Kpco Authorization Guidelines June2020
COLORADO - MEDICATION AUTHORIZATION GUIDELINES CORTICOTROPIN
Generic Brand HICL GCN Exception/Other CORTICOTROPIN ACTHAR HP GEL 02830
GUIDELINES FOR USE 1. Does the patient have a contraindication† to Acthar? (See contraindication list at the end of this guideline)
If yes, do not approve. If no, continue to #2.
2. Will the Acthar injections be administered in a medical office?
If yes, do not approve. This will be a medical benefit. If no, continue to #3.
3. Is the patient less than 2 years old and diagnosed with infantile spasms?
If yes, approve for 28 days with a maximum of 8 vials (each 5mL vial contains 400 units). If no, continue to #4.
4. Does the patient have a diagnosis of nephrotic syndrome?
If yes, continue to #10. If no, continue to #5.
5. Is the patient being treated for acute exacerbation of multiple sclerosis?
If yes, continue to #6. If no, do not approve.
6. Does the patient have a contraindication (documented hypersensitivity) to prednisone, methylprednisolone, and dexamethasone?
If yes, approve up to 120 units/day for up to 21 days (each 5mL vial contains 400 units). If no, continue to #7.
7. Has the 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?
If yes, continue to #8. If no, do not approve.
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES
8. Has the 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?
If yes, continue to #9. If no, do not approve.
9. Has the 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 yes, approve up to 120 units/day for up to 21 days (each 5mL vial contains 400 units). If no, do not approve.
10. Is this prescribed by a nephrologist?
If yes, continue to #11. If no, do not approve.
11. Has the patient previously been approved by Kaiser Permanente Colorado for this medication?
If yes, continue to #17. If no, continue to #12.
12. Has the patient failed prednisone or prednisolone 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)
If yes, continue to #13. If no, do not approve.
13. Has the patient failed cyclosporine or tacrolimus 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)
If yes, continue to #14. If no, do not approve.
14. Has the patient failed mycophenolate mofetil or azathioprine 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)
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES
If yes, continue to #15. If no, do not approve.
15. Has the patient failed cyclophosphamide or chlorambucil 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)
If yes, continue to #16. If no, do not approve.
16. Has the patient failed rituximab 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)
If yes, approve up to 160 units/week for 6 months (each 5mL vial contains 400 units). If no, do not approve.
17. Did the 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 yes, approve up to 160 units/week for 6 months (each 5mL vial contains 400 units). If no, do not approve.
*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
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES 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: 10/25/2013 Effective date: 11/6/2013 Reviewed date: 7/1/2019 Revised date: 11/1/2016
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES DROXIDOPA
Generic Brand HICL GCN Exception/Other DROXIDOPA NORTHERA 40936
GUIDELINES FOR USE 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?
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES
If yes, do not approve. If no, continue to #8.
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 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 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: 7/1/2019 Revised date: 11/1/2016
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES SOMATROPIN
Generic Brand HICL GCN Exception/Other SOMATROPIN GENOTROPIN 02824 HUMATROPE NORDIFLEX NORDITROPIN NUTROPIN NUTROPIN AQ NUTROPIN DEPOT OMNITROPE (FORMULARY) SAIZEN SEROSTIM TEV-TROPIN ZOMACTON ZORBTIVE
GUIDELINES FOR USE 1. Is the requested medication for Serostim, prescribed for the treatment of HIV/AIDS- wasting syndrome?
If yes, continue to #15. If no, continue to #2.
2. Is the requested medication for Zorbtive, prescribed for the treatment of short-bowel syndrome?
If yes, continue to #21. If no, continue to #3.
3. Is the requested medication Omnitrope?
If yes, continue to #5. If no, continue to #4.
4. Has the patient tried or does the patient have a contraindication to Omnitrope?
If yes, continue to #5. If no, do not approve.
5. Does the patient have a diagnosis of Idiopathic Short Stature (not growth hormone- deficient short stature), or is somatropin being prescribed for athletic enhancement or anti-aging purposes?
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES
If yes, do not approve. If no, continue to #6.
6. Is the medication being prescribed by an endocrinologist?
If yes, approve x1 year. If no, continue to #7.
7. Is the medication being prescribed for childhood onset growth hormone deficiency, small for gestational age (SGA), Turner Syndrome, Prader Willi Syndrome, Noonan Syndrome, or SHOX deficiency?
If yes, continue to #12. If no, continue to #8.
8. Is the medication prescribed for an adult with growth hormone deficiency alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary diseases, hypothalamic disease, surgery, radiation therapy, trauma, or continuation of therapy from childhood onset growth hormone deficiency?
If yes, approve x1 year. If no, continue to #9.
9. Is the medication being prescribed for growth failure due to pediatric chronic renal insufficiency (CRI)?
If yes, continue to #10. If no, do not approve.
10. Is the medication prescribed by a nephrologist?
If yes, approve x1 year. If no, continue to #11.
11. Has the patient undergone renal transplantation?
If yes, do not approve. If no, continue to #12.
12. Is this for treatment induction?
If yes, continue to #13. If no, continue to #14.
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES 13. Is the patient’s height equal to or greater than 2 standard deviations (SD) below the mean height for normal children of the same age and gender?
If yes, approve x1 year. If no, do not approve.
14. Does the patient have one or more of the following: --A lack of response defined as gain of growth velocity by at least 2 cm compared with that observed during the previous year. --Patient has reached 50th percentile for target height following growth hormone therapy.
If yes, do not approve. If no, approve x1 year.
15. Is this being prescribed by, or in consultation with, nutrition support specialists, infectious disease specialists, or gastroenterology specialists?
If yes, continue to #16. If no, do not approve.
16. Is the patient on antiviral therapy?
If yes, continue to #17. If no, do not approve.
17. Does the patient meet one of the following criteria: --10% unintentional weight loss over 12 months --7.5% unintentional weight loss over 6 months --5% body cell mass (BCM) loss within 6 months --In men: BCM < 35% of total body weight and body mass index (BMI) < 27kg/m2 --In women: BCM < 23% of total body weight and BMI < 27kg/m2 --BMI < 20kg/m2
If yes, continue to #18. If no, do not approve.
18. Is the patient currently using this drug?
If yes, continue to #20. If no, continue to #19.
19. Has the patient had an inadequate response to cyproheptadine, dronabinol, testosterone, and megestrol acetate?
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES If yes, approve x3 months, limited to 1 vial per day (max dose not to exceed 6mg per day). If no, do not approve.
20. Has the patient shown a clinical benefit as demonstrated by an increase in muscle mass and weight from growth hormone replacement?
If yes, approve for additional 3 months, limited to 1 vial per day (max dose not to exceed 6mg per day). If no, do not approve.
21. Is this being prescribed by, or in consultation with, nutritional support specialists or gastroenterology specialists?
If yes, continue to #22. If no, do not approve.
22. Is the patient currently on specialized nutritional support; (for example, consisting of a high carbohydrate, low-fat diet)?
If yes, continue to #23. If no, do not approve.
23. Has the patient been on the requested medication for at least 4 weeks?
If yes, do not approve. If no, approve x4 weeks, limited to 1 vial per day (max dose not to exceed 8mg per day).
Creation date: 11/16/2016 Effective date: 1/1/2017 Reviewed date: 11/1/2019 Revised date: 11/1/2017
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES KETOCONAZOLE (ORAL)
Generic Brand HICL GCN Exception/Other KETOCONAZOLE NIZORAL 42590
GUIDELINES FOR USE 1. Is this medication being used to treat skin and/or nail fungal infection?
If yes, do not approve. If no, continue to #2.
2. Is this medication being prescribed by an oncologist?
If yes, approve. If no, continue to #3.
3. Is this medication being prescribed by an infectious disease specialist?
If yes, approve. If no, do not approve.
Creation date: 7/27/2016 Effective date: 9/20/2016 Reviewed date: 7/1/2019 Revised date: 7/1/2016
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES DIMETHYL FUMARATE
Generic Brand HICL GCN Exception/Other DIMETHYL TECFIDERA 40168 FUMARATE
GUIDELINES FOR USE INITIAL CRITERIA (NOTE: FOR RENEWAL CRITERIA SEE BELOW)
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. Does the patient have a diagnosis of a relapsing or an 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 Tecfidera with another disease modifying treatment (i.e., Copaxone, Betaseron, Extavia, Rebif, Tysabri, Gilenya, Aubagio, Tecfidera, Rituxan)?
If yes, do not approve. If no, continue to #4
4. Has the patient failed, demonstrated intolerance, or demonstrated significant non- adherence to interferon OR glatiramer acetate therapy?
If yes, continue to #6. If no, continue to #5.
5. Does the patient have a contraindication/serious precaution to both interferon AND glatiramer acetate therapy?
If yes, continue to #6. If no, do not approve.
6. Was a baseline CBC completed within the last 3 months?
If yes, continue to #7.
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES If no, do not approve.
7. 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 Gilenya, Tysabri, or Rituxan and determine response. If unwilling to change or unresponsive, approve Tecfidera x 2 years) If no, approve x 2 years
RENEWAL CRITERIA
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. 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 Tecfidera with another disease modifying treatment (i.e., Copaxone, Betaseron, Extavia, Rebif, Tysabri, Gilenya, Aubagio, Tecfidera, Rituxan)?
If yes, do not approve. If no, continue to #4
4. Has the patient had a CBC 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 (MRI obtained within past 12months): 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
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES 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
Creation date: 12/12/2016 Effective date: 1/1/2017 Reviewed date: 7/1/2019 Revised date: 12/1/2016
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES MIFEPRISTONE
Generic Brand HICL GCN Exception/Other MIFEPRISTONE KORLYM 31485
GUIDELINES FOR USE 1. Does the patient have a diagnosis of endogenous Cushing’s syndrome?
If yes, continue to #2 If no, do not approve.
2. Does the patient have a diagnosis of diabetes type 2 or glucose intolerance?
If yes, continue to #4 If no, continue to #3.
3. Has the patient tried and failed ketoconazole and surgical intervention?
If yes, approve x 1 year, up to 4 tablets per day by GCN/GPID APPROVAL TEXT: Please note this medication has an important FDA Safety Warning: pregnancy must be excluded before the initiation of treatment with Korlym or when therapy is interrrupted for more than 14 days. For more information, discuss with your provider or pharmacist. If no, do not approve
4. Has the patient failed surgical treatment for Cushing’s syndrome or is the patient not a candidate for surgery?
If yes, approve for 1 year, up to 4 tablets per day by GCN.
APPROVAL TEXT: Please note this medication has an important FDA Safety Warning; pregnancy must be excluded before the initiation of treatment with Korlym or when therapy is interrupted for more than 14 days. For more information, discuss with your provider or pharmacist.
If no, do not approve.
Creation date: 11/16/2016 Effective date: 1/1/2017 Reviewed date: 11/1/2019 Revised date: 11/1/2017
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES BECAPLERMIN
Generic Brand HICL GCN Exception/Other BECAPLERMIN REGRANEX 17028
GUIDELINES FOR USE 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: 11/1/2019 Revised date: 11/1/2017
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES IMMUNE GLOBULIN (HUMAN)/HYALURONIDASE SUBCUTANEOUS
Generic Brand HICL GCN Exception/Other IMMUNE GLOBULIN HYQVIA 41391 (HUMAN)/HYALURONIDASE SUBCUTANEOUS
GUIDELINES FOR USE 1. Will this medication be administered in a medical office or infusion center?
If yes, do not approve. If no, continue to #2.
2. Has the patient tried Hizentra and it was ineffective, is the patient intolerant to Hizentra, or does the patient have a contraindication to Hizentra?
If yes, approve x 1 year. If no, do not approve.
Creation date: 11/16/2016 Effective date: 1/1/2017 Reviewed date: 9/1/2019 Revised date: 11/1/2016
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES INSULIN GLARGINE (VIALS)
Generic Brand HICL GCN Exception/Other INSULIN LANTUS (VIALS) 13072 GLARGINE
GUIDELINES FOR USE 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: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
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 GUIDELINES FOR USE Note: The 200 mg and 300 mg strength are formulary. All other strengths are non- formulary.
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?
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES If yes, approve open-ended. If no, go to #6.
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: 7/1/2019 Revised date: 7/1/2018
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES LUMACAFTOR/IVACAFTOR
Generic Brand HICL GCN Exception/Other LUMACAFTOR/IVACAFTOR ORKAMBI 42235
GUIDELINES FOR USE 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.
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES
Creation date: 9/15/2018 Effective date: 10/12/2018 Reviewed date: 7/1/2019 Revised date: 9/1/2018
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES XIIDRA (LIFITEGRAST)
Generic Brand HICL GCN Exception/Other LIFITEGRAST XIIDRA 43610
GUIDELINES FOR USE INITIAL CRITERIA 1. Is this medication prescribed by an optometrist or ophthalmologist?
If yes, continue to #2. If no, do not approve.
2. Does the patient have a diagnosis of dry eye disease (DED)?
If yes, continue to #3. If no, do not approve.
3. Has the patient tried and failed over-the-counter (OTC) artificial tears?
If yes, continue to #4. If no, do not approve.
4. Has the patient tried and failed at least 3 consecutive months of therapy with Restasis?
If yes, approve x 6 months, maximum one box of 60 vials per 30 days. If no, do not approve.
RENEWAL CRITERIA 1. Has the patient been compliant with therapy for the past 6 months?
