neurologist or an affiliated network neurologist with appropriate referral, if needed?

If yes, continue to #2 If no, do not approve.

2. Does the patient have a diagnosis of a relapsing or active form of multiple sclerosis? (This does not include non-active secondary-progressive MS or primary-progressive MS)

If yes, continue to #3 If no, do not approve

3. Is the patient currently using or will the patient be using Avonex with another disease modifying treatment (see table below)?

If yes, do not approve. If no, continue to #4

4. Has the patient had CBC, TSH and LFTs or ALT checked within the last year?

If yes, approve x2 years If no, do not approve.

* High risk features defined as meeting at least 1 of the following criteria: a. Incomplete recovery defined as an attack that lasts ≥ 30 days and has significant functional limitations with the exception of ongoing sensory symptoms b. Relapse w sphincter dysfunction, including urinary urgency or hesitancy c. Motor relapse d. Cerebellar relapse e. 3 or more relapses in the first 2 years after diagnosis f. After at least 6 months of therapy, a relapse in the next 6 months g. Annualized relapse rate of ≥1 h. After 1yr of therapy, ≥ 3 new or enlarging T2, gadolinium-enhancing lesions, or diffusion-weighted imaging lesions i. ≥ 1 cord lesion on imaging

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES Creation date: 5/12/2019 Effective date: 6/16/2020 Reviewed date: 5/1/2020 Revised date: 5/1/2020

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES INTERFERON BETA-1B

Generic Brand HICL GCN Exception/Other INTERFERON BETASERON 70023 BETA-1B

1. Is the requesting provider a CPMG neurologist or an affiliated network neurologist with appropriate referral, if needed?

If yes, continue to #2. If no, do not approve.

2. Has the patient tried Extavia injectable for at least 3 months and experienced significant intolerance or breakthrough in disease that is NOT expected to occur with Betaseron

If yes, approve x 2 years If no, do not approve. Patient needs to try Extavia.

Creation date: 5/26/2019 Effective date: 6/16/2020 Reviewed date: 5/1/2020 Revised date:

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES INTERFERON BETA-1A/ALBUMIN

Generic Brand HICL GCN Exception/Other INTERFERON Rebif 23353 23230, Also includes Avonex BETA-1A/ALBUMIN 15914, 30mcg GPID/GCN 15918, 23230 because it 23286, contains albumin. 34167, Became 34168 obsolete1/2020 but may still be in pharmacies

GUIDELINES FOR USE INITIAL CRITERIA (NOTE: FOR RENEWAL CRITERIA SEE BELOW)

1. Is the requesting physician a CPMG neurologist or an affiliated network neurologist with appropriate referral, if needed?

If yes, continue to #2 If no, do not approve.

2. Does the patient have a diagnosis of a relapsing or active form of multiple sclerosis? (This does not include non-active secondary-progressive MS or primary-progressive MS)

If yes, continue to #3 If no, do not approve

3. Is the patient currently using or will the patient be using Rebif with another disease modifying treatment (see table below)?

If yes, do not approve. If no, continue to #4

4. Has the patient tried and had inadequate responses or intolerances to at least TWO DMT injectables, one from interferon – beta class (i.e., Avonex, Betaseron, Extavia, Plegridy) AND one glatiramer acetate product (i.e., Glatopa or glatiramer acetate 40mg TIW, brand Copaxone 40mg TIW)? Indicate the name and trial duration of the products tried.

If yes, go to #5 If no, do not approve and recommend Extavia or Glatopa 20mg/mL

5. Is there a contraindication or serious precaution to Extavia and/or Glatopa 20mg/mL?

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES If yes, go to #6 If no, do not approve and recommend Extavia or Glatopa 20mg/mL

6. Does the patient have high-risk features* for early progression to non-relapsing progressive MS, or has the patient had any of these high-risk features while on disease modifying treatment?

If yes, do not approve (Suggest Tysabri or preferred biosimilar rituximab or Rituxan and determine response. If unwilling to change or unresponsive, approve Plegridy x 2 years) If no, approve x 2 years

RENEWAL CRITERIA

1. Is the requesting physician a CPMG neurologist or an affiliated network neurologist with appropriate referral, if needed?

If yes, continue to #2 If no, do not approve.

2. Does the patient have a diagnosis of a relapsing or active form of multiple sclerosis? (This does not include non-active secondary-progressive MS or primary-progressive MS)

If yes, continue to #3 If no, do not approve

3. Is the patient currently using or will the patient be using Rebif with another disease modifying treatment (see table below)?

If yes, do not approve. If no, continue to #4

4. Has the patient had CBC, TSH and LFTs or ALT checked within the last year?

If yes, approve x2 years If no, do not approve.

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES f. After at least 6 months of therapy, a relapse in the next 6 months g. Annualized relapse rate of ≥1 h. After 1yr of therapy, ≥ 3 new or enlarging T2, gadolinium-enhancing lesions, or diffusion-weighted imaging lesions i. ≥ 1 cord lesion on imaging

DOSAGE AND ADMINISTRATION Approvals may be subject to dosing limits in accordance with FDA-approved labeling, accepted compendia, and/or evidence-based practice guidelines.

Dosing Limits: The following dosing limits apply: 22 mcg or 44 mcg TIW.

(Convenience/preference is specifically excluded from the benefit)

Creation date: 4/26/2019 Effective date: 6/16/2020 Reviewed date: 5/1/2020 Revised date:

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES PEGINTERFERON BETA-1A

Generic Brand HICL GCN Exception/Other PEGINTERFERON Plegridy 41331 BETA-1A

GUIDELINES FOR USE INITIAL CRITERIA (NOTE: FOR RENEWAL CRITERIA SEE BELOW)

1. Is the requesting physician a CPMG neurologist or an affiliated network neurologist with appropriate referral, if needed?

If yes, continue to #2 If no, do not approve.

2. Does the patient have a diagnosis of a relapsing or active form of multiple sclerosis? (This does not include non-active secondary-progressive MS or primary-progressive MS)

If yes, continue to #3 If no, do not approve

3. Is the patient currently using or will the patient be using Plegridy with another disease modifying treatment (see table below)?

If yes, do not approve. If no, continue to #4

4. Is the patient being prescribed Plegridy because of significant medication adherence issues or significant intolerances with a current or previous interferon-beta injectable disease modifying treatment requiring multiple injections throughout the week (such as Rebif or Extavia/Betaseron)?

If yes, go to #5 If no, do not approve and recommend Extavia or Glatopa 20mg/mL

5. Is the patient being prescribed Plegridy because of significant medication adherence issues or significant intolerances with a current or previous glatiramer acetate injectable disease modifying treatment requiring multiple injections throughout the week (such as Glatopa or glatiramer acetate 40mg TIW)?

If yes, go to #6 If no, do not approve and recommend Glatopa 20mg/mL or Extavia

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES 6. Is the patient being prescribed Plegridy because of significant medication adherence issues or significant intolerances with current or previous Avonex injectable disease modifying treatment?

If yes, go to #7 If no, do not approve and recommend Glatiramer acetate 40mg/mL

7. Is there a contraindication or serious precaution to Extavia or Glatopa?

If yes, go to #8 If no, do not approve and recommend Extavia or Glatopa 20mg/mL

8. Does the patient have high-risk features* for early progression to non-relapsing progressive MS, or has the patient had any of these high-risk features while on disease modifying treatment?

If yes, do not approve (Suggest Tysabri or or preferred rituximab biosimilar or Rituxan and determine response. If unwilling to change or unresponsive, approve Plegridy x 2 years) If no, approve x 2 years

RENEWAL CRITERIA

1. Is the requesting physician a CPMG neurologist or an affiliated network neurologist with appropriate referral, if needed?

If yes, continue to #2 If no, do not approve.

2. Does the patient have a diagnosis of a relapsing or active form of multiple sclerosis? (This does not include non-active secondary-progressive MS or primary-progressive MS)

If yes, continue to #3 If no, do not approve

3. Is the patient currently using or will the patient be using Plegridy with another disease modifying treatment (see table below)?

If yes, do not approve. If no, continue to #4

4. Has the patient had CBC, TSH and LFTs or ALT checked within the last year?

If yes, approve x2 years

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES If no, do not approve.

DOSAGE AND ADMINISTRATION Approvals may be subject to dosing limits in accordance with FDA-approved labeling, accepted compendia, and/or evidence-based practice guidelines

Dosing Limits: The following dosing limits apply: 125 mcg every 14 days.

(Convenience/preference is specifically excluded from the benefit)

Creation date: 5/12/2019 Effective date: 6/21/2019 Reviewed date: 5/1/2020 Revised date: 5/1/2020

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES INSULIN DEGLUDEC

Generic Brand HICL GCN Exception/Other INSULIN TRESIBA 40844 DEGLUDEC FLEXTOUCH U- 100, TRESIBA FLEXTOUCH U- 200

GUIDELINES FOR USE Initial Criteria - For Renewal Criteria see below

1. Is this request for Tresiba 200 units/mL?

If yes, continue to #2. If no, continue to #5.

2. Is the patient currently using 100 units per day or more of a long-acting insulin (includes NPH)?

If yes, continue to #3. If no, do not approve.

3. Is the patient on a total daily insulin dose (basal + bolus) of 200 units/day or 2 units/kg/day or more?

If yes, do not approve. Recommend Humulin R U500 in place of basal and bolus insulin (or offer other formulary insulins available). If no continue to #4.

4. Has the patient been intolerant to, or does the patient have a contraindication to, Toujeo?

If yes, approve x 2 years. If no, do not approve. Patient needs to try Toujeo Max SoloStar.

5. Does the patient have type 1 diabetes mellitus?

If yes, continue to #8. If no, continue #6.

6. Has the patient had nocturnal or severe hypoglycemia* on Humulin N despite appropriate insulin management (ie, basal insulin, bolus/mealtime insulin, hypoglycemia management)?

If yes, continue to #8.

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES If no, continue to #7.

7. Is the patient unable to self-inject insulin due to cognitive function, difficulties with manual dexterity, visual disturbances, visual impairment, uncorrectable poor injection technique, or compromised fine-motor coordination?

If yes, do not approve. Patient must use Humulin N KwikPens. If no, do not approve. Patient must use Humulin N vials.

8. Has the patient had nocturnal or severe hypoglycemia* on glargine despite appropriate insulin management (ie, basal insulin, bolus/mealtime insulin, hypoglycemia management)?

If yes, approve x 2 years. If no, continue to #9.

9. Is the patient unable to self-inject insulin due to cognitive function, difficulties with manual dexterity, visual disturbances, visual impairment, uncorrectable poor injection technique, or compromised fine-motor coordination?

If yes, do not approve. Patient must use Lantus SoloStar. If no, do not approve. Patient must use Lantus vials.

*Severe hypoglycemia can be defined as: -- 2-3 episodes <70 mg/dl on separate days in a week -- An event resulting in coma/seizure -- An event requiring the assistance of another person with glucagon or emergency services.

RENEWAL CRITERIA:

1. Is the patient currently using 100 units per day or more of a long-acting insulin (includes NPH)?

If yes, continue to #2. If no, approve x 2 years

2. Is the patient on a total daily insulin dose (basal + bolus) of 200 units/day or 2 units/kg/day or more?

If yes, do not approve. Recommend Humulin R U500 in place of basal and bolus insulin (or offer other formulary insulins available). If no, approve x 2 years.

Creation date: 5/12/2019

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES Effective date: 6/16/2020 Reviewed date: 5/1/2020 Revised date: 5/1/2020

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES INSULIN DETEMIR PENS

Generic Brand HICL GCN Exception/Other INSULIN DETEMIR LEVEMIR 22836 FLEXTOUCH

INITIAL CRITERIA 1. Is the patient unable to self-inject insulin due to cognitive function, difficulties with manual dexterity, visual disturbances, visual impairment, uncorrectable poor injection technique, or compromised fine-motor coordination?

If yes, continue to #2. If no, do not approve.

2. Has the patient had nocturnal or severe hypoglycemia* on NPH insulin despite appropriate insulin management (ie, basal insulin, bolus/mealtime insulin, hypoglycemia management)?

If yes, continue to #3. If no, do not approve. Patient needs to try Humulin N KwikPen.

3. Has the patient had nocturnal or severe hypoglycemia* on insulin glargine 100 units/mL despite appropriate insulin management (ie, basal insulin, bolus/mealtime insulin, hypoglycemia management)?

If yes, approve x 2 years. If no, do not approve. Patient needs to try Lantus SoloStar.

RENEWAL CRITERIA 1. Is the patient still unable to self-inject insulin due to cognitive function, difficulties with manual dexterity, visual disturbances, visual impairment, uncorrectable poor injection technique, or compromised fine-motor coordination?

If yes, approve indefinitely. If no, do not approve.

Creation date: 5/12/2019 Effective date: 6/16/2020 Reviewed date: 5/1/2020

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES Revised date: 5/1/2020

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES INSULIN DETEMIR (VIALS)

Generic Brand HICL GCN Exception/Other INSULIN DETEMIR LEVEMIR (VIALS)

1. Does the patient have type 1 diabetes?

If yes, continue to #3. If no continue to #2.

2. Has the patient experienced severe hypoglycemia* using NPH despite appropriate insulin management (i.e., basal insulin, bolus/mealtime insulin, hypoglycemia management)?

If yes, continue to #3. If no, do not approve. Patient must use vials of Humulin N.

3. Has the patient failed therapy with glargine 100 units/ml due to adverse drug reaction or intolerance that is not expected to occur with the requested agent?

If yes, approv indefinitely If no, do not approve. Patient must use vials of Lantus.

*Severe hypoglycemia can be defined as: 2-3 episodes <70 mg/dl on separate days in a week Any event resulting in coma/seizure Any event requiring the assistance of another person with glucagon or emergency services.

Creation date: 5/12/2019 Effective date: 6/16/2020 Reviewed date: 5/1/2020 Revised date: 5/1/2020

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES INSULIN GLARGINE (PENS)

Generic Brand HICL GCN Exception/Other INSULIN LANTUS 98637 Prefer Lantus over GLARGINE SOLOSTAR, Basaglar BASAGLAR KWIKPEN INSULIN TOUJEO 37988 GLARGINE SOLOSTAR INSULIN TOUJEO MAX 44561 GLARGINE SOLOSTAR

GUIDELINES FOR USE Initial Criteria ( for renewal criteria see below)

1. Is this request for Toujeo or Toujeo Max Solostar?

If yes, continue to #2. If no, continue to #5.

2. Is the patient currently using 100 units per day or more of a long-acting insulin (includes NPH)?

If yes, continue to #3. If no, do not approve.

3. Is the patient on a total daily insulin dose (basal + bolus) of 200 units/day or 2 units/kg/day or more?

If yes, do not approve. Recommend Humulin R U500 in place of basal and bolus insulin (or other formulary insulins available). If no continue to #4.

4. Is the request for Toujeo Max Solostar?

If yes, approve x 2 years. If no, do not approve. Patient must use Toujeo Max Solostar.

5. Is the requesting provider a CPMG endocrinologist or an affiliated network endocrinologist with appropriate referral, if needed?

If yes, approve Lantus x 2 years, Provider to rx Lantus, NOT Basaglar If no, continue to #6.

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES 6. Is the patient unable to self-inject insulin due to cognitive function, difficulties with manual dexterity, visual disturbances, visual impairment, uncorrectable poor injection technique, or compromised fine-motor coordination?

If yes, continue to #7. If no, do not approve.

7. Does the patient have type 1 diabetes mellitus?

If yes, approve Lantus indefinitely Provider to rx Lantus, NOT Basaglar If no, continue to #8.

8. Has the patient had nocturnal or severe hypoglycemia* despite appropriate insulin management (ie, basal insulin, bolus/mealtime insulin, hypoglycemia management)?

If yes, approve Lantus x 2 years. Provider to rx Lantus, NOT Basaglr If no, do not approve. Patient needs to try Humulin N KwikPen.

RENEWAL CRITERIA:

1. Is the patient currently using 100 units per day or more of a long-acting insulin (includes NPH)?

If yes, continue to #2. If no, approve x 2 years

2. Is the patient on a total daily insulin dose (basal + bolus) of 200 units/day or 2 units/kg/day or more?

If yes, do not approve. Recommend Humulin R U500 in place of basal and bolus insulin (or offer other formulary insulins available). If no, approve x 2 years.

Creation date: 5/12/2019 Effective date: 6/16/2020 Reviewed date: 5/1/2020 Revised date: 5/1/2020

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES MIXED SHORT-ACTING/LONG-ACTING INSULIN PENS

Generic Brand HICL GCN Exception/Other INSULIN LISPRO HUMALOG MIX 93717 PROTAMINE/INSULIN 75/25 KWIKPEN LISPRO INSULIN LISPRO HUMALOG MIX 50461 PROTAMINE/INSULIN 50/50 KWIKPEN LISPRO INSULIN ASPART NOVOLOG MIX 19057 PROTAMINE/INSULIN 70/30 FLEXPEN ASPART INSULIN RYZODEG DEGLUDEC/INSULIN 70/30 ASPART FLEXTOUCH INSULIN NPH HUMULIN 70/30 890 HUMAN PEN ISOPHANE/REG INSULIN HUMAN

GUIDELINES FOR USE INITIAL CRITERIA 1. Is the patient unable to self-inject insulin due to cognitive function, difficulties with manual dexterity, visual disturbances, visual impairment, uncorrectable poor injection technique, or compromised fine-motor coordination?

If yes, continue to #2. If no, do not approve.

2. Is the request for Humulin 70/30 pen?

If yes, approve x 2 years. If no, continue to #3.

3. Has the patient tried and failed Humulin 70/30 pen?

If yes, approve x 2 years. If no, do not approve. Patient needs to try Humulin 70/30 pen.

If yes, approve x indefinitely If no, do not approve.

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES

Creation date: 5/25/2018 Effective date: 6/16/2020 Reviewed date: 5/1/2020 Revised date: 5/1/2020

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES NPH INSULIN PENS

Generic Brand HICL GCN Exception/Other INSULIN NPH HUMULIN N 18488 HUMAN KWIKPEN ISOPHANE

GUIDELINES FOR USE Initial Criteria 1. Is the patient unable to self-inject insulin due to cognitive function, difficulties with manual dexterity, visual disturbances, visual impairment, uncorrectable poor injection technique, or compromised fine-motor coordination?

If yes, approve x 2 years. If no, do not approve.

If yes, approve indefinitely If no, do not approve.

Creation date: 5/4/2017 Effective date: 6/16/2020 Reviewed date: 5/1/2020 Revised date: 5/1/2020

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES SHORT-ACTING INSULIN PENS

Generic Brand HICL GCN Exception/Other INSULIN ASPART NOVOLOG 92336 Authorized Generic FLEXPEN Available INSULIN APIDRA 26508 GLULISINE SOLOSTAR INSULIN LISPRO HUMALOG 96719 AG of Humalog KWIKPEN preferred; Admelog ADEMLOG NOT preferred SOLOSTAR INSULIN LISPRO HUMALOG 37798 KWIKPEN U-200 INSULIN LISPRO HUMALOG 11528 Used in HumaPen CARTRIDGE Luxura for 1/2 unit dosing (device no longer made) INSULIN ASPART NOVOLOG 92886 Used in NovoPen CARTRIDGE Echo device for 1/2 unit dosing INSULIN ASPART FIASP 43053 (NIACINAMIDE) FLEXTOUCH INSULIN LISPRO HUMALOG 43753 Authorized Generic JUNIOR Available; For 1/2 unit KWIKPEN dosing

GUIDELINES FOR USE INITIAL CRITERIA

1. Is the requesting provider a CPMG endocrinologist or an affiliated endocrinologist with appropriate referral, if needed?

If yes, continue to #4. If no, continue to #2.

2. Is the patient unable to self-inject insulin due to cognitive function, difficulties with manual dexterity, visual disturbances, visual impairment, uncorrectable poor injection technique, or compromised fine-motor coordination?

If yes, continue to #4. If no, continue to #3.

3. Does the patient have type 1 diabetes mellitus?

If yes, continue to #4. If no, do not approve.

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES

4. Is the request for Humalog or Insulin Lispro 100 units/mL KwikPens cartridges?

If yes, approve brand Humalog Kwikpen x indefinitely. {enter at the NDC-9 level for 00002-8799-01} If no, continue to #5.

5. Does the patient require half-unit dosing?

If yes, continue to #6. If no, continue to #8.

6. Is the request for Humalog or Insulin Lispro Kwikpen Junior?

If yes, approve brand Humalog Kwikpen Junior x 2 years{ enter at the NDC-9 level for 00002-7714-01} If no, continue to #7.

7. Has the patient tried and failed* Humalog or Insulin Lispro Kwikpen Junior?

If yes, approve generic Insulin Aspart Penfill cartridges for use in a NovoPen Echo device for half-unit dosing {enter at the NDC-9 level for 73070-0103-10} If no, do not approve, must try Humalog Kwikpen Junior

8. Is the request for Fiasp FlexTouch?

If yes, continue to #9. If no, continue to #10.

9. Does the patient have difficulties with timing of mealtime doses or experience late hypoglycemia?

If yes, approve x 2 years. If no, continue to #10.

10. Is the patient currently using 100 units per day or more of a short-acting insulin (includes Regular)?

If yes, continue to #11. If no, continue #12.

11. Is the patient on a total daily insulin dose (basal + bolus) of 200 units/day or 2 units/kg/day or more?

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES If yes, do not approve. Recommend Humulin R U500 in place of basal and bolus insulin (or offer other formulary insulins available). If no, continue #12

12. Has the patient tried and failed* Humalog 100 unit/mL Kwikpens, cartridges, or Humalog Kwikpen Jr?

If yes, approve authorized generic if available or brand if AG unavailable x 2 years. If no, do not approve. Patient needs to try Humalog 100 units/mL KwikPen or Humalog Kwikpen Jr.

*Failure can be defined as an adverse drug reaction or intolerance that is not expected to occur with the requested agent

RENEWAL CRITERIA

1. Does the patient have Type 1 diabetes mellitus?

If yes, approve indefinitely. If no, continue to #2.

2. Is the requesting provider a CPMG endocrinologist or an affiliated endocrinologist with appropriate referral, if needed?

If yes, approve x 2 years. If no, continue to #3.

3. Is the patient still unable to self-inject insulin due to cognitive function, difficulties with manual dexterity, visual disturbances, visual impairment, uncorrectable poor injection technique, or compromised fine-motor coordination?

If yes, approve x 2 years. If no, do not approve. Patient must use vials.

Creation date: 5/12/2019 Effective date: 6/16/2020 Reviewed date: 5/1/2020 Revised date: 5/1/2020

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES TRIKAFTA

Generic Brand HICL GCN Exception/Other ELEXACAFTOR/IVACAFTOR/ TRIKAFTA TEZACAFTOR

GUIDELINES FOR USE Initial Criteria (see below for renewal criteria) Requests for Trikafta will be approved if ALL the following are met: • Prescribed by or in consultation with a pulmonologist • Patient is aged 12 years or older • Patient has a diagnosis of cystic fibrosis (CF) with documentation of at least one F508del mutation • Liver function tests (ALT, AST and bilirubin) within 3 months prior to initiating Trikafta {Use not recommended in severe hepatic impairment}

If above are met, then approve x 1 year

Renewal Criteria Requests for continued use of Trikafta will be approved if ALL the following are met: • Liver function tests (ALT, AST and bilirubin) within the past year AND at least one of the following: • Improved or stable pulmonary health • Improved or stable nutritional health • Prescriber attests to patient having a clinically meaningful response to therapy

If above are met, then approve x 1 year

Creation date: 7/1/2020 Effective date: 9/1/2020 Reviewed date: Revised date:

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES TEZACAFTOR/IVACAFTOR (SYMDEKO)

Generic Brand HICL GCN Exception/Other TEZACAFTOR/IVACAFTOR SYMDEKO

GUIDELINES FOR USE INITIAL CRITERIA (see below for renewal criteria) 1. Is this medication prescribed by or in consultation with a pulmonologist?

If yes, continue to #2. If no, do not approve.

2. Is the patiet 6 years of age or older?

If yes, continue to #3. If no, do not approve.

3. Does the patient have a diagnosis of cystic fibrosis (CF) with documentation of genetic testing confirming the patient is homozygous for the F508del mutation?

If yes, approve x 2 years. If no, continue to #4.

4. Does the patient have a diagnosis of cystic fibrosis (CF) with documentation of at least one of the following mutations in the CFTR gene that is responsive to tezacaftor/ivacaftor? E56K, R117C, A455E, S945L, R1070W, 3849+10kbC→T, P67L, E193K, F1074L, S977F, D1270N R74W, L206W, D579G, F1052V, D1152H, D110E, R347H , 711+3A→G, K1060T, 3272-26A→G, D110H, R352Q, E831X, A1067T, 2789+5G→A, F508del* (*Patient must have two copies of the F508del mutation or at least one copy of a responsive mutation presented in the table above to be indicated)

If yes, continue to #5. If no, do not approve.

5. Does the patient have a baseline FEV1 of at least 40% as documented by lab report or chart notes

If yes, approve x 2 years. If no, do not approve.

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES

If yes, approve x 2 years. If no, do not approve.

Creation date: 7/25/2019 Effective date: 9/1/2020 Reviewed date: 7/1/2020 Revised date: 7/1/2020

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES CORTICOTROPIN

Generic Brand HICL GCN Exception/Other CORTICOTROPIN ACTHAR HP 02830 GEL

GUIDELINES FOR USE

To treat Infantile spasms Patient must meet ALL the following:

If all the above are met, then approve for 28 days with a maximum of 8 vials (each 5mL vial contains 400 units) If above criteria are NOT met, then do not approve

To treat Nephrotic Syndrome *Initial Use Criteria Patient must meet ALL the following:

• patient does NOT have a contraindication† to Acthar (See contraindication list at the end of this guideline) • the corticotropin must NOT be administered within a medical office setting. It must be administered in a home setting by non-healthcare persons • patient must have a diagnosis of nephrotic syndrome • corticotropin must be prescribed by a nephrology specialist • patient must have failed EACH of the following due to side effects or failure to achieve sustained partial* or complete** remission of nephrotic syndrome after 6 months of treatment (See definitions of partial and complete remission at the end of this guideline) o prednisone or prednisolone AND o cyclosporine or tacrolimus AND o mycophenolate mofetil or azathioprine AND o cyclophosphamide or chlorambucil AND o rituximab or rituximab biosimilar

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES If all the above are met, then approve up to 160 units/week for 6 months (each 5mL vial contains 400 units) If above are NOT met, then do not approve

*Renewal Criteria when KPCO approved initial use Patient must meet ALL the following: • patient does NOT have a contraindication† to Acthar (See contraindication list at the end of this guideline) • the corticotropin must NOT be administered within a medical office setting. It must be administered in a home setting by non-healthcare persons • patient must have a diagnosis of nephrotic syndrome • corticotropin must be prescribed by a nephrology specialist • patient achieve sustained partial* or complete** remission of nephrotic syndrome after 6 months of treatment (See definitions of partial and complete remission at the end of this guideline)

If all the above are met, then approve up to 160 units/week for 6 months (each 5mL vial contains 400 units) If above are NOT met, then do not approve

To treat acute exacerbation of Multiple Sclerosis Patient must meet ALL the following:

AND either of the following:

• patient HAS a contraindication (documented hypersensitivity) to prednisone, methylprenisolone, and dexamethasone OR • patient failed a 3-day course of PO prednisone of at least 500mg daily, with or without a short PO prednisone taper afterwards, for this current exacerbation AND • patient failed a 7-day course of IV or PO dexamethasone of at least 8mg daily, with or without a short PO prednisone or dexamethasone taper afterwards, for this current exacerbation AND • patient failed a 3-day course of IV methylprednisolone of at least 500mg daily, with or without a short oral prednisone taper afterwards, for this current exacerbation

If above criteria are met, then 120 units/day for up to 21 days (each 5mL vial contains 400 units)

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES

*A partial response in patients presenting with nephrotic range proteinuria is a reduction of ≥50 percent (either protein:cr or albumin:cr ratio), and to less than 3.5 g/day confirmed by 2 values at least 2 weeks apart AND accompanied by an improvement in creatinine (value less than before treatment started).

**A complete response is a reduction in proteinuria to <200 to 300 mg/day (either protein:cr or albumin:cr ratio) confirmed by 2 values at least 2 weeks apart and accompanied with a normal creatinine (<1.1).

†Contraindications to Acthar A. concomitant use of live or live attenuated vaccines when receiving immunosuppressive corticotropin dose (also a contraindication to prednisone and methylprednisolone) B. congenital infection in infants C. congestive heart failure D. hypertension, uncontrolled E. intravenous administration F. ocular herpes simplex infection G. osteoporosis H. peptic ulcers, history or presence of I. primary adrenocortical insufficiency or adrenocortical hyperactivity J. scleroderma K. sensitivity to porcine protein L. surgery, recent M. systemic fungal infection (also a contraindication to prednisone, methylprednisolone and dexamethasone)

Creation date: 7/1/2020 Effective date: 9/1/2020 Reviewed date: 7/1/2020 Revised date: 7/1/2020

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES FUMARIC ACID DERIVATIVES - MS DRUGS

Generic Brand HICL GCN Exception/Other DIMETHYL TECFIDERA 40168 BRAND is FUMARATE Nonformulary Specialty tier DIROXIMEL VUMERITY 46164 Nonformulary FUMARATE Specialty tier MONOMETHYL BAFIERTAM 46576 FDA approved April FUMARATE 2020; not yet available

Guidelines for Use INITIAL CRITERIA For all requests for Multiple Sclerosis Medications ALL of the following criteria must be met: a) The requesting provider is a CPMG neurologist or an affiliated network neurologist with active referral, if needed AND b) The patient has a diagnosis of relapsing or active form of multiple sclerosis. (This does not include non-active Secondary-Progressive MS or Primary-Progressive MS) AND c) The drug will NOT be given in combination with other disease modifying therapies approved for MS (See list in table below) AND

For BRAND dimethyl fumarate (Tecfidera) requests: the patient must meet ALL of the following criteria: 1. i.)The patient failed, demonstrated intolerance, or demonstrated significant non¬adherence to interferon-beta OR glatiramer acetate self-injection therapy OR ii) The patient has a contraindication/serious precaution to both interferon-beta AND glatiramer acetate self-injection therapy AND 2. The patient has a documented allergy to a specific inactive ingredient in generic dimethyl fumarate that is not expected to occur with brand Tecfidera. AND 3. A baseline CBC and LFT has been completed within the last 3 months AND 4. i.)The patient does NOT have *high-risk features for early progression to non- relapsing progressive MS, OR ii.) the patient has NOT had any of these high-risk features while on disease modifying treatment OR iii.) the patient has an intolerance to a B cell depleting antibody (i.e. anti-CD20 agent) such as rituximab or preferred biosimilar

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES if does not meet criteria #4i,ii or iii, suggest Rituxan or preferred biosimilar (see table below) or Tysabri or Gilenya

If all of the above are met, then approve (dimethyl fumarate) brand Tecfidera per below Tecfidera - approve x 2 years at HICL level (40168) with a max daily dose of 2 per day

For diroximel fumarate (Vumerity) requests: the patient must meet ALL of the above criteria for Tecfidera and the following criteria:

1. Patient has not had hypersensitivity reaction or angioedema as a result of dimethyl fumarate (Tecfidera) therapy AND 2. The patient has experienced documented intolerable gastrointestinal adverse effects which have continued despite at least a 60-day trial of dimethyl fumarate (Tecfidera) AND tolerability measures taken as defined below: a. The patient has trialed a temporary dose reduction of dimethyl fumarate (Tecfidera) (with maintenance dose being resumed within 4 weeks) AND b. The patient has trialed taking dimethyl fumarate (Tecfidera) with food AND c. The GI adverse events remain significant despite maximized use of gastrointestinal symptomatic therapies (such as calcium carbonate, bismuth subsalicylate, PPIs, H2 blockers, anti-bloating/anti-constipation agents, anti-diarrheal, and centrally acting anti-emetics)

If above met, then approve diroximel fumarate (Vumerity) per below Vumerity - approve x 2 years at HICL level (46164) with a max daily dose of 2 per day

For Bafiertam - review based on medical necessity until criteria are developed

RENEWAL CRITERIA All of the following criteria must be met: • The requesting provider is a CPMG neurologist or an affiliated network neurologist with active referral, if needed AND • The patient has a diagnosis of relapsing or active form of multiple sclerosis. (This does not include non-active Secondary-Progressive MS or Primary-Progressive MS) and all of the following AND • The drug will not be given in combination with other disease modifying therapies approved for the treatment of MS (See list in table below) AND • The patient has had a CBC and LFT checked within the last 12 months AND, if applicable: • If renewal request is for Vumerity, after initial 90-day trial then must have documentation of clinically significant reduction in GI adverse events since starting Vumerity therapy

If above met, then approve per table below:

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES Tecfidera - approve x 2 years at HICL level (40168) with a max daily dose of 2 per day Vumerity - approve x 2 years at HICL level (46164) with a max daily dose of 2 per day

Creation date: 7/1/2020 Effective date: 9/1/2020 Reviewed date: 4/1/2021 Revised date: 4/1/2021

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES BLADDER PAIN/INTERSTITIAL CYSTITIS - PENTOSAN POLYSULFATE

Generic Brand HICL GCN Exception/Other PENTOSAN ELMIRON POLYSULFATE SODIUM

INITIAL CRITERIA:

ALL of the following criteria must be met: • The requesting provider is a CPMG Urologist or Uro-gynecologist or an affiliated network Urologist/Uro-Gynecologist with active referral, if needed AND • The patient has a diagnosis of ICS/BPS AND • Patient has had an eye exam with an Ophthalmologist within the past 365 days AND • For patient is < 65 years old: they have had trial, intolerance or failure of a TCA, hydroxyzine, or cimetidine

If initial criteria above are met, approve x 6 months with max daily dose of 1 capsule (100 mg)/day

RENEWAL CRITERIA ALL of the following criteria must be met: 1. The requesting provider is a CPMG Urologist/Uro-gynecologist or an affiliated network Urologist/Uro-gynecologist with active referral, if needed AND 2. Patient has had an eye exam with an Ophthalmologist within the past 365 days AND 3. The patient is having improvement* of condition with pentosan

If renewal criteria above are met, approve x12 months with max daily dose of 1 capsule (100 mg)/day

For Quantity Limit overrides- For all requests of pentosan doses > 100 mg/day • The patient has tried pentosan 100 mg/day with some benefit*

* Benefit/improvement of condition with pentosan: 1) Decrease in pain, urgency and freqeuncy

Creation date: 7/1/2020 Effective date: 9/1/2020 Reviewed date: Revised date:

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES ANTIDEPRESSANTS: TRINTELLIX AND VIIBRYD

Generic Brand HICL GCN Exception/Other VORTIOXETINE TRINTELLIX 40637 35346, 35347, 35349 VILAZODONE VIIBRYD 37597 29916, 29917, 29918, 38253

GUIDELINES FOR USE INITIAL CRITERIA

1. Does the patient have a diagnosis of major depressive disorder (MDD)? a. If yes, continue to #2 b. If no, do NOT approve

2. Is the patient new to KP and stable on vortioxetine or vilazodone? a. If yes, approve X 5 years, max daily dose of 1 unit per day b. If no, continue to step # 3

3. Has the patient tried and failed treatment with at least 4 SSRIs/SNRIs, with at least one SSRI (fluoxetine, citalopram, escitalopram, sertraline, paroxetine) and at least one SNRI (venlafaxine or duloxetine)? a. If yes, continue to #4 b. If no, do NOT approve

4. Has the patient tried and failed treatment with at least 1 atypical antidepressant (bupropion OR nefazodone or mirtazapine)? a. If yes, approve X 5 years, max daily dose of 1 unit per day b. If no, do NOT approve

RENEWAL CRITERIA 1. Patient is stable on therapy a. If renewal criteria above are met, approve x 5 years, max daily dose of 1 unit per day

Creation date: 7/1/2020 Effective date: 8/18/2020 Reviewed date: Revised date:

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES TEDUGLUTIDE (GATTEX)

Generic Brand HICL GCN Exception/Other TEDUGLUTIDE GATTEX 39890 33927

GUIDELINES FOR USE INITIAL CRITERIA 1. Is the requesting provider a CPMG gastroenterologist or an affiliated network gastroenterologist with appropriate referral, if needed?