If yes, approve x 6 months, maximum one box of 60 vials per 30 days. If no, do not approve.
Creation date: 9/26/2018 Effective date: 12/1/2018 Reviewed date: 9/1/2019 Revised date:
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES TRINTELLIX
Generic Brand HICL GCN Exception/Other VORTIOXETINE TRINTELLIX 40637
GUIDELINES FOR USE INITIAL CRITERIA (NOTE: FOR RENEWAL CRITERIA SEE BELOW) 1. Does the patient have a diagnosis of major depressive disorder?
If yes, continue to #2. If no, do not approve.
2. 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)?
If yes, continue to #3. If no, do not approve.
3. Has the patient tried and failed treatment with at least 1 atypical antidepressant (bupropion OR nefazodone OR mirtazapine)?
If yes, approve x 5 years. If no, do not approve.
RENEWAL CRITERIA 1. Is the patient currently stable on therapy with Trintellix?
If yes, approve x 5 years. If no, do not approve.
Creation date: 7/1/2018 Effective date: 11/28/2018 Reviewed date: Revised date:
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES EMICIZUMAB-KXWH (HEMLIBRA)
Generic Brand HICL GCN Exception/Other EMICIZUMAB- HEMLIBRA KXWH
GUIDELINES FOR USE INITIAL CRITERIA (SEE BELOW FOR RENEWAL) 1. Is this medication prescribed by a hematology-oncology specialist?
If yes, continue to #2. If no, do not approve.
2. Does the patient have a diagnosis of hemophilia A?
If yes, continue to #3. If no, do not approve.
3. Does the patient have a documented history of high-titer factor VIII inhibitors (>5 Bethesda units/mL)?
If yes, continue to #4. If no, continue to #5.
4. Has the patient tried and failed first-line therapy of immune tolerance induction (ITI), is the patient not a candidate for ITI (e.g., cannot undergo central line placement), or does the patient require prophylaxis while on ITI therapy?
If yes, approve x 2 years. If no, do not approve. Patient must try and fail therapy with ITI.
5. Does the patient have phenotypically severe hemophilia A (frequent bleeding or higher risk for frequent bleeding, regardless of FVIII level) that requires prophylaxis?
If yes, approve x 2 years. If no, do not approve.
RENEWAL CRITERIA 1. Is the patient adherent with follow-up assessments and medication?
If yes, continue to #2. If no, do not approve.
2. Have bleed rates improved while on emicizumab-kxwh (Hemlibra)?
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES
If yes, approve x 2 years. If no, do not approve.
Creation date: 11/28/2018 Effective date: 12/7/2018 Reviewed date: 11/1/2019 Revised date: 11/1/2018
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES EPIDIOLEX (CANNABIDIOL)
Generic Brand HICL GCN Exception/Other CANNABADIOL EPIDIOLEX
GUIDELINES FOR USE INITIAL CRITERIA 1. Is the patient 2 years of age or older, and is this medication being prescribed by or in consultation with a neurologist?
If yes, continue to #2. If no, do not approve.
2. Is the patient using another cannabis product or a derivative, does the patient have significant hepatic impairment (defined as ALT or AST >3x ULN with total bilirubin >2x ULN), or is the patient pregnant or planning to become pregnant?
If yes, do not approve. If no, continue to #3.
3. Is this medication being used in conjunction with another antiepileptic medication?
If yes, continue to #4. If no, do not approve.
4. In the past 8 weeks, has the patient had weekly seizures despite compliance with optimal dosing of combination therapy of at least 2 antiepileptic medications?
If yes, continue to #5. If no, do not approve.
5. Does the patient have a diagnosis of Lennox-Gastaut Syndrome (LGS)?
If yes, continue to #6. If no, continue to #7.
6. Has the patient tried and failed, or does the patient have contraindication to clobazam, topiramate, and lamotrigine?
If yes, approve x 6 months. If no, do not approve.
7. Does the patient have a diagnosis of Dravet Syndrome (DS)?
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES
If yes, continue to #8. If no, do not approve.
8. Has the patient tried and failed, or does the patient have contraindication to clobazam, topiramate, and a valproic acid derivative product?
If yes, approve x 6 months. If no, do not approve.
RENEWAL CRITERIA 1. Is the patient using another cannabis product or a derivative, does the patient have significant hepatic impairment (defined as ALT or AST >3x ULN with total bilirubin >2x ULN), or is the patient pregnant or planning to become pregnant?
If yes, do not approve. If no, continue to #2.
2. Has the patient maintained adherence to the medication since last approval?
If yes, continue to #3. If no, do not approve.
3. Has the patient continued to experienced weekly seizures while taking Epidiolex?
If yes, do not approve. If no, approve x 1 year.
Creation date: 11/28/2018 Effective date: 12/18/2018 Reviewed date: Revised date:
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES HUMIRA CITRATE FREE
Generic Brand HICL GCN Exception/Other ADALIMUMAB HUMIRA CF
GUIDELINES FOR USE INITIAL CRITERIA 1. Is this being prescribed by a CPMG or an affiliated dermatology, gastroenterology or rheumatology provider with an active referral if necessary?
If yes, continue to #2. If no, do not approve.
2. Is this request for Humira 10 mg/0.1 mL?
If yes, approve x 1 year, maximum 2 pens per 28 days. If no, continue to #3.
3. Does the patient have a contraindication to, or has the patient failed (due to injection site reaction, NOT due to pain) therapy with a preferred formulation of Humira (40 mg/0.8 mL or 20 mg/0.4 mL)?
If yes, approve x 2 years. If no, continue to #4.
4. Is the patient 13 years of age or older?
If yes, do not approve. Patient must use formulary Humira 40 mg/0.8 mL. If no, continue to #5.
5. Is injection site pain causing the patient to be non-compliant with Humira therapy?
If yes, approve x 1 year. If no, do not approve.
Creation date: 11/28/2018 Effective date: 1/2/2019 Reviewed date: Revised date:
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES FULPHILA (PEGFILGRASTIM)
Generic Brand HICL GCN Exception/Other PEGFILGRASTIM- FULPHILA 45010 44881 JMDB 6MG/0.6ML PEGFILGRASTIM NEULASTA 23255 15666/37706 6MG/0.6ML PEGFILGRASTIM NEULASTA 23255 37706 6MG/0.6ML ONPRO PEGFILGRASTIM- UDENYCA 45445 45679 CBQV 6MG/0.6ML PEGFILGRASTIM- ZIEXTENZO 47234 46183 BMEZ 6MG/0.6ML
GUIDELINES FOR USE 1. Is the prescriber a KP affiliated or a CPMG Hematology/Oncology specialist and if applicable, does this member have an active referral? Yes, continue to #2 No, do not approve
2. Is the patient < 18 years old? Yes, continue to #3 No, continue to #4
3. Is this being prescribed for prevention of febrile neutropenia with chemotherapy? Yes, continue to #5 No, do not approve
4. During the last treatment course, did the patient experience febrile neutropenia or neutropenia resulting in cancer treatment delays despite 12 days of Zarxio? Yes, continue to #5 No, request that patient try or continue on Zarxio
5. Is the request for FULPHILA? Yes, approve FULPHILA x 6 months No, deny as patient must use FULPHILA (same active and inactive ingredients)
Creation date: 12/1/2018 Effective date: 2/21/2019 Reviewed date: 1/1/2020 Revised date: 1/1/2020
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
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 ≥ 18 years 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, despite optimized nutritional support with previously unsuccessful attempts to wean off parenteral nutrition/intravenous fluids (PN/IVF)?
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. Has the patient had a colonoscopy in the past 6 months?
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.
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES RENEWAL CRITERIA 1. Is patient still under the care of a CPMG or an affiliated Gastroenterologist?
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. Is the patient up to date with screening colonoscopies (due after 1 year of treatment with teduglutide, then every 5 years, or more frequently if polyps found)?
If yes, approve x 1 year, max 30 vials per 30 days. If no, do not approve.
Creation date: 7/25/2019 Effective date: 8/14/2019 Reviewed date: 7/1/2019 Revised date: 7/1/2019
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES IVACAFTOR
Generic Brand HICL GCN Exception/Other IVACAFTOR KALYDECO 38461
GUIDELINES FOR USE 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.
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES 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 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: 7/1/2019 Revised date: 7/1/2019
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES TEZACAFTOR/IVACAFTOR (SYMDEKO)
Generic Brand HICL GCN Exception/Other TEZACAFTOR/IVACAFTOR SYMDEKO
GUIDELINES FOR USE 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,51070W, 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: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES 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. If no, do not approve.
Creation date: 7/25/2019 Effective date: 8/14/2019 Reviewed date: 7/1/2019 Revised date: 7/1/2019
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
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 1. Is the patient equal or greater than 5 years old and has a diagnosis of Duchenne Muscular Dystrophy (DMD)? a) Yes, proceed to #2 b) No, do not approve
2. Has the patient tried continuous prednisone for at least 12 months? a) Yes, proceed to #3 b) No, do not approve. Try prednisone.
3. Did onset of weakness associated with DMD occur before 5 years of age? a) Yes, proceed to #4 b) No, do not approve.
4. Did the patient experience 'clinically significant'* weight gain during the first 2 years of prednisone use? a) Yes, approve x 1 year b) No, do not approve. Continue prednisone.
GUIDELINES FOR RENEWAL A. Is the patients weight gain persisting or worsening? 1) Yes, do not approve. Consider alternative therapy, prednisone. 2) No, approve x 2 years
Creation date: 9/26/2018 Effective date: 10/20/2019 Reviewed date: 9/1/2019 Revised date: 9/1/2018
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES GLP-1 AGONISTS
Generic Brand HICL GCN Exception/Other EXENATIDE ER BYDUREON 38451 DULAGLUTIDE TRULICITY 41421 LIRAGLUTIDE VICTOZA 36436 LIXISENATIDE ADLYXIN 40782 SEMAGLUTIDE OZEMPIC 44675 EXENATIDE BYETTA 32893
GUIDELINES FOR USE GUIDELINES FOR USE INITIAL CRITERIA (NOTE: FOR RENEWAL CRITERIA SEE BELOW) 1. Is this being prescibed by the KPCO Weight Management department or by a provider affiliated with a weight loss clinic?
If yes, do not approve. If no, continue #2.
2. Does the patient have a diagnosis of diabetes mellitus type 2?
If yes, continue to #3. If no, do not approve.
3. Is the patient 2.0 percentage points or less from their designated HgbA1c goal? (Ask for the patient’s HgbA1c goal and an HgbA1c result drawn in the last 3 months to determine the answer to this question.)
If yes, continue to #4. If no, do not approve.
4. Does the patient have ASCVD?
If yes, continue to #9 If no, continue to #5.
5. Has the patient failed, or does the patient have contraindications to, 2000 mg of metformin (total daily dose), maximum dose of a sulfonylurea, maximum dose of pioglitazone, and all possible combinations thereof?
If yes, continue to #6. If no, do not approve.
6. Is the patient currently using insulin?
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES
If yes, continue to #7. If no, continue to #8.
7. Is it appropriate to adjust the patient's insulin regimen to achieve better control?
If yes, do not approve, adjust insulin. If no, continue to #8.
8. Will this medication cause the patient’s current, active diabetes treatment regimen to contain four or more medications?
If yes, do not approve. If no, continue to #9.
9. Will the patient use this medication with a DPP-4 inhibitor (medications containing alogliptin, linagliptin, saxagliptin, or sitagliptin)?
If yes, do not approve. If no, continue to #10.
10. Does the patient have active, or a past history of, pancreatitis?
If yes, do not approve. If no, continue to #11.
11. Does the patient have a family or personal history of medullary thyroid carcinoma, or does the patient have multiple endocrine neoplasia syndrome type 2?
If yes, do not approve. If no, continue to #12.
12. Does the patient have severe gastrointestinal disease (i.e., colitis, Crohn’s disease, GI obstruction, GI perforation, gastroparesis, ileus, etc.)?
If yes, do not approve. If no, AND patient has ASCVD continue to #16. If no, AND patient does NOT have ASCVD continue to #13
13. Is the requested dose appropriate for the patient’s CrCl or GFR? (Ask for an appropriate measure of the patient’s renal function to determine the answer to this question.)
If yes, continue to #14.
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES If no, do not approve.
14. Is the request for Bydureon?
If yes, approve x 6 months. If no, continue to #15.
15. Has the patient tried and failed Bydureon, or does the patient have a contraindication to the use of Bydureon?
If yes, continue to #17. If no, do not approve. Must try Bydureon.
16. [ASCVD pts only] Is the request for Victoza (liraglutide) AND patient failed Empagliflozin AND Canagliflozin and is currently taking maximum tolerated metformin?
If yes, approve x 6 months. If no, do not approve. The preferred treatment is metformin plus an SGLT2i to reduce CV outcomes..
17. Has the patient tried and failed Victoza, or does the patient have a contraindication to the use of Victoza?
If yes, approve x 6 months. If no, do not approve. Must try Victoza. Note: patients with ASCVD, liraglutide preferred to reduce CV outcomes
RENEWAL CRITERIA 1. Is this medication being used with a DPP-4 inhibitor (medications containing alogliptin, linagliptin, saxagliptin, or sitagliptin)? If yes, do not approve. If no, continue to #2.
2. Does the patient have ASCVD?
If yes, continue to #5 If no, continue to #3
3. Is the patient at HgbA1c goal, or has the patient’s HgbA1c decreased by 1% or more?
If yes, continue to #4. If no, do not approve. .