If yes, continue to #2. If no, do not approve.

2. Is the patient ≥ 1 year old with documented short bowel syndrome (SBS)?

If yes, continue to #3. If no, do not approve.

3. Has the patient been dependent on parenteral nutrition (PN) for ≥ 12 months?

If yes, continue to #4. If no, do not approve.

4. Does the patient have a colon?

If yes, continue to #5. If no, continue to #6.

5. a) If an adult patient - has the patient had a colonoscopy in the past 6 months? b) If a pediatric patient - has fecal occult blood testing been performed in the past 6 months, with a follow up colonoscopy/sigmoidoscopy if unexplained blood was found?

If yes, continue to #6. If no, do not approve.

6. Does the patient have an intolerance or contraindication to, or failure (after adequate trial of at least 4 weeks) to all the following: Proton pump inhibitor, loperamide (up to 16mg/day), codeine sulfate (up to 60mg TID) and octreotide 100mcg TID?

If yes, approve x 6 months, max 30 vials per 30 days. If no, do not approve.

RENEWAL CRITERIA 1. Is patient still under the care of a CPMG or an affiliated Gastroenterologist?

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES If yes, continue to #2. If no, do not approve.

2. Is there documentation demonstrating a decreased need for parenteral support compared to baseline?

If yes, continue to #3. If no, do not approve.

3. Does the patient have a colon?

If yes, continue to #4. If no, approve x 1 year, max 30 vials per 30 days.

4. a) If adult patient - is the patient up to date with screening colonoscopies (due after 1 year of treatment with teduglutide, then every 5 years, or more frequently per current guidelines if polyps found)? b) If a pediatric patient - have annual fecal occult blood tests been performed in years colonoscopy has not been performed?

If yes, approve x 1 year, max 30 vials per 30 days. If no, do not approve

Creation date: 7/25/2019 Effective date: 8/31/2020 Reviewed date: 7/1/2020 Revised date: 7/1/2020

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES NOVEL ACUTE ACTING MIGRAINE AGENTS MD

Generic Brand HICL GCN Exception/Other RIMEGEPANT NURTEC ODT 46383 47762 NONFORM - SPECIALTY TIER LASMIDITAN REYVOW 46082 47084 NONFORM UBROGEPANT UBRELVY 46273 47477, NONFORM - 47478 SPECIALTY TIER

GUIDELINES FOR INITIAL USE

Must meet all of the following criteria: • Patient must be age 18 or older • Must be prescribed by a Neurologist, Pain Specialist, or Headache Specialist • Prescribed for the acute treatment of migraine

AND must meet the diagnosis/drug specific criteria below-

Acute Migraine Treatment Must meet all the following: • Diagnosis of migraine with or without aura, with at least 4 migraine days/month, AND • Documentation of an adequate triala to a total of THREE triptans and/or ergotaminesb of any formulation that resulted in treatment failure or intolerance OR patient has a true contraindicationc to the triptan class, AND • Is currently treated with a migraine preventive medicationd unless contraindications, intolerances and/or failures exist, AND • Has met specific medication criteria below

Ubrogepant (Ubrelvy) Must meet all the following: • No concomitant strong CYP3A4 inhibitors or strong CYP3A4 inducers, AND • If dose requested is 50 mg at the onset of migraine, patient to utilize half-tablet of 100 mg strength

Rimegepant (Nurtec ODT) Must meet all the following: • Patient has tried and failed (treatment failure or intolerance) an adequate triala of ubrogepant OR • Patient has significant nausea and/or vomiting with migraine attacks that require an orally disintegrating tablet (ODT) option AND the patient has tried and failed at least one ODT or non-oral triptan unless a contraindication to the triptan class exists

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES AND • No concomitant… o Strong CYP3A4 inhibitors o Strong or moderate CYP3A inducers o Inhibitors of P-glycoprotein (P-gp) o Inhibitors of breast cancer resistant protein (BCRP)

Lasmiditan (Reyvow) Must meet all the following: • Patient has tried and failed (treatment failure or intolerance) an adequate triala of ubrogepant OR has a contraindication to ubrogepant. • No concomitant P-gp or BCRP substrates

If all of the above are met then approve x12 months NOTE: if Ubrogepant, and dose is 50mg approve the 100mg at ½ tab. Benefit to the member is they receive double the doses per copay.

RENEWAL CRITERIA

Must meet all the following criteria: • Documentation of positive clinical response to therapy

If all of the above are met, then approve x 2 years

a Adequate acute migraine treatment trial = at least a one-month trial b Available triptan/ergotamine options: see table in attachment c True contraindications to triptan class • Ischemic coronary artery disease including angina pectoris, history of myocardial infarction, documented silent ischemia, coronary artery vasospasm (including Prinzmetal’s angina) • History of stroke or transient ischemic attack • Peripheral vascular disease • Ischemic bowel disease • Uncontrolled hypertension • Hemiplegic or basilar migraine • Wolff-Parkinson-White syndrome d Preventive medications for migraine include but are not limited to: see table in attachment

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES Creation date: 9/23/2020 Effective date: 10/20/2020 Reviewed date: Revised date:

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES OVERACTIVE BLADDER ANTICHOLINGERIC MEDICATIONS

Generic Brand HICL GCN Exception/Other TROSPIUM ER SANCTURA XR 17498 99193 Max daily dose 1/day TOLTERODINE ER DETROL LA 18047 12263, Max daily dose 1/day 12264 TOLTERODINE IR DETROL 26595 37061, 37062 FESOTERODINE TOVIAZ 35606 99711, Max daily dose 1/day 99712 DARIFENACIN ENABLEX 26820 24043, Max daily dose 1/day 24044

GUIDELINES FOR USE INITIAL CRITERIA

ALL the following must be met: • Patient has a diagnosis of overactive bladder, urge incontinence, urgency, urinary frequency or bladder spasm • Patient has a history of trial and failure, inadequate response, or intolerance/contraindication to both solifenacin and trospium IR

AND must meet the diagnosis/drug specific criteria below:

1. Patient with a history of cognitive issues (dementia, memory impairment, delirium)

AND based on requested drug: Darifenacin ER – approve x 12 months (max daily dose #1) Trospium ER: o Patient has history of trial and failure, inadequate response, or intolerance/contraindication to darifenacin ER, then approve x 12 months (max daily dose #1). Fesoterodine: o Patient has history of trial and failure, inadequate response, or intolerance/contraindication to darifenacin ER and trospium ER, then approve x 12 months (max daily dose #1). Tolterodine IR or ER: o Patient has history of trial and failure, inadequate response, or intolerance/contraindication to darifenacin ER, trospium ER and fesoterodine then approve x 12 months (tolterodine ER: max daily dose #1)

2. Patient WITHOUT a history of cognitive issues (dementia, memory impairment, delirium)

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES • Patient has a history of trial and failure, inadequate response, or intolerance/contraindication to oxybutynin tablet/syrup

AND based on requested drug: Tolterodine IR – approve x 12 months Darifenacin ER: o Patient has history of trial and failure, inadequate response, or intolerance/contraindication to tolterodine IR, then approve x 12 months (max daily dose #1) Tolterodine ER: o Patient has history of trial and failure, inadequate response, or intolerance/contraindication to tolterodine IR and darifenacin ER, then approve x 12 months (max daily dose #1) Trospium ER: o Patient has history of trial and failure, inadequate response, or intolerance/contraindication to tolterodine IR, darifenacin ER and tolterodine ER then approve x 12 months (max daily dose #1) Fesoterodine: o Patient has history of trial and failure, inadequate response, or intolerance/contraindication to tolterodine IR, darifenacin ER, tolterodine ER and trospium ER then approve x 12 months (max daily dose #1)

RENEWAL CRITERIA

Must meet all the following criteria: • The medication has been safe and effective in treating the member’s medical condition since starting therapy.

If all of the above are met then approve x 12 months (max daily dose of 1 tablet per day for darifenacin ER, tolterodine ER, trospium ER and fesoterodine)

Creation date: 1/15/2019 Effective date: 10/20/2019 Reviewed date: 9/1/2020 Revised date:

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES MIRABEGRON (MYRBETRIQ)

Generic Brand HICL GCN Exception/Other MIRABEGRON MYRBETRIQ 39357 32766, Max daily dose 1/day 32767

GUIDELINES FOR INITIAL USE

All of the following must be met: • Patient has diagnosis of overactive bladder, urge incontinence, urgency, urinary frequency or bladder spasm

AND must meet the diagnosis/drug specific criteria below:

1. Patient has a diagnosis of myasthenia gravis OR

2. Patients WITHOUT a diagnosis of myasthenia gravis AND

Must meet ALL of the following: • Patient has a history of trial and failure, inadequate response, or intolerance/contraindication to all of the following: solifenacin, trospium IR and darifenacin in patients with a history of cognitive issues OR oxybutynin IR/ER, solifenacin, trospium IR and tolterodine IR/ER in patients without cognitive issues.

If all of the above are met then approve x 12 months (max daily dose of 1 tablet per day)

RENEWAL CRITERIA

Must meet all the following criteria: • The medication has been safe and effective in treating the member’s medical condition since starting therapy.

If all of the above are met then approve x 12 months (max daily dose of 1 tablet per day)

Creation date: 9/26/2019 Effective date: 10/23/2019 Reviewed date: Revised date:

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES ALLERGY DERM BIOLOGICS

Generic Brand HICL GCN Exception/Other DUPILUMAB DUPIXENT 44180 43222, Formulary 45522 BENRALIZUMAB FASENRA 44635 Formulary

GUIDELINES FOR INITIAL USE

Must meet all of the following criteria:

• Must be prescribed by a CPMG or an affiliated dermatologist, allergist, or pulmonologist with an active referral if necessary

AND must meet the diagnosis/drug specific criteria below-

CHRONIC RHINOSINUSITIS WITH NASAL POLYPOSIS (CRSwNP): (Dupilumab)

Patient must meet all the following: • Be 18 years of age or older • Diagnosis of CRSwNP with all the following: o Persistent rhinosinusitis symptoms (lasting longer than 12 weeks) with severe nasal obstruction and rhinorrhea or reduce sense of smell o Bilateral nasal polyps and/or failure of normalization of mucosa after sinus surgery and despite medical management (e.g. nasal saline irrigation, intranasal corticosteroids [e.g. fluticasone, mometasone, etc.], antileukotriene antagonists [e.g. montelukast, zafirlukast, zileuton]) o Received two or more courses of oral corticosteroids in the past year AND received a full endoscopic sinus surgery

If above criteria are met, then approve x12 months

ASTHMA (MODERATE/SEVERE): (Dupliumab or Benralizumab)

Patient must meet all the following:

For patients converting from mepolizumab (Nucala) to benralizumab (Fasenra): • Mepolizumab must previously have been ordered and administered by CPMG or affiliated Asthma / Allergy specialist and benralizumab (Fasenra) is ordered by CPMG or affiliated Asthma / Allergy specialist to be dispensed by KP outpatient pharmacy -OR- • Patient already started benralizumab (Fasenra) as a clinic-administered medication by CPMG or affiliated Asthma / Allergy specialist

New start criteria: • 12 years of age or older

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES • Not being used for treatment of eosinophilic granulomatosis with polyangiitis (EGPA) • Diagnosis of asthma as documented by ANY one of the following: o Response to inhaled short-acting beta-agonists (e.g., forced expiratory volume in one second [FEV1] reversibility of >12% with at least a 200 mL increase in FEV1) within 30 minutes after administration of albuterol (90-180 mcg) OR o Positive exercise or methacholine challenge OR o Positive response (at least a 15% increase in FEV1 with at least a 200 mL increase in FEV1) after a course of treatment with inhaled or systemic corticosteroids • Moderate-to-severe persistent asthma as evidenced by spirometry (FEV1 ≤80% of predicted and FEV1/forced vital capacity [FVC] reduced by 5% or greater from age appropriate values) • Uncontrolled asthma as evidenced by ANY of the following: o Two or more asthma exacerbations requiring systemic corticosteroids (≥3 days each) in the past 12 months OR o one asthma-related hospitalization in the past 12 months OR o Asthma Control Test (ACT) consistently <20 • Adherent (>75% proportion of days covered) to optimized drug therapy (triple drug therapy with high-dose ICS (Table 1) plus LABA combination plus tiotropium (Spiriva Respimat) OR has contraindications or intolerance to above in the previous 6 months • The following have been ruled out or managed as much as practical: o Comorbid factors (e.g., allergy, sinusitis, GERD, anxiety disorder, panic disorder, vocal cord dysfunction) o Triggers (e.g., animal dander if allergic, dust mites, foods, pollen, tobacco use, smoke exposure)

See table attached for recommended action based on oral corticosteroid use, serum eosinophils and presence of concurrent nasal polyposis

If above criteria are met, then approve x6 months

ATOPIC DERMATITIS (MODERATE/SEVERE): (Dupilumab)

Patient must meet all the following:

Members coming into Kaiser Permanente Colorado on dupilumab • 6 years of age or older • Diagnosis of moderate to severe atopic dermatitis • Patient has been stable and improving on dupilumab for at least 3 months (or if less than 3 months, then seen by dermatology or allergy and deemed to have symptom improvement)

New start criteria: {requires loading dose} • 6 years of age or older • Diagnosis of moderate to severe atopic dermatitis

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES • History of failure, contraindication, or intolerance to the below topical therapies: See table 2 for relative potencies of topical corticosteroids. O High to very-high potency topical corticosteroid (not applicable for face, eyelids, skin folds, underarms, groin area) -OR- o Low to moderate potency topical steroid and topical calcineurin inhibitor (pimecrolimus, tacrolimus) for symptoms affecting only the following areas: face, eyelids, skin folds, underarms, groin area

• History of inadequate response (after at least 2 months of treatment), intolerance, or relative contraindication* to the following (*See table 3 for relative contraindications)

o For patients age 6-17 years: to at least 1 of the below oral systemic therapies:

o For adult patients age 18 and older: to at least 2 of the below therapies:

 Azathioprine (oral)  Cyclosporine (oral)  Methotrexate (oral)  Mycophenolate (oral)  Phototherapy/narrow-band short wave ultraviolet B (NB-UVB) light) **See table 4 in attachment for Kaiser Permanente Colorado (KPCO) Criteria for Home Phototherapy and contracted provider information

If all of the above are met, then approve x 6 months

RENEWAL CRITERIA

Must meet all the following criteria:

• Adherence to dupilumab (Dupixent) or benralizumab (Fasenra) therapy • Significant improvement of treated condition:

CRSwNP: • Improvements in the size of nasal polyps, symptoms (congestion, smell), use of corticosteroids

Asthma: • Improvements in use of rescue inhalers, frequency of exacerbations (~50% reduction), lung function (improvement in FEV1 from baseline), improvement in asthma control test (ACT), decreased dose of oral corticosteroids (~50% reduction)

Atopic Dermatitis:

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES • Documented > 50% improvement of symptoms per physician global assessment (PGA) of body surface area involved, or pruritus, or severity (ie: redness, excoriations, and lichenification of individual lesions)

If all the above are met, then approve x12 months

Quantity Limits for Dupilumab 200mg and 300mg syringes: Coded within PBM is a limit of 2 syringes/pens per 30 days Loading doses for dermatitis and asthma new starts is 4 syringes/pens per 30 days NEED TO ADD INTO APPROVAL

Creation date: 6/16/2020 Effective date: 6/16/2020 Reviewed date: Revised date:

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES IMMUNE GLOBULIN (HUMAN)/HYALURONIDASE SUBCUTANEOUS

Generic Brand HICL GCN Exception/Other IMMUNE GLOBULIN HYQVIA 41391 (HUMAN)/HYALURONIDASE SUBCUTANEOUS IMMUNE GLOBULIN HIZENTRA

NOTE: HIZENTRA IS A HOME IV PRODUCT - NO NEED TO REVIEW

GUIDELINES FOR USE OF HYQVIA

Must meet ALL the following: • Must not be administered in a medical office or infusion center • Must be self-administered within a home setting • Patient must have tried and failed or was intolerant to or have a contraindication to Hizentra

If the above are met then approve x 1 year

Creation date: 11/16/2016 Effective date: 1/1/2017 Reviewed date: 9/1/2020 Revised date: 11/1/2016

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES XIIDRA (LIFITEGRAST)

Generic Brand HICL GCN Exception/Other LIFITEGRAST XIIDRA 43610

GUIDELINES FOR USE INITIAL CRITERIA for approval

Must meet all of the following: • Prescribed by an optometrist or ophthalmologist • Patient has a diagnosis of dry eye disease (DED) • Patient has tried and failed over-the-counter (OTC) artificial tears • Patient has tried and failed at least 3 consecutive months of therapy with 0.09% cyclosporin ophthalmic drops (Cequa), if did not tolerate Cequa then must try and fail at least 3 consecutive months of therapy with 0.05% cyclosporin ophthalmic drops (if did not tolerate either strength of cyclosporin ophthalmic drops then skip this requirement)

If ALL of the above are met then approve x 6 months, maximum one box of 60 vials per 30 days

RENEWAL CRITERIA

Approve if the following is met:

• patient has been compliant with therapy for the past 6 months

If above is met then approve x 6 months, maximum one box of 60 vials per 30 days

Creation date: 9/26/2018 Effective date: 10/4/2020 Reviewed date: 9/1/2020 Revised date: 9/1/2020

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES MILNACIPRAN

Generic Brand HICL GCN Exception/Other MILNACIPRAN SAVELLA 21229

GUIDELINES FOR INITIAL USE

Must meet all of the following criteria: • Patient must be age 18 or older • Patient has a diagnosis of fibromyalgia

AND must meet the diagnosis/drug specific criteria below-

Must meet all the following: • Patient has tried and failed, have an intolerance to or a contraindication to the following: o At least one TCA or cyclobenzaprine (IF < 65 years of age) AND o At least one SSRI and SNRI AND o At least gabapentin or pregabalin

If all of the above are met, then approve x 12 months

RENEWAL CRITERIA

Must meet all the following criteria: • Patient has shown improvement of symptoms since starting on the drug

If all of the above are met, then approve x12 months

Creation date: 9/26/2018 Effective date: 10/20/2019 Reviewed date: 9/1/2020 Revised date: 9/1/2020

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES CAROSPIR

Generic Brand HICL GCN Exception/Other SPIRONOLACTONE CAROSPIR 02901 15596 ORAL SOLUTION

GUIDELINES FOR INITIAL AND RENEWAL USE

Must meet ANY of the following criteria: • Patient is ≤ 12 years of age • Patient has gastrostomy tube • Dose cannot be obtained by using halved, whole or combinations of the 25-, 50-, or 100-mg tablets • Patient cannot swallow whole tablets and cannot swallow crushed tablets (with or without mixing in apple sauce)

If ANY of the above are met then approve x12 months

Creation date: 9/26/2018 Effective date: 10/20/2019 Reviewed date: 9/1/2020 Revised date: 9/1/2020

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES XPOVIO

Generic Brand HICL GCN Exception/Other SELINEXOR XPOVIO 45854 Non-formulary

GUIDELINES FOR INITIAL USE

Must meet all of the following criteria: • Patient must be age 18 or older • Must be prescribed by a Hematologist/Oncologist • Must have a diagnosis of multiple myeloma or diffuse large B cell lymphoma

AND must meet the diagnosis/drug specific criteria below-

Multiple Myeloma Must meet all the following: • Patient must have been treated with at least 4 prior therapies and whose disease is refractory to at least two proteasome inhibitors (bortezomib, carfilzomib, ixazomib), at least two immunomodulatory agents (thalidomide, lenalidomide, pomalidomide) and one anti-CD38 monoclonal antibody (daratumumab, isatuximab-irfc)

If all of the above are met for Multiple Myeloma then approve x 3 months

Diffuse Large B-cell Lymphoma Must meet all the following: • Patient must have been treated with at least 2 prior lines of systemic therapy

If all of the above are met for Diffuse Large B Cell Lymphoma then approve x 3 months

RENEWAL CRITERIA

Multiple Myeloma Must meet all the following: • Patient’s disease has not progressed since initiation of medication OR treating provider believes patient is deriving significant clinical benefit to justify treatment continuation

If above criteria are met, then approve x 3 months If criteria are not met, then do not approve

Diffuse Large B-cell Lymphoma Must meet all the following: • Patient’s disease has not progressed since initiation of medication OR treating provider believes patient is deriving significant clinical benefit to justify treatment continuation

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES If above criteria are met, then approve x 3 months If criteria are not met, then do not approve

Creation date: 9/23/2020 Effective date: 10/4/2020 Reviewed date: Revised date:

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES MIGRANAL NASAL SPRAY

Generic Brand HICL GCN Exception/Other DIHYDROERGOTAMINE MIGRANAL 24732 Nasal Spray Formulary Specialty tier

GUIDELINES FOR USE INITIAL CRITERIA (NOTE: FOR RENEWAL CRITERIA SEE BELOW)

A) For all requests for acute non-preferred migraine medications all of the following criteria must be met: 1) The patient has a diagnosis of migraine headache with and without aura or cluster headaches AND 2) Female patients cannot have any of the following conditions: currently pregnant, currently breast-feeding, or of child-bearing age (12 – 50 yrs) without a form of contraception AND 3) The patient does not have the following: a contraindication/serious precaution* to DHE nasal spray OR a known hypersensitivity to DHE or other ergot alkaloids or to any of the excipients of DHE nasal spray AND criteria below specific to the diagnosis and clinical situation:

B) For abortive treatment of migraine headaches with or without aura: the patient must meet the following criteria: 1. For typical patients: The patient has a history of failure or intolerance to two oral 5-HT1 receptor agonists in which at least one triptan was trialed along with an NSAID (naproxen Rx/OTC, Ibuprofen Rx/OTC, or celecoxib) AND to triptan nasal spray AND sumatriptan injection OR 2. For patients with prolonged migraines or migraines that recur: the patient is unresponsive or intolerant to an NSAID (naproxen Rx/OTC, Ibuprofen Rx/OTC, or celecoxib) plus oral triptans AND long-acting triptan (naratriptan, frovatriptan) OR 3. For patients with migraines associated with severe nausea/vomiting: the patient has been unresponsive or intolerant to at least one triptan nasal spray AND sumatriptan injection.

If initial criteria A and B above are met, approve x 6 months

C) For abortive treatment of cluster headaches: the patient must meet ALL of the following criteria: 1. The patient is unresponsive or intolerant to high flow oxygen (100%) via non- rebreather mask AND 2. The patient is unresponsive or intolerant to at least 2 triptan nasal sprays AND 3. The patient is unresponsive or intolerant to injectable sumatriptan

If initial criteria A and C above are met, approve x 6 months

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES

RENEWAL CRITERIA ALL the following criteria must be met: 1. The patient has a diagnosis of migraine headache with or without aura or cluster headaches AND 2. The patient does not have a new contraindication/serious precaution* to DHE nasal spray (since the initial review) AND 3. The patient is not experiencing any severe adverse drug reactions

If renewal criteria above are met, approve x 1year

* Contraindications & Serious Precautions to DHE nasal spray: 1) with hemiplegic migraine 2) with migraine with brainstem aura (previously known as basilar artery migraine, basilar migraine and basilar-type migraines) 3) with ischemic heart disease (angina pectoris, history of myocardial infarction, or documented silent ischemia) or to patients who have clinical symptoms or findings consistent with coronary artery vasospasm including Prinzmetal’s variant angina. 4) with uncontrolled hypertension 5) with concurrent prescriptions for both Dihydroergotamine Mesylate Nasal Spray and either 5-HT1 agonists (e.g., sumatriptan), ergotamine-containing or ergot-type medications or methysergide should not be used within 24 hours of each other. 6) with concomitant potent CYP 3A4 inhibitors, such as protease inhibitors and macrolide antibiotics, resulting in vasospasm that led to cerebral ischemia and/or ischemia of the extremities. Examples include ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin, troleandomycin, ketoconazole, and itraconazole. 7) with concomittant peripheral and central vasoconstrictors (i.e., alpha-adrenergic agonists, vasopressin analogues) 8) with known peripheral arterial disease, sepsis, and following vascular surgery 9) with severely impaired hepatic or renal function

Creation date: 5/1/2020 Effective date: 10/20/2020 Reviewed date: Revised date:

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES JATENZO

Generic Brand HICL GCN Exception/Other TESTOSTERONE JATENZO 07304 46152, NON-formulary UNDECANOATE 46153, 46154

GUIDELINES FOR INITIAL USE

Must meet ALL the following criteria: 1. Patient must be age 18 or older 2. Must be prescribed by an Endocrinology specialist OR in consultation with an Endocrinologist 3. A diagnosis of primary hypogonadism or hypogonadotropic hypogonadism with supporting documentation demonstrating morning serum testosterone concentrations below normal range 4. Patient has persistent signs and symptoms (e.g., depressed mood, decreased energy, progressive decrease in muscle mass, osteoporosis, loss of libido) of androgen deficiency prior to treatment 5. Patient does NOT have carcinomas of the breast or prostate 6. Patients' blood pressure is adequately controlled (<140/90) AND 7. Documentation of inadequate response (<400ng/dL total testosterone while adherent to appropriately dosed therapy), intolerance, or contraindication to ALL the following alternative generic testosterone formulations: a. Testosterone cypionate (or enanthate) intramuscular injection* b. Testosterone topical gels - 1% and 1.62% c. Testosterone transdermal solution (e.g., testosterone 30mg/actuation solution) d. Testosterone transdermal patch (e.g., Androderm)

* Documentation of a member having a needle phobia does not qualify as a medically acceptable contraindication or clinical inappropriateness to injectable products.

If ALL the above initial criteria, 1-7, are met then approve x2 years at HICL with max daily dose of 2 capsules/day

RENEWAL CRITERIA

Must meet all the following criteria: 1. Patients' blood pressure is adequately controlled (<140/90) 2. Patient does NOT have carcinomas of the breast or prostate 3. Patient has shown an adequate response to therapy as demonstrated by testosterone levels of >400-600 ng/dL total testosterone, within the most recent year

If ALL the above renewal criteria, 1-3, are met then approve x2 years at HICL, with max daily dose of 2 capsules/day

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES

Creation date: 11/18/2020 Effective date: 12/5/2020 Reviewed date: Revised date:

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES STIRIPENTOL (DIACOMIT)

Generic Brand HICL GCN Exception/Other STIRIPENTOL DIACOMIT 35461 NON-formulary with quantity limit

GUIDELINES FOR USE INITIAL CRITERIA

All the following must be met:

1. patient is 2 years of age or older 2. medication is prescribed by or in consultation with a neurologist 3. medication must be used with both clobazam and valproate, unless patient has a contraindication to valproate then must be used with clobazam. Note: There are no clinical data to support the use of Diacomit as monotherapy in Dravet syndrome 4. a diagnosis of Dravet Syndrome (DS) 5. either has a contraindication to or has previously tried and failed, as evidenced by continuing to have 4 or more generalized tonic - clonic seizures per month despite optimized therapy with all of the following: i. valproate ii. clobazam AND at least 2 of the following a. topiramate b. cannabidiol (requires prior authorization) plus clobazam c. levetiracetam OR fenfluramine (Nonformulary) 6. If female, patient is not pregnant or planning to become pregnant

If above initial criteria, 1 through 6 are met, then approve at HICL x 6 months with a max daily dose of 6 capsules/packets per day. Note: if using 250mg and exceeding 6/day then must use 500mg strength or a combination of both strengths, not to exceed 3000mg per day. If criteria are not met, then do not approve

RENEWAL CRITERIA All the following must be met:

1. patient has not experienced weekly seizures while taking stiripentol 2. is used in combination with clobazam and valproate (unless contraindication) 3. patient has maintained adherence to the medication since last approval 4. female patients are NOT pregnant or planning to become pregnant

If above renewal criteria, 1 through 4, are met, then approve at HICL x 1 year with a max daily dose of 6 capsules/packets per day.

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES Note: if using 250mg and exceeding 6/day then must use 500mg strength or a combination of both strengths, not to exceed 3000mg per day If criteria are not met, then do not approve

Creation date: 11/18/2020 Effective date: 12/5/2020 Reviewed date: Revised date:

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES MIFEPRISTONE

Generic Brand HICL GCN Exception/Other MIFEPRISTONE KORLYM 31485

GUIDELINES FOR USE Initial use and continued criteria

A) All the following must be met:

1. Patient has diagnosis of endogenous Cushing's syndrome 2. If patient is of child bearing age, has a negative pregnancy test at least one month prior to therapy 3. Patient has tried and failed or has a contraindication to ketoconazole 4. Patient has tried and failed, is not a candidate for, or is awaiting surgical/radiologic interventions

If above initial criteria, A1 through A4, are met approve x indefinitely, at GCN/GPID level with a max daily dose of 4 tablets per day

Creation date: 11/16/2016 Effective date: 12/5/2020 Reviewed date: 11/1/2019 Revised date: 11/1/2017

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES KETOCONAZOLE (ORAL)

Generic Brand HICL GCN Exception/Other KETOCONAZOLE NIZORAL 42590

GUIDELINES FOR USE Initial criteria and continued use

A) All the following must be met: 1. Medication is NOT being used to treat a skin and/or nail fungal infection 2. Medication is being used to treat a systemic fungal infection or Cushing's disease 3. Medication is being prescribed by an infectious disease, oncology, or endocrinology specialist

If above initial criteria, A1-3, are met, then approve indefinitely

Creation date: 7/27/2016 Effective date: 12/5/2020 Reviewed date: 11/1/2020 Revised date: 11/1/2020

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES SOMATROPIN

Generic Brand HICL GCN Exception/Other SOMATROPIN GENOTROPIN 02824 Omnitrope Formulary HUMATROPE All others are NON- NORDITROPIN formulary NUTROPIN OMNITROPE (FORMULARY) SAIZEN SEROSTIM ZOMACTON ZORBTIVE

GUIDELINES FOR INITIAL USE

Review based on diagnosis/indication specifically outlined below in A through H: A - HIV/AIDS-wasting syndrome/Cachexia B - Short Bowel Syndrome C - Pediatric (<18yrs) and Growth Hormone Deficiency, Turner Syndrome, growth failure due to renal disease - Use for New Members currently using growth hormone D - Prader Willi Syndrome - Use for New Members currently using growth hormone E - Pediatric (<18yrs) and small for gestational age (sga) - Use for New Members currently using growth hormone F - Adults (>18yrs) and Growth Hormone Deficiency either alone or with multiple hormone deficiencies (hypopituitarism) - Use for New Members currently using growth hormone G - Infertility (females) - Use for New Members currently using growth hormone H - All other indications Renewal criteria is below H

A) To treat HIV/AIDS-wasting syndrome/cachexia: New members currently using Serostim see Renewal criteria below Must meet all of the following criteria: 1. Patient has a diagnosis of HIV/AIDS 2. Requested medication is Serostim (only medication with literature support) 3. medication is prescribed by or consultation with, nutrition support specialists, infectious disease specialists, or gastroenterology specialists 4. patient is on anti-retroviral therapy for HIV/AIDs 5. patient meets one of the following criteria: I. 10% unintentional weight loss over 12 months II. 7.5% unintentional weight loss over 6 months III. 5% body cell mass (BCM) loss within 6 months IV. In men: BCM < 35% of total body weight and body mass index (BMI) < 27kg/m2

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES V. In women: BCM < 23% of total body weight and BMI < 27kg/m2 VI. BMI < 20kg/m2 6. Patient has had an inadequate response or contraindication to the following cyproheptadine, dronabinol, testosterone, and megestrol acetate If meets above initial criteria, A1-6, approve Serostim at GPID level x 3 months with max daily dose of 1 vial per day (63405-4mg, 25955-5mg, 25960-6mg)

B) To treat Short Bowel Syndrome: (Therapy is only 4 weeks per lifetime) Must meet all the following: 1. Patient has a diagnosis of Short Bowel Syndrome 2. Requested medication is Zorbtive (only medication with literature support) 3. Medication is prescribed by or in consultation with nutritional support specialists or gastroenterology specialists 4. Patient is currently on specialized nutritional support, such as a high carbohydrate, low-fat diet

If meets above initial criteria, B1-4, approve Zorbtive at GPID level x 4 weeks with max daily dose of 1 vial per day (12767) and a maximum duration of 4 weeks in a lifetime.

C) For Pediatric patients, age <18 years old diagnosed with growth hormone deficiency, Turner Syndrome, or growth failure with pediatric chronic renal insufficiency (CRI)/chronic kidney disease (CKD) prior to renal transplant Must meet all the following: 1. Medication is prescribed by, or in consultation with, an Endocrinologist or for CRI/CKD a Nephrologist 2. At least one of the following is true: I. Patients height is greater than or equal to 2 standard deviations (SD) below the mean height for normal children of the same age and gender II. Height velocity is less than the 25th percentile for age III. Documented low peak growth hormone (less than 10ng/mL) on two GH stimulation tests or insulin-like growth factor 1 (IGF-1) greater than or equal to 2 SD below the mean for age and gender

AND must meet criteria based on requested drug: a. Omnitrope cartridges If meets above initial criteria, C1-2 and a, approve at GPID level x 12 months b. Genotropin Patient has tried and failed, has an intolerance or a contraindication to Omnitrope cartridges If meets above initial criteria, C1-2 and b, approve at GPID level x 12 months c. Omnitrope vials Patient has tried and failed, has an intolerance or a contraindication to Omnitrope cartridges and Genotropin If meets above initial criteria, C1-2 and c, approve at GPID level x 12 months d. Saizen

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES Patient has tried and failed, has an intolerance or a contraindication to Omnitrope cartridges, Genotropin and Omnitrope vials If meets above initial criteria, C1-2 and d, approve at GPID level x 12 months e. Nutropin Patient has tried and failed, has an intolerance or a contraindication to Omnitrope cartridges, Genotropin, Omnitrope vials and Saizen If meets above initial criteria, C1-2 and e, approve at GPID level x 12 months f. Humatrope Patient has tried and failed, has an intolerance or a contraindication to Omnitrope cartridges, Genotropin, Omnitrope vials, Saizen and Nutropin If meets above initial criteria, C1-2 and f, approve at GPID level x 12 months g. Norditropin Patient has tried and failed, has an intolerance or a contraindication to Omnitrope cartridges, Genotropin, Omnitrope vials, Saizen, Nutropin and Humatrope If meets above initial criteria, C1-2 and g, approve at GPID level x 12 months h. Zomacton Patient has tried and failed, has an intolerance or a contraindication to Omnitrope cartridges, Genotropin, Omnitrope vials, Saizen, Nutropin, Humatrope and Norditropin If meets above initial criteria, C1-2 and h, approve at GPID level x 12 months

D) To treat Prader Willi Syndrome Must meet all the following: 1. Medication is prescribed by, or in consultation with, an Endocrinologist 2. Patient has a diagnosis of Prader Willi Syndrome

AND must meet criteria based on requested drug: a. Omnitrope cartridges If meets above initial criteria, D1-2 and a, approve at GPID level indefinitely b. Genotropin Patient has tried and failed, has an intolerance or a contraindication to Omnitrope cartridges If meets above initial criteria, D1-2 and b, approve at GPID level indefinitely c. Omnitrope vials Patient has tried and failed, has an intolerance or a contraindication to Omnitrope cartridges and Genotropin If meets above initial criteria, D1-2 and c, approve at GPID level indefinitely d. Saizen Patient has tried and failed, has an intolerance or a contraindication to Omnitrope cartridges, Genotropin and Omnitrope vials If meets above initial criteria, D1-2 and d, approve at GPID level indefinitely e. Nutropin Patient has tried and failed, has an intolerance or a contraindication to Omnitrope cartridges, Genotropin, Omnitrope vials and Saizen If meets above initial criteria, D1-2 and e, approve at GPID level indefinitely f. Humatrope

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES Patient has tried and failed, has an intolerance or a contraindication to Omnitrope cartridges, Genotropin, Omnitrope vials, Saizen and Nutropin If meets above initial criteria, D1-2 and f, approve at GPID level indefinitely g. Norditropin Patient has tried and failed, has an intolerance or a contraindication to Omnitrope cartridges, Genotropin, Omnitrope vials, Saizen, Nutropin and Humatrope If meets above initial criteria, D1-2 and g, approve at GPID level indefinitely h. Zomacton Patient has tried and failed, has an intolerance or a contraindication to Omnitrope cartridges, Genotropin, Omnitrope vials, Saizen, Nutropin, Humatrope and Norditropin If meets above initial criteria, D1-2 and h, approve at GPID level indefinitely

E) For Pediatric patients, age <18 years old with 'small gestational age' (sga) Must meet all the following: 1. Medication is prescribed by, or in consultation with, an Endocrinologist 2. Patient with no 'catch-up growth' by 2 years of age 3. Patients height greater than or equal to 2 standard deviations (SD) below the mean height for normal children of the same age and gender

AND must meet criteria based on requested drug: a. Omnitrope cartridges If meets above initial criteria, E1-3 and a, approve at GPID level x 12 months b. Genotropin Patient has tried and failed, has an intolerance or a contraindication to Omnitrope cartridges If meets above initial criteria, E1-3 and b, approve at GPID level x 12 months c. Omnitrope vials Patient has tried and failed, has an intolerance or a contraindication to Omnitrope cartridges and Genotropin If meets above initial criteria, E1-3 and c, approve at GPID level x 12 months d. Saizen Patient has tried and failed, has an intolerance or a contraindication to Omnitrope cartridges, Genotropin and Omnitrope vials If meets above initial criteria, E1-3 and d, approve at GPID level x 12 months e. Nutropin Patient has tried and failed, has an intolerance or a contraindication to Omnitrope cartridges, Genotropin, Omnitrope vials and Saizen If meets above initial criteria, E1-3 and e, approve at GPID level x 12 months f. Humatrope Patient has tried and failed, has an intolerance or a contraindication to Omnitrope cartridges, Genotropin, Omnitrope vials, Saizen and Nutropin If meets above initial criteria, E1-3 and f, approve at GPID level x 12 months g. Norditropin

Effective: July 2021 NOTE: these guidelines may change at any time

F) For Adults with continued Growth Hormone Deficiency or Growth Hormone Deficiency associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary diseases, hypothalamic disease, surgery, radiation therapy, or trauma. Must meet all the following: 1. Patient has a diagnosis of Growth Hormone Deficiency alone or associated with hormone deficiencies resulting from pituitary disease, hypothalamic disease, surgery, radiation therapy or trauma 2. Medication is prescribed by, or in consultation with, an Endocrinologist

AND must meet criteria based on requested drug: a. Omnitrope cartridges If meets above initial criteria, F1-2 and a, approve at GPID level x 12 months b. Genotropin Patient has tried and failed, has an intolerance or a contraindication to Omnitrope cartridges If meets above initial criteria, F1-2 and b, approve at GPID level x 12 months c. Omnitrope vials Patient has tried and failed, has an intolerance or a contraindication to Omnitrope cartridges and Genotropin If meets above initial criteria, F1-2 and c, approve at GPID level x 12 months d. Saizen Patient has tried and failed, has an intolerance or a contraindication to Omnitrope cartridges, Genotropin and Omnitrope vials If meets above initial criteria, F1-2 and d, approve at GPID level x 12 months e. Nutropin Patient has tried and failed, has an intolerance or a contraindication to Omnitrope cartridges, Genotropin, Omnitrope vials and Saizen If meets above initial criteria, F1-2 and e, approve at GPID level x 12 months f. Humatrope Patient has tried and failed, has an intolerance or a contraindication to Omnitrope cartridges, Genotropin, Omnitrope vials, Saizen and Nutropin If meets above initial criteria, F1-2 and f, approve at GPID level x 12 months g. Norditropin Patient has tried and failed, has an intolerance or a contraindication to Omnitrope cartridges, Genotropin, Omnitrope vials, Saizen, Nutropin and Humatrope If meets above initial criteria, F1-2 and g, approve at GPID level x 12 months h. Zomacton

Effective: July 2021 NOTE: these guidelines may change at any time

G) Infertility treatment for females Must meet all the following: 1. Patient is currently enrolled in a prescription benefit plan that covers infertility/fertility medications 2. Medication is prescribed by an Endocrinologist specializing in infertility/fertility

AND must meet criteria based on requested drug: a. Omnitrope cartridges If meets above initial criteria, G1-2 and a, approve at GPID level x 2 (two) months b. Genotropin Patient has tried and failed, has an intolerance or a contraindication to Omnitrope cartridges If meets above initial criteria, G1-2 and b, approve at GPID level x 2 (two) months c. Omnitrope vials Patient has tried and failed, has an intolerance or a contraindication to Omnitrope cartridges and Genotropin If meets above initial criteria, G1-2 and c, approve at GPID level x 2 (two) months d. Saizen Patient has tried and failed, has an intolerance or a contraindication to Omnitrope cartridges, Genotropin and Omnitrope vials If meets above initial criteria, G1-2 and d, approve at GPID level x 2 (two) months e. Nutropin Patient has tried and failed, has an intolerance or a contraindication to Omnitrope cartridges, Genotropin, Omnitrope vials and Saizen If meets above initial criteria, G1-2 and e, approve at GPID level x 2 (two) months f. Humatrope Patient has tried and failed, has an intolerance or a contraindication to Omnitrope cartridges, Genotropin, Omnitrope vials, Saizen and Nutropin If meets above initial criteria, G1-2 and f, approve at GPID level x 2 (two) months g. Norditropin Patient has tried and failed, has an intolerance or a contraindication to Omnitrope cartridges, Genotropin, Omnitrope vials, Saizen, Nutropin and Humatrope If meets above initial criteria, G1-2 and g, approve at GPID level x 2 (two) months h. Zomacton Patient has tried and failed, has an intolerance or a contraindication to Omnitrope cartridges, Genotropin, Omnitrope vials, Saizen, Nutropin, Humatrope and Norditropin If meets above initial criteria, G1-2 and h, approve at GPID level x 2 (two) months

H) All other indications Somatropin is not covered for other indications such as:

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES 1. Idiopathic Short Stature (non-GH deficiency) 2. Athletic Enhancement 3. Anti-aging 4. Other indications not listed in A-G above Do NOT approve. Literature does not support the use of somatropin for these diagnoses.

RENEWAL CRITERIA

A) For HIV/AIDS-wasting syndrome/cachexia - New members on Serostim and renewals Must meet all the following criteria:

1. Medication is prescribed by or consultation with, nutrition support specialists, infectious disease specialists, or gastroenterology specialists 2. Patient is on anti-retroviral therapy for HIV/AIDs 3. Patient has shown a clinical benefit as demonstrated by an increase in muscle mass and weight from baseline (weight gain >2kg), while on growth hormone replacement

If meets above renewal criteria, A1-3, approve Serostim at GPID level x 8 months, with max daily dose of 1 vial per day (63405-4mg, 25955-5mg, 25960-6mg) Note: there is no data supporting more than 48 weeks of therapy

B) For Pediatric patients, age <18 years old diagnosed with growth hormone deficiency, Turner Syndrome, or growth failure with pediatric chronic renal insufficiency (CRI)/chronic kidney disease (CKD) prior to renal transplant and small for gestational age Must meet all the following criteria: 1. Medication is prescribed by or consultation with, an Endocrinologist 2. One of the following is true: I. Patient gain of growth velocity by at least 2 cm compared with that observed during the previous year II. Patient has reached 50th percentile for target height following growth hormone therapy

If meets above renewal criteria B1-2, approve x 12 months

C) Infertility treatment for females Must meet all the following: 1. Patient is currently enrolled in a prescription benefit plan that covers infertility/fertility medications 2. Medication is prescribed by an Endocrinologist specializing in infertility/fertility

If meets above renewal criteria, C1-2, approve x 6 months

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES

Creation date: 11/16/2016 Effective date: 12/5/2020 Reviewed date: 11/1/2020 Revised date: 11/1/2020

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES DEFLAZACORT (EMFLAZA)

Generic Brand HICL GCN Exception/Other DEFLAZACORT EMFLAZA 18MG 11668 43012 GSN 77113 DEFLAZACORT EMFLAZA 11668 43016 GSN 77117 22.75MG/ML SUSP DEFLAZACORT EMFLAZA 30MG 11668 23762 GSN 27605 DEFLAZACORT EMFLAZA 36MG 11668 43015 GSN 77116 DEFLAZACORT EMFLAZA 6MG 11668 23761 GSN 27604

GUIDELINES FOR USE INITIAL CRITERIA:

A) All the following must be met: 1. Patient is equal to or greater than 5 years old 2. Patient has a diagnosis of Duchenne Muscular Dystrophy (DMD) 3. Patient had onset of weakness associated with DMD that occurred before 5 years of age 4. Patient has tried continuous prednisone for at least 12 months AND experienced 'clinically significant' weight gain during the first 2 years of prednisone use

If all initial criteria, A1 through A4, are met, approve at HICL x 1 year

RENEWAL CRITERIA:

All the following must be met: 1. Patients weight gain must not be persisting or worsening

If above renewal criteria are met, approve at HICL x 2 years

Creation date: 9/26/2018 Effective date: 12/5/2020 Reviewed date: 11/1/2020 Revised date: 9/1/2018

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES BEMPEDOIC ACID (NEXLETOL, NEXLIZET)

Generic Brand HICL GCN Exception/Other BEMPEDOIC ACID NEXLETOL 46382 47755 NON-formulary BEMPEDOIC ACID NEXLIZET 46386 47765 NON-formulary / EZETIMIBE

GUIDELINES FOR INITIAL USE

A) Must meet all the following criteria:

1. Diagnosis of heterozygous familial hypercholesterolemia (HeFH) and/or atherosclerotic cardiosvascular disease (ASCVD-defined below) 2. LDL remains >100 mg/dL despite current use (or documented intolerance/contraindication-defined below) of maximum tolerated statin, ezetimibe, and PCSK9 inhibitor

If all above initial criteria, A1 and A2, are met, then approve both Nexletol and Nexlizet x 6 months

RENEWAL CRITERIA

Must meet all the following criteria: 1. Current LDL was reduced by ≥10% from baseline, after starting Nexletol or Nexlizet

If all renewal criteria are met, then approve both Nexletol and Nexlizet x 2 years

Definitions: ASCVD includes acute coronary syndromes (ACS), coronary artery disease (CAD), history of myocardial infarction (MI), stable or unstable angina, coronary or other arterial revascularization, ischemic stroke, transient ischemic attack (TIA), or symptomatic peripheral arterial disease (PAD)

Statin intolerance is defined as inability to tolerate at least 2 statins, with at least one started at lowest starting daily dose

Creation date: 11/18/2020 Effective date: 12/5/2020 Reviewed date: Revised date:

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES AVAPRITINIB (AYVAKIT)

Generic Brand HICL GCN Exception/Other AVAPRITINIB AYVAKIT 46291

GUIDELINES FOR USE A) INITIAL USE – If New Member currently using Ayvakit see Renewal criteria below

Must meet all of the following criteria: 1. Patient must be > 18 years of age 2. Patient must have unresectable or metastatic GIST (gastrointestinal stromal tumor) 3. Patient must have a PDGFRA D842V mutation

If all above initial criteria, A1-3, are met then approve x 12 months with max daily dose of 1 tablet/day

B) RENEWAL AND NEW KP MEMBERS CURRENTLY USING AVAPRITINIB Must meet all the following criteria: 1. Patient’s disease has not progressed since treatment initiation OR treating provider believes patient is deriving significant clinical benefit to justify treatment continuation

If above renewal criteria, B1, is met, then approve x 12 months with max daily dose of 1 tablet/day

Creation date: 11/18/2020 Effective date: 12/5/2020 Reviewed date: Revised date:

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES APALUTAMIDE (ERLEADA) DAROLUTAMIDE (NUBEQA)

Generic Brand HICL GCN Exception/Other APALUTAMIDE ERLEADA 44773 44446 DAROLUTAMIDE NUBEQA 45909 46746

GUIDELINES FOR USE INITIAL USE CRITERIA

A) Must meet all of the following criteria: 1. Patient has a diagnosis of prostate adenocarcinoma 2. Must be prescribed by an Oncology specialist 3. No metastasis observable on radiologic scans 4. Must have PSA greater than or equal to 2ng/dL 5. Must have had PSA double in 10 months or less while on ADT (androgen deprivation therapy includes: leuprorelin, goserelin, triptorelin, histrelin, degarelix) 6. Patient cannot have a history of disease progession on any of the following: a) enzalutamid (Xtandi) b) abiraterone acetate(Zytiga,Yonsa) c) darolutamide(Nubeqa) d) apalutamide(Erleada) e) docetaxel(Taxotere) f) or other treatments beyond ADT (androgen deprivation therapy) g) bicalutamide 7. Patient has tried and failed, is intolerant to or has a contraindication (hx of seizures, on CYP3A4 inducers, etc) to enzalutamide

AND based on requested drug, B or C:

B) Darolutamide (Nubeqa) 1. Patient has a history of seizures or seizure disorder 2. Patient cannot be currently treated with any strong CYP3A4 inducers

If initial criteria A and B are met, then approve at HICL x 1 year

C) Apalutamide (Erleada) 1. Patient does not have a history of seizures or seizure disorder 2. Patient is currently being treated with a strong CYP3A4 inducer

If initial criteria A and C above are met, then approve x 1 year at HICL

If initial criteria B or C are not met, patient should try Enzalutamide

Creation date: 11/1/2018 Effective date: 12/5/2020

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES Reviewed date: Revised date:

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES AMLODIPINE SUSPENSION

Generic Brand HICL GCN Exception/Other AMLODIPINE KATERZIA 45864 46652 Formulary SUSPENSION

INITIAL AND RENEWAL CRITERIA

A) ONE of the following must be met: 1. patient age < 12 years ld OR 2. at least one of the following is true: a. the dose cannot be administered via halved, whole or combo of the amlodipine 5 mg tablet (i.e. 2.5 mg or 7.5 mg) b. patient has a gastrostomy tube c. patient cannot swallow other tablets whole, halved or crushed (or swallow contents of opened capsules)

If all above criteria A1 and A2 are met, approve x 12 months

If above criteria are not met, do not approve and suggest one of the following: I. Changing to tablet strengths that can be halved or used in combination II. Crushing amlodipine tabs before administration and take with or w/o applesauce

Creation date: 10/1/2019 Effective date: 12/5/2020 Reviewed date: 11/1/2020 Revised date: 11/1/2020

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES AMIFAMPRIDINE

Generic Brand HICL GCN Exception/Other AMIFAMPRIDINE RUZURGI 31458 46265 NON-Formulary - 1st preferred AMIFAMPRIDINE FIRDAPSE 36930 28457 NON-Formulary 2nd PHOSPHATE preferred

GUIDELINES FOR USE

INITIAL USE and NEW MEMBER CRITERIA A) Must meet all of the following criteria: 1. Patient must be age 6 or older 2. Must be prescribed by a Neurologist or if clinically appropriate, an oncologist

AND must meet the diagnosis/drug specific criteria below-

B) Lambert-Eaton Myasthenic Syndrome (LEMS)

Must meet all the following: 1. Has a diagnosis of LEMS and has weakness that interferes with normal function 2. Has baseline LFTs and serum creatinine (obtained within prior 3 months) 3. Has documentation of a baseline clinical muscle strength assessment (examples include either the Quantitative Myasthenia Gravis (QMG) score or the triple-timed up- and-go test (3TUG)) 4. Those members with pregnancy potential should have a negative pregnancy test and should be on highly effective contraception unless there is a valid reason not to and should not be lactating. 5. Must not have a history of seizure disorder or have active brain metastasis 6. Must not have End Stage Renal Disease (ESRD) 7. Must not be taking with central acetylcholinesterase inhibitors* or other medication* that can lower seizure threshold concurrently (see Table of examples in attachment) 8. The requested agent is Rizurgi OR the patient has a documented intolerance, FDA labeled contraindication, or hypersensitivity to Ruzurgi that is not expected to occur with the requested agent

If all above initial criteria A and B are met, then approve x3 months with max daily dose of: Ruzurgi = 10 tablets/day or Firdapse = 8 tablets per day

RENEWAL CRITERIA

Must meet all the following criteria: 1. Meets all of the initial applicable criteria 2. Has been adherent with medication

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES 3. Using a clinical muscle strength assessment (e.g., the QMG score or the 3TUG test), the clinician attests to the improvement or stabilization in muscle weakness compared to baseline assessed within at least 3 months of therapy initiation and at least annually thereafter. 4. No drug-related serious adverse events occurred while on treatment

If all above renewal criteria are met, then approve x 12 months with max daily dose of: Ruzurgi = 10 tablets/day or Firdapse = 8 tablets per day

Creation date: 11/18/2020 Effective date: 12/5/2020 Reviewed date: Revised date:

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES CONTINUOUS INSULIN DELIVERY DEVICES (CIDD)

Generic Brand HICL GCN Exception/Other INSULIN PUMP OMNIPOD DASH 33823, 94200 CARTRIDGE 40278 SUBCUTANEOUS V-GO 38483, 94200 INSULIN 38484, DELIVERY 38486 DEVICE

GUIDELINES FOR USE FOR NEW STARTS AND NEW PATIENTS TO KP USING THESE PRODUCTS

Must meet all the following criteria based on type of diabetes: A. Type 1 Diabetes Must meet ALL the following: 1. Patient must have diagnoses of Type 1 Diabetes, confirmed by fasting C-peptide, fasting blood sugar, positive Beta cell autoantibody or positive glutamate decarboxylase 65 autoantibody test 2. The prescriber must be an Endocrinology or Diabetes specialist 3. Request must be for Omnipod DASH or Omnipod pump cartridge 4. Completed a comprehensive diabetes education program 5. Has been on a program of at least 3 daily injections of insulin with frequent self- adjustments of dose for at least 1 to 2 months prior to this request 6. Has documented frequency of glucose self-testing of at least 3 times per day for 1 to 2 months prior to this request 7. Meets one or more of the following, while on the multiple injection regimen: a. Glycosylated hemoglobin level (HbA1C) greater than 7 % b. History of recurring hypoglycemia c. Wide fluctuations in blood glucose before mealtime d. Dawn phenomenon with fasting blood sugars frequently exceeding 200 mg/dl e. History of severe glycemic excursions 8. Patient must have a need for a tubeless delivery device, such as one of the following: a. Participates in strenuous exercise for more than 1 hour per day, routinely b. Works in a hazardous environment with a risk of dislodging pump tubing c. Frequent exposure to water, such as swimming routinely d. Severe needle phobia

If meets initial criteria above, A1-8, then approve x 1 year. If patient does not meet all the above, then do not approve

B. Type 2 Diabetes Must meet ALL the following, based on product requested:

Omnipod- (1 and 2 OR 3-11)

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES

1. Patient must be pregnant and at high risk of developing pregnancy-related complications 2. Prescriber must be an Endocrinology or Maternal Fetal Medicine provider OR 3. Prescriber must be an Endocrinology or Diabetes specialist 4. Currently using at least 3-4 insulin injections per 24 hrs or uses and insulin pump 5. Monitors blood glucose at least 3-4 times per 24 hrs 6. Has worked with a Diabetes Care Specialist for at least 6 months on insulin adjustments and the following continue to occur: a) At least 2 or more nocturnal hypoglycemia episodes (blood glucose <65mg/dL) in the past month b) Use of glucagon in the past 12 months 7. Completed a comprehensive diabetes education program 8. Has been on a program of at least 3 daily injections of insulin with frequent self- adjustments of dose for at least 1 to 2 months prior to this request 9. Has documented frequency of glucose self-testing of at least 3 times per day for 1 to 2 months prior to this request 10. Meets one or more of the following, while on the multiple injection regimen: a) Glycosylated hemoglobin level (HbA1C) greater than 7 % b) History of recurring hypoglycemia c) Wide fluctuations in blood glucose before mealtime d) Dawn phenomenon with fasting blood sugars frequently exceeding 200 mg/dl e) History of severe glycemic excursions 11. Patient must have a need for a tubeless delivery device, such as one of the following: a) Participates in strenuous exercise for more than 1 hour per day, routinely b) Works in a hazardous environment with a risk of dislodging pump tubing c) Frequent exposure to water, such as swimming routinely d) Severe needle phobia

If meets initial criteria, B1-2 OR B3-11, then approve x 1 year

C. V-Go 1. Prescriber must be an Endocrinology or Diabetes specialist 2. Currently using at least 3-4 insulin injections per 24 hrs or uses and insulin pump 3. Monitors blood glucose at least 3-4 times per 24 hrs 4. Is using 40 units or less of basal insulin per day 5. Has worked with a Diabetes Care Specialist for at least 6 months on insulin adjustments and the following continue to occur: a) At least 2 or more nocturnal hypoglycemia episodes (blood glucose <65mg/dL) in the past month b) Use of glucagon in the past 12 months 6. Completed a comprehensive diabetes education program 7. Has been on a program of at least 3 daily injections of insulin with frequent self- adjustments of dose for at least 1 to 2 months prior to this request

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES 8. Has documented frequency of glucose self-testing of at least 3 times per day for 1 to 2 months prior to this request 9. Meets one or more of the following, while on the multiple injection regimen: f) Glycosylated hemoglobin level (HbA1C) greater than 7 % g) History of recurring hypoglycemia h) Wide fluctuations in blood glucose before mealtime i) Dawn phenomenon with fasting blood sugars frequently exceeding 200 mg/dl j) History of severe glycemic excursions 10. Patient must have a need for a tubeless delivery device, such as one of the following: e) Participates in strenuous exercise for more than 1 hour per day, routinely f) Works in a hazardous environment with a risk of dislodging pump tubing g) Frequent exposure to water, such as swimming routinely h) Severe needle phobia

If meets initial criteria, C1-10, then approve x 1 year

RENEWAL CRITERIA

A. Patient been evaluated by the treating provider at least every 6 months B. Patient must continue to have a need for a tubeless delivery device, such as one of the following: 1. Participates in strenuous exercise for more than 1 hour per day, routinely 2. Works in a hazardous environment with a risk of dislodging pump tubing 3. Frequent exposure to water, such as swimming routinely 4. Severe needle phobia If meets renewal criteria, A-B, then approve x 1 year

Creation date: 11/20/2019 Effective date: 12/5/2020 Reviewed date: 11/1/2020 Revised date: 11/1/2020

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES DPP-4 INHIBITORS/DPP-4 INHIBITOR COMBINATIONS

Generic Brand HICL GCN Exception/Other LINAGLIPTIN TRADJENTA 29890 NonFormulary most Preferred ALOGLIPTIN NESINA 39968 NF- 2nd Preferred SAXAGLIPTIN ONGLYZA 36471 NF - 3rd Preferred SITAGLIPTIN JANUVIA 34126 NF - 4th Preferred

GUIDELINES FOR INITIAL USE

A - DM2 in adults older than 25yrs old B - DM2 in pediatrics/young adults aged 10 to 25yrs

Review based on age -

A. To treat type 2 diabetes in adults older than 25 years of age

All requests must meet all the following criteria, 1 through 8:

1. Patient is at least 25years old 2. Most recent HgbA1c is within 1% or less from their designated goal 3. Not currently using a GLP-1 receptor agonist (medications containing semaglutide, liraglutide, exenatide, lixisenatide, dulaglutide) 4. Has contraindications to OR currently using OR has failed maximum doses of metformin IR and subsequently metformin ER, maximum dose of a sulfonylurea, maximum dose of pioglitazone, and all possible combinations thereof 5. If on insulin, unable to adjust insulin regimen to achieve better control 6. Patient has tried and failed, has an intolerance or a contraindication to the KPCO preferred SGLT-2 inhibitor [empagliflozin (1st line, F/PA) 7. If DPP-4 is approved, the patient’s current diabetes treatment regimen will not contain four or more medications 8. Does not have active, or a past history of pancreatitis

AND based on requested drug: i. Linagliptin (Tradjenta)

If meets A1-8 initial criteria and Linagliptin is requested then approve x 6 months.

ii. Alogliptin (Nesina): • Patient does not have active, or a past history of, heart failure AND • Patient has appropriate CrCL or GFR for the requested dose AND • Patient has tried and failed, has an intolerance or a contraindication to linagliptin

If meets A1-8 and ii initial criteria, then approve x 6 months.

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES iii. Saxagliptin (Onglyza): • Patient does not have active, or a past history of, heart failure AND • Patient has appropriate CrCL or GFR for the requested dose AND • Patient has tried and failed, has an intolerance or a contraindication to linagliptin and alogliptin,

If meets A1-8 and iii initial criteria, then approve x 6 months.

iv. Sitagliptin (Januvia) • Patient has appropriate CrCL or GFR for the requested dose AND • Patient has tried and failed, has an intolerance or a contraindication to linagliptin, alogliptin, and saxagliptin

If meets A1-8 and iv initial criteria, then approve x 6 months.

B) For the treatment of type 2 diabetes in young adult/pediatric patients 10 years of age to less than 25 years of age.

All requests must meet all the following criteria, 1 through 4:

1. Not currently using a GLP-1 receptor agonist (medications containing semaglutide, liraglutide, exenatide, lixisenatide, dulaglutide) 2. Has contraindications to OR currently using OR has failed maximum doses of metformin IR and subsequently metformin ER, and maximum dose of pioglitazone, and all possible combinations thereof 3. Patient has tried and failed, has an intolerance or a contraindication to KPCO preferred SGLT-2 inhibitor [empagliflozin (1st line, F/PA) 4. Does not have active, or a past history of pancreatitis

AND based on requested drug:

i. Linagliptin (Tradjenta)

If meets B1-4 initial criteria and Linagliptin is requested then approve x 6 months.

If meets B1-4 and ii initial criteria, then approve x 6 months.

iii. Saxagliptin (Onglyza): • Patient does not have active, or a past history of, heart failure AND • Patient has appropriate CrCL or GFR for the requested dose AND

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES • Patient has tried and failed, has an intolerance or a contraindication to linagliptin and alogliptin

If meets B1-4 and iii initial criteria, then approve x 6 months.

If meets B1-4 and iv initial criteria, then approve x 6 months.