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES 4. Is the requested dose appropriate for the patient’s CrCl or GFR? (Ask for an appropriate measure of the patient’s renal function to determine the answer to this question.)
If yes, continue to #6. If no, do not approve.
5. Is the A1C >10.5%?
If yes, do not approve. Benefit for CV outcomes A1C >10.5% use is minimal in literature. If no, continue to #6
6. Has the patient developed severe gastrointestinal disease (i.e., colitis, Crohn’s disease, GI obstruction, GI perforation, gastroparesis, ileus, etc.), or pancreatitis?
If yes, do not approve. If no, approve x 1 year.
Creation date: 9/26/2018 Effective date: 10/20/2019 Reviewed date: 09/2019 Revised date: 09/2019
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES DPP-4 INHIBITORS/DPP-4 INHIBITOR COMBINATIONS
Generic Brand HICL GCN Exception/Other SAXAGLIPTIN ONGLYZA 36471 SITAGLIPTIN JANUVIA 34126 SITAGLIPTIN/METFORMIN JANUMET, 34665 JANUMET XR ALOGLIPTIN NESINA 39968 LINAGLIPTIN TRADJENTA 29890 ALOGLIPTIN/METFORMIN KAZANO 39970 LINAGLIPTIN/METFORMIN JENTADUETO, 38464 JENTADUETO XR SAXAGLIPTIN/METFORMIN KOMBIGLYZE 37246 XR ALOGLIPTIN/PIOGLITAZONE OSENI 39967
GUIDELINES FOR USE GUIDELINES FOR USE INITIAL CRITERIA (NOTE: FOR RENEWAL CRITERIA SEE BELOW) 1. Does the patient have a diagnosis of diabetes mellitus type 2?
If yes, continue to #2. If no, do not approve.
2. Is the patient 1 percentage point or less from their designated HgbA1c goal? (Ask for the patient’s HgbA1c goal and an HgbA1c result drawn in the last 3 months to determine the answer to this question.)
If yes, continue to #3. If no, do not approve.
3. Has the patient failed, or does the patient have contraindications to, 2000 mg of metformin (total daily dose), maximum dose of a sulfonylurea, maximum dose of pioglitazone, and all possible combinations thereof?
If yes, continue to #4. If no, do not approve.
4. Will the patient use this medication with a GLP-1 agonist (medications containing albiglutide, exenatide, dulaglutide, liraglutide, lixisenatide, semaglutide)?
If yes, do not approve. If no, continue to #5.
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES 5. Will this medication cause the patient’s current, active diabetes treatment regimen to contain four or more medications?
If yes, do not approve. If no, continue to #6. 6. Is the patient currently using insulin?
If yes, continue to #7. If no, continue to #8.
7. Is it appropriate to adjust the patient's insulin regimen to achieve better control?
If yes, do not approve, adjust insulin. If no, continue to #8.
8. Is the requested dose appropriate for the patient’s CrCl or GFR? (Ask for an appropriate measure of the patient’s renal function to determine the answer to this question.)
If yes, continue to #9. If no, do not approve.
9. Does the patient have heart failure or history of heart failure?
If yes, do not approve. If no, continue to #10.
10. Does the patient have active, or a past history of, pancreatitis?
If yes, do not approve. If no, continue to #11.
11. Is the request for linagliptin or a linagliptin/metformin product?
If yes, approve x 6 months. If no, continue to #12.
12. Has the patient tried and failed linagliptin or a linagliptin/metformin product, or does the patient have a contraindication to the use of linagliptin?
If yes, continue to #13. If no, do not approve.
13. Is the request for alogliptin or an alogliptin/metformin product?
If yes, approve x 6 months.
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES If no, continue to #14.
14. Has the patient tried and failed alogliptin or an alogliptin/metformin product, or does the patient have a contraindication to the use of alogliptin?
If yes, approve x 6 months. If no, do not approve.
RENEWAL CRITERIA 1. Is this medication being used with a GLP-1 agonist (medications containing albiglutide, exenatide, dulaglutide, liraglutide, lixisenatide, semaglutide)?
If yes, do not approve. If no, continue to #2.
2. Is the patient at HgbA1c goal?
If yes, continue to #3. If no, do not approve.
3. Is the requested dose appropriate for the patient’s CrCl or GFR? (Ask for an appropriate measure of the patient’s renal function to determine the answer to this question.)
If yes, continue to #4. If no, do not approve.
4. Has the patient developed pancreatitis or heart failure since starting the medication?
If yes, do not approve. If no, approve x1 year.
Creation date: 9/26/2018 Effective date: 10/20/2019 Reviewed date: 9/2019 Revised date: 9/2019
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES MILNACIPRAN
Generic Brand HICL GCN Exception/Other MILNACIPRAN SAVELLA 21229
GUIDELINES FOR USE INITIAL USE CRITERIA 1. Is the patient equal to or over the age of 18 yrs. old?
If yes, proceed to #2. If no, do not approve.
2. Does the patient have a diagnosis of fibromyalgia?
If yes, proceed to #3. If no, do not approve.
3. Is the patient age < 65 yrs. old?
If yes, proceed to #4. If no, proceed to #5.
4. Has the patient tried and failed* or have contraindications to at least one TCA/cyclobenzaprine or have contraindications to all TCAs and cyclobenzaprine?
If yes, proceed to #5. If no, do not approve. The patient must try and fail at least one formulary TCA or cyclobenzaprine.
5. Has the patient tried and failed* at least one SSRI and SNRI?
If yes, proceed to #6. If no, do not approve. The patient must try and fail one formulary SSRI and SNRI.
6. Has the patient tried and failed* or have contraindications to gabapentin and pregabalin
If yes, approve at HICL MDD #2. If no, do not approve. The patient must try and fail either one formulary gabapentanoid.
*A failure is an intolerance to or inefficacy of the medication after an adequate trial. An adequate trial is considered 6 weeks due to the delay in achieving maximum benefit.
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES Creation date: 9/26/2018 Effective date: 10/20/2019 Reviewed date: 9/2019 Revised date: 9/2019
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES OVERACTIVE BLADDER ANTICHOLINGERIC MEDICATIONS
Generic Brand HICL GCN Exception/Other Trospium ER Sanctura XR 17498 99193 Tolterodine ER Detrol LA 18047 12263, 12264 Tolterodine IR Detrol 26595 37061, 37062 Fesoterodine Toviaz 35606 99711, 99712 Darifenacin Enablex 24043, 24044
GUIDELINES FOR USE INITIAL CRITERIA 1. Does the patient have overactive bladder, urge incontinence, urgency, urinary frequency or bladder spasm?
If yes, continue to #2. If no, do not approve.
2. Does the patient have a history of cognitive issues (dementia, memory impairment, delirium)?
If yes, continue to #3. If no, continue to #4.
3. Does the patient have a history of trial and failure, inadequate response, or intolerance/contraindication to both solifenacin and trospium IR?
If yes, continue to #7. If no, do not approve, recommend solifenacin or trospium IR.
4. Does the patient have a history of trial and failure, inadequate response, or intolerance/contraindication to all of the following oxybutynin tab or syrup, solifenacin and trospium IR?
If yes, continue to #5. If no, do not approve, recommend oxybutynin tab or syrup, solifenacin or trospium IR.
5. Is the request for tolterodine IR?
If yes, approve x 12 months. If no, continue to #6.
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES 6. Does the patient have a history of trial and failure, inadequate response, or intolerance/contraindication to tolterodine IR?
If yes, continue to #7. If no, do not approve, recommend tolterodine IR.
7. Is the request for darifenacin ER?
If yes, approve x 12 months, maximum daily dose #1. If no, continue to #8.
8. Does the patient have a history of trial and failure, inadequate response, or intolerance/contraindication to darifenacin ER?
If yes, continue to #9. If no, do not approve, recommend darifenacin ER (maximum daily dose #1).
9. Is the request for tolterodine ER?
If yes, approve x 12 months, maximum daily dose #1 . If no, continue to #10.
10. Does the patient have a history of trial and failure, inadequate response, or intolerance/contraindication (including history of cognitive issues) to tolterodine ER?
If yes, continue to #11. If no, do not approve, recommend tolterodine ER (maximum daily dose #1).
11. Is the request for trospium ER?
If yes, approve x 12 months, maximum daily dose #1. If no, continue to #12.
12. Does the patient have a history of trial and failure, inadequate response, or intolerance/contraindication to trospium ER?
If yes, approve fesoterodine x 12 months (maximum daily dose #1). If no, do not approve, recommend trospium ER (maximum daily dose #1).
RENEWAL CRITERIA 1. Does the patient have a history of trial and failure, inadequate response, or intolerance to solifenacin?
If yes, approve x 12 months If no, do not approve, recommend solifenacin.
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES
Creation date: 1/15/2019 Effective date: 10/20/2019 Reviewed date: Revised date:
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES CAROSPIR
Generic Brand HICL GCN Exception/Other SPIRONOLACTONE CAROSPIR 02901 15596 ORAL SOLUTION
GUIDELINES FOR USE 1. Is the patient 12 years old or younger?
If yes, approve x 1 year. If no, continue to #2.
2. Can the dose be administered via halved, whole or combo of the spironolactone 25 mg, 50mg or 100mg tablet? a. If yes, continue to #3 b. If no, approve X 12 months
3. Does patient have a gastrostomy tube? c. If yes, approve X 12 months d. If no, continue to #4
4. Can the patient swallow other tablets whole, halved or crushed (or swallow contents of opened capsules)? e. If yes, do not approve – suggest patient crush spironolactone tabs before administration and take with or w/o applesauce f. If no, approve x 12 months
Creation date: 9/26/2018 Effective date: 10/20/2019 Reviewed date: Revised date:
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES AMLODIPINE SUSPENSION
Generic Brand HICL GCN Exception/Other AMLODIPINE KATERZIA 45864 46652 SUSPENSION
GUIDELINES FOR USE 1. Is the patient age < 12 yo? a. If yes, approve x 12 months b. If no, continue # 2
2. Can the dose be administered via halved, whole or combo of the amlodipine 5 mg tablet (i.e. 2.5 mg or 7.5 mg)? a. If yes, continue to #3 b. If no, approve X 12 mo
3. Does patient have a gastrostomy tube? a. If yes, approve X 12 months b. If no, continue to #4
4. Can the patient swallow other tablets whole, halved or crushed (or swallow contents of opened capsules)? a. If yes, do not approve – suggest patient crush amlodipine tabs before administration and take with or w/o applesauce b. If no, approve x 12 months
Creation date: 10/1/2019 Effective date: 10/23/2019 Reviewed date: Revised date:
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES SELEXIPAG
Generic Brand HICL GCN Exception/Other SELEXIPAG UPTRAVI 42922
GUIDELINES FOR USE INITIAL USE 1. Is the requesting physician a CPMG cardiologist or pulmonologist, or is the requesting physician an affiliated network cardiologist or pulmonologist with appropriate referral, if needed?
If yes, continue to #2. If no, do not approve.
2. Does the patient have a diagnosis of pulmonary arterial hypertension (PAH, WHO Group 1) verified by right heart catheterization?
If yes, continue to #3. If no, do not approve.
3. Does the patient currently display WHO Functional Class II-IV symptoms?
If yes, continue to #4. If no, do not approve.
4. Is the patient currently using an appropriate dose and duration of, has the patient tried and failed an appropriate dose and duration of, or does the patient have a contraindication to each of the following: --one phosphodiesterase type 5 (PDE5) inhibitor (e.g., Adcirca, Revatio) -- --one endothelin receptor antagonist (ERA) [e.g., Tracleer, Letairis or Opsumit]
If yes, continue to #5. If no, do not approve.
5. Is the patient unable to use an intravenous (IV) prostanoid (e.g., Veletri, Flolan) for any of the following reasons: --risk of catheter infection --significant issues with adherence to treatment regimens --lack of social support for indefinite use of a continuous IV medication --significant issues gaining or maintaining peripheral or central access --patient unwilling
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES If yes, approve Uptravi Titration Pack (GPID) x1 fill, the #140 bottle of 200mcg (GPID) x 1 fill, and the 600mcg (HICL).for 5 months with a max daily dose #2 starting 1 month from start for 5 months duration. The total initial approval will be for 6 months. If no, do not approve.
Creation date: 3/12/2019 Effective date: 11/26/2019 Reviewed date: 3/1/2019 Revised date: 3/1/2019
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES TKI 2nd Generation
Generic Brand HICL GCN Exception/Other DASATINIB SPRYCEL 33855 NILOTINIB TASIGNA 35149
GUIDELINES FOR USE INITIAL USE 1. Does patient have diagnosis of CML or ALL? a. If No, do NOT approve - contact Oncology Clinical Pharmacy Specialist if one of following (or another disease state): gastrointestinal stromal tumors (GIST), hypereosinophilic syndrome, eosinophilic leukemia, dermatofibrosarcoma, chordoma b. If Yes, continue to # 2
2. Does patient have one of the following BCR-ABL1 mutations? Recommend and approve the specific agent noted below for respective mutation. - Y253H, E255K/V or F359V/C/I Dasatinib - F317L/V/I/C, T315A, or V299L Nilotinib - E255K/V, F317L/V/I/C, F359V/C/I, T315A, or Y253H Bosutinib - T315I Ponatinib a. If yes, approve corresponding TKI X 2 years b. If no, continue to # 3
3. Does patient have one of the following 1) Intermediate or high Sokol score (score of 0.8 or greater), 2) History of Accelerated Phase CML, 3) History of Blast Phase CML, 4) ALL with Philadelphia Chromosome (aka BCR-ABL)? a. If yes, suggest/approve dasatinib X 1 year b. If no, continue to # 5
4. Did patient have inadequate response/TKI resistance to imatinib by BCR-ABL1 per NCCN criteria that is NOT due to patient nonadherence AND patient adherence has been assessed? a. If yes, suggest/approve dasatinib X 1 year b. If no, continue to #6
5. Does the patient have prior documented intolerance/side effects to imatinib not alleviated by dose reductions (<200 mg/day)? a. If yes, approve dasatinib X 1 year b. If no, continue to #6
6. Is the request for nilotinib and the patient has tried and failed, inadequate response, or intolerance to dasatinib AND imatinib (despite appropriate dose reductions if due to intolerance) or if there was a specific mutation as noted in criteria number 2? a. If yes, approve nilotinib X 1 year b. If no, do NOT approve and suggest imatinib or dasatinib
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES
Renewal criteria: Approve if been on TKI the prior month and meets the response criteria per NCCN.
Creation date: 11/20/2019 Effective date: 12/9/2019 Reviewed date: Revised date:
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES IL-17 Inhibitors (Biologics)
Generic Brand HICL GCN Exception/Other BRODALUMAB SILIQ 44102 IXEKIZUMAB TALTZ 43193
GUIDELINES FOR USE INITIAL USE
Psoriasis indications (both Siliq and Taltz): a). Restricted to Dermatology for patients age 18 years and older b). Moderate to severe psoriasis (at least 10% of body surface area (BSA) is affected) c). History of failure, contraindication, or intolerance to topical therapies (below). If patient is noted to have very high disease activity (ie: > 50% BSA) – proceed to step g • High to very-high potency topical corticosteroid (not applicable for face, eyelids, skin folds, underarms, groin area) -AND/OR- • Vit D Analogue -OR-
• 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 d). Phototherapy is not contingent to the approval criteria, but strongly encouraged as a treatment option e). Patient with failure, intolerance, or contraindication to at least 2 pre-biologic therapies. If patient is noted to have very high disease activity (ie: > 50% BSA) – proceed to step f • Acitretin • Cyclosporine • Methotrexate • Apremilast f). Patient with failure, intolerance, or contraindication to at least 2 TNF inhibitors (adalimumab, etanercept, or infliximab-dyyb/infliximab) and Cosentyx (Secukinumab) Y/N g). Patient with failure, intolerance or contraindication to Tremfya (Guselkumab), Risankizumab-rzaa (Skyrizi), and Stelara (Ustekinumab) – Y/N h). Approve for 16 weeks with re-review for efficacy. Do not approve if no improvement in symptoms. See quantity limits below.
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES
Quantity Limits: Siliq (Brodalumab)
Quantity limit #4 for 30 day loading dose #2 for 30 day maintenance dose (q4wk)
Taltz (Ixekizumab)
#4 for first 30 day loading dosing #2 for the next two 30 day loading dosing #1 for 30 day maintenance dose (after 12 week load; q4 wk dosing)
Dose: 160 mg once, followed by 80 mg at weeks 2, 4, 6, 8, 10, and 12, and then 80 mg every 4 weeks.
Rheumatologic Indications: (Taltz only)
1. Psoriatic Arthritis indication: a. Patient with failure, intolerance, or contraindication to at least 2 DMARDs (including methotrexate) or high disease activity (as determined by Rheumatologist) b. Patient with failure, intolerance, or contraindication to at least 2 of the following: adalimumab, etanercept, or infliximab-dyyb c. Patient with failure, intolerance, or contraindication to cosentyx d. Patient with failure, intolerance, or contraindication to stelara
2. Ankylosing Spondylitis/Axial spondyloarthritis indication: a. Patient with failure, intolerance, or contraindication to at least 2 DMARDs (including methotrexate) or high disease activity (as determined by Rheumatologist) b. Patient with failure, intolerance, or contraindication to at least 2 of the following: adalimumab, etanercept, or infliximab-dyyb c. Patient with failure, intolerance, or contraindication to cosentyx
Qty limit/30 day supply: i. Induction: #4 syringes/month for first 3 months
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES ii. Maintenance: #1 syringe/month
1. Approve for 16 weeks only with re-review for efficacy. Discontinue if no efficacy at least after 12 weeks of treatment
Creation date: 11/20/2019 Effective date: 12/9/2019 Reviewed date: Revised date:
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES IL-23 Inhibitors (Biologics)
Generic Brand HICL GCN Exception/Other GUSELKUMAB TREMFYA 44418 RISANKIZUMAB- SKYRIZI 46215 RZAA
GUIDELINES FOR USE INITIAL USE
Indication: Psoriasis a. Restricted to Dermatology for patients age 18 years and older b. Moderate to severe psoriasis (at least 10% of body surface area (BSA) is affected) c. History of failure, contraindication, or intolerance to topical therapies (below). If patient is noted to have very high disease activity (ie: > 50% BSA) – proceed to step f • High to very-high potency topical corticosteroid (not applicable for face, eyelids, skin folds, underarms, groin area) -AND/OR- • Vit D Analogue -OR- • 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 d. Phototherapy is not contingent to the approval criteria, but strongly encouraged as a treatment option e. Patient with failure, intolerance, or contraindication to at least 2 pre-biologic therapies. If patient is noted to have very high disease activity (ie: > 50% BSA) – proceed to step g • Acitretin • Cyclosporine • Methotrexate • Apremilast f. Patient with failure, intolerance, or contraindication to at least 2 TNF inhibitors (adalimumab, etanercept, or infliximab-dyyb/infliximab) and Cosentyx (Secukinumab) Y/N g. Approve for 24 weeks with re-review for efficacy. Discontinue if no improvement in symptoms.
Quantity Limits: Tremfya (Guselkumab) Skyrizi (Risankizumab-rzaa)
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES #2 for 30 day loading dose #1 for 30 day maintenance dose (q8wk dosing maintenance) #4 for 30 day loading dose #1 for 30 day maintenance dose (q12wk dosing maintenance)
Creation date: 11/20/2019 Effective date: 12/9/2019 Reviewed date: Revised date:
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES TAFAMIDIS
Generic Brand HICL GCN Exception/Other TAFAMIDIS VYNDAMAX 45729 46258 TAFAMIDIS VYNDAQEL 37584 41631 May be discontinued MEGLUMINE in 2020
GUIDELINES FOR USE INITIAL USE
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
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES If all the above are met, approve x 1 year If any of the above are NOT met, do not approve
Creation date: 3/25/2020 Effective date: 3/30/2020 Reviewed date: Revised date:
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES ADVAIR HFA STEP THERAPY - ICS LABA
Generic Brand HICL GCN Exception/Other FLUTICASONE/SALMETEROL ADVAIR HFA 19963 Formulary with Age and Step through Advair Diskus
GUIDELINES FOR USE Step Therapy Criteria
• Patient is less than 12 years of age • Has the patient tried and failed Advair diskus, 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)
Creation date: 3/30/2020 Effective date: 3/30/2020 Reviewed date: Revised date:
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES CGRP INHIBITORS
Generic Brand HICL GCN Exception/Other ERENUMAB AIMOVIG 46116, Acts on receptor 44753 FREMANEQUMAB AJOVY 45306 Acts on Ligand GLACANEZUMAB EMGALITY 46397 Acts on Ligand 100MG/ML 100MG/ML
GUIDELINES FOR USE GUIDELINES FOR USE
1. Has the patient already tried and failed at least one CGRP mAb acting on the receptor and at least one acting on the ligand?
If yes, do not approve. If no, continue to #2
2. Is the requesting provider a CPMG or an affiliated network neurologist or headache specialist, with appropriate referral if needed?
If yes, continue to #3 If no, do not approve
3. Is the patient between the ages of 18 and 65 years?
If yes, continue to #4 If no, do not approve
4. Is the patient using a triptan, ergotamine, opiate or any combination of these agents for 10 or more days/month for more than 3 months, or a non-opioid analgesic for 15 or more days/month for more than 3 months?
If yes, do not approve If no, continue to #5
5. Has the patient been taking an opiate (including tramadol) or barbiturate (including butalbital-containing products) for the treatment of headache for more than 4 days in the month prior to initiation?
If yes, do not approve If no, continue to #6
6. Is the patient pregnant or intending to become pregnant soon?
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES
If yes, do not approve If no, continue to #7
7. Does the patient have elevated LFTs (ALT or AST >1.5x ULN) or known liver disease?
If yes, do not approve If no, continue to #8
8. Does the patient have cardiovascular comorbidities (uncontrolled hypertension, cardiovascular disease, history of dissections, stroke, unstable angina, pulmonary embolism, evidence of peripheral vascular disease, etc.)?
If yes, do not approve If no, continue to #9
9. Does the patient 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)?
If yes, do not approve If no, continue to #10
10. Does the patient have 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)?
If yes, continue to #21 If no, continue to #11
11. Has the patient tried and failed therapy with an adequate trial* of 3 preventative agents from at least two migraine prophylaxis classes: (anticonvulsants [divalproex, valproate, topiramate], beta blockers [atenolol, metoprolol, nadolol, propranolol, timolol], antidepressants [amitriptyline, nortriptyline, venlafaxine], or does the patient have a documented intolerance, hypersensitivity, or contraindication to treatment alternatives listed above? *An adequate trial is defined as at least 2 months at a maximally tolerated dose.
If yes, continue to #12 If no, do not approve
12. Does the patient have a Migraine Disability Assessment (MIDAS) questionnaire AND is there documentation of headache days per month in chart notes or through a headache diary, completed in the past three months?
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES If yes, continue to #13 If no, do not approve
13. Does the patient have 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)?
If yes, continue to #15 If no, continue to #14
14. Does the patient have a diagnosis of frequent episodic migraine (defined as > 8 headache days per month or > 2 disabling migraines per month, lasting at least 72 hours for the past three months)?
If yes, continue to #16 If no, do not approve
15. Has the patient tried and failed therapy with onabotulinumtoxinA for migraine prevention?
If yes, continue to #16 If no, do not approve. Patient must try and fail onabotulinumtoxinA (Botox) therapy prior to approval for a CGRP mAb.
16. Has the patient received treatment with onabotulinumtoxinA within the past 8 weeks?
If yes, do not approve If no, continue to #17
17. Does the patient have a BMI less than 18 or greater than 40?
If yes, do not approve If no, continue to #18
18. Does the patient have a history of hemiplegic migraines?
If yes, do not approve If no, continue to #19
19. Has the patient tried and failed a CGRP mAb acting on the ligand, such as Emgality (galcanezumab) or Ajovy (fremanezumab)?
If yes, continue to #20 If no, approve Emgality x 3 months Do not approve Ajovy. Trial Emgality first.
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES 20. Has the patient tried and failed a CGRP mAb acting on the receptor, such as Aimovig (erenumab)?
If yes, do not approve. If no, approve Aimovig 70mg x 3 months
21. Is the request for Emgality (galcanezumab) 100 mg syringe- 300 mg subcutaneously q month?
If yes, continue to #22 If no, do not approve
22. Is the patient currently experiencing cluster headaches with frequency of attacks ranging from one attack every other day to 8 attacks per day?
If yes, continue to #23 If no, do not approve
23. Is the patient currently using indomethacin and/or suspected of having another distinct trigeminal autonomic cephalalgia?
If yes, do not approve If no, continue to #24
24. Has the patient experienced inadequate relief from at least 3 other acute/abortive medication/therapy trials (used as mono or polytherapy) including triptans, oxygen, APAP and NSAIDs, unless contraindicated?
If yes, continue to #25 If no, do not approve
25. Is the patient currently using any CGRP mAb?
If yes, do not approve If no, continue to #26
26. Has the patient tried Emgality 100 mg syringe– 300 mg subcutaneously q month previously for cluster headache, but did not achieve a >30% reduction in cluster headache frequency from baseline?
If yes, do not approve If no, approve Emgality 100 mg syringe- 300 mg subcutaneously q month x 1 month
RENEWAL CRITERIA
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES
1. Is the patient using Emgality for episodic cluster headache?
If yes, continue to #2 If no, continue to #4
2. Has the episodic cluster headache continued after 1 month (= 1 dose) of Emgality (galcanezumab) 100 mg syringe – 300 mg subcutaneously q month?
If yes, continue to #3 If no, do not approve
3. Has there been improvement in cluster attacks since starting Emgality (galcanezumab)?
If yes, approve Emgality for 1 more month (Note: Emgality should not be used for more than 2 months total per cluster headache period) If no, do not approve
4. Has the patient had a 30% or more reduction in headache days per month? (please provide baseline # of headache days per month and current # of headache days per month)
If yes, continue to #6 If no, continue to #5
5. Has the patient had a 50% or more improvement in Migraine Disability Assessment (MIDAS) scores after 3 months of treatment? (please provide baseline MIDAS score and current MIDAS score)
If yes, continue to #6 If no, do not approve
6. Does the patient have any of the following conditions: * is pregnant or intending to become pregnant soon * have a BMI less than 18 or greater than 40 * elevated LFTs (ALT or AST >1.5x ULN) or known liver disease * received any onabotulinumtoxinA injections for migraine prophylaxis in the past 4 months * developed any cardiovascular comorbidities (uncontrolled hypertension, cardiovascular disease, dissections, stroke, etc) since starting the medication
If yes, do not approve If no, continue to #7
7. Is the request for the same dose as the initial approval?
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES
If yes, approve x 1 year If no, do not approve the requested dose. Approve the initial dose x 1 year
At any time KPCO may request chart notes related to headache assessment and treatment
Creation date: 7/25/2019 Effective date: 3/30/2020 Reviewed date: 3/1/2020 Revised date: 3/1/2020
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES MD RESTRICTION - EMGALITY 120MG/ML
Generic Brand HICL GCN Exception/Other GALCENEZUMAB EMGALITY 40418, Acts on Ligand Non- 120MG/ML 40419 formulary
GUIDELINES FOR USE GUIDELINES FOR USE for Commercial and Self-Funded
1. Is the requesting provider a CPMG or an affiliated network neurologist or headache specialist, with appropriate referral if needed?