RENEWAL CRITERIA FOR ALL INDICATIONS

Must meet all the following criteria: 1. Not currently using a GLP-1 receptor agonist (medications containing semaglutide, liraglutide, exenatide, lixisenatide, dulaglutide) 2. Patient has not developed any contraindications to DPP-4 inhibitors 3. HgbA1c is at goal

If above renewal criteria are met, approve x 12 months

Creation date: 7/2/2020 Effective date: 2/1/2021 Reviewed date: 1/1/2021 Revised date: 1/1/2021

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES GLP-1 AGONISTS

Generic Brand HICL GCN Exception/Other SEMAGLUTIDE OZEMPIC 44675 1st Preferred INJECTION regardless of ASCVD LIRAGLUTIDE VICTOZA 36436 2nd Preferred regardless of ASCVD Non-ASCVD max 2- pack ASCVD max 3-pack SEMAGLUTIDE RYBELSUS Max 1 tab/day ORAL EXENATIDE ER BYDUREON 38451 EXENATIDE IR BYETTA 32893 LIXISENATIDE ADLYXIN 40782 DULAGLUTIDE TRULICITY 41421

GUIDELINES FOR INITIAL USE - see Renewal criteria for continued use

A - ALL requests must meet B - Adults > 25 years of age with DM2 with ASCVD C - Adults > 25 years of age with DM2 without ASCVD D - Pediatrics/Young Adults >10 and < 25 years of age with DM2 E - Any age, all other indications and diagnoses are NOT covered

A) All requests must meet ALL the following criteria, 1 through 9: 1. Medication is not prescribed by an internal or an external provider affiliated with a weight loss clinic 2. Patient has type 2 diabetes 3. Most recent HgbA1c is within 2% or less from their designated goal 4. Has contraindications to OR currently using OR has failed maximum doses of metformin IR and subsequently metformin ER 5. Not currently using a DPP4 inhibitor (medications containing alogliptin, linagliptin, saxagliptin, or sitagliptin) 6. Does not have active, or a past history of, pancreatitis 7. Does not have a family or personal history of medullary thyroid carcinoma, and does not have multiple endocrine neoplasia syndrome type 2 8. Does not have severe gastrointestinal disease (i.e., colitis, Crohn’s disease, GI obstruction, GI perforation, gastroparesis, ileus, etc.) 9. Must have appropriate CrCL or GFR for the requested drug

AND Review based on the diagnosis/drug specific criteria below, B or C:

B) To treat type 2 diabetes in patients WITH ASCVD (acute coronary syndromes (ACS), history of myocardial infarction (MI), stable or unstable angina, coronary or other

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES arterial revascularization, ischemic stroke, transient ischemic attack (TIA), or symptomatic peripheral arterial disease (PAD)

Must meet the following: 1. Patient has tried and failed to reach A1C goals with any SGLT-2 inhibitor for 3 months OR 2. Patient has intolerance or a contraindication to the two KPCO preferred SGLT-2 inhibitors [empagliflozin (1st line, F/PA), canagliflozin (2nd line, NF/PA)]

AND must meet criteria listed below based on requested drug: a. Semaglutide injection (Ozempic) If initial criteria A, B1 or B2 and Ba are met, approve at HICL x 6 months (44675) with a max 1 box (3mLs) per 30 days

b. Liraglutide (Victoza): Patient has tried and failed, has an intolerance or a contraindication to semaglutide injection If initial criteria A, B1 or B2 and Bb are met, approve x 6 months at GPID (26189) with a max 1 box/3 pens/9mLs per 30 days

c. Dulaglutide (Trulicity):Patient has tried and failed, has an intolerance or a contraindication to semaglutide injection and liraglutide If initial criteria A, B1 or B2 and Bc are met, approve at HICL x 6 months (41421) 1 box/4 pens/2mLs per 30 days

d. Semaglutide oral (Rybelsus):Patient has tried and failed, has an intolerance or a contraindication to semaglutide injection, liraglutide and dulaglutide If initial criteria A, B1 or B2 and Bd are met, approve at HICL x 6 months (44675) with max daily dose of 1 tablet/day

e. Exenatide ER (Bydureon): Patient has tried and failed, has an intolerance or a contraindication to semaglutide injection, liraglutide, dulaglutide and semaglutide oral If initial criteria A, B1 or B2 and Be are met, then approve at HICL x 6 months (38451) with a max 1 box/4 pens per 30 days

f. Exenatide IR (Byetta): Patient has tried and failed, has an intolerance or a contraindication to semaglutide injection, liraglutide, dulaglutide, semaglutide oral, and exenatide ER If initial criteria A, B1 or B2 and Bf are met, then approve at HICL x 6 months (32893) with a max 1 box/1 pen/2.4mLs per 30 days

g. Lixisenatide (Adlyxin):Patient has tried and failed, has an intolerance or a contraindication to semaglutide injection, liraglutide, dulaglutide, semaglutide oral, exenatide ER, and exenatide IR If initial criteria A, B1 or B2 and Bg are met, then approve at HICL x 6 months (40782) with a max 1 box/2 pens/6mLs per 30 days

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES

C) To treat type 2 diabetes in patients WITHOUT ASCVD

Must meet ALL the following: 1. Patient has contraindications to OR currently using OR has failed maximum doses of sulfonylurea, maximum dose of pioglitazone, and all possible combinations thereof 2. If on insulin, unable to adjust the patient's insulin regimen to achieve better control 3. Patient has tried and failed to reach A1C goals with any SGLT-2 inhibitor for 3 months OR 4. Patient has intolerance or a contraindication to the two KPCO preferred SGLT-2 inhibitors [empagliflozin (1st line, F/PA), canagliflozin (2nd line, NF/PA)]

AND criteria listed below based on requested drug: a. Semaglutide injection (Ozempic) If initial criteria A, C1—2 and C3 or C4 and Ca are met, approve at HICL x 6 months (44675) with a max 1 box/3mLs per 30 days

b. Liraglutide (Victoza: Patient has tried and failed, has an intolerance or a contraindication to semaglutide injection If initial criteria A, C1—2 and C3 or C4 and Cb are met, then approve 2-pack at NDC level x 6 months (000169-4060-12) with a max 1 box/2 pens/6mLs per 30 days

c. Semaglutide oral (Rybelsus): Patient has tried and failed, has an intolerance or a contraindication to semaglutide injection and liraglutide If initial criteria A, C1—2 and C3 or C4 and Cc are met, then approve at HICL x 6 months (44675) with max daily dose of 1 tablet/day

d. Exenatide ER (Bydureon): Patient has tried and failed, has an intolerance or a contraindication to semaglutide injection, liraglutide, and semaglutide oral If initial criteria A, C1—2 and C3 or C4 and Cd are met, then approve at HICL x 6 months (38451) with a max 1 box/4 pens per 30 days

e. Exenatide IR (Byetta): Patient has tried and failed, has an intolerance or a contraindication to semaglutide injection, liraglutide, and semaglutide oral, exenatide ER If initial criteria A, C1—2 and C3 or C4 and Ce are met, then approve at HICL x 6 months (32893) with a max 1 box/1 pen/2.4mLs per 30 days

f. Lixisenatide (Adlyxin): Patient has tried and failed, has an intolerance or a contraindication to semaglutide injection, liraglutide, semaglutide oral, exenatide ER, and exenatide IR If initial criteria A, C1—2 and C3 or C4, Cf are met, then approve at HICL x 6 months (40782) with a max of 1 box, 2 pens/6mLs per 30 days

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES

g. Dulaglutide (Trulicity): Patient has tried and failed, has an intolerance or a contraindication to semaglutide injection, liraglutide, semaglutide oral, exenatide ER, exenatide IR and lixisenatide If initial criteria A, C1-—2 and C3 or C4 and Cg are met then approve at HICL x 6 months (41421) with a max 1 box/4 pens/2mLs per 30 days

D) To treat type 2 diabetes in pediatric patients > 10 but <25 years of age

1. Has contraindications to OR currently using OR has failed maximum doses of metformin IR and subsequently metformin ER 2. Patient has contraindications to OR currently using OR has failed maximum dose of pioglitazone 3. Not currently using a DPP4 inhibitor (medications containing alogliptin, linagliptin, saxagliptin, or sitagliptin) 4. Does not have active, or a past history of, pancreatitis 5. Does not have a family or personal history of medullary thyroid carcinoma, and does not have multiple endocrine neoplasia syndrome type 2 6 . Does not have severe gastrointestinal disease (i.e., colitis, Crohn’s disease, GI obstruction, GI perforation, gastroparesis, ileus, etc.) AND 7. Patient has tried and failed to reach A1C goals with any SGLT-2 inhibitor for 3 months OR 8. Patient has intolerance or a contraindication to the two KPCO preferred SGLT-2 inhibitors [empagliflozin (1st line, F/PA), canagliflozin (2nd line, NF/PA)]

AND criteria listed below based on requested drug: a. Semaglutide injection (Ozempic) If criteria D1-6 and D7 or D8 and Da are met, approve at HICL x 6 months (44675) with a max 1 box/3mLs per 30 days

b. Liraglutide (Victoza: Patient has tried and failed, has an intolerance or a contraindication to semaglutide injection If criteria D1-6 and D7 or D8 and Db are met, then approve 2-pack at NDC level x 6 months (000169-4060-12) with a max 1 box/2 pens/6mLs per 30 days

c. Semaglutide oral (Rybelsus): Patient has tried and failed, has an intolerance or a contraindication to semaglutide injection and liraglutide If criteria D1-6 and D7 or D8 and Dc are met, then approve at HICL x 6 months (44675) with max daily dose of 1 tablet/day

d. Exenatide ER (Bydureon): Patient has tried and failed, has an intolerance or a contraindication to semaglutide injection, liraglutide, and semaglutide oral If criteria D1-6 and D7 or D8 and Dd are met, then approve at HICL x 6 months (38451) with a max 1 box/4 pens per 30 days

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES

e. Exenatide IR (Byetta): Patient has tried and failed, has an intolerance or a contraindication to semaglutide injection, liraglutide, and semaglutide oral, exenatide ER If criteria D1-6 and D7 or D8 and De are met, then approve at HICL x 6 months (32893) with a max 1 box/1 pen/2.4mLs per 30 days

f. Lixisenatide (Adlyxin): Patient has tried and failed, has an intolerance or a contraindication to semaglutide injection, liraglutide, semaglutide oral, exenatide ER, and exenatide IR If criteria D1-6 and D7 or D8 Df are met, then approve at HICL x 6 months (40782) with a max 1 box/2 pens/6mLs per 30 days

g. Dulaglutide (Trulicity): Patient has tried and failed, has an intolerance or a contraindication to semaglutide injection, liraglutide, semaglutide oral, exenatide ER, exenatide IR and lixisenatide If criteria D1-6 and D7 or D8 and Dg are met, then approve at HICL x 6 months (41421) with a max 1 box/4 pens/2mLs per 30 days

RENEWAL CRITERIA Choose 1, 2 or 3 based on diagnosis and age

1. To treat type 2 diabetes in patients WITH ASCVD

Must meet ALL the following criteria: a) Patient has appropriate CrCL or GFR for the requested dose b) Patient has not developed any contraindications to GLP-1 agonist (pancreatitis, severe gastrointestinal disease (i.e., colitis, Crohn’s disease, GI obstruction, GI perforation, gastroparesis, ileus, etc.), medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2) c) Not currently using a DPP4 inhibitor (medications containing alogliptin, linagliptin, saxagliptin, or sitagliptin)

2. To treat type 2 diabetes in patients WITHOUT ASCVD

Must meet ALL the following: a) Patient has appropriate CrCL or GFR for the requested dose b) Patient has not developed any contraindications to GLP-1 agonist (pancreatitis, severe gastrointestinal disease (i.e., colitis, Crohn’s disease, GI obstruction, GI perforation, gastroparesis, ileus, etc.), medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2) c) Not currently using a DPP4 inhibitor (medications containing alogliptin, linagliptin, saxagliptin, or sitagliptin) d) HgbA1c is either at goal or at least has decreased by 1% or more

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES

3. To treat type 2 diabetes in pediatric patients <25 years of age

Must meet ALL the following: a) Patient has not developed any contraindications to GLP-1 agonist (pancreatitis, severe gastrointestinal disease (i.e., colitis, Crohn’s disease, GI obstruction, GI perforation, gastroparesis, ileus, etc.), medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2) b) Not currently using a DPP-IV 4inhibitor (medications containing alogliptin, linagliptin, saxagliptin, or sitagliptin) c) HgbA1c is either at goal or at least has decreased by 1% or more

If the above renewal criteria, 1, 2 or 3, are met, then approve x 12 months with the following quantity limits: Semaglutide (Ozempic) at HICL (44675) with a max 1 box/3mL per 30 days Liraglutide (Victoza) with ASCVD at GPID (26189) with a max 1 box/3pens/9mL per 30 days. Liraglutide (Victoza) without ASCVD at NDC (000169-4060-13) with a max of 1 box/2pens/6mL per 30 days Semaglutide oral (Rybelsus) at HICL (44675) with a max of 1 tablet/day Exenatide ER (Bydureon) at HICL (38451) with a max of 1 box/4 pens per 30 days Exenatide IR (Byetta) at HICL (32893) with a max of 1 box/1 pen/2.4 mL per 30 days Lixisenatide (Adlyxin) at HICL (40782) with a max of 1 box/2 pens/6mL per 30 days Dulaglutide (Trulicity) at HICL (41421) with a max of 1 box/4 pens/2 mL per 30 days

Creation date: 9/26/2018 Effective date: 2/1/2021 Reviewed date: 3/1/2021 Revised date: 3/1/2021

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES EPIDIOLEX (CANNABIDIOL)

Generic Brand HICL GCN Exception/Other CANNABADIOL EPIDIOLEX

INITIAL CRITERIA see specific diagnosis

A) To treat Lennox-Gastaut Syndrome (LGS) All the following must be met:

1) patient is 1 year of age or older 2) medication is prescribed by or in consultation with a neurologist 3) this medication must be used in conjunction with another antiepileptic medication 4) patient has a diagnosis of Lennox-Gastaut Syndrome (LGS) 5) patient has had weekly seizures despite compliance with optimal dosing of combination therapy of at least 2 antiepileptic medications, in the past 8 weeks 6) patient must have tried & failed or have a contraindication to all of the following: a. clobazam b. topiramate c. lamotrigine AND 7) patient cannot be using another cannabis product or derivative during the use of this medication 8) patient cannot have significant hepatic impairment (defined as ALT or AST >3x ULN with total bilirubin >2x ULN) 9) female patients cannot be pregnant or planning to become pregnant

If above initial criteria, A 1-9, are met, then approve x 6 months If criteria are not met, then do not approve

B) To treat Dravet Syndrome (DS) All the following must be met:

1) patient is 1 year of age or older 2) medication is prescribed by or in consultation with a neurologist 3) this medication must be used in conjunction with another antiepileptic medication 4) patient has a diagnosis of Dravet Syndrome (DS) 5) patient has had weekly seizures despite compliance with optimal dosing of combination therapy of at least 2 antiepileptic medications, in the past 8 weeks 6) patient must have tried & failed or have a contraindication to all of the following: a. clobazam b. topiramate c. a valproic acid derivative product AND 7) patient cannot be using another cannabis product or derivative during the use of this medication

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES 8) patient cannot have significant hepatic impairment (defined as ALT or AST >3x ULN with total bilirubin >2x ULN) 9) female patients cannot be pregnant or planning to become pregnant

If above initial criteria, B 1-9, are met, then approve x 6 months If criteria are not met, then do not approve

C) To treat Tuberous Sclerosis Complex (TSC) associated seizures All the following must be met:

1) patient is 1 year of age or older 2) medication is prescribed by or in consultation with a neurologist 3) patient is treatment refractory to optimal dosing of at least two antiepileptic drugs (AEDs) that are appropriate for the epilepsy diagnosis 4) patient has a diagnosis of TSC either by confirmed genetic testing or meeting clinical criteria for definitive diagnosis outline by the 2012 International Tuberous Sclerosis Complex Consensus Group 5) patient has experienced the following over the past 4 weeks: a. At least 8 seizures b. At least 1 focal seizure ocurring in at least 3 of the 4 weeks 6) this medication must be used in conjunction with at least one another antiepileptic medication

AND 7) patient cannot be using another cannabis product or derivative during the use of this medication 8) patient cannot have significant hepatic impairment (defined as ALT or AST >3x ULN with total bilirubin >2x ULN) 9) female patients cannot be pregnant or planning to become pregnant

If above initial criteria, C 1-9, are met, then approve x 6 months If criteria are not met, then do not approve

RENEWAL CRITERIA All the following must be met: 1. patient has not experienced weekly seizures while taking Epidiolex 2. patient has maintained adherence to the medication since last approval 3. patient is NOT using another cannabis product or a derivative while taking Epidiolex 4. patient has not developed significant hepatic impairment (defined as ALT or AST >3x ULN with total bilirubin >2x ULN) 5. female patients are NOT pregnant or planning to become pregnant

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES If above renewal criteria 1 - 5 are met, then approve x 1 year If criteria are not met, then do not approve

Creation date: 7/1/2020 Effective date: 2/6/2021 Reviewed date: 1/1/2021 Revised date: 1/1/2021

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES ORIAHNN

Generic Brand HICL GCN Exception/Other ELAGOLIX / ORIAHNN 46577 ESTRADIOL / NORETHINDRONE

GUIDELINES FOR INITIAL USE (If currently using or historically used Oriahnn, See Renewal Criteria)

A) Must meet all the following criteria: 1. Patient is > 18 year-old and female 2. Medication is prescribed by or in consultation with an OB/GYN (with an appropriate referral, if required) 3. Have a diagnosis of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) 4. Premenopausal 5. Patient has tried and failed, have an intolerance to or a contraindication to each of the following: a. One NSAID b. Oral contraceptive pill (OCP) - Note: cannot take concurrently with Oriahnn. c. Levonorgestrel-releasing Intrauterine device (LNG IUD) d. One progestin (norethindrone, medroxyprogesterone) e. Tranexamic acid f. GnRH (leuprolide) 6. Patient does NOT have any of the following: a. must not have a high risk of arterial, venous thrombosis or thromboembolic disordera b. a diagnosis of uncontrolled hypertension c. known liver impairment or disease d. undiagnosed abnormal uterine bleeding e. a BMD within the last 12 months that shows osteoporosis, other metabolic bone disease, or a BMD T-score of -1.5 or less at the lumbar spine, total hip, or femoral neck f. current breast cancer or a history of breast cancer or other hormonally- sensitive malignancies g. a known hypersensitivity to ingredients of elagolix+E2/NETA capsules 7. Patient is not any of the following: a. Currently pregnant (negative pregnancy test prior to initiation or history of sterilization) b. Planning on becoming pregnant in the next 24 months c. currently breastfeeding 8. Patient must not have previously completed 24 months of treatment with elagolix +E2/NETA

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES 9. Patient must not be on an organic anion transporting polypeptide (OATP)1B1 inhibitorb (most common: cyclosporine, gemfibrozil; see comprehensive list in footnote)

If initial criteria, A 1-9, are met, then approve x6 months

RENEWAL / NEW MEMBER / CONTINUED USE CRITERIA

Must meet at least of the following criteria:

1. Patient currently taking elagolix+E2/NETA for less than 24 months and has a history of blood transfusion OR 2. Patient has experienced a clinically significant improvement in fibroid-induced heavy menstrual bleeding defined as at least 50% reduction in menstrual blood loss from baseline to the final month (6 months) Note: Pt has not been on Oriahnn for 24 months or more

If renewal criteria #1 above is met then approve for ONE 30-day supply only, to allow time to be evaluated by Ob/Gyn If renewal criteria #2 above is met, then approve for the number of months to meet the maximum of 24 total months of therapy.

Creation date: Effective date: Reviewed date: Revised date:

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES ORILISSA

Generic Brand HICL GCN Exception/Other ELAGOLIX ORILISSA 45108 45026, 45028

GUIDELINES FOR INITIAL USE

A) For Orilissa requests Must meet all the following:

1. Patient is > 18-year-old and female 2. Medication is prescribed by or in consultation with an obstetrician/gynecologist (with an appropriate referral, if required) 3. Patient has a surgically confirmed diagnosis of endometriosis with or without dyspareunia 4. Patient cannot be any of the following: a. currently pregnant b. planning on becoming pregnant in the next 24 months c. currently breastfeeding 5. Patient has one of the following: a. a sterilization procedure performed b. a current negative pregnancy test AND is willing to repeat urine pregnancy test in fourteen days to confirm 6. Patient has tried and failed or have an absolute contraindication to ALL the following: a. At least two combined oral contraceptives (pill, patch or ring) taken in a continuous fashion (skipping placebo tablets) with different progestins OR have an absolute contraindication to estrogens b. Depo-medroxyprogesterone acetate injection, norethindrone acetate oral, or medroxyprogesterone acetate oral OR have an absolute contraindication to progesterone c. GnRH agonist (nafarelin , leuprolide, goserelin or triptorelin) with add-back hormonal therapy OR have an absolute contraindication to GnRH agonists d. At least two NSAIDs OR have an absolute contraindication to NSAIDs 7. Patient does not have any of the following: a. a diagnosis of severe hepatic impairment (Child-Pugh class C) b. abnormal LFT's (liver function tests), either current (within the last 12 months) or most recent LFTs c. a diagnosis of uncontrolled hyperlipidemia d. undiagnosed vaginal bleeding OR an undiagnosed breast mass e. a diagnosis of osteoporosis OR a BMD T-score of < -2.5 8. Patient has a BMD within the last 12 months 9. If patient has a diagnosis osteopenia (or a BMD T-score of -1 to -2.5) and has risk factors3, then patient must agree to supplementation with calcium 1200mg/day and vitamin D 1000-2000units/day and get a BMD at 6 months

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES 10. Patient cannot be currently on a strong organic anion transporting polypeptide 1b1 inhibitor (most common: cyclosporine, gemfibrozil, see comprehensive list in footnote)4 11. Patient is willing to use two forms of non-hormonal contraception while on elagolix therapy (Patients must be on non-hormonal contraception while on elagolix therapy) 12. Patient is willing to adhere with routine (at least every three month) lab work to confirm has not become pregnant while on elagolix

If above initial criteria, A1-12, are met then approve per diagnosis: Endometriosis: 150mg once daily for 12 months Endometriosis with dyspareunia: 200mg twice daily for 6 months (FDA-approved duration)

RENEWAL CRITERIA Need to know date when patient started therapy

A) For Orilissa renewals Must meet the following: 1. Patient had at least a 50% improvement of symptoms? Compare current score to baseline (on previous treatment) pain score on the Numeric Rating Scale (0 [no pain] to 10 [worst pain ever]) and Patient Global Impression of Change questionnaire

AND based on indication:

B) For endometriosis with dyspareunia: a. patient has not completed 6 months of treatment (FDA-approved duration) b. patient has current LFTs (while on therapy) that are WNL If meets renewal criteria A and B1a-b, then approve x number of months to meet and not exceed 6 total months of therapy

C) For endometriosis a. patient has not completed 24 months of treatment (FDA-approved duration)? b. patient has a BMD after 12 months of elagolix therapy which showed a decrease from baseline of less than 8% in spine, femoral neck or total hip c. patient has a current a negative pregnancy test AND is willing to come back to confirm not pregnant with repeat urine pregnancy test in fourteen days, OR had sterilization procedure d. patient has current (post-treatment initiation) LFTs that are WNL?

If meets above renewal criteria, A, Ca-d, then approve elagolix for the number of months to meet the maximum of 24 total months of treatment (surgically proven endometriosis) or 6 total months of treatment (surgically proven endometriosis with

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES primary symptom of dyspareunia). Note: we need to know when treatment was started in order to code approval to maximum length of therapy.

Creation date: 3/30/2020 Effective date: 2/6/2021 Reviewed date: Revised date:

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES FENFLURAMINE - FINTEPLA

Generic Brand HICL GCN Exception/Other FENFLURAMINE FINTEPLA 02116 48284

GUIDELINES FOR INITIAL USE

All the following must be met:

1. patient is 2 years of age or older 2. medication is prescribed by or in consultation with a neurologist 3. patient has a diagnosis of Dravet Syndrome (DS) 4. patient has a contraindication to or has previously trialed each of the following: valproate, clobazam, topiramate, levetiracetam, cannabidiol, stiripentol and continued to have 4 or more convulsive seizures per month despite optimized therapy 5. will be used as adjunctive therapy with at least one other anti-seizure drug

AND

6. has documentation of an Echocardiogram as per REMS requirement (within prior 6mos) 7. Patient does not have either of the following: - moderate or severe renal impairment defined as < 50ml/min - a diagnosis of liver disease. See Appendix for examples. 8. female patients cannot be pregnant or planning to become pregnant

If above initial criteria 1-8 are met, then approve x 6 months If criteria are not met, then do not approve

RENEWAL CRITERIA All the following must be met:

1. patient has not experienced weekly seizures while taking fenfluramine 2. female patients are NOT pregnant or planning to become pregnant 3. will continue to be used as adjunctive therapy with at least one other antiepileptic drug

If above renewal criteria 1-3 are met, then approve x 1 year If criteria are not met, then do not approve

Creation date: 1/30/2021 Effective date: 2/6/2021 Reviewed date: Revised date:

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES LAROTRECTINIB VITRAKVI

Generic Brand HICL GCN Exception/Other LAROTRECTINIB VITRAKVI 45494 Nonformulary SULFATE

GUIDELINES FOR INITIAL USE

A) Solid Tumor with NTRK gene fusion Must meet all of the following criteria:

1) Must be prescribed by an oncology specialist 2) Must have a solid tumor 3) Must have a confirmed neurotrophic receptor tyrosine kinase (NTRK) gene fusion 4) Must not have a known acquired resistance mutation 5) Must have metastatic disease or non-metastatic disease that cannot be surgically resected without likely resulting in severe morbidity 6) Must have no satisfactory alternative treatment options or must have progressed following alternative treatment 7) Must not have progressed through entrectinib 8) Must have an intolerance or contraindication to entrectinib

If above initial criteria, A 1-8, are met, then approve x 12 months If criteria are not met, then do not approve; recommend entrectinib if patient has not progressed through, and does not have an intolerance or contraindication to entrectinib

RENEWAL/NEW MEMBER/CONTINUED USE CRITERIA Must meet all the following criteria: • Patient’s disease has not progressed since initiation of medication OR treating provider believes patient is deriving significant clinical benefit to justify treatment continuation

If above renewal criteria are met, then approve x 12 months If criteria are not met, then do not approve

Creation date: 1/30/2021 Effective date: 2/6/2021 Reviewed date: Revised date:

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES MYCAPSSA - OCTREOTIDE

Generic Brand HICL GCN Exception/Other OCTREOTIDE MYCAPSSA 02826 48334 Nonformulary ACETATE

GUIDELINES FOR INITIAL USE

A) Must meet all of the following criteria: 1. Patient must be age 18 or older 2. Must be prescribed by an Endocrinology specialist or in consultation with an Endocrinologist 3. Must have a diagnosis of acromegaly 4. Must have had an inadequate response to surgery or radiation or had documentation these are not appropriate 5. The patient has tolerated and responded to, and is currently stable (defined as currently receiving a stable dose for at least the previous 3 months) on an injectable somatostatin analog therapy (e.g., octreotide, lanreotide, pasireotide) 6. Documentation of severe injection site pain or reaction using injectable somatostatin analog therapy for long-term maintenance treatment

*Documentation of a member having a needle phobia or unwillingness to receive injections does not qualify as a medically acceptable contraindication or clinical inappropriateness to injectable products.

If ALL the above initial criteria, 1-6, are met then approve x 3 months with max daily dose of 4 capsules per day

RENEWAL CRITERIA

Must meet all the following criteria: 1. Individual’s condition responded while on therapy defined as meeting ALL of the following criteria: a. Achieved and maintains both: i. GH levels are < 1 µg/L within 2-hours after 75 g of oral glucose ii. IGF-1 levels are less than or equal to the upper limit of normal for the patient’s age and gender b. No evidence of disease progression

If ALL, the above renewal criteria is met then approve x 12 months with max daily dose of 4 capsules per day

Creation date: 1/30/2021 Effective date: 2/6/2021 Reviewed date: Revised date:

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES ONGENTYS - OPICAPONE

Generic Brand HICL GCN Exception/Other OPICAPONE ONGENTYS 45536 45838 Nonformulary

GUIDELINES FOR INITIAL AND NEW MEMBER USE

A) Must meet all of the following criteria: 1. Patient must be age 18 or older 2. Must be prescribed by a Neurologist or given in consultation with a neurologist 3. Must have a diagnosis of Parkinson's disease 4. Is experiencing≥ 2 hours ‘off’ time despite maximally tolerated levodopa/carbidopa 5. Have failed two of the following adjunct drugs prescribed in combination with levodopa/carbidopa, unless contraindicated or clinically significant adverse effects are experienced: a) COMT inhibitor: entacapone (Comtan®, Stalevo® or their generics) AND b) MAO-B inhibitor: selegiline OR c) Dopamine agonist: ropinirole, pramipexole

If initial criteria A 1-5, above are met, then approve at GPID x6 months

RENEWAL CRITERIA

Must meet all the following criteria: 1. Currently receiving medication via KPCO benefit or has previously met initial approval criteria 2. Patient has shown improvement of symptoms since starting on the drug

If renewal criteria above are met, then approve at GPID x12 months

Creation date: 1/30/2021 Effective date: 2/6/2021 Reviewed date: Revised date:

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES FULPHILA (PEGFILGRASTIM)

Generic Brand HICL GCN Exception/Other PEGFILGRASTIM- FULPHILA 45010 44881 biologic JMDB 6MG/0.6ML PEGFILGRASTIM NEULASTA 23255 15666/37706 6MG/0.6ML PEGFILGRASTIM NEULASTA 23255 37706 6MG/0.6ML ONPRO PEGFILGRASTIM- UDENYCA 45445 45679 biologic CBQV 6MG/0.6ML PEGFILGRASTIM- ZIEXTENZO 47234 46183 biologic BMEZ 6MG/0.6ML PEGFILGRASTIM- NYVEPRIA anticipated in 2021 UNKNOWN

GUIDELINES FOR INITIAL USE and CONTINUED USE CRITERIA A) ADULT USE Must meet all the following criteria (ADULT): 1. Must be 18 years of age or older 2. Must be prescribed by a Hematology/Oncology specialist 3. Must have experienced febrile neutropenia or neutropenia resulting in delay of chemotherapy despite 14 days of Zarxio If criteria A above are met, then approve Fulphila x6 months. If does not meet criteria, direct to Zarxio.

B) PEDIATRIC USE Must meet all the following criteria (PEDS): 1. Must be <18 years of age 2. Must be prescribed by a Hematology/Oncology specialist 3. Must be using pegfilgrastim to prevent febrile neutropenia with chemotherapy

If criteria B above are met, then approve Fulphila x6 months. If not, direct to Zarxio.

Creation date: 12/1/2018 Effective date: 2/7/2021 Reviewed date: 1/1/2021 Revised date: 1/1/2021

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES TKI 2nd Generation

Generic Brand HICL GCN Exception/Other DASATINIB SPRYCEL 33855 Formulary NILOTINIB TASIGNA 35149 Formulary BOSUTINIB BOSULIF 39590 NonFormulary PONATINIB ICLUSIG 39859 NonFormulary

GUIDELINES FOR INITIAL USE

A - Dasatinib (Sprycel) for Chronic Phase of Chronic Myeloid Leukemia (CML) B - Dasatinib (Sprycel) for Accelerated or Blast Phase of Chronic Myeloid Leukemia (CML) C - Dasatinib (Sprycel) for Acute Lymphoblastic Leukemia (ALL) D - Nilotinib (Tasigna) for Chronic Myeloid Leukemia (CML) E - Nilotinib (Tasigna) for Acute Lymphoblastic Leukemia (ALL) F - Bosutinib (Bosulif) for All Phases of CML and ALL G - Ponatinib (Iclusig) for All Phases of CML and ALL H - Dasatinib (Sprycel), Nilotinib (Tasigna) for Gastrointestinal Stromal Tumor (GIST) I - All other indications

Must meet the following criteria based on drug and diagnosis:

A. Dasatinib for CML – Chronic Phase Must meet all of the following 1. Must be prescribed by an Oncology specialist 2. Patient must have Philadelphia Chromosome (aka BCR-ABL) and ONE OF the following: a. Patient has tried and failed imatinib with an inadequate response/TKI resistance by BCR-ABL1 per NCCN criteria that is NOT due to patient nonadherence AND patient adherence has been assessed b. Patient must have a documented intolerance to imatinib not alleviated by dose reductions (<200 mg/day [adult] or 260mg/m2 [peds; if this calculates to >200mg/day use adult dose cutoff]) c. Patient has a contraindication to imatinib d. Patient has Intermediate or High Sokal Score (0.8 or greater) e. Patient has one of the following BCR-ABL1 mutations: Y253H, E255K/V or F359V/C/I

If above initial criteria, A, are met, then approve x 2 years If criteria are not met, do not approve and direct to imatinib

B. Dasatinib for CML – Accelerated Phase or Blast Phase 1. Accelerated Phase a. Must be prescribed by an Oncology specialist

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES b. Patient must have Philadelphia Chromosome (aka BCR-ABL) and ONE OF the following: i. Peripheral blood myeloblasts ≥15% and <30% ii. Peripheral blood myeloblasts and promyelocytes combined ≥30% iii. Peripheral blood basophils ≥20% iv. Platelet count ≤100 x 109/L unrelated to therapy v. Additional clonal cytogenetic abnormalities in Ph+ cells 2. Blast Phase a. Must be prescribed by an Oncology specialist b. Patient must have Philadelphia Chromosome (aka BCR-ABL) and ONE OF the following: i. ≥30% blasts in the blood, marrow, or both ii. Extramedullary infiltrates of leukemic cells

If above initial criteria, B, are met, then approve x 2 years If criteria are not met, do not approve

C. Dasatinib for Acute Lymphoblastic Leukemia (ALL) Must meet all the following: 1. Must be prescribed by an Oncology specialist 2. Patient must have Philadelphia Chromosome (aka BCR-ABL) 3. Must NOT have any of the following BCR-ABL1 mutations: T315I/A, F317L/V/I/C or V299L

If above initial criteria, C, are met, then approve indefinitely If criteria are not met, do not approve

D. Nilotinib for CML (any phase) Must meet all of the following: 1. Must be prescribed by an Oncology specialist 2. Patient must have Philadelphia Chromosome (aka BCR-ABL) and ONE OF the following: a. Patient has tried and failed dasatinib with an inadequate response/TKI resistance by BCR-ABL1 per NCCN criteria that is NOT due to patient nonadherence AND patient adherence has been assessed b. Patient must have a documented intolerance to dasatinib not alleviated by dose reductions (<70 mg/day for adults]; for peds use below weight-based dosing) c. Patient developed pulmonary arterial hypertension (PAH) during treatment with dasatinib (at any dose) d. Patient must have one of the following BCR-ABL1 mutations: F317L/V/I/C, T315A, or V299L

If above initial criteria, D, are met, then approve x 2 years If criteria are not met, do not approve and direct to dasatinib (if meets that criteria) or imatinib

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES

E. Nilotinib for ALL Must meet all of the following: 1. Must be prescribed by an Oncology specialist 2. Patient must have Philadelphia Chromosome (aka BCR-ABL) and ONE OF the following: a. Patient must have a documented intolerance to dasatinib not alleviated by dose reductions (<70 mg/day for adults]; for peds use below weight-based dosing) b. Patient developed pulmonary arterial hypertension (PAH) during treatment with dasatinib (at any dose) c. Patient must NOT have any of the following BCR-ABL1 mutations: T315I, Y253H, E255K/V, F359V/C/I or G250E

If above initial criteria, E, are met, then approve indefinitely If criteria are not met, do not approve and direct to dasatinib (if meets that criteria) or imatinib

F. Bosutinib for CML (any phase) or ALL Must meet all of the following: 1. Must be prescribed by an Oncology specialist 2. Patient must be 18 years or older 3. Patient must have Philadelphia Chromosome (aka BCR-ABL) and ONE OF the following criteria: a. Patient must have a documented intolerance to dasatinib AND nilotinib not alleviated by dose reductions (see below) i. Nilotinib: 400mg/day ii. Dasatinib: 70mg/day 1. If patient developed pulmonary arterial hypertension (PAH) during treatment with dasatinib (at any dose), patient may be deemed “intolerant” b. Patient must have one of the following BCR-ABL1 mutations: E255K/V, F317L/V/I/C, F359V/C/I, T315A, or Y253H c. CML ONLY: Patient has tried and failed dasatinib AND nilotinib with an inadequate response/TKI resistance by BCR-ABL1 per NCCN criteria that is NOT due to patient nonadherence AND patient adherence has been assessed d. ALL ONLY (must meet both): i. Must NOT have any of the following BCR-ABL1 mutations: T315I, V299L, G250E or F317L ii. Patient has tried and failed dasatinib AND nilotinib

If above initial criteria, F, are met, then approve x 2 years If criteria are not met, do not approve

G. Ponatinib for CML (any phase) or ALL Must meet all of the following:

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES 1. Must be prescribed by an Oncology specialist 2. Patient must be 18 years or older 3. Patient must have Philadelphia Chromosome (aka BCR-ABL) and ONE OF the following criteria: a. Patient has tried and failed dasatinib AND nilotinib AND bosutinib with an inadequate response/TKI resistance by BCR-ABL1 per NCCN criteria that is NOT due to patient nonadherence AND patient adherence has been assessed b. Patient must have a documented intolerance to ALL OF the following agents not alleviated by dose reductions: i. Bosutinib: ≤300mg/day ii. Nilotinib: 400mg/day iii. Dasatinib: 70mg/day 1. If patient developed pulmonary arterial hypertension [PAH] during treatment with dasatinib at any dose, patient may be deemed “intolerant” c. Patient must have one of the following BCR-ABL1 mutations: T315I

If above initial criteria, G, are met, then approve indefinitely If criteria are not met, do not approve

H. Dasatinib or Nilotinib for Gastrointestinal Stromal Tumor (GIST) Must meet all the following: 1. Must be prescribed by an Oncology specialist 2. Patient must have metastatic or unresectable GIST 3. Patient has had disease progression, documented intolerance, or contraindications to ALL of the following: imatinib, avapritinib, sunitinib, regorafenib, ripretinib 4. Dasatinib ONLY: Patient must have PDGFRA D842V mutation

If above initial criteria, H, are met, then approve indefinitely If criteria are not met, do not approve

I. Any of the above medications for any other diagnosis (eg, hypersosinophilic syndrome, eosinophilic leukemia, dermatofibrosarcoma, chordoma) Must meet all the following: 1. Prescribed by an Oncologist 2. Use must meet the Medicare Compendia criteria as detailed in the following policy: Medicare Benefit Policy Manual Chapter 15 – Covered Medical and Other Health Services Section 50.4.5 – Off-Label Use of Drugs and Biologicals in an Anti-Cancer Chemotherapeutic Regimen

If above criteria are met, then approve x 1 year If criteria are not met, do not approve

RENEWAL AND CONTINUED USE CRITERIA (any indication)

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES Must meet ONE of the following criteria: 1. Patient has been on the TKI for greater than 3 months and ONE OF the following criteria: a. Disease progression or relapse are NOT noted in the chart b. Patient has experienced improvement in disease symptoms since starting the medication c. New KPCO member and seen/prescribed by an Oncologist

If the above renewal criteria are met, then approve x 2 years

Creation date: 11/20/2019 Effective date: 2/7/2021 Reviewed date: Revised date:

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES AZACITIDINE - ONUREG

Generic Brand HICL GCN Exception/Other AZACITIDINE ONUREG 26361 48540, Nonformulary 48545 Specialty Tier

GUIDELINES FOR INITIAL USE

A) Must meet all of the following criteria: 1. Patient must be age 18 or older 2. Must be prescribed by an Oncologist 3. Must have diagnosis of acute myeloid leukemia (AML) 4. Must be in first complete response (CR or Cri, see below) after receiving initial intensive induction therapy (cytarabine + anthracycline) for AML - CR=complete response = Blasts <5%, ANC >1000, Platelets ≥100,000, patient currently independent of transfusions - CRi = complete response but with incomplete hematologic recovery = all CR criteria met (including current transfusion independence) but with persistent neutropenia (ANC <1000) and/or thrombocytopenia (<100,000) 5. Attained CR/CRi within prior 4 months 6. Must NOT be a hematopoietic stem cell transplant (HSCT, aka BMT) candidate 7. Does NOT have an allergy to mannitol or azacitidine

If initial criteria A 1-8 above are met, then approve at HICL level x12 months and a maximum dose of #14 tabs in 28 days

RENEWAL CRITERIA

Must meet all the following criteria: 1. Patient does not have disease relapse of AML (>15% blasts on bone marrow or in blood) 2. Patient has not undergone hematopoietic stem cell transplant (HSCT, aka BMT)

If renewal criteria above are met, then approve at HICL level x12 months and a maximum dose of #14 tabs in 28 days.