If yes, approve x 6 months (override NF and Restriction) If no, do not approve
Creation date: 3/30/2020 Effective date: 3/30/2020 Reviewed date: Revised date:
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES TAFINLAR
Generic Brand HICL GCN Exception/Other DABRAFENIB TAFINLAR 34723, Non-Formulary 34724
GUIDELINES FOR USE INITIAL USE 1. Is this medication prescribed by an oncologist? If yes, continue to #2. If no, do not approve.
2. Does the patient have a BRAF V600E or BRAF V600K activating mutation positive tumor? If yes, continue to #3. If no, do not approve. Dabrafenib is not indicated for treatment of patients with wild-type BRAF tumors or tumors with other mutations.
3. Does the patient have a diagnosis of cutaneous melanoma? If yes, continue to #4. If no, evaluate request appropriateness for patient specific diagnosis or contact Oncology CPS.
4. Is the request for use of medication in adjuvant setting? If yes, approve Dabrafenib x 1 year. If no, continue to #5.
5. Is the request for use of medication in unresectable or metastatic (advanced) setting? If yes, continue to #6. If no, do not approve.
6. Has the patient progressed through other BRAF-targeted therapy in advanced setting? If yes, continue to #7. If no, continue to #9.
7. Has the patient progressed through both a BRAF and MEK-targeted agent in advanced setting? If yes, do not approve. There is not enough evidence to support use of dabrafenib monotherapy or dabrafenib/ trametinib combination therapy after progression on another combination BRAF and MEK-targeted therapy. If no, continue to #8.
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES 8. Is dabrafenib being requested in combination with trametinib? If yes, continue to #9. If no, do not approve. There is not enough evidence to support use of dabrafenib monotherapy after progression on a BRAF-targeted agent.
9. Does the patient have confirmed brain metastases? If yes, approve Dabrafenib x 1 year. If no, do not approve. Patient must use Vemurafenib.
Creation date: 3/30/2020 Effective date: 3/30/2020 Reviewed date: Revised date:
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
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 OMBITASVIR/PARITAPREVIR/ TECHNIVIE 41734 RITONAVIR SOFOSBUVIR/VELPATASVIR EPCLUSA 43561 SOFOSBUVIR/VELPATASVIR/ VOSEVI VOXILAPREVIR SOFOSBUVIR SOVALDI DACLATASVIR DAKLINZA
GUIDELINES FOR USE INITIAL USE 1. Is this patient receiving an HCV positive transplant? If yes, continue to #5. If no, continue to #2.
2. Does the patient have 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.)
If yes, continue to #3. If no, do not approve.
3. Has the patient had a suspected acute HCV exposure in the last 6 months?
If yes, do not approve. If no, continue to #4.
4. Has the patient been drinking no more than 7 alcoholic beverages/week if female (average of 1 alcoholic beverage/day) or no more than 14 alcoholic beverages/week if male (average of 2 alcoholic beverages/day) for the last 3 months, and has the patient abstained from illegal (per Colorado state law) drug use for the last 3 months?
If yes, continue to #5. If no, do not approve.
5. Is the patient at least 3 years old and currently supervised by a gastroenterologist, infectious disease specialist, provider specializing in the treatment of hepatitis (for
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES example, a hepatologist), or a specially trained group such as ECHO (Extension for Community Healthcare Outcomes) model?
If yes, continue to #6. If no, do not approve.
6. Is the patient currently taking any medications that have a clinically significant interaction with the Hepatits C medication ordered? *
If yes, do not approve If no, continue to #7.
7. Does the patient have a limited life expectancy (less than 12 months) due to non-liver related comorbid conditions?
If yes, do not approve. If no, continue to #8.
8. Does the requested drug correlate 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 yes, approve for length of recommended treatment regimen If no, do not approve ^
Creation date: 3/12/2019 Effective date: 3/30/2020 Reviewed date: 3/1/2020 Revised date: 3/1/2020
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
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 FLUTICASONE/VILANTEROL BREO 40319 ELLIPTA FLUTICASONE/SALMETEROL AIR DUO 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 Symbicort HFA.
Creation date: 12/23/2019 Effective date: 3/30/2020 Reviewed date: 3/1/2020 Revised date: 3/1/2020
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES NON-PREFERRED JAK INHIBITORS
Generic Brand HICL GCN Exception/Other TOFACITINIB XELJANZ 5MG, 33617, Xeljanz 10mg tablets XELJANZ XR 38086, are Preferred and 11MG 22MG 47546 Formulary and NOT Specialty tier BARICITINIB OLUMIANT 1MG 47205, Nonformulary 2 MG 43468 Specialty tier UPACITINIB RINVOQ 15MG 46822 Nonformulary Specialty tier
GUIDELINES FOR USE INITIAL USE:
1. Is the patient 18 years of age or older, and is this being prescribed by a CPMG or an affiliated gastroenterologist or rheumatologist, with an active referral if necessary?
2. Do not approve if medication being requested is in combination with biologic or relevant immunosuppressive therapy (TNFi, IL 12/23i, IL 17i, alpha4beta7 Integrin-I, azathioprine, cyclosporine) listed in medication table below.
3. For Rheumatoid Arthritis indication: a. Xeljanz 5 mg, 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, 1/2-tab BID, due to a clinical/physical/medical reason (i.e. dexterity or vision issues) b. Olumiant 1 mg, 2 mg will be approved if all the following criteria are met: i. Trial of at least 2 DMARDs (see table) ii. Trial of xeljanz c. Rinvoq 15 mg will be approved if all the following criteria are met: i. Trial of at least 2 DMARDs (see table) ii. Trial of xeljanz iii. Trial of olumiant
4. For Psoriatic Arthritis indication: a. Xeljanz 5 mg, 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, 1/2-tab BID, due to a clinical/physical/medical reason (i.e. dexterity or vision issues)
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES
5. For ulcerative colitis (UC) or inflammatory bowel disease-unspecified/indeterminate colitis (IBD-U) indications: a. Xeljanz 5 mg will be approved if the following criteria are met: i. Patient stepped down from 10 mg po bid to 5 mg po bid and unable to unable to use 10 mg tablets, 1/2-tab BID, due to a clinical/physical/medical reason (i.e. dexterity or vision issues) b. Xeljanz 11mg or 22 mg XR -- do not approve, use the 10mg tab for equivalent daily dose
Note: there are no renewal criteria due to reviews and approvals using above criteria being indefinite
APPROVAL AND DENIAL LANGUAGE: IF meets above criteria (#1 and #2 and applicable criteria per diagnosis) then Approve Formulary & PA override at GCN indefinitely with the following Max Daily Dose, as applicable:
Brand Name Dosage Form Strength(s) # units per day supply or dispense
Xeljanz tablet 5 mg 2 per day Xeljanz XR tablet 11 mg, 22mg 1 per day Olumiant tablet 1 mg , 2 mg 1 per day Rinvoq tablet 1mg 1 per day
IF does not meet above criteria do not approve, based on criteria not met
Creation date: 3/30/2020 Effective date: 3/30/2020 Reviewed date: Revised date:
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES NARCOLEPSY
Generic Brand HICL GCN Exception/Other SODIUM OXYBATE XYREM 12346 18104 Least preferred PITOLISANT HCL WAKIX 45575 45948, 2nd most preferred 45949 SOLRIAMFETOL SUNOSI 45666 46126, Most preferred HCL 46127
GUIDELINES FOR USE GUIDELINES FOR USE FOR ALL NEW STARTS
1. Is this medication prescribed by a physician who is Board Certified in Sleep Medicine or Neurology?
If yes, continue to #2. If no, do not approve.
2. For excessive daytime sleepiness due to Narcolepsy or Idiopathic Hypersomnia: 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 ii. Trial of Sunosi, unless reason for contraindication provided c. 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 ii. Trial of Sunosi, unless reason for contraindication provided iii. Trial of Wakix, unless reason for contraindication provided
3. For cataplexy (not excessive daytime sleepiness) due to Narcolepsy a. Xyrem will be approved if all the following criteria are met:
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES 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) 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 all criteria, per diagnosis, then approve x 1 year with the following restrictions: Sunosi - max daily dose 1/day Wakix - max daily dose of 2/day Xyrem - not applicable
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 #3 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 If no, do not approve.
Creation date: 3/30/2020 Effective date: 3/30/2020 Reviewed date: Revised date:
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES TNF (NON-FORMULARY) SIMPONI
Generic Brand HICL GCN Exception/Other GOLIMUMAB SIMPONI 36278
GUIDELINES FOR USE INITIAL USE:
1. Is the requesting physician a CPMG rheumatologist, dermatologist, or gastroenterologist or an affiliated rheumatologist, dermatologist, or gastroenterologist with active referral if necessary?
If yes, continue to #2. If no, do not approve.
2. Is this being prescribed for the treatment of rheumatoid arthritis?
If yes, continue to #3. If no, continue to #7.
3. Has the patient tried and failed at least two DMARDs including methotrexate, hydroxychloroquine, sulfasalazine, or leflunomide, or does the patient have a contraindication to methotrexate, hydroxychloroquine, sulfasalazine, AND leflunomide?
If yes, continue to #4. If no, do not approve.
4. Has the patient tried and failed tofacitinib (Xeljanz), or does the patient have a contraindication to tofacitinib (Xeljanz)?
If yes, continue to #5. If no, do not approve.
5. Has the patient tried and failed or has a contraindication to at least 2 TNF inhibitors (i.e. Humira, Enbrel, Inflectra)?
If yes, approve x 1 year, max 1 syringe per month. If no, do not approve. 6.
Has the patient tried and failed or has a contraindication to at least 2 non-TNF inhibitor biologics, including, tocilizumab (Actemra).
If yes, continue to #7.
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES If no, do not approve.
7. Is this being prescribed for the treatment of psoriatic arthritis?
If yes, continue to #8. If no, continue to #14.
8. Does the patient have active enthesitis/dactylitis or predominantly axial disease?
If yes, continue to #11. If no, continue to #9.
9. Has the patient tried and failed at least two DMARDs including methotrexate, hydroxychloroquine, sulfasalazine, or leflunomide, or does the patient have a contraindication to methotrexate, hydroxychloroquine, sulfasalazine, AND leflunomide?
If yes, continue to #10. If no, do not approve.
10. Has the patient tried and failed apremilast (Otezla), or does the patient have a contraindication to apremilast (Otezla)?
If yes, continue to #11. If no, do not approve.
11. Has the patient tried and failed or has a contraindication to at least 2 TNF inhibitors (i.e. Humira, Enbrel, Inflectra)?
If yes, continue to #12. If no, do not approve.
12. Has the patient tried and failed or has contraindication to secukinumab (Cosentyx), or does the patient have a contraindication to secukinumab (Cosentyx)?
If yes, continue to #13. If no, do not approve.
13. Has the patient tried and failed or has contraindication to ustekinumab (Stelara), or does the patient have a contraindication to ustekinumab (Stelara)?
If yes, approve x 1 year, max 1 syringe per month. If no, do not approve.
14. Is this being prescribed for the treatment of ankylosing spondylitis?
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES If yes, continue to #15. If no, continue to #19.
15. Has the patient tried and failed NSAID therapy, or does the patient have a contraindication to NSAID therapy?
If yes, continue to #16. If no, do not approve. Preferred alternatives include sulindac tablets (150 mg, 200 mg); ibuprofen tablets (400 mg, 600 mg, 800 mg); naproxen tablets (250 mg, 375 mg, 500 mg); ketoprofen capsules (50 mg, 75 mg); nabumetone tablets (500 mg, 750 mg); salsalate tablets (500 mg, 750 mg); etodolac capsules (200 mg, 300 mg); etodolac tablets (400 mg, 500 mg); meloxicam tablets (7.5 mg, 15 mg)
16. Has the patient tried and failed at least two DMARDs including methotrexate, hydroxychloroquine, sulfasalazine, or leflunomide, or does the patient have a contraindication to methotrexate, hydroxychloroquine, sulfasalazine, AND leflunomide?
If yes, continue to #17. If no, do not approve.
17. Has the patient tried and failed or contraindication to at least 2 TNF inhibitors (i.e. Humira, Enbrel, Inflectra)?
If yes, continue to #18. If no, do not approve.
18. Has the patient tried and failed secukinumab (Cosentyx), or does the patient have a contraindication to secukinumab (Cosentyx)?
If yes, approve x 1 year, max 1 syringe per month. If no, do not approve.
19. Is this being prescribed for the treatment of ulcerative colitis?
If yes, continue to #20. If no, do not approve.
20. Has the patient tried and failed at least 2 preferred TNF inhibitors (i.e. Humira, Inflectra)?
If yes, continue to #21. If no, do not approve.
21. Has the patient tried and failed therapy with tofacitinib (Xeljanz), or does the patient have a contraindication to tofacitinib (Xeljanz)?
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES If yes, continue to #22. If no, do not approve.
22. Has the patient tried and failed therapy with vedolizumab (Entyvio), or does the patient have a contraindication to vedolizumab (Entyvio)?
If yes, approve the 100mg at GPID/GSN level x 1 year. First month, max 3 syringes per month, then max 1 syringe per month x 11 months. If no, do not approve.
Creation date: 11/16/2016 Effective date: 3/30/2020 Reviewed date: 3/1/2020 Revised date: 3/1/2020
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES TRAMETINIB
Generic Brand HICL GCN Exception/Other TRAMETINIB MEKINIST 40361 34726, DIMETHYL 34727 SULFOXIDE
GUIDELINES FOR USE INITIAL USE:
1. Is this medication prescribed by an oncologist? If yes, continue to #2. If no, do not approve.
2. Does the patient have a diagnosis of cutaneous melanoma? If yes, continue to #3. If no, evaluate request appropriateness for patient specific diagnosis or contact Oncology CPS.
3. Does the patient have a BRAF V600E or BRAF V600K activating mutation positive tumor? If yes, continue to #4. If no, do not approve. Trametinib is not indicated for treatment of cutaneous melanoma patients with wild-type BRAF tumors or other mutations.
4. Is the request for use of medication in adjuvant setting? If yes, continue to #5. If no, continue to #6.
5. Is trametinib being requested in combination with dabrafenib? If yes, approve Trametinib x 1 year. If no, do not approve. Trametinib is not indicated to be used as monotherapy in adjuvant melanoma setting. Recommend combination Dabrafenib and Trametinib.
6. Is the request for use of medication in unresectable or metastatic (advanced) setting? If yes, continue to #7. If no, do not approve.
7. Has the patient progressed through other MEK-targeted therapy in advanced setting? If yes, do not approve. There is not enough evidence to support use of trametinib after progression on a prior MEK-targeted agent. If no, continue to #8.
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES 8. Does the patient have confirmed brain metastases? If yes, approve Trametinib x 1 year. If no, do not approve. Recommend use of Cobimetinib.
Creation date: 3/30/2020 Effective date: 3/30/2020 Reviewed date: Revised date:
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES ORILISSA
Generic Brand HICL GCN Exception/Other ELAGOLIX ORILISSA 45108 45026, 45028
GUIDELINES FOR USE INITIAL USE:
1. Is the patient a >18 year-old female AND is this being prescribed by or in consultation with an obstetrician/gynecologist (with an appropriate referral, if required)?
If yes, continue to #2 If no, do not approve.
2. Does the patient have a surgically confirmed diagnosis of endometriosis with or without dyspareunia?
If yes continue to #3 If no, do not approve.
3. Is the patient currently pregnant, OR planning on becoming pregnant in the next 24 months OR is currently breastfeeding?
If no, continue to #4 If yes, do not approve.
4. Has the patient failed prior therapy for endometriosis with 2 combined oral contraceptives (pill, patch or ring) taken in a continuous fashion (skipping placebo tablets) with different progestins OR have an absolute contraindication to estrogen?
If yes, continue to #5 If no, do not approve.
5. Has the patient failed prior therapy with depo-medroxyprogesterone acetate injection, norethindrone acetate oral, or medroxyprogesterone acetate oral OR have an absolute contraindication to progesterone? If yes, continue to #6 If no, do not approve
6. Has the patient failed prior therapy for endometriosis with GnRH agonist (nafarelin , leuprolide, goserelin or triptorelin) with add-back hormonal therapy OR have an absolute contraindication to GnRH agonists?
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES
If yes, continue to #7 If no, do not approve.
7. Does the patient have an absolute contraindication to hormonal therapy for endometriosis AND has failed prior therapy for endometriosis with 2 NSAIDs OR have an absolute contraindication to NSAIDs?
If yes, continue to #8 If no, do not approve.
8. Does the patient have diagnosis of severe hepatic impairment (Child-Pugh class C) OR does not have current (within the last 12 months) liver function tests (LFTs) or most recent LFTs were abnormal?
If no, continue to #9 If yes, do not approve.
9. Does the patient have a diagnosis of uncontrolled hyperlipidemia1?
If no, continue to #10 If yes, do not approve
10. Does the patient have undiagnosed vaginal bleeding OR an undiagnosed breast mass?
If no, continue to #11 If yes, do not approve
11. Does the patient have a BMD within the last 12 months?
If yes, continue to #12 If no, do not approve.
12. Does the patient have a diagnosis of osteoporosis OR a BMD T-score of < -2.5 ?2
If no, continue to #13 If yes, do not approve.
13. Does the patient have a diagnosis osteopenia (or a BMD T-score of -1 to -2.5) with risk factors?3
If no, continue to #14 If yes, do not approve unless prescribed concurrent calcium and vitamin D (calcium 1200mg and vit D 1000-2000 units/day) and get BMD at 6 months.
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES
14. Is the patient currently on a strong organic anion transporting polypeptide 1b1 inhibitor (most common: cyclosporine, gemfibrozil, see comprehensive list in footnote)4
If no, continue to #15 If yes, do not approve.
15. Does the patient have 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? If yes, continue to #17 If no, do not approve
16. Is the patient willing to use two forms of non-hormonal contraception while on elagolix therapy? Patients must be on non-hormonal contraception while on elagolix therapy.
If yes, continue to #18 If no, do not approve.
17. Is the patient willing to adhere with routine (at least every three month) lab work to confirm has not become pregnant while on elagolix?
If yes, approve therapy: Endometriosis: 150mg once daily for 12 months Endometriosis with dyspareunia: 200mg twice daily for 6 months (FDA-approved duration) If no, do not approve.
RENEWAL CRITERIA
1. Has the 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.
If yes, continue to #2 If no, do not approve.
2. Is the indication for treatment endometriosis with dyspareunia AND patient has completed 6 months of treatment (FDA-approved duration)?
If no, continue to #6 If yes, do not approve
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES 3. Is the indication for treatment endometriosis AND patient has completed 24 months of treatment (FDA-approved duration)?
If no, continue to #4 If yes, do not approve
4. Has the patient had a BMD after 12 months of elagolix therapy?
If yes, continue to #5 If no, do not approve
5. Does the patient’s BMD show a decrease from baseline of 8% or more in spine, femoral neck, or total hip?
If no, continue to #6 If yes, do not approve.
6. Does the patient have 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?
If yes, continue to #7 If no, do not approve.
7. Does the patient have current (post-treatment initiation) LFTs that are WNL?
If yes, approve elagolix for maximum of 24 total months of treatment (surgically proven endometriosis) or 6 total months of treatment (surgically proven endometriosis with primary symptom of dyspareunia). Note: we need to know when treatment was started in order to code approval to maximum length of therapy. Date of treatment initiation: If no, do not approve.
Creation date: 3/30/2020 Effective date: 3/30/2020 Reviewed date: Revised date:
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES USTEKINUMAB
Generic Brand HICL GCN Exception/Other USTEKINUMAB STELARA 36187
GUIDELINES FOR USE INITIAL USE
1. Is the patient 12 years of age or older, and is this being prescribed by a CPMG or an affiliated dermatologist, gastroenterologist or rheumatologist with an active referral if necessary?
If yes, continue to #2. If no, do not approve.
2. Is the patient currently stable on therapy with ustekinumab (Stelara)?
If yes, approve x2 years. If no, continue to #3.
3. Is this being prescribed for severe psoriasis with greater than 10% body surface area (BSA) involvement?
If yes, continue to #4. If no, continue to #8.
4. Is the patient noted to have a very high disease activity (ie. >50% BSA)?
If yes, continue to #7 If no, continue to #5
5. Has the patient tried, failed, not tolerated or have a contraindication to the below topical therapies: • high to very high potency topical corticosteroid (e.g., mometasone 0.1% ointment, triamcinolone 0.5% ointment, fluocinonide cream/gel/ointment, betamethasone dipropionate 0.05% cream/ointment, augmented betamethasone dipropionate 0.05% cream/ointment, clobetasol cream/ointment) [not applicable for face, eyelids, skin folds, underarms, groin area] and/or • a topical vitamin D analog (e.g., calcitriol 3 mcg/g ointment or calcipotriene 0.005% solution) or • 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
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES
If yes, continue to #6. If no, do not approve.
6. Has the patient tried, failed, not tolerated, or have a contraindication to at least 2 pre- biologic therapies: • Acitretin • Cyclosporin • Methotrexate • Apremilast
If yes, continue to #7. If no, do not approve.
7. Has the patient tried, failed, not tolerated, or have a contraindication to at least 2 TNF inhibitors (adalimumab, etanercept, infliximab-dyyb/infliximab) and Cosentyx (secukinumab)?
If yes, approve x 1 year. If no, do not approve.
8. Is the patient 18 years of age or older, and does the patient have active psoriatic arthritis?
If yes, continue to #9. If no, continue to #11.
9. Has the patient tried, failed, not tolerated, or have a contraindication to at least two DMARDs (including methotrexate) or high disease activity (as determined by Rheumatologist)?
If yes, continue to #10. If no, do not approve.
10. Has the patient tried, failed, not tolerated, or have a contraindication to at least 2 TNF inhibitors (adalimumab, etanercept, or infliximab-dyyb/infliximab) and Cosentyx (secukinumab?
If yes, approve x 1 year. If no, do not approve.
11. Is the patient 18 years of age or older, and does the patient have Crohn’s disease or a diagnosis of IBD-unclassified with Crohn’s features?
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES
If yes, continue to #12. If no, go to #14.
12. Has the patient tried and failed at least 2 anti-TNF’s 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)? If yes, continue to #13 If no, must try a TNF inhibitor
13. Has the patient tried vedolizumab? If yes, approve for 1 year If no, do not approve. Must try vedolizumab
14. Is the patient 18 years of age and older and does the patient have moderately to severly active Ulcerative Colitis?
If yes, continue to #15 If no, do not approve.
15. Has the patient tried and failed at least 2 anti-TNF’s 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)? If yes, continue to #16 If no, must try a TNF inhibitor
16. Has the patient tried, failed, not tolerated or have a contraindication to Xeljanz (tofacitinib)?
If yes, continue to #17 If no,do not approve. Must try Xeljanz first.
17. Has the patient tried vedolizumab? If yes, approve for 1 year If no, do not approve. Must try vedolizumab first
Creation date: 9/26/2018 Effective date: 3/30/2020 Reviewed date: 3/1/2020 Revised date: 3/1/2020
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
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 INITIAL 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: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES SGLT-2 INHIBITORS/SGLT-2 INHIBITOR COMBINATIONS
Generic Brand HICL GCN Exception/Other CANAGLIFLOZIN INVOKANA 40171 2ND PREFERRED DAPAGLIFLOZIN FARXIGA 40137 EMPAGLIFOZIN JARDIANCE 41217 FORMULARY PREFERRED ERTUGLIFLOZIN STEGLATRO 44709 CANAGLIFLOZIN/METFORMIN INVOKAMET 42187 XR, INVOKAMET DAPAGLIFOZIN/METFORMIN XIGDUO XR 41188 EMPAGLIFOZIN/METFORMIN SYNJARDY, 42183 SYNJARDY XR ERTUGLIFLOZIN/METFORMIN SEGLUROMET 44716 EMPAGLIFOZIN/LINAGLIPTIN GLYXAMBI 41724 DAPAGLIFOZIN/SAXAGLIPTIN QTERN 43957 ERTUGLIFLOZIN/SITAGLIPTIN STEGLUJAN 44706
GUIDELINES FOR USE GUIDELINES FOR USE
INITIAL CRITERIA (NOTE: FOR RENEWAL CRITERIA SEE BELOW)
1. Does the patient have a diagnosis of diabetes mellitus type 2?
If yes, continue to #2. If no, do not approve.
2. Does the patient have clinical 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) or Heart failure (with ejection fraction < or equal to 40%)?
If yes, AND meets the following criteria: a) Has contraindications to OR is currently using or has failed maximum doses of metformin IR and subsequently maximum doses of Metformin ER OR maximum doses of Metformin ER b) GFR is >30 ml/min then, approve Jardiance (F) x 6 months at max daily dose of 0.5 tab. If previously failed Jardiance, approve Invokana x 6 months at max daily dose of 0.5 tab
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES If no, continue to #3
3. Does the patient have chronic renal disease based on GFR between 30 and 59 ml/min and/or urinary albumin-to-creatinine ratio > 300 with GFR of 30 ml/min or greater, If yes, AND meets the following criteria: a) Has contraindications to OR is currently using or has failed maximum doses of metformin IR and subsequently maximum doses of Metformin ER OR maximum doses of Metformin ER then, approve Jardiance (F) x 6 months at max daily dose of 0.5 tab. If previously failed Jardiance, approve Invokana x 6 months at max daily dose of 0.5 tab.
If no, continue to #4.
4. Is the patient less than 2% from their designated HgbA1c goal? (Ask for the patient’s HgbA1c goal and an HgbA1c result drawn in the last 3 months to determine the answer to this question.)
If yes, continue to #5 . If no, do not approve.
5. Does the patient have contraindications to OR has the patient failed, all the following (a – d): a. Maximum doses of Metformin IR and subsequently maximum doses Metformin ER OR maximum dose of Metformin ER b. maximum dose of a sulfonylurea c. maximum dose of pioglitazone AND d. all possible combinations thereof?