Creation date: 3/24/2021 Effective date: 4/15/2021 Reviewed date: Revised date:

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES ENSPRYNG

Generic Brand HICL GCN Exception/Other SATRALIZUMAB- ENSPRYNG 46781 48477 Nonformulary MWGE Specialty Tier

For New Members to KP on Satralizumab within 90days of membership start date - Approve up to a 90-day transitional supply - After the (up to) 90-day transitional supply has expired use new start criteria for review of continuation of therapy

GUIDELINES FOR INITIAL USE and New Members after the 90 day transition period

A) Must meet all the following criteria: 1. Patient must be age 18 or older 2. Must be prescribed by a Neurologist 3. At the time of the initial request, member does not have a) active hepatitis B infection (positive results for hepatitis B surface antigen and anti-hepatitis B virus tests) or b) active or untreated latent tuberculosis or c) neutrophil counts within normal limits (obtained within 3 months) d) AST or ALT levels > 1.5 times upper limit of normal (obtained within 3 months)

AND must meet the diagnosis/drug specific criteria below-

B) To treat Neuromyelitis Optica Spectrum Disorder Must meet all the following: 1. Diagnosis of NMOSD with positive serologic test for anti-AQP4 antibodies. 2. Member must have experienced either: a. Patient has achieved relapse freedom on Tocilizumab IV 8mg/kg q4weeks but has a documented severe infusion reaction with Tocilizumab AND b. Must meet one of the following: i. A severe* breakthrough relapse while on rituximab or biosimilar for at least 6-months at recommended NMO dosing** not attributed rapid steroid withdrawal or discontinuation ii. Recurrent breakthrough relapse after 6-month trial of rituximab or biosimilar at recommended NMO dosing** in combination with maximum tolerated doses of either mycophenolate mofetil or azathioprine

3. Patient has a documented severe intolerance to or a contraindication to rituximab or biosimilar. 4. Patient will not be receiving satralizumab in combination with any of the following: a. Disease modifying therapies for the treatment of multiple sclerosis [e.g., Gilenya (fingolimod), Tecfidera (dimethyl fumarate), Ocrevus (ocrelizumab), etc.]

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES b. Complement inhibitors [e.g., Soliris (eculizumab)] c. Anti-IL6 therapy [e.g., Actemra (tocilizumab)] d. B-cell depletion therapy [e.g. rituximab, Uplizna (inebilizumb-cdon)]

If initial criteria A and B above are met, then approve at HICL level (override PA Res and Formulary) x 6 months

RENEWAL CRITERIA

Must meet all the following criteria: 1. Currently receiving medication via prior KPCO approval or member has previously met initial approval criteria; 2. Member is responding positively to therapy – including but not limited to improvement or stabilization in any one of the following parameters: a. Frequency of relapse b. Pain and/or fatigue and/or motor function or in progression of symptoms c. Visual acuity 3. Patient is not receiving satralizumab in combination with any of the following: a. Disease modifying therapies for the treatment of multiple sclerosis [e.g., Gilenya (fingolimod), Tecfidera (dimethyl fumarate), Ocrevus (ocrelizumab), etc.] b. Complement inhibitors [e.g., Soliris (eculizumab)]; Anti-IL6 therapy [e.g., Actemra (tocilizumab)]; B-cell depletion therapy [e.g. rituximab, Uplizna (inebilizumb- cdon)] 4. Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include the following: severe hypersensitivity reactions, serious infections, severe hepatotoxicity, severe neutropenia, etc.

If renewal criteria above, 1 through 4, are met, then approve at HICL level (override PA Res and Formulary) x12 months If no, do not approve

Creation date: 3/24/2021 Effective date: 4/15/2021 Reviewed date: Revised date:

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES EVRYSDI

Generic Brand HICL GCN Exception/Other RISDIPLAM EVRYSDI 46765 48456 Nonformulary Specialty Tier Survival motor neuron 2 (SMN2) - directted RNA splicing modifier

GUIDELINES FOR INITIAL USE (see Renewal for New Members and continued use)

Must meet all the following criteria: 1) Patient must be between 6 months to 25 years of age 2) Must be prescribed by a Neurologist

AND

Must meet all the following criteria for Spinal Muscular Atrophy (SMA): 3) Confirmed diagnosis of 5q-autosomal recessive SMA (biallelic deletions or mutations in the SMN1 gene) 4) ≥2 SMN2 gene copies 5) No prior or planned treatment with onasemnogene abeparvovec or other gene therapy for SMA 6) No concurrent treatment with nusinersen (Spinraza) 7) Patient does not require/have permanent invasive ventilation or tracheostomy 8) Patient is not dependent on invasive or non-invasive ventilation during waking hours each day to control hypercarbia, or development of hypercarbia without ventilatory support

AND

All the following baseline assessments MUST be completed and documented: 9) Recent LFT and PT/PTT completed (see rationale if abnormal) 10) Motor function assessment(s) as appropriate based on age and ambulatory status(see attached) 11) Pulmonary assessment(s) as appropriate based on age and ambulatory status(see attached)

If patient is < 6 months of age, recommend onasemnogene abeparvovec-xioi (Zolgensma)

If all initial criteria, 1 – 11, above are met, approve at HICL level (override PA Res and Formulary) x12 months

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES Notify neurology clinical pharmacy specialists and KP CPMG neurologist representative for all approvals and denials^ (See attached)

RENEWAL and CONTINUED USE CRITERIA (Use for New members)

Must meet all the following criteria: 1) LFTs, PT, PTT completed at least annually while on therapy 2) Motor function assessment(s)* completed at least annually while on therapy 3) Pulmonary assessment* completed at least annually while on therapy 4) No concurrent treatment with nusinersen (Spinraza) 5) Patient does not require/have permanent invasive ventilation or tracheostomy 6) Patient is not dependent on invasive or non-invasive ventilation during waking hours each day to control hypercarbia, or development of hypercarbia without ventilatory support 7) Patient has not experienced loss of function or progressive weakness (physical and/or pulmonary)

If all Renewal/Continued use criteria, 1 – 7, above are met, then approve at HICL level (override PA Res and Formulary) x12 months

Creation date: 3/24/2021 Effective date: 4/15/2021 Reviewed date: Revised date:

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES ISTURISA

Generic Brand HICL GCN Exception/Other OSILODROSTAT ISTURISA 46396 47793, Nonformulary 47794, 47795

GUIDELINES FOR INITIAL USE

A. Must meet ALL of the following criteria: 1. Patient must be 18 years of age or older 2. Prescriber must be an Endocrinologist 3. Documented diagnosis of Cushing’s disease 4. Documentation of failed pituitary surgery or contraindication to pituitary surgery 5. ALL of the following baseline tests have been completed before initiation of treatment with continued monitoring as clinically appropriate: + Serum potassium and magnesium + Electrocardiogram (ECG)

AND must meet the diagnosis/drug specific criteria below:

B. Treatment to inhibit cortisol synthesis (steroidogenesis inhibitors) in Cushing’s disease Individual has failed, or is intolerant to, has a contraindication, to ALL of the following or if neither drug is available due to National shortage, then skip this criteria : a. Oral ketoconazole b. Oral metyrapone

C. Treatment to reduce ACTH level’s in Cushing’s disease related to pituitary tumor Individual has failed, or is intolerant to, or has a contraindication to ALL of the following: a. Oral ketoconazole b. Oral cabergoline c. Injectable pasireotide

If initial criteria, A1-5 AND either B or C, above are met, then approve at HICL level x 3 months with a quantity limit of 6 tablets per day

RENEWAL CRITERIA

Must meet ALL the following criteria: 1. Individual’s condition responded while on therapy. Response is defined as: • Achieved and maintains at least THREE of the following: - A urinary free cortisol (UFC) ≤ the upper limit of normal (ULN) - Cortisol levels is within normal limits - No symptoms consistent with Cushing’s disease - No evidence or symptoms of hypocorticolism

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES - No evidence of disease progression 2. Individual has not developed any significant level 4 adverse drug effects that may exclude continued use such as: adrenal insufficiency, QTc prolongation, hypokalemia that is uncontrolled with supplementation and use of mineralocorticoid antagonist and severe hypocortisolism

If renewal criteria above are met, then approve at HICL level x 12 months with a quantity limit of 6 tablets per day

Creation date: 3/24/2021 Effective date: 4/15/2021 Reviewed date: Revised date:

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES TAFINLAR

Generic Brand HICL GCN Exception/Other DABRAFENIB TAFINLAR 34723, Non-Formulary 34724

GUIDELINES FOR INITIAL USE (See New KP Member/Renewal Criteria at the Bottom)

A) Must meet all the following criteria: 1. Must be prescribed by an oncologist 2. Must have a BRAF V600 activating mutation positive tumor

AND must meet the diagnosis/drug specific criteria below- - Evaluate appropriateness of request for patient specific diagnosis (if other than cutaneous melanoma)

B) CUTANEOUS MELANOMA (ADJUVANT SETTING) 1. Must be requested in the adjuvant treatment setting

If initial criteria A and B above are met, then approve x 12 months with max daily dose of 4 tablets/day.

C) CUTANEOUS MELANOMA (UNRESECTABLE OR METASTATIC SETTING) 1. Must be requested in unresectable or metastatic (advanced) setting 2. Must have confirmed brain metastasis OR patient is already on vemurafenib and is having unacceptable toxicities despite adequate dose reductions when appropriate AND either 3 or 4- 3. If the request is for dabrafenib monotherapy: Must NOT have progressed through other BRAF-targeted therapies in the unresectable or metastatic (advanced) setting - Examples of other BRAF-targeted therapies include vemurafenib, encorafenib 4. If the request is for dabrafenib/trametinib combination therapy: Must NOT have progressed through other BRAF/MEK combination therapy in the unresectable or metastatic (advanced) setting - Examples of other BRAF/MEK combination therapies include vemurafenib/cobimetinib, encorafenib/binimetinib

-If initial criteria A and C above are met, then approve x 12 months with max daily dose of 4 tablets/day. -If initial criteria A is met, but C.2. is not met, patient must use vemurafenib. -If initial criteria A is met, but C.3. is not met, inform requesting provider that there is not enough evidence to support use of dabrafenib monotherapy after progression on other BRAF-targeted therapies in the unresectable or metastatic (advanced) setting. -If initial criteria A is met, but C.4. is not met, inform requesting provider there is not enough evidence to support use of dabrafenib/trametinib combination therapy after progression on other BRAF/MEK combination therapies in the unresectable or metastatic (advanced) setting.

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES

RENEWAL CRITERIA or NEW KP MEMBER

Must meet all the following criteria: 1. Patient’s disease has not progressed since treatment initiation OR treating provider believes patient is deriving significant clinical benefit to justify treatment continuation a. Note that provider does NOT need to prove lack of progression via imaging, a clinical evaluation suffices for renewal/new KP member

If renewal criteria above are met then - Approve for duration needed to complete a total of 12 months of adjuvant treatment (for adjuvant setting) with max daily dose of 4 tablets/day. - Approve x 12 months (for unresectable or metastatic setting) with max daily dose of 4 tablets/day.

Creation date: 3/30/2020 Effective date: 4/15/2021 Reviewed date: Revised date:

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES TRAMETINIB

Generic Brand HICL GCN Exception/Other TRAMETINIB MEKINIST 40361 34726, Nonformulary DIMETHYL 34727 SULFOXIDE

GUIDELINES FOR INITIAL USE (See New KP Member/Renewal Criteria at the Bottom)

A) Must meet all of the following criteria: 1. Must be prescribed by an oncologist 2. Must have a BRAF V600 activating mutation positive tumor

AND must meet the diagnosis/drug specific criteria below- - Evaluate appropriateness of request for patient specific diagnosis (if other than cutaneous melanoma)

B) CUTANEOUS MELANOMA (ADJUVANT SETTING) 1. Must be requested in the adjuvant treatment setting 2. Must be requested in combination with dabrafenib

If initial criteria A and B above are met, then approve x 12 months with max daily dose of 3 tablets/day.

C) CUTANEOUS MELANOMA (UNRESECTABLE OR METASTATIC SETTING) 1. Must be requested in unresectable or metastatic (advanced) setting 2. Must be requested in combination with dabrafenib 3. Must NOT have progressed through other MEK-targeted therapies in the unresectable or metastatic (advanced) setting - Examples of other MEK-targeted therapies include cobimetinib, binimetinib 4. Must have confirmed brain metastasis OR patient is already on cobimetinib and is having unacceptable toxicities despite adequate dose reductions when appropriate

-If initial criteria A and C above are met, then approve x 12 months with max daily dose of 3 tablets/day. -If initial criteria A is met, but C.2. is not met, inform requesting provider that trametinib must be used in combination with dabrafenib. -If initial criteria A is met, but C.3. is not met, inform requesting provider that there is not enough evidence to support use of trametinib after progression on other MEK-targeted therapies in the unresectable or metastatic (advanced) setting. -If initial criteria A is met, but C.4. is not met, patient must use cobimetinib (in combination with vemurafenib).

RENEWAL CRITERIA or NEW KP MEMBER

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES Must meet all the following criteria: 1. Patient’s disease has not progressed since treatment initiation OR treating provider believes patient is deriving significant clinical benefit to justify treatment continuation a. Note that provider does NOT need to prove lack of progression via imaging, a clinical evaluation suffices for renewal/new KP member

If renewal criteria above are met then - Approve for duration needed to complete a total of 12 months of adjuvant treatment (for adjuvant setting) with max daily dose of 3 tablets/day. - Approve x 12 months (for unresectable or metastatic setting) with max daily dose of 3 tablets/day.

Creation date: 3/30/2020 Effective date: 4/15/2021 Reviewed date: Revised date:

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES BRAND GLATIRAMER ACETATE

Generic Brand HICL GCN Exception/Other GLATIRAMER COPAXONE 20 12810 17178 Brand is ACETATE MG/ML GPID Nonformulary GLATIRAMER COPAXONE 40 12810 35983 Brand is ACETATE MG/ML GPID Nonformulary

GUIDELINES FOR INITIAL USE and NEW MEMBERS

Must meet all the following criteria: 1. Must be prescribed by a CPMG neurologist or an affiliated network neurologist with appropriate referral, if needed. 2. Diagnosis of a relapsing or active form of multiple sclerosis (this does not include non-active secondary progressive MS or primary progressive MS). 3. Patient has tried generic glatiramer acetate and experienced a significant intolerance* that is NOT expected to occur with brand Copaxone. 4. Patient has tried and failed (intolerable side effects) or has a precaution or contraindication to dimethyl fumarate AND an interferon beta-1b/1a.

If all of the above are met, then approve at GPID level x 2 years

RENEWAL CRITERIA

If all the above renewal criteria are met, then approve at GPID level x 2 years

* Significant Intolerance is: A known symptom of the drug entity, that is not expected with the brand and did not resolve after several months of therapy while on the generic. Example: local injection site reaction(s) with the generic that did not resolve with continued teaching and did not occur with the brand product prior. If patient has NOT had a prior trial of brand product, then would not expect local injection site reactions to resolve with conversion from generic to brand (approval in this case should NOT be given).

Significant Intolerance should not mean: • A side effect that might be caused by another therapy the patient is using or a drug-drug interaction • A side effect that could be attributed to the disease state itself. MS symptoms may fluctuate and come and go.

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES • A side effect that my dissipate with continued use

Creation date: 7/26/2018 Effective date: 4/15/2021 Reviewed date: 3/1/2021 Revised date: 3/1/2021

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES HEPATITIS C MEDICATIONS: DIRECT ACTING ANTIVIRALS

Generic Brand HICL GCN Exception/Other DASABUVIR/OMBITASVIR/ VIEKIRA PAK, 41644 PARITAPREVIR/ RITONAVIR VIEKIRA XR ELBASVIR/GRAZOPREVIR ZEPATIER 43030 GLECAPREVIR/PIBRENTASVIR MAVYRET 44453 LEDIPASVIR/SOFOSBUVIR HARVONI 41457 Formulary OMBITASVIR/PARITAPREVIR/ TECHNIVIE 41734 RITONAVIR SOFOSBUVIR/VELPATASVIR EPCLUSA 43561 Formulary SOFOSBUVIR/VELPATASVIR/ VOSEVI 44428 Formulary VOXILAPREVIR SOFOSBUVIR SOVALDI 40795 Formulary

GUIDELINES FOR USE

Patient must meet criteria #1 OR #2-4: 1. Patient is receiving an HCV positive transplant.

2. Patient has a detectable HCV RNA level. (If the patient has evidence of prescriptions for past HCV treatment, the detectable HCV RNA level must be from at least 12 weeks after completion of the previous treatment.)

AND

3. Patient does NOT have a suspected acute HCV exposure in the last 6 months.

AND

4. Provider attests to the best of their knowledge that patient is NOT abusing/misusing alcohol and/or illegal drugs (per Colorado state law) OR if patient is abusing/misusing alcohol and/or illegal drugs (per Colorado state law), provider attests that the patient is receiving or will be enrolled in counseling or substance use treatment program prior to initiating HCV treatment.

AND Patient must meet all criteria #5-8:

5. Patient is at least 3 years old and currently supervised by a gastroenterologist, infectious disease specialist, provider specializing in the treatment of hepatitis (for example, a hepatologist), or a specially trained group such as ECHO (Extension for Community Healthcare Outcomes) model.

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES 6. Patient is NOT currently taking any medications that have a clinically significant interaction with the Hepatits C medication ordered.*

7. Patient does NOT have a limited life expectancy (less than 12 months) due to non- liver related comorbid conditions.

8. The requested drug correlates with a drug listed within the current KP HCV Treatment Options Table, based on genotype, therapy history and cirrhosis status. (table attached in References section)

If patient meets criteria [#1 and #5-8]: Approve for length of recommended treatment regimen. For Epclusa 400/100 mg (61958-2201-01) and Harvoni 90/400 mg (61958-1801-01), approve a restriction override by using a forced or 'F', at NDC-9 level for the brand product, both are formulary and will be dispensed by the Mayo pharmacy in Arizona (post-transplant) [the force will override the 'must be dispensed by a KP pharmacy restriction'. Otherwise approve at GPID level and override restriction by using a forced or 'F' only for Vosevi and Sovaldi and add a formulary override to Mavyret, Technivie, Zepatier and Viekira

If patient meets criteria [#2-4 AND #5-8]: Approve for length of recommended treatment regimen. For Epclusa 400/100 mg (61958-2201-01) and Harvoni 90/400 mg (61958-1801-01), approve a restriction override at NDC-9 level for the brand product, both are formulary. Otherwise approve at GPID level and override restriction only for Vosevi and Sovaldi and add a formulary override to Mavyret, Technivie, Zepatier and Viekira.

If patient does NOT meet above criteria as outlined: Do not approve^

Note: Only if patient is out of state at a Mayo Clinic and just received an HCV+ liver transplant may you place a force override to allow the Hep C drug to be dispensed by a non-KP pharmacy. Very rare!! ONLY if immediate post transplant and out of state. Note: There are no renewal criteria as reviews using above criteria apply for a one-time treatment regimen.

Creation date: 3/12/2019 Effective date: 4/15/2021 Reviewed date: 3/1/2021 Revised date: 3/1/2021

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES OREXIN RECEPTOR ANTAGONISTS

Generic Brand HICL GCN Exception/Other LEMBOREXANT DAYVIGO 46275 Nonformulary SUVOREXANT BELSOMRA 41333 Nonformulary

GUIDELINES FOR INITIAL USE

A. Must meet ALL of the following criteria: 1. Patient must be age 18 or older 2. Diagnosis of insomnia characterized by difficulties with sleep onset and/or sleep maintenance 3. Potential factors contributing to sleep disturbances have been addressed (e.g., inappropriate sleep hygiene, sleep environment issues and co-morbid conditions contributing to insomnia) 4. Patient has no history of substance abuse 5. Patient has no history of narcolepsy

AND must meet ONE of the age-specific criteria below, B or C:

B. Age > 65 years of age Must meet all the following: 1. History of trial and failure of at least 2 weeks, contraindication, or intolerance to trazodone 2. History of trial and failure of at least 2 weeks, contraindication, or intolerance to ramelteon or OTC melatonin

C. Age < 65 years of age Must meet all the following: 1. History of trial and failure of at least 2 weeks, contraindication, or intolerance to trazodone 2. History of trial and failure of at least 2 weeks, contraindication, or intolerance to ramelteon or OTC melatonin 3. History of trial and failure of at least 2 weeks, contraindication, or intolerance to at least TWO of the following sedative-hypnotic alternatives: zolpidem (F), zaleplon (NF), eszopiclone (NF)

AND must meet criteria listed below based on requested drug: 1. Lemborexant (Dayvigo)

a. If initial criteria A and age criteria B or C are met, approve at HICL level (override PA Res and Formulary) x 6 months with max daily dose of 1 tablet per day

2. Suvorexant (Belsomra):

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES a. Patient has tried and failed, has an intolerance or a contraindication to lemborexant (Dayvigo)

If initial criteria A and age criteria B or C and 2a are met, approve at HICL level (override PA Res and Formulary) x 6 months with max daily dose of 1 tablet per day.

RENEWAL CRITERIA

Must meet all the following criteria: 1. Patient has shown improvement of symptoms since starting on the drug and has not developed any intolerances or contraindications.

If renewal criteria above are met then approve at HICL level x 12 months with a max daily dose of 1 tablet per day

Creation date: 3/24/2021 Effective date: 4/15/2021 Reviewed date: Revised date:

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES LHRH ANTAGONIST ORGOVYX

Generic Brand HICL GCN Exception/Other RELUGOLIX ORGOVYX 47035 49005 Nonformulary

GUIDELINES FOR INITIAL USE

A) Must meet all of the following criteria: 1. Patient must be age 18 or older 2. Must be prescribed by an Oncologist or Urologist 3. Must have biopsy-confirmed prostate adenocarcinoma 4. Serum PSA level at diagnosis >2ng/mL

AND must meet the drug specific criteria below-

B) Relugolix (Orgovyx) Must meet ALL of the following: 1. Must have metastatic disease or biochemical recurrence 2. Must be castration-sensitive (no history of progression or PSA rise on androgen deprivation therapy [leuprolide,goserelin, triptorelin, histrelin, degarelix, bilateral orchiectomy) 3. No active uncontrolled Crohn’s disease or active peptic ulcer disease or history of gastric bypass surgery or gastrectomy 4. Must have a history of a major cardiovascular event (myocardial infarction, angina, symptomatic ischemic heart disease, CHF, ventricular arrhythmias, 2nd degree heart block, stroke) 5. Serum testosterone level at diagnosis ≥150ng/dL 6. Patient must be intolerant of degarelix

If initial criteria A and B above are met, then approve at HICL indefinitely

Creation date: 3/24/2021 Effective date: 4/15/2021 Reviewed date: Revised date:

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES NARCOLEPSY

Generic Brand HICL GCN Exception/Other SODIUM XYREM 12346 18104 Least preferred OXYBATE PITOLISANT HCL WAKIX 45575 45948, 2nd most preferred 45949 SOLRIAMFETOL SUNOSI 45666 46126, Most preferred HCL 46127 SODIUM, XYWAV 46743 48419 3rd preferred CALCIUM, MAG, POT. OXYBATE

GUIDELINES FOR USE FOR ALL NEW STARTS

IS THE PATIENT CURRENTLY USING ONE OF THESE PRODUCTS? If yes, use the RENEWAL CRITERIA If not currently using (new start) then continue with #1 immediately below

1. Is this medication prescribed by a physician who is Board Certified in Sleep Medicine or Neurology?

If yes, continue to #2, #3 or #4 based on diagnosis If no, do not approve.

2. For excessive daytime sleepiness due to Narcolepsy or Idiopathic Hypersomnia, based on drug requested: a. Sunosi will be approved if all the following criteria are met: i. A formulary alternative of each of the following has been tried and failed (need medication name, dose and reason for failure or reason for contraindication) 1. Amphetamines 2. Methylphenidate 3. Modafinil/Armodafinil

b. Wakix will be approved if all of the following criteria are met: i. A formulary alternative of each of the following has been tried and failed (need medication name, dose and reason for failure or reason for contraindication) 1. Amphetamines 2. Methylphenidate 3. Modafinil/Armodafinil AND ii. Trial of Sunosi, unless reason for contraindication provided

c. Xywav will be approved if all of the following criteria are met: i. A formulary alternative of each of the following has been tried and failed (need medication name, dose and reason for failure or reason for contraindication)

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES 1. Amphetamines 2. Methylphenidate 3. Modafinil/Armodafinil AND ii. Trial of Sunosi, unless reason for contraindication provided AND iii. Trial of Wakix, unless reason for contraindication provide

d. Xyrem will be approved if all of the following criteria are met: i. A formulary alternative of each of the following has been tried and failed (need medication name, dose and reason for failure or reason for contraindication) 1. Amphetamines 2. Methylphenidate 3. Modafinil/Armodafinil AND ii. Trial of Sunosi, unless reason for contraindication provided AND iii. Trial of Wakix, unless reason for contraindication provided AND iv. Trial of Xywav, unless resason for contraindication provided

If all meets initial criteria, 1 and 2 a, b, c or d, then approve x 1 year with the following restrictions: Sunosi - max daily dose 1 tablet/day Wakix - max daily dose of 2 tablets/day Xyrem/Xywav – max daily dose of 18 mL/day

3. For cataplexy (not excessive daytime sleepiness) due to Narcolepsy Based on drug requested: a. Wakix will be approved if all the following criteria are met: i. A formulary alternative of the one of the following has been tried and failed (need medication name, dose and reason for failure or reason for contraindication) 1. a tricyclic antidepressant (TCA) 2. a selective serotonin reuptake inhibitor (SSRI) 3. a selective serotonin-norepinephrine (SNRI) b. Xywav will be approved if all the following criteria are met: i. A formulary alternative of the one of the following has been tried and failed (need medication name, dose and reason for failure or reason for contraindication) 1. a tricyclic antidepressant (TCA) 2. a selective serotonin reuptake inhibitor (SSRI) 3. a selective serotonin-norepinephrine (SNRI) AND ii. Trial of Wakix, unless reason for contraindication provided c. Xyrem will be approved if all the following criteria are met: i. A formulary alternative of the one of the following has been tried and failed (need medication name, dose and reason for failure or reason for contraindication)

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES 1. a tricyclic antidepressant (TCA) 2. a selective serotonin reuptake inhibitor (SSRI) 3. a selective serotonin-norepinephrine (SNRI) AND ii. Trial of Wakix, unless reason for contraindication provided AND iii. Trial of Xywav, unless reason for contraindication provided

If all meets initial criteria, 1 and 3 a, b or c, then approve x 1 year with the following restrictions: Wakix - max daily dose of 2 tablets/day Xyrem/Xywav – max daily dose of 18 mL/day

4. For Hypersomnia associated with Obstructive sleep apnea: a. Sunosi will be approved if all the following criteria are met: i. A formulary alternative of each of the following has been tried and failed (need medication name, dose and reason for failure or reason for contraindication) 1. Amphetamines 2. Methylphenidate 3. Modafinil/Armodafinil If all meets initial criteria, 1 and 4a, then approve x 1 year with the following restrictions: Sunosi - max daily dose 1 tablet/day

RENEWAL CRITERIA FOR USE IN ALL CASES THE PATIENT IS ALREADY USING:

1. Is the the drug prescribed by a physician who is Board Certified in Sleep Medicine or Neurology?

If yes, continue to #2 If no, do not approve

2. Is the drug being used for an FDA-approved indication or supported off-label indication for the specific drug (indications listed in initial criteria)?

If yes, approve x 2 years with the following max daily dose Sunosi - max daily dose 1 tablet/day Wakix - max daily dose of 2 tablets/day Xyrem/Xywav – max daily dose of 18 mL/day If no, do not approve.

Creation date: 3/30/2020 Effective date: 4/15/2021 Reviewed date: 3/1/2021 Revised date: 3/1/2021

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES HUMIRA - ADALIMUMAB

Generic Brand HICL GCN Exception/Other ADALIMUMAB HUMIRA 24800 Formulary ADALIMUMAB HUMIRA (CF) 24800 Formulary

A- Rheumatoid Arthritis (RA) B- Uveitis C- Mild-Moderate Psoriatic Arthritis (PsA) D- Severe PsA E- Ankylosing Spondylitis F- Ulcerative Colitis or Crohn's Disease G- Psoriasis H- Hidradenitis Suppurativa (HS)

GUIDELINES FOR INITIAL USE – Rheumatology Indications:

A) RHEUMATOID ARTHRITIS (RA):

I. NEW START and New member CRITERIA: All the following must be met: #1 or #2,3 &4 below 1. Patient has a diagnosis of RA, is currently stable on therapy with Humira and is prescribed by CPMG or affiliated rheumatologist OR 2. Patient has a diagnosis of RA and is prescribed by CPMG or affiliated rheumatologist AND 3. Patient with failure, intolerance, contraindication to the following: i. at least 2 DMARDs (including methotrexate) ii. tofacitinib (Xeljanz) AND 4. Medication is not being used in combination with another biologic (see references)

If above initial criteria, A1 or A2,3&4, are met, then approve x 2 pens/syringes per 28 days x 2 years If above criteria are not met, then do not approve

III. RENEWAL CRITERIA: 1. Patient’s RA has been assessed by rheumatologist in the past 2 years

If above criteria are met, then approve x 2 pens/syringes per 28 days x 2 years If above criteria are not met, then do not approve

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES

B) UVEITIS:

I. NEW START CRITERIA: All the following must be met: #1 or #2,3 &4 1. Patient has a diagnosis of Uveitis, is currently stable on therapy with Humira and is prescribed by CPMG or affiliated rheumatologist or ophthalmologist

2. Patient has a diagnosis of Uveitis and is prescribed by CPMG or affiliated rheumatologist or ophthalmologist 3. Patient with failure, intolerance, contraindication to at least 1 DMARD AND 4. Severe disease activity (refer to last rheumatologist and/or ophthalmologist visit note)

If above initial criteria, B1 or B2,3 &4, are met, then approve x 4 pens/syringes per 28 days x 2 years If above initial criteria are not met, then do not approve

III. RENEWAL CRITERIA: 1. Patient’s uveitis has been assessed by rheumatologist and/or ophthalmologist in the past 2 years

If above renewal criteria are met, then approve x 4 pens/syringes per 28 days x 2 years If above criteria are not met, then do not approve

ALL PsA DIAGNOSES (C-D): New Start criteria is followed by New Member then Renewal Criteria

I. NEW START CRITERIA:

C) Mild-Moderate PSA: All the following must be met: C1 or C2 and 3 1. Patient has a diagnosis of mild-moderate PsA, is currently stable on therapy with Humira and is prescribed by CPMG or affiliated rheumatologist

2. Patient has a diagnosis of mild-moderate PsA and is prescribed by CPMG or affiliated rheumatologist 3. Patient with failure, intolerance or contraindication to: i. at least two DMARDs (including methotrexate) ii. tofacitinib (Xeljanz)

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES

If above initial criteria, C1 or C2 &3, are met, then approve x 2 pens/syringes per 28 days x 2 years If above criteria are not met, then do not approve

D) Severe PsA: All the following must be met: #1 or #2 &3 1. Patient has a diagnosis of severe PsA, is currently stable on therapy with Humira and is prescribed by CPMG or affiliated rheumatologist OR 2. Patient has a diagnosis of severe PsA and is prescribed by CPMG or affiliated rheumatologist 3. Documentation of poor prognostic factors (refer to last rheumatologist visit note) o Poor prognostic factors includes the presence of 1 or more of the following: erosive disease, dactylitis, elevated ESR/CRP, long-term damage that interferes with function (e.g. joint deformities), high active disease that causes a major impairment in quality of life (i.e. active psoriatic inflammatory disease at many sites [including dactylitis, enthesitis], axial disease, or function-limiting inflammatory disease at few sites), and rapidly progressive disease.

If above initial criteria, D1 or D2&3, are met, then approve x 2 pens/syringes per 28 days x 2 years If above criteria are not met, then do not approve

III. RENEWAL CRITERIA (C – D): 1. Patient’s PsA has been assessed by rheumatologist in the past 2 years

If above renewal criteria are met, then approve x 2 pens/syringes per 28 days x 2 years If above renewal criteria are not met, then do not approve

E) ANKYLOSING SPONDYLITIS:

I. NEW START CRITERIA and New member: The following must be met: 1. Patient has a diagnosis of Ankylosing Spondylitis 2. Request is for a new start on Humira or patient is currently stable on therapy with Humira

If above initial criteria are met, then approve x 2 pens/syringes per 28 days x 1 year If above initial criteria are not met, then do not approve

III. RENEWAL CRITERIA:

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES 1. Patient’s ankylosing spondylitis has been assessed by rheumatologist in the past 2 years

If above renewal criteria are met, then approve x 2 pens/syringes per 28 days x 2 years If above renewal criteria are not met, then do not approve

F) ULCERATIVE COLITIS AND CROHN’S DISEASE:

I. NEW START CRITERIA: All the following must be met: 1. Patient is 6 years of age or older 2. Medication is prescribed by or in consultation with a gastroenterologist 3. Diagnosis of ulcerative colitis, Crohn’s disease, or indeterminant colitis

If above criteria are met, then approve x 6 pens/syringes (loading dose) x 28 days, followed by 2 pens/syringes per 28 days (maintenance dose) x 2 years If above criteria are not met, then do not approve

II. NEW MEMBER TRANSITION CRITERIA: All the following must be met: 1. Diagnosis of ulcerative colitis, Crohn’s disease, or indeterminant colitis 2. Patient is currently stable on therapy with Humira

If above criteria are met, then approve x 3 months until able to be seen by gastroenterology If above criteria are not met, then do not approve

III. RENEWAL CRITERIA based on requested dose:

-Requests for standard maintenance dose (2 pens/syringes per 28 days) All the following must be met: 1. Patient has been assessed by a gastroenterologist in the last 2 years OR 2. IF renewal for a new member who received 3-month transitional supply, please ensure patient has established care with a gastroenterologist If above criteria are met, then approve x 2 pens/syringes per 28 days (quantity in accordance with Rx) x 2 years If above criteria are not met, then do not approve

-Requests for escalated (burst) doses (>2 pens/syringes per 28 days) 1. Patient has been assessed by a gastroenterologist in the last 1 year AND the gastroenterologist evaluated if the dose can be de-escalated and determined that the escalated dose continues to be medically necessary OR

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES 2. If renewal for a new member who received 3-month transitional supply, please ensure patient has established care with a gastroenterologist

If above criteria are met, then approve x 4 pens/syringes per 28 days (quantity in accordance with Rx) x 2 years If above criteria are not met, then do not approve

IV. ESCALATION CRITERIA (FOR QUANTITY LIMIT OVERRIDE FOR MAINTENANCE DOSE): All the following must be met: 1. Patient was on standard maintenance dose of 2 pens/syringes per 28 days x > 3 months with inadequate drug level (< 7.5 mcg/mL) 2. Uncontrolled IBD symptoms OR Objective signs of inflammation (elevated C- reactive protein [CRP], elevated fecal calprotectin, colonoscopy, or MRE/CTE)

If above criteria are met, then approve x 4 pens/syringes per 28 days x 1 year If above criteria are not met, then approve x 2 pens/syringes per 28 days x 2 years

G. PSORIASIS

I. GUIDELINES FOR INITIAL USE: 1. Diagnosis of moderate to severe psoriasis 2. Prescribed by a Dermatology provider

AND either #3 or #4 below

3) Patient is currently stable on adalimumab (Humira): I. Patient assessed by dermatology provider and currently stable/doing well on adalimumab (Humira)

-OR-

4) Moderate to severe psoriasis (4A-4C)

*If patient is reported as having very high disease activity (ie: > 50% BSA, erythrodermic, pustular psoriasis) or disease affecting critical areas (ie: genitals, face), or prior biologic therapy within the past 4 months – proceed to step 4C

(4A) Inadequate response, intolerance, or contraindication to a topical corticosteroid OR topical calcineurin inhibitor (pimecrolimus, tacrolimus)

-AND-

(4B) Inadequate response (after at least 2 months), intolerance, or relative contraindication to the following:

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES

*For patients age < 17 years: to at least 1 of the below therapies:

*For patients age >/= 18 years: to at least 2 of the below therapies:

a) Acitretin (oral) – FDA approved for adults only b) Cyclosporine (oral) c) Methotrexate (oral d) Apremilast (oral) – FDA approved for adults only e) Phototherapy or narrow-band short wave ultraviolet B (NB-UVB) light therapy -AND-

(4C) Inadequate response (after at least 2 months), intolerance, or relative contraindication to secukinumab (Cosentyx)

If criteria [G1,2 & 3 OR 1, 2 & 4(A-C)] are met, approve 4 pens/syringes per 28 days (loading dose) for 1 month, then 2 pens/syringes per 28 days (maintenance dose) x 2 years If above criteria are not met, then do not approve

II. RENEWAL CRITERIA: 1) Patient’s psoriasis been assessed by a dermatology provider in the past 2 years

If criteria met, then approve 2 pens/syringes per 28 days x 2 years If criteria is not met, then do not approve

H. HIDRADENITIS SUPPURATIVA (HS):

I. NEW START CRITERIA: 1. Prescribed by a Dermatology provider 2. Patient is diagnosed with moderate to severe HS (Hurley stage II-III)

AND either #3 or #4 below

3) Patient is currently stable on adalimumab (Humira): I. Patient assessed by dermatology provider to be currently stable/doing well on adalimumab (Humira) -OR-

4) For patients with Hurley stage II: I. Inadequate response, intolerance, or contraindication to 3 of the following: (medication trials can be within the same drug category) a. Oral antibiotic (8-week trial unless intolerance is documented)

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES b. Oral retinoid (isotretinoin, acitretin) c. Intralesional steroid d. Hormonal agent (ie: metformin, spironolactone, oral contraceptive for women) e. Laser hair removal f. Infliximab infusion -OR-

5) For patients with Hurley stage III: I. Inadequate response, contraindication, or intolerance to: i. Infliximab infusion - If there is a documented barrier for patient to obtain infusion - then proceed with adalimumab therapy approval

If criteria (1,2 AND 3 OR 4 OR 5) are met, then approve 6 syringes/pens per 28 days (loading dose) x 1 month (loading dose), then 4 syringes/pens per 28 days (maintenance dose) x 2 years If above criteria are not met, then do not approve

II: RENEWAL CRITERIA: 1) Patient’s hidradenitis suppurativa been assessed by a dermatology provider in the past 2 years

If criteria met, then approve x 4 pens/syringes per 28 days x 2 years If criteria is not met, then do not approve

Creation date: 1/30/2021 Effective date: 6/15/2021 Reviewed date: 5/1/2021 Revised date: 5/1/2021

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES ADEMPAS

Generic Brand HICL GCN Exception/Other RIOCIGUAT ADEMPAS 40644

GUIDELINES FOR INITIAL AND CONTINUED USE

Must meet all the following criteria based on indication:

A) Pulmonary Arterial Hypertension (PAH) (WHO Group 1) Must meet all the following: 1. Prescriber must be a cardiologist or a pulmonologist 2. Patient has a diagnosis of pulmonary arterial hypertension (PAH) (WHO Group 1) verified by right heart catheterization with EACH of the following features: a. Mean Pulmonary Arterial Pressure (mPAP) greater than or equal to 25 mmHg b. Pulmonary Arterial Wedge Pressure (PWAP) greater than or equal to 15 mmHg c. Pulmonary Vascular Resistance (PVR) greater than or equal to 3 wood units (WU) 3. Patient currentlhas WHO Functional Class II, III or IV symptoms 4. Patient has tried and failed ohas an intolerance to or a contraindication to all the following: a. One phosphodiesterase type 5 (PDE5) inhibitor i. sildenafil (Revatio®) or tadalafil (Adcirca®) b. One endothelin receptor antagonist (ERA) i. Bosentan (Tracleer®) or Ambrisentan (Letairis®) or macitentan (Opsumit®)

If all initial criteria in A are met, then approve indefinitely

B) Chronic Thromboembolic Pulmonary Hyptertension (CTEPH) (WHO Group 4) 1. Prescriber must be a pulmonologist or a cardiologist 2. Patient has a diagnosis of chronic thromboembolic pulmonary hypertension (CTEPH) (WHO Group 4) verified by right heart catheterization with EACH of the following features: a. Mean Pulmonary Arterial Pressure (mPAP) greater than or equal to 25 mmHg b. Pulmonary Arterial Wedge Pressure (PWAP) greater than or equal to 15 mmHg c. Pulmonary Vascular Resistance (PVR) greater than or equal to 3 wood units (WU) AND must meet one the following: 3. Patient is not a candidate for pulmonary endarterectomy OR 4. Patient with persistent recurrent CTEPH after pulmonary endarterectomy

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES

If all initial criteria in B are met, then approve indefinitely.

Creation date: 9/23/2020 Effective date: 6/15/2021 Reviewed date: 5/1/2021 Revised date: 5/1/2021

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD)

Generic Brand HICL GCN Exception/Other TOLVAPTAN SAMSCA 36348 24294, Off-Label for Ascites, 24302 Heart Failure FDA approved for ADPKD, Hyponatremia TOLVAPTAN JYNARQUE 36348 39957, PACK 39958, 39956 TOLVAPTAN JYNARQUE 36348 24294, 24302

GUIDELINES FOR USE

A. SAMSCA

Must meet all the following criteria: 1. Prescribed by a nephrologist 2. Samsca started or restarted in the hospital for hyponatremia

If above initial criteria A is met, approve for a total duration of 30 days with a maximum daily dose of 2 tablets/day.

B. JYNARQUE

Must meet all the following criteria: 1. Prescribed by a nephrologist 2. Patient has diagnosis of autosomal dominant polycystic kidney disease (ADPKD) confirmed by baseline CT scan or MRI of the kidneys (typical is defined as bilateral/diffuse cyst distribution) 3. Patient is at high risk of disease progression defined by Mayo ADPKD Classification as “Typical (Class 1) ADPKD” and classified as either 1C, 1D, or 1E 4. Patient is in one of the following three groups: i. Age 18 to 50 years; AND estimated glomerular filtration rate (eGFR) is at least 60 mL/min/1.73m2 AND total kidney volume (TKV) is at least 750 mL. ii. Age 18 to 55 years; AND eGFR is at least 25 to 65 mL/min/1.73m2 iii. Age 56 to 65 years; AND eGFR is at least 25 to 44 mL/min/1.73m2; AND eGFR decline is greater than 2 mL/min/1.73m2 per year.

If above initial criteria B is met, approve x 1 year (monitoring for labs is recommended monthly for 18 months)

RENEWAL CRITERIA

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES

Must meet both criteria below: 1. Prescribed by a nephrologist. 2. Prescriber attests to evidence of disease improvement, such as improved eGFR, rate of growth in TKV, and ADPKD Impact Scale.

If above clinical criteria is met, approve x 1 year (monthly lab monitoring recommended for first 18 months of therapy, and every 3 months thereafter.)

Creation date: 3/12/2019 Effective date: 6/15/2021 Reviewed date: 5/1/2021 Revised date: 5/1/2021

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES CIMZIA - CERTOLIZUMAB

Generic Brand HICL GCN Exception/Other CERTOLIZUMAB CIMZIA 35554 99615, Nonformulary 23471

GUIDELINES FOR INITIAL USE

A- Rheumatoid Arthritis B- Psoriatic Arthritis C- Ankylosing Spondylitis D- Crohn's Disease E- Psoriasis

A) RHEUMATOID ARTHRITIS:

I. NEW START CRITERIA:

All the following must be met: 1. Diagnosis of RA 2. Patient is 18 years of age or older 3. Medication is being prescribing by or in consultation with a Rheumatologist 4. Patient with failure, intolerance, or contraindication to: i. at least 2 DMARDs (including methotrexate) ii. tofacitinib iii. at least 2 of the following: adalimumab, etanercept, or infliximab or its biosimilars iv. at least 2 non-TNF inhibitor biologics (see references)

If above criteria are met, then approve x 6 pens/syringes per 28 day supply x 1 month, then 2 pens/syringes per 28 days x 2 years If above criteria are not met, then do not approve

III. RENEWAL CRITERIA: 1. Patient’s RA been assessed by rheumatologist in the past 2 years

If above criteria are met, then approve x 2 pens/syringes per 28 days x 2 years If above criteria are not met, then do not approve

B) PSORIATIC ARTHRITIS (PsA):

I. NEW START CRITERIA: All the following must be met: 1. Patient has a diagnosis of PsA 2. Patient must be 18 years of age or older

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES 3. Must be prescribed by or in consultation with a Rheumatologist or Dermatologist 4. patient with failure, intolerance or contraindication to: i. at least two DMARDs (including methotrexate) ii. tofacitinib (Xeljanz) iii. at least 2 of the following: adalimumab, etanercept, or infliximab or its biosimilars iv. at least 1 non-TNF inhibitor biologics: secukinumab (Cosentyx) and guselkumab (Tremfya)

If above criteria are met, then approve x 6 pens/syringes per 28 day supply x 1 month, then 2 syringes/pens per 28 days x 2 years If above criteria are not met, then do not approve

III. RENEWAL CRITERIA: 1. Patient’s PsA has been assessed by rheumatologist in the past 2 years

If above criteria are met, then approve x 2 pens/syringes per 28 days x 2 years If above criteria are not met, then do not approve

C) ANKYLOSING SPONDYLITIS:

I. NEW START CRITERIA:

All the following must be met: 1. Must have diagnosis of ankylosing spondylitis 2. Patient must be 18 years of age or older 3. Must be prescribed by or in consultation with a Rheumatologist 4. Patient with failure, intolerance, or contraindication to: i. at least 2 of the following: adalimumab, etanercept, or infliximab or its biosimilars ii. secukinumab (Cosentyx)

If above criteria are met, then approve x 6 pens/syringes per 28 day supply x 1 month, then 2 pens/syringes per 28 days x 2 years If above criteria are not met, then do not approve

III. RENEWAL CRITERIA: 1. Patient’s ankylosing spondylitis has been assessed by rheumatologist in the past 2 years

If above criteria are met, then approve x 2 pens/syringes per 28 days x 2 years If above criteria are not met, then do not approve

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES D) CROHN’S DISEASE:

I. NEW START CRITERIA: All the following must be met: 1. Patient is 18 years of age or older 2. Medication is prescribed by or in consultation with a gastroenterologist 3. Diagnosis of Crohn’s disease or indeterminant colitis with Crohn’s features 4. Patient with failure, intolerance, or contraindication to infliximab-dyyb OR infliximab AND adalimumab

If above criteria are met, then approve x 4 pens/syringes (loading dose) per 28 days, followed by 2 pens/syringes per 28 days (maintenance dose) x 2 years If above criteria are not met, then do not approve

II. NEW MEMBER TRANSITION CRITERIA: All of the following must be met: 1. Diagnosis of Crohn’s disease or indeterminant colitis with Crohn’s features

If above criteria are met, then approve x 3 months until able to be seen by gastroenterology If above criteria are not met, then do not approve

III. RENEWAL CRITERIA based on requested dose:

--Requests for standard maintenance dose (2 pens/syringes per 28 days) All the following must be met: 1. Patient has been assessed by a gastroenterologist in the last 2 years OR 2. IF renewal for a new member who received 3-month transitional supply, please ensure patient has established care with a gastroenterologist

If above criteria are met, then approve x 2 pens/syringes per 28 days (quantity in accordance with Rx) x 2 years If above criteria are not met, then do not approve

--Requests for escalated (burst) doses (>2 pens/syringes per 28 days) All the following must be met: 1. Patient has been assessed by a gastroenterologist in the last 1 year AND the gastroenterologist evaluated if the dose can be de-escalated and determined that the escalated dose continues to be medically necessary OR 2. IF renewal for a new member who received 3-month transitional supply, please ensure patient has established care with a gastroenterologist

If above criteria are met, then approve x 4 pens/syringes per 28 days (quantity in accordance with Rx) x 2 years

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES If above criteria are not met, then do not approve

IV. ESCALATION CRITERIA (FOR QUANTITY LIMIT OVERRIDE FOR MAINTENANCE DOSE): All of the following must be met: 1. Patient was on standard maintenance dose of 2 pens/syringes per 28 days x > 3 months with inadequate drug level (< 20 mcg/mL) 2. Uncontrolled IBD symptoms OR Objective signs of inflammation (elevated C-reactive protein [CRP], elevated fecal calprotectin, colonoscopy, or MRE/CTE)

If above criteria are met, then approve x 4 pens/syringes per 28 days x 1 year If above criteria are not met, then approve x 2 pens/syringes per 28 days x 2 years

E. PSORIASIS

I. GUIDELINES FOR INITIAL USE: 1) Diagnosis of moderate to severe psoriasis 2) Prescribed by a Dermatology provider

AND #3 OR #4 below

3) Patient is currently stable on certolizumab (Cimiza) • Patient is currently pregnant or breastfeeding and assessed by dermatology provider to be stable on certolizumab (Cimiza) -OR- • Patient is not pregnant or breastfeeding, but has been assessed by dermatology provider to be stable on certolizumab (Cimzia) AND previous trial with inadequate response (after at least 2 months of treatment), intolerance, or relative contraindication to the following biologics: - 1 TNF Inhibitors: adalimumab (Humira), etanercept (Enbrel), or infliximab (Remicade or biosimilar) -AND- - Secukinumab (Cosentyx)

-OR-

4) Moderate to severe psoriasis (4A-4C)

*If patient is reported as having very high disease activity (ie: > 50% BSA, erythrodermic, pustular psoriasis), disease affecting critical areas (ie: genitals, face), or past biologic therapy within the past 4 months – proceed to step 4C

(4A) Inadequate response, intolerance, or contraindication to a topical corticosteroid OR topical calcineurin inhibitor (pimecrolimus, tacrolimus) -AND-

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES

(4B) Inadequate response (after at least 2 months), intolerance, or relative contraindication to the following to at least 2 of the below therapies:

• Acitretin (oral) – FDA approved for adults only • Cyclosporine (oral) • Methotrexate (oral • Apremilast (oral) – FDA approved for adults only • Phototherapy or narrow-band short wave ultraviolet B (NB-UVB) light therapy -AND-

(4C) Inadequate response (after at least 2 months), intolerance, or relative contraindication to the following: • Secukinumab (Cosentyx) • Guselkumab (Tremfya) • Risankizumab-rzaa (Skyrizi) • Ustekinumab (Stelara) • 1 TNF inhibitor (etanercept (Enbrel), adalimumab (Humira), infliximab (Remicade, Inflectra, or other biosimilar)

If criteria [1-2 AND 3 OR 4(A-C)] are met, then approve 4 syringes per 28 days x 2 years If above criteria are not met, do not approve

II. RENEWAL CRITERIA: 1) For renewal of prior PA approval NOT related to pregnancy or breastfeeding: Patient’s psoriasis been assessed by a dermatology provider in the past 2 years -OR- 2) For patient with previous PA approval related to pregnant or breastfeeding and is no longer pregnant or breastfeeding AND has history of inadequate response (after at least 2 months of treatment), intolerance, or relative contraindication to the following biologics: • 1 of the following TNF Inhibitors: Adalimumab, Etanercept, or Infliximab (Remicade, Inflectra or other biosimilars) • Secukinumab (Cosentyx)

If criteria 1 OR 2 are met, then approve 4 syringes per 28 days x 2 years If criteria is not met, then do not approve

Creation date: 1/30/2021 Effective date: 6/15/2021 Reviewed date: Revised date:

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES ENBREL - ETANERCEPT

Generic Brand HICL GCN Exception/Other ETANERCEPT ENBREL 18830 Some formulary and others not

A- Rheumatoid Arthritis B- Mild-Moderate Psoriatic Arthritis (PsA) C- Severe PsA D- Ankylosing Spondylitis E- Psoriasis

A) RHEUMATOID ARTHRITIS: I. NEW START and New member CRITERIA: All the following must be met: #1 or #2, #3 and #4 1. Patient has a diagnosis of RA, is currently stable on Enbrel and is prescribed by CPMG or affiliated rheumatologist OR 2. Patient has a diagnosis of RA and is prescribed by CPMG or affiliated rheumatologist 3. Patient with failure, intolerance, contraindication to the following: i. at least 2 DMARDs (including methotrexate) ii. tofacitinib (Xeljanz) AND 4. Medication is not being used in combination with another biologic (see references)

For Enbrel 50 mg: If above initial criteria, A1 or A2,3 &4, are met, approve x 4 pens/syringes per 28 days x 2 years For Enbrel 25 mg: If above initial criteria are met, A1 or A2,3 &4, approve x 8 vials/syringes per 28 days x 2 years If above criteria are not met, do not approve

III. RENEWAL CRITERIA: 1. Patient’s RA been assessed by rheumatologist in the past 2 years

For Enbrel 50 mg: If above renewal criteria are met, approve x 4 pens/syringes per 28 days x 2 years For Enbrel 25 mg: If above renewal criteria are met, approve x 8 vials/syringes per 28 days x 2 years If above criteria are not met, do not approve

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES ALL PsA DIAGNOSES (B-C): New Start criteria is followed by New Member then Renewal criteria

I. NEW START and New member CRITERIA:

B) Mild-Moderate PSA: All the following must be met: #1 or #2 and #3 1. Patient has a diagnosis of mild-moderate PsA, is currently stable on therapy with Enbrel and is prescribed by CPMG or affiliated rheumatologist OR 2. Patient has a diagnosis of mild-moderate PsA and is prescribed by CPMG or affiliated rheumatologist 3. Patient with failure, intolerance or contraindication to: i. at least two DMARDs (including methotrexate) ii. tofacitinib (Xeljanz)

For Enbrel 50 mg: If above initial criteria, B1 or B2&3, are met, approve x 4 pens/syringes per 28 days x 2 years For Enbrel 25 mg: If above initial criteria, B1 or B2&3, are met, approve x 8 vials/syringes per 28 days x 2 years If above criteria are not met, do not approve

C) Severe PsA: All of the following must be met: #1 or #2 & 3 1. Patient has a diagnosis of severe PsA, is currently stable on therapy with Enbrel and is prescribed by CPMG or affiliated rheumatologist OR 2. Patient has a diagnosis of PsA and is prescribed by CPMG or affiliated rheumatologist 3. Documentation of poor prognostic factors (refer to last rheumatologist visit note) o Poor prognostic factors includes the presence of 1 or more of the following: erosive disease, dactylitis, elevated ESR/CRP, long-term damage that interferes with function (e.g. joint deformities), high active disease that causes a major impairment in quality of life (i.e. active psoriatic inflammatory disease at many sites [including dactylitis, enthesitis], axial disease, or function-limiting inflammatory disease at few sites), and rapidly progressive disease.

For Enbrel 50 mg: If above initial criteria, C1 or C2&3, are met, approve x 4 pens/syringes per 28 days x 2 years For Enbrel 25 mg: If above initial criteria, C1 or C2&3, are met, approve x 8 vials/syringes per 28 days x 2 years If above criteria are not met, do not approve

III. RENEWAL CRITERIA (B – C): 1. Patient’s PsA has been assessed by rheumatologist in the past 2 years

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES

F) ANKYLOSING SPONDYLITIS:

I. NEW START CRITERIA and NEW member: The following must be met: 1. Patient has a diagnosis of Ankylosing spondylitis 2. Request is for a new start on Enbrel or patient is currently stable on therapy with Enbrel

For Enbrel 50 mg: If above initial criteria are met, approve x 4 pens/syringes per 28 days x 2 years For Enbrel 25 mg: If above initial criteria are met, approve x 8 vials/syringes per 28 days x 2 years If above criteria are not met, do not approve

III. RENEWAL CRITERIA: 1. Patient’s ankylosing spondylitis has been assessed by rheumatologist in the past 2 years

G. PSORIASIS

I. GUIDELINES FOR INITIAL USE: 1) Diagnosis of moderate to severe psoriasis 2) Prescribed by a Dermatology provider

AND either #3 or #4 below

3) Patient is currently stable on etanercept (Enbrel): • Patient assessed by dermatology provider to be currently stable/doing well on etanercept (Enbrel) -OR-

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES

4) Moderate to severe psoriasis (4A-4C)

(4A) Inadequate response, intolerance, or contraindication to a topical corticosteroid OR topical calcineurin inhibitor (pimecrolimus, tacrolimus) -AND-

(4B) Inadequate response (after at least 2 months), intolerance, or relative contraindication to the following:

*For patients age < 17 years: to at least 1 of the below therapies: *For patients age >/= 18 years: to at least 2 of the below therapies:

(4C) Inadequate response (after at least 2 months), intolerance, or relative contraindication to secukinumab (Cosentyx)

If criteria [1-2 & 3 OR 1,2 & 4(A-C)] are met, then approve: • Enbrel 50mg: 4 syringes/pens per 28 days x 3 months (loading dose), then 2 syringes/pens per 28 days (maintenance dose) x 21 months • Enbrel 25 mg: 8 vials/syringes per 28 days x 3 months (loading dose), then 2 vials/syringes per 28 days (maintenance dose) x 21 months If above criteria are not met, do not approve

II. RENEWAL CRITERIA: 1) Patient’s psoriasis been assessed by a dermatology provider in the past 2 years

If renewal criteria met, then approve: • Enbrel 50 mg: 4 pens/syringes per 28 days x 2 years • Enbrel 25 mg: 8 vials/syringes per 28 days x 2 years

If criteria is not met, then do not approve

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES IV. ESCALATION CRITERIA (FOR QUANTITY LIMIT OVERRIDE FOR MAINTENANCE DOSE): All the following must be met: 1. Prescribed by a dermatology provider 2. Documentation of experiencing flaring on once weekly etanercept therapy OR patient is resuming therapy after a gap in treatment (to reload)

For Enbrel 50 mg: If above are met, then approve for 4 syringes/pens per 28 days x 3 months (loading dose), then 2 syringes/pens per 28 days (maintenance dose) x 2 years For Enbrel 25 mg: If above criteria are met, then approve for 8 vials/syringes per 28 days x 3 months (loading dose), then 2 vials/syringes per 28 days (maintenance dose) x 2 years If above criteria are not met, do not approve

Creation date: 1/30/2021 Effective date: 6/15/2021 Reviewed date: Revised date:

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES TAVALISSE

Generic Brand HICL GCN Exception/Other FOSTAMATINIB TAVALISSE 44895 44702, 44703

GUIDELINES FOR INITIAL USE (Use Renewal criteria for new members)

A) Must meet all the following criteria: 1. Must be prescribed by a Hematologist/Oncologist 2. Diagnosis of Idiopathic Thrombocytopenic Purpura (ITP) 3. Patient has tried and failed each of the following for the treatment of ITP: a) at least one prior systemic corticosteroid b) rituximab c) IVIG d) romiplostim e) eltrombopag

If initial criteria A, are met, then approve x 3 months with quantity limit of 2 tablets per day.

RENEWAL CRITERIA

Must meet all the following criteria: 1. Prescriber must have evaluated for a response to fostamatinib after the patient completed at least 11 weeks of fostamatinib therapy 2. Prescriber must have assessed and determined the patient’s platelet count increased above baseline to a level which has been sufficient to avoid clinically important bleeding

If renewal criteria above are met, then approve x 12 months with a quantity limit of 2 tablets per day.

Creation date: 5/1/2019 Effective date: 6/15/2021 Reviewed date: 5/1/2020 Revised date: 5/1/2019

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES SIMPONI - GOLIMUMAB

Generic Brand HICL GCN Exception/Other GOLIMUMAB SIMPONI 36278 Nonformulary GOLIMUMAB SIMPONI ARIA 36278 Nonformulary

GUIDELINES FOR INITIAL USE

A- Rheumatoid Arthritis B- Psoriatic Arthritis C- Ankylosing Spondylitis D- Ulcerative Colitis

A) RHEUMATOID ARTHRITIS:

I. NEW START CRITERIA: All the following must be met: 1. Diagnosis of RA 2. Patient is 18 years of age or older 3. Medication is being prescribing by or in consultation with a rheumatologist 4. Patient with failure, intolerance, or contraindication to: i. at least 2 DMARDs (including methotrexate) ii. tofacitinib iii. at least 2 of the following: adalimumab, etanercept, or infliximab or its biosimilars iv. at least 2 non-TNF inhibitor biologics (see references)

If above criteria are met, then approve x 1 pen/syringe x 28 days x 2 years If above criteria are not met, then do not approve

III. RENEWAL CRITERIA: 1. Patient’s RA been assessed by rheumatologist in the past 2 years

If above criteria are met, then approve x 1 pen/syringe x 28 days x 2 years If above criteria are not met, then do not approve

B) PSORIATIC ARTHRITIS (PsA):

I. NEW START CRITERIA: All the following must be met: 1. Patient has a diagnosis of PsA 2. Patient must be 18 years of age or older 3. Must be prescribed by or in consultation with a Rheumatologist or Dermatologist 4. patient with failure, intolerance or contraindication to: i. at least two DMARDs (including methotrexate)

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES ii. tofacitinib (Xeljanz) iii. at least 2 of the following: adalimumab, etanercept, or infliximab or its biosimilars iv. at least 1 non-TNF inhibitor biologics: secukinumab (Cosentyx) and guselkumab (Tremfya)

If above criteria are met, then approve x 1 pen/syringe x 28 days x 2 years If above criteria are not met, then do not approve

III. RENEWAL CRITERIA: 1. Patient’s PsA has been assessed by rheumatologist in the past 2 years

If above criteria are met, then approve x 1 pen/syringe x 28 days x 2 years If above criteria are not met, then do not approve

C) ANKYLOSING SPONDYLITIS:

I. NEW START CRITERIA: All the following must be met: 1. Must have diagnosis of ankylosing spondylitis 2. Patient must be 18 years of age or older 3. Must be prescribed by or in consultation with a Rheumatologist 4. Patient with failure, intolerance, or contraindication to: i. at least 2 of the following: adalimumab, etanercept, or infliximab or its biosimilars ii. secukinumab (Cosentyx)

If above criteria are met, then approve x 1 pen/syringe x 28 days x 2 years If above criteria are not met, then do not approve

III.RENEWAL CRITERIA: 1. Patient’s ankylosing spondylitis has been assessed by rheumatologist in the past 2 years

If above criteria are met, then approve x 1 pen/syringe x 28 days x 2 years If above criteria are not met, then do not approve

D) ULCERATIVE COLITIS:

I. NEW START CRITERIA: All the following must be met: 1. Patient is 18 years of age or older 2. Medication is prescribed by or in consultation with a gastroenterologist

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES 3. Diagnosis of ulcerative colitis or indeterminant colitis with ulcerative colitis features 4. Patient with failure, intolerance, or contraindication to infliximab biosimilars OR infliximab AND adalimumab

If above criteria are met, then approve x 3 pens/syringes (loading dose) x 28 days, followed by 1 pen/syringe per 28 days (maintenance dose) x 2 years If above criteria are not met, then do not approve

II. NEW MEMBER TRANSITION CRITERIA: All the following must be met: 1. Diagnosis of ulcerative colitis or indeterminant colitis with ulcerative colitis features

If above criteria are met, then approve x 3 months until able to be seen by gastroenterology If above criteria are not met, then do not approve

III. RENEWAL CRITERIA based on requested dose:

-Requests for standard maintenance dose (1 pen/syringe per 28 days) All the following must be met: 1. Patient has been assessed by a gastroenterologist in the last 2 years OR 2. IF renewal for a new member who received 3-month transitional supply, please ensure patient has established care with a gastroenterologist

If above criteria are met, then approve x 1 pen/syringe per 28 days (quantity in accordance with Rx) x 2 years If above criteria are not met, then do not approve

-Requests for escalated (burst) doses (2 pens/syringes per 28 days) All the following must be met: 1. Patient has been assessed by a gastroenterologist in the last 1 year AND the gastroenterologist evaluated if the dose can be de-escalated and determined that the escalated dose continues to be medically necessary OR 2. IF renewal for a new member who received 3-month transitional supply, please ensure patient has established care with a gastroenterologist

If above criteria are met, then approve x 2 pens/syringes per 28 days (quantity in accordance with Rx) x 2 years If above criteria are not met, then do not approve

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES IV. ESCALATION CRITERIA (FOR QUANTITY LIMIT OVERRIDE FOR MAINTENANCE DOSE): All the following must be met: 1. Patient was on standard maintenance dose of 1 pen/syringe per 28 days x > 3 months with inadequate drug level (< 2.4 mcg/mL) 2. Uncontrolled IBD symptoms OR Objective signs of inflammation (elevated C- reactive protein [CRP], elevated fecal calprotectin, colonoscopy, or MRE/CTE)

If above criteria are met, then approve x 2 pens/syringes per 28 days x 1 year If above criteria are not met, then approve x 1 pen/syringe per 28 days x 2 years

Creation date: 3/1/2020 Effective date: 6/15/2021 Reviewed date: 1/1/2021 Revised date: 1/1/2021

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES HEDGEHOG PATHWAY INHIBITORS

Generic Brand HICL GCN Exception/Other SONIDEGIB ODOMZO 42369 39217 Preferred NF for BCC PHOSPHATE VISMODEGIB ERIVEDGE 38455 31307 Not preferred NF GLASDEGIB DAURISMO 45502 45798, NF; Not preferred for 45797 AML; Not indicated for BCC

GUIDELINES FOR INITIAL USE (See New KP Member/Renewal Criteria at the Bottom)

A) Must meet all of the following criteria: 1. Must be prescribed by a provider specializing in Dermatology or Oncology

AND must meet the diagnosis/drug specific criteria below-

B) BASAL CELL CARCINOMA (BCC) Must meet all the following for Sonidegib (Odomzo): 1. Patient must have metastatic disease OR 2. Patient has had a recurrence of BCC following surgery or radiation therapy OR patient is not a candidate for surgery or radiation therapy - Use is also appropriate in locally advanced disease setting where medication is used in an effort to shrink tumor and allow patient to become a surgical candidate

If initial criteria A and B above are met, then approve sonidegib (Odomzo) x 12 months

C) BASAL CELL CARCINOMA (BCC) Must meet the following for Vismodegib (Erivedge): 1. One of the following: a) Patient must have metastatic disease OR b) Patient has had a recurrence of BCC following surgery or radiation therapy OR patient is not a candidate for surgery or radiation therapy I. Use is also appropriate in setting where medication is used in an effort to shrink tumor anallow patient to become a surgical candidate AND 2. Patient has tried and failed previous trial of sonidegib (Odomzo) due to intolerability, after appropriate dose reductions AND 3. Patient has NOT progressed on sonidegib (Odomzo)

If initial criteria A and C above are met, then approve vismodegib (Erivedge) x 12 months

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES

D) ACUTE MYELOID LEUKEMIA (AML) Must meet all the following for Glasdegib (Daurismo): 1. Patient is newly diagnosed with AML 2. Patient is considered ineligible for use of an AML regimen that includes venetoclax (please provide reason) 3. Patient is ≥ 75 years of age OR patient has comorbidities that preclude the use of an intensive induction chemotherapy (please provide reason) 4. Glasdegib will be used in combination with low-dose cytarabine

If initial criteria A and D above are met, then approve x 12 months

RENEWAL CRITERIA or NEW KP MEMBER

Must meet all the following criteria: 1. Patient's disease has not progressed since treatment initiation as assessed by treating physician OR treating physician believes patient is deriving significant clinical benefit to justify treatment continuation. NOTE: physician does NOT need to prove lack of progression via imaging, a clinical evaluation suffices for renewal/new KP member

If renewal criteria above are met, then approve x 12 months

Creation date: 3/8/2019 Effective date: 6/16/2021 Reviewed date: 5/1/2020 Revised date: 5/1/2020

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES IBS-C AND CIC GUIDELINE

Generic Brand HICL GCN Exception/Other LUBIPROSTONE AMITIZA 33451 99658, Formulary, also 26473 indicated for OIC PLECANATIDE TRULANCE 44054 42925 Formulary LINACLOTIDE LINZESS 39583 42975, Nonformulary 33187, 33188 PRUCALOPRIDE MOTEGRITY 36920 28445, Nonformulary 28446 TEGASEROD ZELNORM 23178 15381 Not on market yet TENAPANOR IBSRELA Not on market yet LACTITOL PIZENSY

GUIDELINES FOR INITIAL USE A. Must meet all of the following criteria: 1. The patient must be 18 years of age or older

2. The patient has a diagnosis of irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC). If opioid induced constipation (OIC), review per OIC guideline.