If yes, continue to #6. If no, do not approve.
6. Is the patient currently using insulin?
If yes, continue to #7. If no, continue to #8.
7. Is it appropriate to adjust the patient’s insulin regimen to achieve better control?
If yes, do not approve, adjust insulin. If no, continue to #8.
8. Will this medication cause the patient’s current, active diabetes treatment regimen to contain four or more medications?
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES
If yes, do not approve. If no, continue to 9.
9. Does the patient have a history of ketoacidosis?
If yes, do not approve. If no, continue to #10.
10. Is the requested dose appropriate for the patient’s CrCl or GFR? (Ask for an appropriate measure of the patient’s renal function to determine the answer to this question.)
If yes, continue to #11. If no, do not approve.
11. Is the request for Jardiance (formulary)?
If yes, approve for 6 months, maximum daily dose 0.5 tablets. If no, continue to #12.
12. Has the patient tried and failed Jardiance, or does the patient have a contraindication to the use of Jardiance?
If yes, continue to #13. If no, do not approve.
13. Is the request for Invokana (canagliflozin) or Invokamet (canagliflozin/metformin)?
If yes, approve Invokana for 6 months, maximum daily dose 0.5 tablets. (If Invokamet requested, must prescribe drugs separately) . If no, continue to #14.
14. Is the request for Steglatro?
If yes, approve for 6 months, maximum daily dose #1. If no, continue to #15.
15. Has the patient tried and failed Steglatro, or does the patient have a contraindication to the use of Steglatro?
If yes, approve x 6 months If no, do not approve
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES
RENEWAL CRITERIA 1. Does the patient have ASCVD, HF (with reduced ejection fraction) and/or CKD (as defined in Initial Criteria)?
If yes, continue to #5 If no, continue to #2
2. Is the patient at HgbA1c goal?
If yes, continue to #3. If no, do not approve.
3. Has the patient developed ketoacidosis since starting the medication?
If yes, do not approve. If no, continue to #4.
4. Is the requested dose appropriate for the patient’s CrCl or GFR? (Ask for an appropriate measure of the patient’s renal function to determine the answer to this question.)
If yes, approve x 1 year. If no, do not approve.
5. Is the GFR < 30 ml/min?
If yes, do not approve. (GFR <45 increase risk of DKA (benefit vs risk in clinical ASCVD, CKD, and HF with reduced ejection fraction). If no, approve x 1 year with max daily dose of 0.5 tab
Creation date: 10/18/2018 Effective date: 4/2/2020 Reviewed date: 3/1/2020 Revised date: 3/1/2020
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES ALLERGY DERM BIOLOGICS
Generic Brand HICL GCN Exception/Other DUPILUMAB DUPIXENT 44180 43222, 45522 BENRALIZUMAB FASENRA 44635
GUIDELINES FOR USE INITIAL CRITERIA (NOTE: FOR RENEWAL CRITERIA, SEE BELOW)
1. Is patient converting from mepolizumab (Nucala) previously ordered and administered by CPMG Asthma / Allergy to benralizumab (Fasenra) also ordered by CPMG Asthma / Allergy to be dispensed by KP outpatient pharmacy OR has patient already started benralizumab (Fasenra) as a clinic-administered medication by CPMG Asthma / Allergy ? If yes, approve x 6 months. If no, continue to #2
2. Is drug being prescribed by a CPMG or an affiliated dermatologist, allergist, or pulmonologist with an active referral if necessary?
If yes, continue to #3. If no, do not approve.
3. Is the patient 12 years of age or older?
If yes, continue to #4 If no, do not approve
4. Is patient being treated for eosinophilic granulomatosis with polyangiitis (EGPA)?
If yes, do not approve If no, continue to #5
5. Is the prescription for dupilumab (Dupixent) and for moderate to severe atopic dermatitis?
If yes, continue to #6 If no, continue to #9
6. Does the patient have a history of failure, contraindication, or intolerance to the below topical therapies: {See table 1 for relative potencies of topical corticosteroids}
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES • High to very-high potency topical corticosteroid (not applicable for face, eyelids, skin folds, underarms, groin area) -OR- • 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
If yes, continue to #7 If no, do not approve.
7. Does patient have a history of failure, relative contraindications*, or intolerance to narrow-band short wave ultraviolet B (NB-UVB) light) *See table 3 for relative contraindications **See table 3 for Kaiser Permanente Colorado (KPCO) Criteria for Home Phototherapy and contracted provider information
If yes continue to #8 If no, do not approve
8. Does the patient have a history of inadequate response (after at least 2 months of treatment), intolerance, or relative contraindication*: *See table 3 for relative contraindications
• For adolescent patients age 12-17 years: to at least 1 of the following systemic therapies: • For adult patients age 18 and older: to at least 2 of the following systemic therapies: i. Azathioprine ii. Cyclosporine iii. Methotrexate iv. Mycophenolate
If yes, then approve for six-month trial If no, do not approve
Adult Dosing - Atopic dermatitis: Initial: 600 mg (given as two 300 mg injections) x1 Maintenance: 300 mg once every other week
Pediatric Dosing (children > 12 to 17 years ol)d Atopic dermatitis: <60 kg: Initial: 400 mg (given as two 200 mg injections) x1 Maintenance: 200 mg once every other week
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES
≥60 kg: Initial: 600 mg (given as two 300 mg injections) x1 Maintenance: 300 mg once every other week
9. Is dupilumab (Dupixent) or benralizumab (Fasenra) being prescribed for Asthma?
If yes, continue to #10 If no, continue to #17 for CRSwNP criteria
10. Does the patient have a diagnosis of asthma as documented by ANY one of the following: • 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 • Positive exercise or methacholine challenge OR • 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
If yes, continue to #11 If no, do not approve
11. Does patient have 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)?
If yes, continue to #12 If no, do not approve
12. Have the following comorbid factors been ruled out or managed as much as practical? (e.g., allergy, sinusitis, GERD, anxiety disorder, panic disorder, vocal cord dysfunction)?
If yes, continue to #13 If no, do not approve
13. Have the following triggers been eliminated from the home as much as practical? (e.g., animal dander if allergic, dust mites, foods, pollen, smoke exposure)?
If yes, continue to #14 If no, do not approve
14. Does patient have uncontrolled asthma as evidenced by ANY of the following?
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES • Two or more asthma exacerbations requiring systemic corticosteroids (≥3 days each) in the past 12 months OR • one asthma-related hospitalization in the past 12 months OR • Asthma Control Test (ACT) consistently <20
If yes, continue to #15 If no, do not approve
15. Has patient been adherent (>75% proportion of days covered) to optimized drug therapy (triple drug therapy with high-dose ICS (Table 2) plus LABA combination plus tiotropium (Spiriva Respimat) OR does patient have contraindications or intolerance to above during the previous 6 months?
If yes, continue to #16 If no, do not approve
16. See table in attachment or below for recommended action based on oral corticosteroid use, serum eosinophils and presence of concurrent nasal polyposis:
Concurrent nasal polyposis NO, Dependent on oral corticosteroids (OCS) NO, Serum eosinop >300 /microliter then Approve benralizumab 6 months Concurrent nasal polyposis NO, Dependent on oral corticosteroids (OCS) N, Serum eosinop 150-299 /microliter then Apprve dupilumab x 6 months Concurrent nasal polyposis NO, Dependent on oral corticosteroids (OCS) N, Serum eosinop <150 /microliter then Recommend DENIAL Concurrent nasal polyposis NO, Dependent on oral corticosterois (OCS) YES, Serum eosinop >/= 150 /microliter then Approve benralizumab x 6 months Concurrent nasal polyposis NO, Dependent on oracorticosteroids (OCS) YES, Serum eosinop < 150 /microliter then Approve dupilumab x 6 months Concurrent nasal polyposis YES, Dependent on oracorticosteroids (OCS) NO, Serum eosinop >/=150 /microliter then Approve dupilumab x 6 months Concurrent nasal polyposis YES, Dependent on orl corticosteroids (OCS) NO, Serum eosinop <150 /microliter then Continue to #18 (CRSwNP criteria) Concurrent nasal polyposis YES, Dependent on orl corticosteroids (OCS) YES, Serum eosinophils at any level then Approve dupilumab x 6 months
17. Is the prescription for dupilumab (Dupixent) for chronic rhinosinusitis with nasal polyposis (CRSwNP)?
If yes, continue to #18 If no, do not approve
18. Is the patient age 18 or older?
If yes, continue to #19
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES If no, do not approve
19. Does the patient have 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 yes, approve x 1 year If no, do not approve
======
RENEWAL CRITERIA
1) Patient adherent to dupilumab (Dupixent) or benralizumab (Fasenra) therapy? If yes, continue to #2 If no, do not approve 2) Has there been significant improvements in the following: • For atopic dermatitis: • 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 yes, approve x 1 year If no, do not approve • For 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) If yes, approve x 6 months If no, do not approve • For CRSwNP: • improvements in the size of nasal polyps, symptoms (congestion, smell), use of corticosteroids If yes, approve x 1 year If no, do not approve
Creation date: 6/16/2020 Effective date: 6/16/2020 Reviewed date: Revised date:
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES TAVALISSE
Generic Brand HICL GCN Exception/Other FOSTAMATINIB TAVALISSE 44895 44702, 44703
GUIDELINES FOR USE INITIAL USE: 1. Is the request from an affiliated or internal practitioner specializing in Hematology/Oncology?
If yes, continue to #2 If no, do not approve
2. Has the patient tried and failed each of the following: at least one prior systemic corticosteroid for the treatment of ITP, rituximab, IVIG, Nplate, Promacta?
If yes, approve x 14 weeks with a quantity limit of 2 per day. {NOTE: Patient needs reassess at 12 weeks for continued therapy} If no, do not approve
RENEWAL CRITERIA 1. Has the patient completed as least 12 weeks of Tavalisse therapy?
If yes, continue to #2 If no, do not approve. Pt needs at least 11 weeks of therapy
2. Per the prescriber, has the patients' platelet count increased to a level sufficient to avoid clinically important bleeding?
If yes, approve x 1 year with a quantity limit of 2 per day If no, do not approve
Creation date: 5/1/2019 Effective date: 5/1/2019 Reviewed date: 5/1/2020 Revised date: 5/1/2019
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES GLATIRAMER ACETATE
Generic Brand HICL GCN Exception/Other GLATIRAMER COPAXONE 20 Applies to: NDC-9: ACETATE MG/ML 68546-0317 COPAXONE 40 NDC-9: 68546-0325 MG/ML GLATIRAMER COPAXONE 40 35983 ACETATE MG/ML GPID GLATIRAMER GLATIRAMER 35983 ACETATE ACETATE GPID 40MG/ML GLATIRAMER GLATOPA 40 35983 ACETATE MG/ML GPID
GUIDELINES FOR USE INITIAL USE: 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. 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 brand Copaxone or Glatiramer acetate 40mg/mL with another disease modifying treatment (see table below)?
If yes, do not approve If no, cotninue to #4
4. Which Glatiramer product is requested?
If Copaxone or generic Glatiramer 40 mg/mL 3 times/week, go to #5. If Copaxone 20 mg/mL, go to #6.
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES 5. Does the patient have significant intolerance to daily injection of generic Glatiramer Acetate 20 mg/mL that is NOT expected to occur with Copaxone/Glatiramer 40 mg/mL 3 times/week?
If yes, continue to #7. If no, do not approve. Patient needs to try generic Glatopa 20 mg/mL.
6. Has the patient tried generic Glatiramer Acetate 20 mg/mL and experienced a significant intolerance that is NOT expected to occur with brand Copaxone 20 mg/mL?
If yes, approve x 2 years If no, do not approve. Patient needs to try generic Glatopa 20 mg/mL.
7. Is the request for generic Glatiramer Acetate 40mg/ml?
If yes, approve x 2 years {PAS team see coding instructions below} If no, continue to #8
8. Does the patient have significant intolerance*# to generic Glatiramer Acetate 40mg/ml that is not expected to occur with brand Copaxone 40mg/ml?
If yes, approve x 2 years If no, do not approve. Patient needs to try generic Glatopa 40mg/ml
Creation date: 7/26/2018 Effective date: 8/15/2018 Reviewed date: 5/1/2020 Revised date: 5/1/2020
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES IBS-C AND CIC GUIDELINE
Generic Brand HICL GCN Exception/Other LINACLOTIDE LINZESS 39583 42975, Formulary 33187, 33188 LUBIPROSTONE AMITIZA 33451 99658, 26473 PLECANATIDE TRULANCE 44054 42925 PRUCALOPRIDE MOTEGRITY 36920 28445, 28446 TEGASEROD ZELNORM 23178 15381
GUIDELINES FOR USE NEW REQUEST CRITERIA
1. Is the patient equal to or over the age of 18 years?
If yes, proceed to #2. If no, do not approve.
2. Is there known or suspected mechanical obstruction?
If yes, do not approve. If no, continue to #3.
3. Does the patient have a diagnosis of irritable bowel syndrome with constipation (IBS- C) or chronic idiopathic constipation (CIC) ?
If yes, proceed to #4. If no, do not approve. If the request is for Amitiza in opioid induced constipation (OIC), review per OIC guideline.
4. Has 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)?
If yes, proceed to #5. If no, do not approve. The patient must try and fail at least one laxative from each class, bulk forming and oxmotic laxative, listed in this guideline.