3. The patient tried and failed at least one bulk-forming laxative (a bulk forming laxative contains psyllium, methylcellulose, or polycarbophil and examples may include Metamucil, Citrucel, FiberCon)

4. The patient tried and failed at least one osmotic laxative (an osmotic laxative contains magnesium hydroxide, polyethylene glycol, lactulose, magnesium citrate, or glycerin and examples may include milk of magnesia or Miralax)?

AND either B or C by indication-

B. For IBS-C indication by drug requested: 1. Amitiza : i. requested drug is Amitiza If above initial criteria A and B1 are met, then approve at HICL level with a max of 2 caps per day x 6 months 2. Trulance: i. requested drug is Trulance ii. patient has tried and failed, has an intolerance or a contraindication to Amitiza If above initial criteria A and B2 are met, then approve at HICL level with a max of 1 cap per day x 6 months 3. Linzess: i. requested drug is Linzess

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES ii. patient has tried and failed, has an intolerance or a contraindication to both Amitiza and Trulance If above initial criteria A and B3 are met, then approve at HICL level with a max of 1 tab per day x 6 months 4. Zelnorm : i. requested drug is Zelnorm ii. patient has tried and failed, has an intolerance or a contraindication to each of the following: Amitiza, Linzess, Trulance iii. patient is female and <65 years of age If above initial criteria A and B4 are met, then approve at HICL level with a max of 2 tabs per day x 6 months

C. For CIC indication by drug requested: 1. Amitiza: i. requested drug is Amitiza If above initial criteria A and C1 are met, then approve at HICL level with a max 2 caps per day x 6 months 2. Trulance: i. requested drug is Trulance ii. patient has tried and failed or has an intolerance or a contraindication to Amitiza If above initial criteria A and C2 are met, then approve at HICL level with a max of 1 cap per day x 6 months 3. Linzess: i. requested drug is Linzess ii. patient has tried and failed or has an intolerance or a contraindication to both Amitiza and Trulance If above initial criteria A and C3 are met, then approve at HICL level with a max of 1 tab per day x 6 months 4. Motegrity: i. requested drug is Motegrity ii. patient has tried and failed, has an intolerance or a contraindication to each of the following: Amitiza, Linzess and Trulance

If above initial criteria A and C4 are met, then approve at HICL level with a max of 1 tab per day x 6 months NOTE: Tegaserod (Zelnorm) is not covered for CIC because it is not FDA-approved for that indication and the other agents available for CIC are safer. Tegaserod was taken off the market due to CV risks and then brought back in 2019. It was studied in other GI motility disorders but those studies were done with its 2002 approval.

RENEWAL CRITERIA

1. The request is to continue current therapy

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES 2. There has been improvement in IBS-C or CIC symptoms from baseline

If above renewal criteria are met, then approve x 1 year with quantity limits of: Amitiza - max 2 per day Linzess - max 1 per day Trulance - max 1 per day Motegrity - max 1 per day Zelnorm - max 1 per day

If the request is for Amitiza in opioid induced constipation (OIC), review OIC guideline.

Creation date: 3/15/2017 Effective date: 6/15/2021 Reviewed date: 3/1/2021 Revised date: 3/1/2021

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES COMBINATION INHALED CORTICOSTEROID AND LONG-ACTING BETA-AGONIST

Generic Brand HICL GCN Exception/Other MOMETASONE/FORMOTEROL DULERA 37050 BUDESONIDE/FORMOTEROL SYMBICORT 21993 Brand is preferred FLUTICASONE/VILANTEROL BREO 40319 ELLIPTA FLUTICASONE/SALMETEROL AIRDUO 19963

GUIDELINES FOR USE INITIAL CRITERIA

1. Has the patient tried and failed, or does the patient have contraindications [eg, documented true allergy (anaphylaxis, hives) to either fluticasone or salmeterol, documented milk protein allergy, concomitant use of strong CYP3A4 inhibitor] to Advair diskus or is the patient unable to utilize diskus formulation (eg, insufficient inspiratory flow rate to inhale dry powder) or age < 12 years?

If yes, continue to #2. If no, do not approve. Recommend Advair diskus.

2. Has the patient tried and failed Advair HFA, or does the patient have a contraindication to Advair HFA [eg, documented true allergy (anaphylaxis, hives) to either fluticasone or salmeterol or concomitant use of strong CYP3A4 inhibitor]?

If yes, continue to #3. If no, do not approve. Recommend Advair HFA.

3. Has the patient tried and failed Symbicort HFA, or does the patient have a contraindication to Symbicort HFA [eg, documented true allergy (anaphylaxis, hives) to either budesonide or salmeterol]?

If yes, approve non-formulary medication (Dulera, Airduo or Breo) indefinitely. If no, do not approve. Recommend non-formulary brand Symbicort HFA.

Creation date: 12/23/2019 Effective date: 6/15/2021 Reviewed date: 3/1/2020 Revised date: 3/1/2020

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES IL-17 INHIBITORS (BIOLOGICS)

Generic Brand HICL GCN Exception/Other BRODALUMAB SILIQ 44102 NON-FORMULARY IXEKIZUMAB TALTZ 43193 NON-FORMULARY

GUIDELINES FOR INITIAL USE

A) Must meet all of the following criteria: 1. Must be prescribed by a CPMG or affiliated Dermatologist or Rheumatologist

AND must meet the diagnosis/drug specific criteria below:

Dermatology indications: Either ixekizumab (Taltz) or brodalumab (Siliq)

B) PSORIASIS

1) Patient is currently stable on ixekizumab (Taltz) or brodalumab (Siliq) a) Patient assessed by dermatology provider to be currently stable/doing well on ixekizumab (Taltz) or brodalumab (Siliq) -AND- b) Previous trial with inadequate response (at least 2 months), intolerance, or relative contraindication to secukinumab (Cosentyx) -OR-

2) Moderate to severe psoriasis (2A-2C)

(2A) Inadequate response, intolerance, or contraindication to a topical corticosteroid OR topical calcineurin inhibitor (pimecrolimus, tacrolimus) -AND-

(2B) Inadequate response (after at least 2 months), intolerance, or relative contraindication to the following:

*For patients age < 17 years: to at least 1 of the below therapies:

*For patients age >/= 18 years: to at least 2 of the below therapies:

i. Acitretin (oral) – FDA approved for adults only ii. Cyclosporine (oral) iii. Methotrexate (oral iiii. Apremilast (oral) – FDA approved for adults only

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES v. Phototherapy or narrow-band short wave ultraviolet B (NB-UVB) light therapy -AND-

(2C) Inadequate response (after at least 2 months), intolerance, or relative contraindication to the following: i. Secukinumab (Cosentyx) ii. Guselkumab (Tremfya) iii. Risankizumab-rzaa (Skyrizi) iiii. Ustekinumab (Stelara) iv. 1 TNF inhibitor (etanercept (Enbrel), adalimumab (Humira), infliximab (Remicade, Inflectra, or other biosimilar)

If criteria [A1 and B1 OR A1 and B2] are met, approve x 2 years with quantity limits noted below If above criteria are not met, then do not approve

Siliq (Brodalumab) - #4 per 30 days for loading dose and #2 per 30 days for maintenance dose Taltz (Ixekizumab) - #4 for first 30 days for loading dose, #2 for the next two 30 days for load and then #1 per 30 days for maintenance dose (example: 160mg once, then 80mg at weeks 2, 4, 6, 8, 10 and 12, then 80mg every 4 weeks)

II. RENEWAL CRITERIA: 1) Patient’s psoriasis been assessed by a dermatology provider in the past 2 years

If criteria met, then approve: • 1 pens/syringe per 28 days x 2 years for ixekizumab (Taltz) • 2 syringes per 28 days for brodalumab (Siliq) If criteria is not met, then do not approve

RHEUMATOLOGIC indications - Taltz ONLY

C) Psoriatic Arthritis

Must meet the following: 1. Patient is currently stable on therapy with Taltz OR 2. Patient has tried and failed, has an intolerance to, or a contraindication to at least 2 DMARDs (including methotrexate) or Xeljanz or has high disease activity (as determined by Rheumatologist and/or documentation of poor prognostic factors: includes the presence of 1 or more of the following: erosive disease, dactylitis, elevated ESR/CRP, long-term damage that interferes with function (e.g. joint deformities), high active disease that causes a major impairment in quality of life (i.e. active psoriatic

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES inflammatory disease at many sites [including dactylitis, enthesitis], axial disease, or function-limiting inflammatory disease at few sites), and rapidly progressive disease.) AND 3. Patient has tried and failed, has an intolerance to, or a contraindication to all of the following: i. at least 2 TNF inhibitors (adalimumab, etanercept, infliximab- dyyb/infliximab) ii. Cosentyx iii. Stelara iv. Tremfya If above initial criteria, A and C are met, then approve x 16 weeks.

D) ANKYLOSING SPONDYLITIS OR AXIAL SPONDYLOARTHRITIS: 1. Patient is currently stable on therapy with Taltz OR 2. Patient has tried and failed, has an intolerance to, or a contraindication to at least 2 DMARDs (including methotrexate) or high disease activity (as determined by Rheumatologist) AND 3. Patient has tried and failed, has an intolerance to, or a contraindication to all of the following: i. at least 2 TNF inhibitors (adalimumab, etanercept, infliximab- dyyb/infliximab) ii. Cosentyx If above initial criteria, A and D are met, then approve x 16 weeks.

Quantity Limits: 1. Psoriatic arthritis and ankylosing spondylitis: i. Induction: #2 syringes for first 30 days ii. Maintenance: #1 syringe/30 day through 16th week (4th month) 2. Axial spondylitis i. #1 syringe/30 days

Renewal criteria: 1. Patient’s psoriatic arthritis, ankylosing spondylitis, or axial spondyloarthritis has been assessed by a rheumatologist in the last 2 years If above criteria are met, then approve x 1 syringe per 30 days x 1 year

Creation date: 11/20/2019 Effective date: 6/15/2021 Reviewed date: 11/1/2020 Revised date: 11/1/2020

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES IL-23 INHIBITORS (Biologics)

Generic Brand HICL GCN Exception/Other GUSELKUMAB TREMFYA 44418 RISANKIZUMAB- SKYRIZI 46215 RZAA

GUIDELINES FOR USE A. PSORIASIS

GUIDELINES FOR INITIAL USE: 1) Diagnosis of moderate to severe psoriasis 2) Prescribed by a Dermatology provider

AND either 3 or 4, new start or stable on therapy:

3) Moderate to severe psoriasis (3A-3C)

(3A) Inadequate response, intolerance, or contraindication to a topical corticosteroid OR topical calcineurin inhibitor (pimecrolimus, tacrolimus) -AND-

(3B) Inadequate response (after at least 2 months), intolerance, or relative contraindication to the following:

*For patients age < 17 years: to at least 1 of the below therapies:

*For patients age >/= 18 years: to at least 2 of the below therapies:

i. Acitretin (oral) – approved for adults only ii. Cyclosporine (oral) iii. Methotrexate (oral iiii. Apremilast (oral) – approved for adults only iv. Phototherapy or narrow-band short wave ultraviolet B (NB-UVB) light therapy -AND-

(3C) Inadequate response (after at least 2 months), intolerance, or relative contraindication to secukinumab (Cosentyx)

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES 4) Patient is currently stable on guselkumab (Tremfya) or risankizumab-rzaa (Skyrizi) i. Patient assessed by dermatology provider to be currently stable/doing well on guselkumab (Tremfya) or risankizumab-rzaa (Skyrizi)

If criteria [A1-2 AND 3 OR A1-2 AND 4] are met, approve guselkumab (Tremfya) or risankizumab-rzaa (Skyrizi) for 2 years with quantity limits listed below If above criteria are not met, then do not approve

Tremfya (Guselkumab)- #1 per 30 days x 2 months for load, then #1 per 60 days for maintenance Skyrizi (Risankizumab)- #2 per 30 days x 2 months for load, then #1 per 90 days for maintenance

II. RENEWAL CRITERIA for PSORIASIS: 1) Patient’s psoriasis been assessed by a dermatology provider in the past 2 years

If criteria met, then approve guselkumab (Tremfya) or risankizumab-rzaa (Skyrizi) for 2 years If criteria is not met, then do not approve

B) PSORIATIC ARTHRITIS - GUIDELINES FOR INITIAL USE: a. Patient is 18 years of age or older b. Diagnosis of psoriatic arthritis c. Prescribed by CPMG or affiliated rheumatologist

AND must meet the diagnosis/drug specific criteria below: 1. Patient is currently stable on therapy with Tremfya OR 2. Patient with failure, intolerance or contraindication to at least 2 DMARDs (including methotrexate) or Xeljanz, or has high disease activity (as determined by Rheumatologist and/or documentation of poor prognostic factors: includes the presence of 1 or more of the following: erosive disease, dactylitis, elevated ESR/CRP, long-term damage that interferes with function (e.g. joint deformities), high active disease that causes a major impairment in quality of life (i.e. active psoriatic inflammatory disease at many sites [including dactylitis, enthesitis], axial disease, or function-limiting inflammatory disease at few sites), and rapidly progressive disease.) AND 3. Patient with failure, intolerance or contraindication to at least 2 TNF inhibitors (adalimumab, etanercept, infliximab-dyyb/infliximab) and Cosentyx

If initial criteria B are met, then approve x 6 months per quantity limits below Quantity limits:

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES For Tremfya - override Formulary and PA requirement with a maximum qty of #2 for the first month initial load, and place a subsequent approval with a maximum quantity of #1 for the remaining 5 months

RENEWAL CRITERIA for Psoriatic Arthritis 1.Patient’s psoriatic arthritis has been assessed by a rheumatologist in the last 2 years.

If above criteria are met, then approve Tremfya, 1 syringe per 8 weeks x 1 year

Creation date: 11/20/2019 Effective date: 6/15/2021 Reviewed date: Revised date:

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES INPEN SMART INSULIN PEN DEVICE

Generic Brand HICL GCN Exception/Other INSULIN INPEN SMART 20334 Formulary ADMINISTRATION INSULIN PEN DEVICE

GUIDELINES FOR INITIAL USE

A) Must meet all of the following criteria: 1. Patient has a diagnosis of type 1 diabetes 2. Must be prescribed by an Endocrinologist 3. Prescriber has documented a need for detailed electronic monitoring the patient’s insulin dose administered and time of administration 4. The patient will be using InPen with Humalog, Novolog, or Fiasp U-100 insulin only

If initial criteria above are met, then approve at HICL level (20334) indefinitely with maximum quantity of 1 per 365 days

Creation date: 5/25/2021 Effective date: 7/20/2021 Reviewed date: Revised date:

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES JAK INHIBITORS - NON-PREFERRED

Generic Brand HICL GCN Exception/Other TOFACITINIB XELJANZ 5MG, 33617, Xeljanz 10mg tablets XELJANZ XR 38086, are Preferred 11MG 22MG 47546, Formulary and NOT 1MG/ML 48684 Specialty tier BARICITINIB OLUMIANT 1MG 47205, Nonformulary 2 MG 43468 Specialty tier UPACITINIB RINVOQ 15MG 46822 Nonformulary Specialty tier

GUIDELINES FOR INITIAL USE:

A) Must meet all the following criteria: 1. Patient must be age 18 or older OR for xeljanz 1mg/ml solution, patient must be age 2 or older and indication of active polyarticular juvenile idiopathic arthritis (JIA) 2. Must be prescribed by CPMG or an affiliated gastroenterologist or rheumatologist 3. Is not being used in combination with another biologic or relevant immunosuppressive therapy (TNFi, IL 12/23i, IL 17i, alpha4beta7 Integrin-I, azathioprine, cyclosporine).

AND must meet the diagnosis/drug specific criteria below -

B) For Rheumatoid Arthritis indication: 1. Xeljanz 5 mg OR 11 mg XR will be approved if all the following criteria are met: i. Trial of at least 2 DMARDs (see table) including methotrexate, hydroxychloroquine, sulfasalazine, or leflunomide. ii. Patient unable to use 10 mg tablets, one-half tablet (5 mg) 2 times a day, due to a clinical/physical/medical reason (i.e. dexterity or vision issues)

If initial criteria A and B1 above are met, then approve indefinitely.

2. Olumiant 1 mg OR 2 mg will be approved if all the following criteria are met: i. Trial of at least 2 DMARDs (see table) including methotrexate, hydroxychloroquine, sulfasalazine, or leflunomide ii. Trial of xeljanz

If initial criteria A and B2 are met, then approve indefinitely.

3. Rinvoq 15 mg will be approved if all the following criteria are met: i. Trial of at least 2 DMARDs (see table) including methotrexate, hydroxychloroquine, sulfasalazine, or leflunomide ii. Trial of xeljanz iii. Trial of olumiant

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES If initial criteria A and B3 are met, then approve indefinitely.

C) For Psoriatic Arthritis indication: 1. Xeljanz 5 mg OR 11 mg XR will be approved if all the following criteria are met: i. Trial of at least 2 DMARDs including methotrexate, hydroxychloroquine, sulfasalazine, or leflunomide. ii. Patient unable to use 10 mg tablets, one-half tablet (5 mg) 2 times a day, due to a clinical/physical/medical reason (i.e. dexterity or vision issues)

If initial criteria A and C above are met, then approve indefinitely.

D) For ulcerative colitis (UC) or inflammatory bowel disease- unspecified/indeterminate colitis (IBD-U) indications: 1. Xeljanz 5 mg will be approved if the following criteria are met: i. Patient stepped down from 10 mg po 2 times a day to 5 mg po 2 times a day and unable to use 10 mg tablets, one-half tablet (5 mg) 2 times a day, due to a clinical/physical/medical reason (i.e. dexterity or vision issues) 2. Xeljanz 11mg or 22 mg XR -- do not approve, use the 10mg tab for equivalent daily dose

If above criteria A and D are met, then approve indefinitely.

E) For active polyarticular JIA indication: 1. Xeljanz 1 mg/ml solution will be approved if the following criteria are met: i. Trial, failure or intolerance to at least one DMARD AND ii. Patient body weight is < 40 kg OR iii. Patient body weight is ≥ 40 kg AND unable to swallow tablets 2. Xeljanz 5 mg will be approved if the following criteria are met: i. Patient body weight is ≥ 40 kg ii. Patient unable to use 10 mg tablets, one-half tablet (5 mg) 2 times a day, due to a clinical/physical/medical reason (i.e. dexterity or vision issues)

If initial criteria A and E above are met, then approve indefinitely.

Note: there are no renewal criteria due to reviews and approvals using above criteria being indefinite

Creation date: 3/30/2020 Effective date: 4/15/2021 Reviewed date: 3/1/2021 Revised date: 3/1/2021

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES MELATONIN RECEPTOR AGONIST (Sleep agents)

Generic Brand HICL GCN Exception/Other TASIMELTEON HETLIOZ 40927 36068 Nonformulary TASIMELTEON HETLIOZ LQ 40927 48937 Nonformulary SUSPENSION RAMELTEON ROZEREM 33126 25202 Nonformulary

GUIDELINES FOR USE Initial criteria for New starts and New members:

A. Requests for Ramelteon: 1. Patient has insomnia characterized by difficulty with sleep onset 2. Patient has tried and failed oral melatonin or has a contraindication to melatonin

If all the above initial criteria A1 and A2 are met, then approve generic ramelteon at HICL level x 3 months

B. Requests for Tasimelteon: ONE of the following must be met: 1) Patient has a diagnosis of Non-24-Hour Sleep Wake Disorder (N24HSWD) AND a) Prescribed by a Sleep Specialist (CPMG or affiliated network provider with active referral as necessary) b) Patient has tried oral melatonin, if no contraindication to use exists, for at least 1 month without efficacy c) Patient has tried oral ramelteon, if no contraindication for use exists, for at least 1 month without efficacy d) Patient has used non-pharmacologic sleep entrainment (alignment of the internal biological clock rhythm to external time cues, such as the natural dark-light cycles) including: I. Bright light therapy (in patients with light perception) AND/OR II. Optimizing sleep therapy

2) Patient is already stable on the drg

3) Patient has a diagnosis of nighttime sleep disturbances in Smith-Magenis syndrome (SMS) AND a. Patient has tried and failed maximally-tolerated melatonin therapy b. Prescribed by a Sleep Specialist (CPMG or affiliated network provider with active referral as necessary)

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES If either B1, B2 or B3 above are met, approve x 3 months with a maximum daily dose of 1/day. Prescriber to re-evaluate treatment after 2 months.

If any of above criteria are not met, do not approve

Renewal Criteria:

1. Ramelteon renewals: All the following must be met: a) Documentation of a positive clinical response

If above renewal criteria, 1a is met, approve x 12 months

2. Tasimelteon renewals: All the following must be met: a) Documentation of positive clinical response If above renewal criteria are met, approve x 12 months with a maximum daily dose of 1/day

If any of above are not met, do not approve

Creation date: 5/30/2018 Effective date: 6/15/2021 Reviewed date: 5/1/2021 Revised date: 5/1/2021

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES OIC GUIDELINE

Generic Brand HICL GCN Exception/Other LUBIPROSTONE AMITIZA 33451 Nonformulary NALOXEGOL MOVANTIK 41686 Nonformulary NALDEMEDINE SYMPROIC 44176 Nonformulary METHYLNALTREXONE RELISTOR 35611 Nonformulary - Oral form and injectable form

GUIDELINES FOR INITIAL USE

A. Must meet all the following criteria:

1. The patient must be 18 years of age or older

2. The requested medication is prescribed by an oncologist, a hospice/palliative care clinician for a patient currently enrolled in hospice or palliative care program, a gastroenterologist or after consultation with a pain management specialist

3. The patient has a diagnosis of opioid induced constipation (OIC) and an active opioid prescription. If the request is for Amitiza in irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC), review per IBS-C/CIC guideline.

4. The patient currently uses opioids chronically

5. The patient has tried and failed a trial of one stimulant laxative (a stimulant laxative contains sennosides or bisacodyl and examples may include Senokot, Ex-Lax, and Dulcolax)

6. The patient has tried and failed a trial of an osmotic laxative (an osmotic laxative contains magnesium hydroxide, polyethylene glycol, lactulose, magnesium citrate, or glycerin and examples may include milk of magnesia or Miralax)

AND by drug requested below:

B. Amitiza:

If above initial criteria A1-6 are met and Amitiza is requested, then approve at HICL level with a max of 2 caps per day x 1 year

C. Movantik:

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES i. The patient has tried and failed or has an intolerance or contraindication to Amitiza

If above initial criteria A1-6 and C are met, approve at HICL level with a max of 1 tablet per day x 1 year

D. Symproic: i. The patient has tried and failed or has an intolerance or contraindication to Amitiza and Movantik

If above initial criteria A1-6 and D are met, then approve at HICL level with a max of 1 tablet per day x 1 year

E. Oral Relistor: i. The patient tried and failed or has an intolerance or contraindication to Amitiza, Movantik and Symproic

If the above initial criteria A1-6 and E are met, approve at GPID level (41923 Relistor 150mg tab) x1 year, maximum daily dose of #3 tablets

F. Injectable Relistor: i. The patient tried and failed or has an intolerance or contraindication to Amitiza, Movantik, Symproic and oral Relistor

ii. The patient is unable to take ANY oral medications (or unable to use any oral laxatives through feeding tube)

If the above initial criteria A1-6 and F are met, approve at HICL level (35611) injectable Relistor for 1 year, max 1 dose/day (injection)

RENEWAL CRITERIA

1. The request is to continue current therapy

2. Provider states that there has been improvement in OIC symptoms from baseline

If above renewal criteria are met, then approve x 2 years.

If the request is for Amitiza for IBS-C / CIC, review IBS-C / CIC guideline.

Creation date: 6/16/2020 Effective date: 6/15/2021 Reviewed date: 5/1/2021 Revised date: 5/1/2021

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES OPSUMIT

Generic Brand HICL GCN Exception/Other MACITENTAN OPSUMIT 40677 35443 Formulary

GUIDELINES FOR INITIAL USE

A. Pulmonary Arterial Hypertension (PAH) (WHO Group 1) Must meet all the following: 1. Prescriber must be either a pulmonologist or a cardiologist 2. Patient has a diagnosis of pulmonary arterial hypertension (PAH) (WHO Group 1) verified by right heart catheterization with EACH of the following features: a. Mean Pulmonary Arterial Pressure (mPAP) is greater than or equal to 25 mmHg b. Pulmonary Arterial Wedge Pressure (PWAP) is greater than or equal to 15 mmHg c. Pulmonary Vascular Resistance (PVR) is greater than or equal to 3 wood units (WU) 3. Patient currently has WHO Functional Class II, III or IV symptoms 4. Patient has tried and failed or has an intolerance to or a contraindication to all the following: a. Bosentan (Tracleer®) b. Ambrisentan (Letairis®)

If all the above initial criteria are met, then approve indefinitely.

Creation date: 5/26/2021 Effective date: 6/15/2021 Reviewed date: Revised date:

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES CLADRIBINE (MAVENCLAD) ORAL

Generic Brand HICL GCN Exception/Other CLADRIBINE MAVENCLAD 07840 44338 Oral Formulation

GUIDELINES FOR USE

Initial Criteria at the top Renewal Criteria in the middle New KP Member Criteria at bottom

INITIAL CRITERIA

All the following must be met: 1. Prescribed by a CPMG neurologist or affiliated network neurologist with appropriate referral, if needed 2. Patient is 18 years or older 3. Patient is diagnosed with a relapsing or active form of multiple sclerosis, but NOT clinically isolated syndrome (CIS) (this does not include non-active secondary- progressive MS or primary-progressive MS) 4. The patient must have: a) Baseline normal LFT's within 30 days prior to initiation of therapy b) Baseline ALC (absolute lymphocyte count) of greater than 0.8 (800 cells/L), checked within 30 days prior to initiation of therapy 5. The patient must have high-risk features** for early progression to non-relapsing progressive MS, or any of these high-risk features while on disease modifying treatment 6. If patient or patient’s partner can become pregnant, highly effective contraception must be used 7. The patient has had a trial and inadequate response or intolerance to at least 3 alternative drugs indicated for the treatment of multiple sclerosis including: a) Rituximab or its biosimilar b) Ocrelizumab c) Ofatumumab AND either d) Natalizumab (if JCV neg) e) Fingolimod f) Siponimod g) Ozanimod h) Ponesimod

If the above are met then approve for 2 fills only, within 11 months

Treatment course 1: Cycle 1: start day 0-5

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES Cycle 2: start on days 23-27 to finish on days 27-32

Wait at least 43 weeks after last dose of Course 1, Cycle 2

Treatment course 2: Cycle 1: start day 0-5 Cycle 2: start on days 23-27 to finish on days 27-32

Mavenclad will not be approved for use beyond 2 years as the FDA states treatment beyond 2 years may further increase the risk of malignancy. Quantity Limit: 10 tablets per 28 days. Maximum 2 fills per 334 days

RENEWAL CRITERIA

For the treatment of Multiple Sclerosis -

All the following must be met: 1. Prescribed by a CPMG neurologist or affiliated network neurologist with appropriate referral, if needed 2. Patient is 18 years or older 3. Patient is diagnosed with a relapsing or active form of multiple sclerosis, but NOT CIS (this does not include non-active Secondary-Progressive MS or Primary- Progressive MS) 4. Patient must have completed no more than 1 treatment course (consisting of 2 treatment cycles) approximately 1 year prior 5. Previous initial treatment course must have been approved by and covered by Kaiser Permanente (if initial course was denied by Kaiser Permanente, second course will not be covered) 6. Baseline normal LFT's within 30 days prior to initiation of this second treatment course 7. Baseline ALC (absolute lymphocyte count) of greater than 0.8 (800 cells/L), checked within 30 days prior to initiation of this second treatment course

If the above are met, then approve for 2 fills only for second, final treatment course.

NEW KP MEMBERS

Must meet all the following:

1. Must have started with KPCO within the past year 2. Must have had at least one and no more than one treatment course (consisting of 2 treatment cycles) of cladribine, with last dose at least 43 weeks prior (if no prior treatment course, use initial criteria)

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES 3. Must have a diagnosis of a relapsing or active form of multiple sclerosis, but NOT clinically isolated syndrome (CIS) (this does not include non-active secondary- progressive MS or primary-progressive MS) 4. Baseline normal LFT's within 30 days prior to initiation of this second treatment course 5. Baseline ALC (absolute lymphocyte count) of greater than 0.8 (800 cells/L), checked within 30 days prior to initiation of this second treatment course

If above New Member criteria are met, then approve for 2 fills only for second, final treatment course

Creation date: 5/2/2020 Effective date: 6/15/2021 Reviewed date: Revised date:

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES ORENITRAM

Generic Brand HICL GCN Exception/Other TREPROSTINIL ORENITRAM 40827

GUIDELINES FOR INITIAL AND CONTINUED USE

Must meet all the following criteria based on indication:

A. Pulmonary Arterial Hypertension (PAH) (WHO Group 1) Must meet all the following: 1. Prescriber must be either a pulmonologist or a cardiologist 2. Patient has a diagnosis of pulmonary arterial hypertension (PAH) (WHO Group 1) verified by right heart catheterization with EACH of the following features: a. Mean Pulmonary Arterial Pressure (mPAP) greater than or equal to 25 mmHg b. Pulmonary Arterial Wedge Pressure (PWAP) greater than or equal to 15 mmHg c. Pulmonary Vascular Resistance (PVR) greater than or equal to 3 wood units (WU) 3. Patient currently has WHO Functional Class II, III or IV symptoms 4. Patient has tried and failed or has an intolerance to or a contraindication to all the following: a. One phosphodiesterase type 5 (PDE5) inhibitor i. Sildenafil (Revatio®) or Tadalafil (Adcirca®) b. One endothelin receptor antagonist (ERA) i. Bosentan (Tracleer®) or Ambrisentan (Letairis®) or macitentan (Opsumit®)

If all the above are met, then approve indefinitely.

Creation date: 9/23/2020 Effective date: 6/15/2021 Reviewed date: 5/1/2021 Revised date: 5/1/2021

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES PCSK9 INHIBITORS

Generic Brand HICL GCN Exception/Other ALIROCUMAB PRALUENT PEN, 42347 Nonformulary PRALUENT SYRINGE EVOLOCUMAB REPATHA 42378 Nonformulary SURECLICK, REPATHA SYRINGE REPATHA PUSHTRONEX

GUIDELINES FOR INITIAL USE

A) Must meet all of the following criteria: 1. Must have a diagnosis of homozygous familial hypercholesterolemia (HoFH) or a diagnosis of heterozygous familial hypercholesterolemia (HeFH) or atherosclerotic cardiovascular disease (ASCVD) with a clinical event^^* 2. a) Patient must have been taking atorvastatin 80mg or rosuvastatin 40mg daily OR statin therapy at the maximally tolerated dose for at least 30 days prior to LDL lab OR b) Patient must have an absolute contraindication to statin therapy (active, decompensated liver disease; nursing female, pregnancy, or plans to become pregnant; hypersensitivity reaction; documented history of CPK >10x ULN or rhabdomyolysis attributed to a statin and not explained by a drug interaction, fall, or prolonged immobility) OR c) Patient is statin intolerant as defined by the National Lipid Association Statin Intolerance Panel** 3. Patient must have been taking ezetimibe (Zetia) for at least 30 days prior to LDL lab OR patient has a contraindication or intolerance to ezetimibe (Zetia) 4. Must have a current LDL level drawn within the last 90 days of greater than or equal to 70mg/dL for ASCVD or greater than or equal to 100 mg/dL for HeFH/HoFH.

AND must meet the drug specific criteria below-

B) EVOLOCUMAB (REPATHA)

1. Requested drug is evolocumab (Repatha) If initial criteria A and B above are met, then approve at HICL level x6 months, with a maximum of 2 syringes/pens or 1 Pushtronex per 28 days

C) ALIROCUMAB (PRALUENT) Must meet all the following:

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES 1. Requested drug is alirocumab (Praluent) 2. Patient has tried and failed an appropriate dose of, has history of adverse events to, has an allergy to or a contraindication to evolocumab (Repatha) If initial criteria A and C above are met, then approve at HICL level x6 months, with a maximum of 2 pens per 28 days If does not meet criteria, patient must try evolocumab (Repatha)

RENEWAL CRITERIA

Must meet all the following criteria: 1. Patient's LDL decreased by at least 20% after starting the PCSK9 inhibitor when compared to pre-PCSK9 inhibitor levels

If renewal criteria above are met then approve at HICL level indefinitely, with a maximum of 2 syringes/pens or 1 Pushtronex per 28 days

Creation date: 5/25/2018 Effective date: 6/15/2021 Reviewed date: 5/1/2020 Revised date: 5/1/2020

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES S1P RECEPTOR MODULATORS - MS DRUGS

Generic Brand HICL GCN Exception/Other FINGOLIMOD GILENYA 37180 Formulary - Specialty tier SIPONIMOD MAYZENT 45670 NF - Specialty tier OZANIMOD ZEPOSIA ** FDA approved but not on market yet

GUIDELINES FOR USE

Initial Criteria at the top New KP Members in the middle section Renewal Criteria at the bottom

INITIAL CRITERIA for NEW STARTS and New members who have already received a transitional 3-month approval • (NOTE: FOR RENEWAL CRITERIA SEE BELOW)

A - General criteria for All (B, C, D and E) requests B - Fingolimod (Gilenya) requests C - Ozanimod (Zeposia) requests D - Siponimod (Mayzent) requests E - Ponesimod (Ponvory) requests F - New Member to KP transitional request

A. For all requests for Multiple Sclerosis medications all the following criteria must be met: 1. The requesting provider is a CPMG neurologist or an affiliated network neurologist with active referral, if needed 2. The patient has a diagnosis of relapsing or active form of multiple sclerosis. (This does not include non-active Secondary-Progressive MS or Primary-Progressive MS) 3. The medication will not be given in combination with other disease modifying therapies approved for the treatment of MS (See list in table below)

AND Review based on Drug specific criteria below, B, C, D or E:

B. For Fingolimod (Gilenya) requests: the patient must meet ALL the following criteria: 1. The patient does not have a contraindication/serious precaution* to fingolimod AND 2. Does not have known hypersensitivity to fingolimod or to any of the excipients of fingolimod AND

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES 3. i) The patient has a significant prior intolerance to glatiramer acetate OR at least one interferon-beta (see table below) OR ii) The patient DOES have **high-risk features for early progression to non-relapsing progressive MS, or has had any of these high-risk features while on disease modifying treatment

If initial criteria, A and B, are met, then approve at HICL level x 1 year, with a max 1 cap/day

C. For Ozanimod (Zeposia) requests: the patient must meet ALL the following criteria: 1. i) The patient does have a contraindication OR serious precaution* with fingolimod that is not expected to occur with ozanimod OR ii) The patient has a significant intolerance OR allergy to inactive ingredients OR drug-drug interaction with fingolimod that is not expected to occur with ozanimod 2. i) The patient has a significant prior intolerance to glatiramer acetate OR at least one interferon-beta (see table below) OR ii) The patient DOES have **high-risk features for early progression to non- relapsing progressive MS, or has had any of these high-risk features while on disease modifying treatment

If all initial criteria, A and C, are met, approve at HICL level x 1 year, with a max 1 cap/day

D. For Siponimod (Mayzent) requests: the patient must meet ALL the following criteria: 1. i) The patient does have a contraindication/serious precaution* with fingolimod that is not expected to occur with siponimod OR ii) The patient has a significant intolerance OR allergy to inactive ingredients OR drug-drug interaction with fingolimod that is not expected to occur with siponimod AND 2. i) The patient does have a contraindication/serious precaution* with ozanimod that is not expected to occur with siponimod OR ii) The patient has a significant intolerance OR allergy to inactive ingredients OR drug-drug interaction with ozanimod that is not expected to occur with siponimod AND 3. The CYP2C9 genotype has been confirmed prior to starting treatment a. Patient does NOT have CYP2C9*3/*3 genotype (siponimod is contraindicated in this genotype)

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES b. For genotypes CYP2C9 *1/*3 and *2/*3 only: prescriber will not exceed FDA labeled dose of 1 mg/day c. For all other genotypes: prescriber will not exceed FDA labeled maximum dose of 2 mg/day 4. i) The patient has a significant prior intolerance to glatiramer acetate OR at least one interferon-beta (see table below) OR ii) The patient DOES have **high-risk features for early progression to non- relapsing progressive MS, or has had any of these high-risk features while on disease modifying treatment

If initial criteria, A and D, are met, then approve at HICL level x 1 year

E. For Ponesimod (Ponvory) requests: the patient must meet ALL of the above criteria and the following criteria: 1. i) The patient does have a contraindication/serious precaution* with fingolimod that is not expected to occur with ponesimod OR ii) The patient has a significant intolerance OR allergy to inactive ingredients OR drug-drug interaction with fingolimod that is not expected to occur with ponesimod AND 2. i) The patient does have a contraindication/serious precaution* with ozanimod that is not expected to occur with ponesimod OR ii) The patient has a significant intolerance OR allergy to inactive ingredients OR drug-drug interaction with ozanimod that is not expected to occur with ponesimod 3. i) The patient has a significant prior intolerance to glatiramer acetate OR at least one interferon-beta (see table below) OR ii) The patient DOES have **high-risk features for early progression to non- relapsing progressive MS, or has had any of these high-risk features while on disease modifying treatment

If all initial criteria, A and E, are met, approve at HICL level x 1 year

F. NEW MEMBER TO KP If patient is a new transitioning member to KP and currently stable on requested medication, then approve x 3 months

RENEWAL CRITERIA ALL the following criteria must be met: 1. The requesting provider is a CPMG neurologist or an affiliated network neurologist with active referral, if needed

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES 2. The patient has a diagnosis of relapsing or active form of multiple sclerosis. (This does not include non-active Secondary-Progressive MS or Primary-Progressive MS) 3. The drug will NOT be given in combination with other disease modifying therapies approved for the treatment of MS (see list in table below) 4. The patient does NOT have a new or existing contraindication/ serious precaution* to siponimod (Mayzent) or fingolimod (Gilenya) or ozanimod (Zeposia) or ponesimod (Ponvory)

If all of the above Renewal criteria are met, then approve x 1 year

Creation date: 5/4/2020 Effective date: 6/15/2021 Reviewed date: 5/1/2021 Revised date: 5/1/2021

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES AUBAGIO (TERIFLUNOMIDE)

Generic Brand HICL GCN Exception/Other TERIFLUNOMIDE AUBAGIO 39624 33262, 33259

NEW MEMBERS TO KP: If new member to KP and stable on Aubagio, approve x 3 months to allow transition of care to CPMG or KP affiliated provider

INITIAL CRITERIA FOR NEW STARTS AND NEW MEMBERS AFTER THE TRANSITIONAL SUPPLY (NOTE: FOR RENEWAL CRITERIA SEE BELOW)

Must meet ALL the following: A. Requesting physician is a CPMG or an affiliated network neurologist, with appropriate referral if necessary B. Patient has a diagnosis of a relapsing or active form of multiple sclerosis (this does not include non-active secondary-progressive MD or primary-progressive MS C. Patient is currently using or will be using Aubagio as monotherapy (not in combination with another disease modifying treatment (see table below) D. i) Patient has had an inadequate response, demonstrated intolerance or demonstrated significant nonadherence to at least TWO self-injectable medications; one from the interferon-beta class (Rebif, Extavia, Betaseron, etc) and one glatiramer acetate product (Copaxone, Glatopa, glatiramer acetate) OR ii) The patient has a contraindication/serious precaution to interferon-beta and/or glatiramer E. i) The patient has tried dimethyl fumarate and experienced significant intolerance or nonadherence OR ii) The patient has a contraindication/serious precaution to dimethyl fumarate F. Patient must have a significant intolerance or allergy to inactive ingredients with leflunomide that is not expected to occur with Aubagio G. Patient does not have high-risk features* for early progression to non-relapsing progressive MS and patient has not had any of these high-risk features while on disease modifying treatment

If all the above initial criteria, A through G, are met, then approve x 2 years

If E or F are not met, suggest generic dimethyl fumarate or leflunomide (leflunomide 10mg as an alternative to teriflunomide 7mg or leflunomide 20mg as an alternative to terflunomide 14mg)

If G is not met, suggest Gilenya, Tysabri or a preferred rituximab biosimilar.

RENEWAL CRITERIA

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES

Must meet ALL the following: 1. Requesting physician is a CPMG neurologist or an affiliated network neurologist with appropriate referral, if needed 2. Patient has a diagnosis of a relapsing or active form of multiple sclerosis (This does not include non-active secondary-progressive MS or primary-progressive MS) 3. Patient is currently using or will be using Aubagio as monotherapy (not in combination with another disease modifying treatment (see table below)

If all the above renewal criteria, 1 through 3, are met, then approve x 2 years

Creation date: 5/12/2019 Effective date: 6/15/2021 Reviewed date: 5/1/2020 Revised date: 5/1/2020

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES SELEXIPAG (UPTRAVI)

Generic Brand HICL GCN Exception/Other SELEXIPAG UPTRAVI 42922 40278 GPID 40355GPID 42922 HICL at 2/day

GUIDELINES FOR USE

Must meet all the following criteria based on indication:

A. Pulmonary Arterial Hypertension (PAH) (WHO Group 1) Must meet all the following criteria: 1. Prescriber must be either a pulmonologist or a cardiologist

2. Patient has a diagnosis of pulmonary arterial hypertension (PAH, WHO Group 1) verified by right heart catheterization with EACH of the following features:

a. Mean Pulmonary Arterial Pressure (mPAP) greater than or equal to 25 mmHG b. Pulmonary Arterial Wedge Pressure P(PWAP) greater than or equal to 15 mmHg c. Pulmonary Vascular Resistance (PVR) greater than or equal to 3 wood units (WU)

3. Patient currently has WHO Functional Class II, III or IV symptoms

4. Patient has tried and failed, has an intolerance to or a contraindication to all the following: a. one phosphodiesterase type 5 (PDE5) inhibitor (e.g., Adcirca, Revatio) b. one endothelin receptor antagonist (ERA) [e.g., Tracleer, Letairis or Opsumit]

If all initial criteria above are met, then approve Uptravi Titration Pack (GPID) x1 fill, the #140 bottle of 200mcg (GPID) x 1 fill, and the 600mcg (HICL).for indefinite time period with a max daily dose #2 starting 1 month from start. The total initial approval will be indefinite.

Creation date: 3/12/2019 Effective date: 6/15/2021 Reviewed date: 5/1/2021 Revised date: 5/1/2021

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES USTEKINUMAB (STELARA) FOR OUTPATIENT USE

Generic Brand HICL GCN Exception/Other USTEKINUMAB STELARA 36187 Nonformulary

GUIDELINES FOR USE

A) Must meet all of the following initial criteria: 1. Patient must be age 12 or older 2. Must be prescribed by a CPMG or affiliated dermatologist, gastroenterologist, or rheumatologist

AND must meet the diagnosis/drug specific criteria below (A and B, C, D or E):

B) Psoriatic Arthritis: Must meet the following initial criteria: 1. Patient is currently stable on therapy with Stelara OR 2. Patient has tried, failed, not tolerated, or have a contraindication to at least two DMARDs (including methotrexate) or Xeljanz or has high disease activity (as determined by Rheumatologist and/or documentation of poor prognostic factors: includes the presence of 1 or more of the following: erosive disease, dactylitis, elevated ESR/CRP, long-term damage that interferes with function (e.g. joint deformities), high active disease that causes a major impairment in quality of life (i.e. active psoriatic inflammatory disease at many sites [including dactylitis, enthesitis], axial disease, or function-limiting inflammatory disease at few sites), and rapidly progressive disease.) AND 3. Patient has tried, failed, not tolerated, or have a contraindication to at least 2 TNF inhibitors (adalimumab, etanercept, infliximab-dyyb/infliximab) and Cosentyx (secukinumab)

If initial criteria A and B above are met, then approve x 1 year with quantity limits below

Quantity limits: 1. Months 1 and 2: 1 syringe per 28 days 2. Months 3 and thereafter: 1 syringe per 12 weeks

Renewal criteria: 1. Patient’s psoriatic arthritis has been assessed by a rheumatologist in the last 2 years.

If above criteria are met, than approve x 1 syringe per 12 weeks x 2 years

C) Psoriasis: Must meet the following initial criteria:

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES 1) Diagnosis of moderate to severe psoriasis 2) Prescribed by a Dermatology provider

AND either 3 or 4, new start or stable on therapy

3) Moderate to severe psoriasis (3A-3C)

(3A) Inadequate response, intolerance, or contraindication to a topical corticosteroid OR topical calcineurin inhibitor (pimecrolimus, tacrolimus) -AND-

(3B) Inadequate response (after at least 2 months), intolerance, or relative contraindication to the following:

*For patients age < 17 years: to at least 1 of the below therapies: *For patients age >/= 18 years: to at least 2 of the below therapies:

i. Acitretin (oral) – FDA approved for adults only ii. Cyclosporine (oral) iii. Methotrexate (oral iv. Apremilast (oral) – FDA approved for adults only v. Phototherapy or narrow-band short wave ultraviolet B (NB-UVB) light therapy -AND-

(3C) Inadequate response (after at least 2 months), intolerance, or relative contraindication to the following: i. Secukinumab (Cosentyx) ii. Guselkumab (Tremfya) iii. Risankizumab-rzaa (Skyrizi)

OR 4) Patient is currently stable on ustekinumab (Stelara) - Patient assessed by dermatology provider to be currently stable/doing well on ustekinumab (Stelara)

If criteria [C1-2 AND 3, OR C1-2 AND 4] are met, then approve maximum of 1 syringe per 28 day supply x 2 years If above criteria are not met, then do not approve

II. RENEWAL CRITERIA: 1) Patient’s psoriasis been assessed by a dermatology provider in the past 2 years

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES If criteria met, then approve maximum of 1 syringe per 28 day supply x 2 years If criteria is not met, then do not approve

D. Crohn’s Disease or unclassified IBD with Crohn’s features: Must meet all the following: 1. The patient has tried, failed, not tolerated at least 2 anti-TNF’s (infliximab, adalimumab or certolizumab) OR is there appropriate and documented rationale as to why only 1 anti-TNF was tried (i.e. primary or secondary non-response despite therapeutic drug level +/- presence of anti-drug antibodies or adverse effect requiring a different mechanism of action) 2. The patient has tried, failed, not tolerated vedolizumab (Entyvio)

If initial criteria A and D above are met, then approve x 1 year with 1 syringe every 8 weeks

Quantity limits: 1. One syringe every 8 weeks

Renewal criteria: 1. Patient’s Crohn’s disease has been assessed by a Gastroenterologist in the last 2 years. If above criteria are met, than approve x 1 syringe per 8 weeks x 2 years

E.Ulcerative Colitis Must meet all of the following criteria: 1. The patient has tried, failed, not tolerated at least 2 anti-TNF’s (infliximab, adalimumab or golimumab) OR is there appropriate and documented rationale as to why only 1 anti-TNF was tried (i.e. primary or secondary non-response despite therapeutic drug level +/- presence of anti-drug antibodies or adverse effect requiring a different mechanism of action) 2. The patient has tried, failed, not tolerated tofacitinib (Xeljanz) 3. The patient has tried, failed, not tolerated vedolizumab (Entyvio)

If initial criteria A and E above are met, then approve x 1 year with 1 syringe every 8 weeks

Quantity limits: 1. One syringe every 8 weeks

Renewal criteria: 1. Patient’s Ulcerative Colitis disease has been assessed by a Gastroenterologist in the last 2 years.

If above criteria are met, than approve x 1 syringe per 8 weeks x 2 years

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES

Creation date: 9/26/2018 Effective date: 6/15/2021 Reviewed date: 3/1/2020 Revised date: 3/1/2020

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES SGLT-2 INHIBITORS/SGLT-2 INHIBITOR COMBINATIONS

Generic Brand HICL GCN Exception/Other EMPAGLIFOZIN JARDIANCE 41217 FORMULARY and Preferred CANAGLIFLOZIN INVOKANA 40171 NON-formulary and 2nd preferred DAPAGLIFLOZIN FARXIGA 40137 NON-formulary and 3rd preferred ERTUGLIFLOZIN STEGLATRO 44709 NON-formulary and 4th preferred

GUIDELINES FOR INITIAL USE

A - General criteria for all adult (B, C, D and E) requests B - Adults > 25 years of age with DM2 with ASCVD C - Adults > 25 years of age with DM2 with Nephropathy D - Adults > 25 years of age with Heart Failure E - Adults > 25 years of age with DM2 without ASCVD or Nephropathy F - Pediatrics/Young Adults >10 and < 25 years of age with DM2

A) All requests, B, C, D and E must meet all the following criteria, 1 through 5:

1. GFR = to or >30mL/min 2. Does not have type 1 diabetes 3. At least 25 years of age at diagnosis 4. Does not have active diabetic foot ulcers or prior amputations 5. Does not have a history of diabetic ketoacidosis (DKA)

AND

Review based on the following diagnosis specific criteria below, B, C, D or E:

B) To treat type 2 diabetes with established atherosclerotic cardiovascular disease (ASCVD) (acute coronary syndromes (ACS), history of myocardial infarction (MI), stable or unstable angina, coronary or other arterial revascularization, ischemic stroke, transient ischemic attack (TIA), or symptomatic peripheral arterial disease (PAD))

Must meet the following criteria:

1. Has contraindications to OR currently using OR has failed maximum doses of metformin IR and subsequently metformin ER

AND must meet criteria listed below based on requested drug:

a. Empagliflozin (Jardiance)

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES If initial criteria A1-5 and B1 are met, approve at HICL x 1 year with a maximum daily dose of 0.5 tab (41217)

b. Canagliflozin (Invokana): Patient has tried and failed or has an intolerance or a contraindication to empagliflozin (Jardiance) If initial criteria A1-5, B1 and B1b are met, then approve at HICL x 1 year with a maximum daily dose of 0.5 tab (40171)

c. Dapagliflozin (Farxiga): Patient has tried and failed or has an intolerance or a contraindication to both empaglifozin (Jardiance) and canagliflozin (Invokana) If initial criteria A1-5, B1 and B1c are met, approve at HICL x 1 year with a maximum daily dose of 1 tab (40137)

d. Ertugliflozin (Steglatro): Patient has tried and failed or has an intolerance or a contraindication to empagliflozin (Jardiance), canagliflozin (Invokana), and dapagliflozin (Farxiga) If initial criteria A1-5, B1 and B1d are met, then approve at HICL x 1 year with a maximum daily dose of 1 tab (44709)

C) To treat type 2 diabetes with diabetic nephropathy

Must meet all the following criteria:

1. GFR between 30 and 59 ml/min and/or urinary albumin-to-creatinine ratio > 300 with GFR of 30 ml/min or greater 2. Has contraindications to OR currently using OR has failed maximum doses of metformin IR and subsequently metformin ER

AND must meet criteria listed below based on requested drug:

a. Empagliflozin (Jardiance) If initial criteria A1-5 and C1-2 are met, approve at HICL x 1 year with a maximum daily dose of 0.5 tab (41217)

b. Canagliflozin (Invokana): Patient has tried and failed or has an intolerance or a contraindication to empagliflozin (Jardiance) If initial criteria A1-5, C1-2 and Cb are met, approve at HICL x 1 year with a maximum daily dose of 0.5 tab (40171)

c. Dapagliflozin (Farxiga): Patient has tried and failed or has an intolerance or a contraindication to both empaglifozin (Jardiance) and canagliflozin (Invokana) If initial criteria A1-5, C1-2 and Cc are met, approve at HICL x 1 year with a maximum daily dose of 1 tab (40137)

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES d. Ertugliflozin (Steglatro): Patient has tried and failed or has an intolerance or a contraindication to empagliflozin (Jardiance), canagliflozin (Invokana), and dapagliflozin (Farxiga) If initial criteria A1-5, C1-2 and Cd are met, then approve at HICL x 1 year with a maximum daily dose of 1 tab (44709)

D) To treat HFrEF (with or without type 2 diabetes)

Must meet all the following criteria:

1. Heart failure with reduced ejection fraction (HFrEF) – previous or current EF ≤ 40% 2. NYHA Class II-IV 3. Has contraindications to OR is currently using OR has failed all of the following: I. ACEI or ARB or ARNI (Entresto) II. Beta blocker III. Aldosterone antagonist (e.g. spironolactone, eplerenone)

AND must meet criteria listed based on requested drug:

a. Empagliflozin (Jardiance) If initial criteria A1-5 and D1-3 are met, approve at HICL x 1 year with a maximum daily dose of 0.5 tab (41217)

b. Canagliflozin (Invokana): Patient has tried and failed or has an intolerance or a contraindication to empagliflozin (Jardiance) If initial criteria A1-5, D1-3 and Db are met, approve at HICL x 1 year with a maximum daily dose of 0.5 tab (40171)

c. Dapagliflozin (Farxiga): Patient has tried and failed or has an intolerance or a contraindication to both empaglifozin (Jardiance) and canagliflozin (Invokana) If initial criteria A1-5, D1-3 and Dc are met, approve at HICL x 1 year with a maximum daily dose of 1 tab (40137)

d. Ertugliflozin (Steglatro): Patient has tried and failed or has an intolerance or a contraindication to empagliflozin (Jardiance), canagliflozin (Invokana), and dapagliflozin (Farxiga) If initial criteria A1-5, D1-3 and Dd are met, then approve at HICL x 1 year with a maximum daily dose of 1 tab (44709)

E) To treat type 2 diabetes without ASCVD, diabetic nephropathy, or HFrEF

Must meet all the following criteria:

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES 1. Most recent HgbA1c is within 2% or less from their designated goal 2. Patient has contraindications to OR currently using OR has failed maximum doses of metformin IR and subsequently metformin ER, sulfonylurea, maximum dose of pioglitazone, and all possible combinations thereof 3. If on insulin, unable to adjust the patient's insulin regimen to achieve better control

AND must meet criteria listed based on requested drug:

a. Empagliflozin (Jardiance) If initial criteria A1-5 and E1-3 are met, approve at HICL x 6 months with a maximum daily dose of 0.5 tab (41217)

b. Canagliflozin (Invokana): Patient has tried and failed or has an intolerance or a contraindication to empagliflozin (Jardiance) If initial criteria A1-5, E1-3 and Eb are met, approve at HICL x 6 months with a maximum daily dose of 0.5 tab (40171)

c. Dapagliflozin (Farxiga): Patient has tried and failed or has an intolerance or a contraindication to both empaglifozin (Jardiance) and canagliflozin (Invokana) If initial criteria A1-5, E1-3 and Ec are met, approve at HICL x 6 months with a maximum daily dose of 1 tab (40137)

d. Ertugliflozin (Steglatro): Patient has tried and failed or has an intolerance or a contraindication to empagliflozin (Jardiance), canagliflozin (Invokana), and dapagliflozin (Farxiga) If initial criteria A1-5, E1-3 and Ed are met, then approve at HICL x 6 months with a maximum daily dose of 1 tab (44709)

F) To treat type 2 diabetes in young adult/pediatric patients 10 years of age to < 25 years of age

Must meet all the following criteria: 1. Patient has contraindications to OR currently using OR has failed maximum doses of metformin IR and subsequently metformin ER and maximum dose of pioglitazone, and all possible combinations there of 2. GFR > 30 ml/min AND must meet criteria listed based on requested drug:

a. Empagliflozin (Jardiance) If F1-2 and Fa are met, approve at HICL x 6 months with a maximum daily dose of 0.5 tab (41217)

b. Canagliflozin (Invokana): Patient has tried and failed or has an intolerance or a contraindication to empagliflozin (Jardiance)

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES If F1-2 and Fb are met, approve at HICL x 6 months with a maximum daily dose of 0.5 tab (40171)

c. Dapagliflozin (Farxiga): Patient has tried and failed or has an intolerance or a contraindication to both empaglifozin (Jardiance) and canagliflozin (Invokana) If F1-2 and Fc are met, approve at HICL x 6 months with a maximum daily dose of 1 tab (40137)

d. Ertugliflozin (Steglatro): Patient has tried and failed or has an intolerance or a contraindication to empagliflozin (Jardiance), canagliflozin (Invokana), and dapagliflozin (Farxiga) If F1-2 and Fd are met, then approve at HICL x 6 months with a maximum daily dose of 1 tab (44709)

RENEWAL CRITERIA

A) To treat type 2 diabetes with established ASCVD, diabetic nephropathy, or to treat HFrEF (with or without type 2 diabetes)

Must meet all the following criteria: 1. GFR >30mL/min 2. Patient has not developed any contraindications to SGLT2 inhibitors

If above renewal criteria, A1-2, are met, approve x 1 year

B) To treat type 2 diabetes without ASCVD, diabetic nephropathy, or HFrEF

Must meet all the following criteria: 1. GFR >30mL/min 2. Patient has not developed any contraindications to SGLT2 inhibitors 3. HgbA1c is either at goal or at least has decreased by 0.5% or more

If above renewal criteria, B1-3, are met, approve x 1 year

C) To treat type 2 diabetes in pediatric patients < 25 years of age

Must meet all the following criteria: 1. Patient has not developed any contraindications to SGLT2 inhibitors 2. HgbA1c is either at goal or at least has decreased by 0.5% or more

If above renewal criteria, C1-2, are met, approve x 1 year

Creation date: 11/18/2020

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES Effective date: 7/6/2021 Reviewed date: 1/1/2021 Revised date: 1/1/2021

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES CGRP INHIBITORS

Generic Brand HICL GCN Exception/Other ERENUMAB AIMOVIG 46116, Acts on receptor 44753 GLACANEZUMAB EMGALITY 46397, Acts on Ligand 40418, 40419

GUIDELINES FOR USE

INITIAL CRITERIA for NEW STARTS and NEW MEMBERS who have already received a transitional 3-month approval • NOTE: For new KP members who need a transitional supply and renewal criteria, see below

A - General criteria for All (B, C, D, and E) requests B - Episodic Migraine C - Chronic Migraine D - Cluster (Episodic) E - New Member after a transitional supply if needed

A) For all requests for CGRP-mAb medications ALL the following criteria must be met: 1. Patient is NOT a new transitioning member to KP (if new member, see E below) 2. Requesting provider is a CPMG or an affiliated network neurologist or headache specialist (with an appropriate referral if needed) 3. Prescriber attests to: If patient has diagnosis of medication overuse headache (MOH), treatment plan includes a plan to taper off offending MOH medication 4. Patient is NOT taking an opiate (including tramadol) or barbiturate (including butalbital-containing product) for the treatment of headache for more than 4 days per month, including in the month prior to CGRP-mAb request 5. Patient will only be using requested CGRP-mAb (not in combination with another CGRP-mAb) 6. Patient does NOT have any of the following comorbidities: a. Known liver disease b. Cardiovascular disease (including uncontrolled hypertension, coronary artery disease, history of dissections, stroke, unstable angina, pulmonary embolism, evidence of peripheral vascular disease, etc) AND, review based on Diagnosis specific criteria below, B, C or G:

B) For Episodic Migraine diagnosis: the patient must meet ALL the following criteria: 1. Patient has a diagnosis of episodic migraine (< 15 migraine days per month) AND has at least 4 migraine days per month

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES 2. Patient has documented intolerance (due to side effects), contraindication, and/or inadequate response after an adequate trial* of at least 3 preventive agents from at least three migraine preventive classes: - Anticonvulsants: divalproex, valproate, topiramate - Beta blockers: atenolol, metoprolol, nadolol, propranolol, timolol - Antidepressants: amitriptyline, nortriptyline, venlafaxine, duloxetine 3. Patient has a Migraine Disability Assessment (MIDAS) completed AND/OR documentation of the number of headache days per month (in chart notes or through headache diary), completed for at least one month in the past three months

AND based on drug requested:

A. Erenumab (Aimovig) a. Patient has tried and failed, by intolerability or lack of efficacy, a CGRP-mAb that acts on the ligand (examples: fremanezumab (Ajovy), galcanezumab (Emgality), eptinezumab (Vyepti)) b. If the member naive to erenumab and if initial criteria A1-6 and B1-3 are met, then approve erenumab 70mg at GPID (44753) x 3 months c. If request is for 140 mg dose and the member is not naïve to erenumab and initial criteria A1-6 and B1-3 are met, then approve erenumab 140mg at HICL (44923) x 3 months

If patient has not tried and failed a CGRP-mAb that acts on the ligand, recommend Ajovy 225 mg monthly or 675 mg every 3 months

B. Galcanezumab (Emgality) a. Patient has tried and failed, by intolerability or lack of efficacy, or has a contraindication to, at least one CGRP-mAb that acts on the ligand (examples: fremanezumab (Ajovy), eptinezumab (Vyepti)) AND a CGRP-mAb that acts on the receptor (Erenumab (Aimovig)), then approve galcanezumab 120 mg at GPID (40418 or 40419) x 3 months

If patient has not tried and failed a CGRP-mAb that acts on the ligand, recommend Ajovy 225 mg monthly or 675 mg every 3 months. If patient has not tried and failed a CGRP-mAb that acts on the receptor, recommend Aimovig 70 mg monthly.

C) For Chronic Migraine diagnosis: the patient must meet ALL the following criteria: 1. Patient has a diagnosis of chronic migraine (defined as > 15 headache days [migraine-like or tension-like] per month for the past 3 months, of which > 8 days are migraines) 2. Patient has documented intolerance (due to side effects), contraindication, and/or inadequate response after an adequate trial* of at least 3 preventive agents from at least three migraine preventive classes: - Anticonvulsants: divalproex, valproate, topiramate - Beta blockers: atenolol, metoprolol, nadolol, propranolol, timolol

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES - Antidepressants: amitriptyline, nortriptyline, venlafaxine, duloxetine - Botulinum toxin: onabotulinumtoxinA 3. Patient has a Migraine Disability Assessment (MIDAS) completed AND/OR documentation of the number of headache days per month (in chart notes or through headache diary), completed in the past three months 4. Patient has NOT received treatment for migraine with onabotulinumtoxinA in the past 8 weeks AND CGRP-mAb is not being used in combination with onabotulinumtoxinA

AND based on drug requested:

A. Erenumab (Aimovig) a. Patient has tried and failed, by intolerability or lack of efficacy, a CGRP-mAb that acts on the ligand (examples: fremanezumab (Ajovy), galcanezumab (Emgality), eptinezumab (Vyepti)) b. If the member naive to erenumab and if initial criteria A1-6 and C1-4 are met, then approve erenumab 70mg at GPID (44753) x 3 months c. If request is for 140 mg dose and the member is not naïve to erenumab and initial criteria A1-6 and C1-4 are met, then approve erenumab 140mg at HICL (44923) x 3 months

If patient has not tried and failed a CGRP-mAb that acts on the ligand, recommend Ajovy 225 mg monthly or 675 mg every 3 months

D) For Episodic Cluster Headache diagnosis: the patient must meet ALL the following criteria: 1. Patient has a diagnosis of episodic cluster headache (cluster attacks that occur in periods lasting from 7 days to 1 year, with remission periods between attacks > 3 months) 2. Patient does NOT have a diagnosis of chronic cluster headache (cluster attacks that occur for one year or longer without remission, or with remission periods lasting less than 3 months)

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES 3. Patient is currently experiencing cluster headaches with frequency of attacks ranging from one attack every other day or greater 4. Request is for galcanezumab (Emgality) 100 mg/mL syringes and patient is not using another CGRP-mAb 5. Patient has documented intolerance (due to side effects), contraindication, and/or inadequate response in the past to at least 3 other acute/abortive medication/therapy trials (used as mono or polytherapy) including triptans, oxygen, APAP and NSAIDs. 6. Patient has documented intolerance (due to side effects), contraindication, and/or inadequate response in the past to at least 2 standard cluster headache preventive therapies (lithium, verapamil, melatonin, prednisone, occipital nerve block, topiramate, valproate, memantine). 7. Patient has NOT had an inadequate response to prior trial of galcanezumab (Emgality) 300 mg monthly for cluster headache (inadequate response = < 30% reduction in cluster headache frequency after 4 weeks from baseline)

If initial criteria, A1-6 and D1-7 are met, then approve galcanezumab (Emgality) 100 mg/ml at GPID level (46397) x 1 month

E) New member to KP 1. If patient is a new transitioning member to KP and currently stable on CGRP- mAb

Approve current therapy x 3 months if for migraine prevention Approve current therapy x 1 month if for cluster headache

RENEWAL CRITERIA

A) For episodic or chronic MIGRAINE indications: ALL the following criteria must be met: 1. Prescriber attests to: If patient has/had diagnosis of medication overuse headache (MOH), frequency of use of the offending MOH medication has decreased or stopped 2. Patient has demonstrated improvement after at least 3 months of starting CGRP- mAb, by ONE of the following: - ≥ 30% reduction in headache days per month - ≥ 50% improvement in MIDAS score 3. Patient has not received onabotulinumtoxinA injection for migraine in the past 4 months

If renewal criteria A1-4 are met, then approve at HICL level x 1 year

B) For episodic CLUSTER headache indication: ALL the following criteria must be met:

Effective: July 2021 NOTE: these guidelines may change at any time

COLORADO - MEDICATION AUTHORIZATION GUIDELINES 1. Episodic cluster headaches have continued after 1 month (=1 dose) 2. Patient has experienced improvement in cluster attacks since the first dose of galcanezumab 300 mg 3. Patient has NOT received two consecutive monthly doses of Emgality in the last two months

If renewal criteria B1-3 are met, then approve galcanezumab 100 mg/mL at GPID level (46397) x 1 additional month (Note: galcanezumab should not be used for more than 2 months total per cluster headache period)

* Adequate trials of non-CGRP mAb preventive medication trials FOR MIGRAINE: • Oral migraine preventive medicaton: at least 6-8 weeks at maximally tolerated dose • OnabotulinumtoxinA: at least two quarterly injections with response assessed 6 months after initiation

Creation date: 7/25/2019 Effective date: 7/20/2021 Reviewed date: 3/1/2020 Revised date: 3/1/2020

Effective: July 2021 NOTE: these guidelines may change at any time