5. Has 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)?
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES
If yes, continue to #6 If no, do not approve.
6. Is the request for Amitiza in a patient with CIC OR a female patient with IBS-C?
If yes, approve x1 year, maximum daily dose #2 If no, continue to #7.
7. Has the patient tried and failed or was intolerant to Amitiza OR is the patient a male patient with IBS-C? If yes, continue to #8 If no, do not approve, must try Amitiza
8. Is the request for Linzess? If yes, approve x 1 year, maximum daily dose #1 If no, continue to #9
9. Has the patient tried and failed or have an intolerance to Linzess? If yes, continue to #10 If no, do not approve
10. Is the request for Trulance? If yes, approve x 1 year, maximum daily dose of #1 If no, continue to #11
11. Has the patient tried and failed or have an intolerance to Trulance? If yes, continue to #12 If no, do not approve, must try Trulance
12. Is this request for Motegrity? If yes, continue to #13 If no, continue to #16
13. Does the patient have CIC? If yes, continue to #14 If no, do not approve
14.Does the patient have an intestinal perforation or obstruction due to structural or functional disorder of the gut wall or a severe inflammatory condition of the GI tract (e.g. Crohn's disease, ulcerative colitis, toxic megacolon/megarectum)? If yes, do not approve If no, continue to #15
15. Does the patient have a history of depression, suicidality or risks for suicide? If yes, do not approve ^
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES If no, approve x 1 year , maximum daily dose of #1. Note:caution provider on renal dosing if CrCl<30 and drug interactions
16. Has the patient tried and failed or have an intolerance to Motegrity? If yes, continue to #17 If no, do not approve, must try Motegrity
17. Is the request for Zelnorm? If yes, continue to #18 If no, do not approve, must try Zelnorm
18. Does the patient have IBS-C AND is the patient a female < 65 years of age? If yes, continue to #19 If no, do not approve
19. Does the patient have severe renal impairment (eGFR < 15 mL/minute/1.73 m2) or end-stage renal disease OR moderate or severe hepatic impairment (Child-Pugh Class B or C)? If yes, do not approve If no, continue to #20
20. Does the patient have history of bowel obstruction, symptomatic gallbladder disease, suspected sphincter of Oddi dysfunction, or abdominal adhesions OR history of ischemic colitis or other forms of intestinal ischemia? If yes, do not approve If no, continue to #21
21. Does the patient have a history of myocardial infarction, stroke, transient ischemic attack, or angina? If yes, do not approve If no, approve Zelnorm x 1 year, maximum daily dose of #2
RENEWAL CRITERIA
1. Is this a request to continue current therapy?
If yes, continue to #2 If no, use the new request criteria
2. Is the requested drug used to treat IBS-C or CIC?
If yes, continue to #3 If no, do not approve per this guideline criteria If the request is for Amitiza in opioid induced constipation (OIC), review per OIC guideline.
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES 3. Has there been an improvement in CIC and/or IBS-C symptoms from baseline?
If yes, approve x 1 year If no, do not approve
Creation date: 3/15/2019 Effective date: 6/16/2020 Reviewed date: 5/1/2020 Revised date: 5/1/2020
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES OIC GUIDELINE
Generic Brand HICL GCN Exception/Other LUBIPROSTONE AMITIZA 33451 NALOXEGOL MOVANTIK 41686 NALDEMEDINE SYMPROIC 44176 METHYLNALTREXONE RELISTOR 35611 Oral form and injectable form
GUIDELINES FOR USE NEW REQUEST CRITERIA
1. Is the patient equal to or over the age of 18 years?
If yes, proceed to #2. If no, do not approve.
2. Is there known or suspected mechanical obstruction?
If yes, do not approve. If no, continue to #3.
3. Is the requested medication 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?
If yes, continue to #4 If no, do not approve
4. Does the patient have a diagnosis of opioid induced constipation (OIC) and an active opioid prescription?
If yes, proceed to #5. If no, do not approve per this guideline criteria. 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.
5. Does the patient have currently have one of the following: • active cancer • documented attempts to reduce constipation by changing to less constipating analgesics or reduction of opioid dose • medical/clinical justification why changes are unable to be made in current regimen?
If yes proceed to #6
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES If no, do not approve. Change current therapy.
6. Has the patient tried and failed at least a one month trial of one stimulant laxative (a stimulant laxative contains sennosides or bisacodyl and examples may include Senokot, Ex-Lax, and Dulcolax)?
If yes, proceed to #7. If no, do not approve. The patient must try and fail at least one stimulant laxative and one osmotic laxative
7. Has the patient tried and failed at least a one month 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)?
If yes, continue to #8. If no, do not approve. The patient must try and fail at least one stimulant laxative and one osmotic laxative
8. Is the request for Movantik?
If yes, continue to #9 If no, continue to #10
9. Does the patient take concomitant strong CYP3A4 inhibitors (eg, clarithromycin, ketoconazole)?
If yes and use is not avoidable, then do not approve (combination contraindicated) If no, approve Movantik x 1 year, maximum daily dose #1
10. Has the patient tried and failed or have an intolerance or contraindication to Movantik? If yes, continue to #11 If no, do not approve, must try Movantik
11. Is the request for Amitiza?
If yes, approve Amitiza x1 year, maximum daily dose #2 If no, continue to #12.
12. Has the patient tried and failed or was intolerant to Amitiza?
If yes, continue to #13 If no, do not approve, must try Amitiza
13. Is the request for Symproic?
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES
If yes, approve Symproic x 1 year, maximum daily dose of #1 If no, continue to #14
14. Has the patient tried and failed or have a contraidication or intolerance to Symproic?
If yes, continue to #15 If no, do not approve, must try Symproic
15. Does the patient have ESRD and /or is on dialysis? If yes, do not approve If no, continue to #16
16. Is this request for oral Relistor?
If yes, then approve Relistor for 1 year, maximum daily dose of #3 tablets If no, continue to #17
17. Is this request for injectable Relistor?
If yes, continue to #18 If no, do not approve, must try Amitiza, Movantik, Symproic or oral Relistor
18. Is this request for a patient who is unable to take ANY oral medications (or unable to use any oral laxatives through feeding tube)?
If yes, approve injectable Relistor for 1 year, max 1 dose/day (injection) If no, do not approve, must try Amitiza, Movantik, Symproic or oral Relistor
RENEWAL CRITERIA
1. Is this a request to continue current therapy?
If yes, continue to #2 If no, use the new request criteria
2. Is the requested drug used to treat OIC?
If yes, continue to #3 If no, do not approve per this guideline criteria.
3. Is there known or suspected mechanical obstruction? If no, continue to #4
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES If yes, do not approve
4. Has there been an improvement in OIC symptoms from baseline? If yes, approve x 1 year If no, do not approve
Creation date: 6/16/2020 Effective date: 6/16/2020 Reviewed date: Revised date:
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
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 INITIAL USE 1. Is tolvaptan being prescribed by a nephrologist? If yes, continue to #2 If no, do not approve.
2. Is this request for Samsca? If yes, continue to #12 If no, continue to #3
3. Does the patient have Typical Autosomal Dominant Polycystic Kidney Disease (typical is defined as bilateral/diffuse cyst distribution)? If yes, continue to #4 If no, do not approve
4. Is the patient aged 18-55 years old? If yes, continue to #5 If no, do not approve
5. Is the patients GFR >= 25? If yes, continue to #6 If no, do not approve
6. Does the patient have any of the following: pregnant/lactating, uncorrected hypernatremia, hx of significant liver injury (except polycystic liver w/o liver dysfunction), hypovolemia, inability to sense or respond to thirst, or a urinary tract obstruction? If yes, do not approve If no, continue to #7
7. Is the patient currently adhering to basic renal protective measures such as: non- smoker, controlled blood pressure (<110/75 if 18-50 yrs and GFR>60) otherwise
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES <130/85, ACE or ARB use if requiring anti-hypertensive and no contraindication, 24hr urine volume >3 liters, sodium restriction of <2000mg/day, urine osmolality <=280 mOsm/kr x 2, serum phosphorus <4.5 and serum bicarbonate >=22 meq/L, routine exercie and weight management)? If yes, continue to #8 If no, do not approve
8. Is there a baseline CT scan or MRI of the kidneys? If yes, continue to #9 If no, do not approve
9. Does the patient have a high risk for ADPKD progression, defined by Mayo Class 1C, 1D or 1E? (see references for guidance) If yes, continue to #10 If no, do not approve
10. Has the patient reviewed the tolvaptan potential risks and benefits, and wishes to proceed with therapy? If yes, continue to #11 If no, do not approve
11. Does the patient have normal liver function tests and no history of liver disease? If yes, approve x 1 year (monitoring for labs is recommended monthly for 18 months) If no, do not approve
12. Was the patient initiated or re-initiated on Samsca in the hospital setting for hyponatremia? If yes, approve for a total duration of therapy of 30 days with a max dose 60 mg/day (2 30 mg tablets) If no, do not approve. Samsca for hyponatremia must be started in-patient due to risk of rapid sodium correction and osmotic demylination [Black Box Warning].
RENEWAL CRITERIA Yet to be determined
Creation date: 3/12/2019 Effective date: 6/16/2020 Reviewed date: 5/1/2020 Revised date: 5/1/2020
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES TASIMELTEON (Hetlioz)
Generic Brand HICL GCN Exception/Other TASIMELTEON HETLIOZ 40927
GUIDELINES FOR USE Initial criteria for use:
1) All of the following must be met: • Prescribed by a Sleep Specialist (CPMG or affiliated network provider with active referral as necessary) • Diagnosis of Non-24-Hour_Sleep-Wake Disorder (N24HSWD) • Patient has tried oral melatonin, if no contraindication to use exists, for at least 2 months without efficacy • Patient has tried oral ramelteon, if no contraindication for use exists, for at least 2 months without efficacy • 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: o Bright light therapy (in patients with light perception) AND/OR o Optimizing sleep therapy OR
2) Patient is already stable on the drug
If either #1 or #2 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:
Both of the following must be met: • Documentation of positive clinical response of at least a 45-minute gain in nighttime sleep • A 45-minute decrease in daytime sleep (napping) during the worst part of the cycle
If above are met, approve x 12 months with a maximum daily dose of 1/day
If any of above are not met, do not approve
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES Creation date: 5/30/2018 Effective date: 6/16/2020 Reviewed date: 5/1/2020 Revised date: 5/1/2020
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
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 USE INITIAL USE 1. Is the medication prescribed by a CPMG or Affiliated provider specializing in Dermatology or Oncology?
If yes, continue to #2 If no, do not approve
2. Is the patient > 18 years of age?
If yes, continue to appropriate diagnosis (#3 or #4) and requested drug If no, do not approve
3. For locally advanced or metastatic basal cell carcinoma (BCC): a. Sonidegib (Odomzo) will be approved if one of the following criteria are met: i. The patient has had a recurrence of BCC following surgery or radiation therapy OR ii. The patient is not a candidate for surgery or radiation therapy (please provide reason) b. Vismodegib (Erivedge) will be approved if all of the following criteria are met: i. The patient has had a recurrence of BCC following surgery or radiation therapy AND ii. The patient is not a candidate for surgery or radiation therapy (please provide reason) AND iii. The patient has tried and failed previous trial of sonidegib (Odomzo) due to intolerability (NOT progression – see rationale)
4. For acute myeloid leukemia (AML): a. Glasdegib (Daurismo) will be approved if all the following criteria are met: i. The patient is newly diagnosed with AML AND ii. Is considered ineligible for use of an AML regimen that includes venetoclax (please provide reason) AND
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES iii. a) Is > 75 years of age OR b) The patient has comorbidities that preclude the use of intensive induction chemotherapy (please provide reason) AND iv. Will be used in combination with low-dose cytarabine
If patient meets above applicable criteria, approve x 1 year If does not meet applicable criteria, then do not approve
Creation date: 3/8/2019 Effective date: 6/16/2020 Reviewed date: 5/1/2020 Revised date: 5/1/2020
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES PCSK9 INHIBITORS
Generic Brand HICL GCN Exception/Other ALIROCUMAB PRALUENT PEN, 42347 PRALUENT SYRINGE EVOLOCUMAB REPATHA 42378 SURECLICK, REPATHA SYRINGE REPATHA PUSHTRONEX
GUIDELINES FOR USE INITIAL CRITERIA (NOTE: FOR RENEWAL CRITERIA SEE BELOW)
1. Is this being prescribed by a cardiologist or endocrinologist (with an appropriate referral, if required)? If yes, continue to #2. If no, do not approve.
2. Does the patient have a diagnosis of homozygous familial hypercholesterolemia (HoFH)? * If yes, continue to #4. If no, continue to #3.
3. Does the patient have a diagnosis of heterozygous familial hypercholesterolemia (HeFH) or atherosclerotic cardiovascular disease (ASCVD) with a clinical event^^? * If yes, continue to #4. If no, do not approve.
4. Has the patient been taking atorvastatin 80mg or rosuvastatin 40mg daily OR statin therapy at the maximally tolerated dose for at least the 30 days prior to LDL lab? * If yes, continue to #7. If no, continue to #5.
5. Does the patient 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)? * If yes, continue to #7. If no, continue to #6.
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES 6. Is the patient statin intolerant as defined by the National Lipid Association Statin Intolerance Panel**? * If yes, continue to #7. If no, do not approve.
7. Has the patient been taking ezetimibe (Zetia) for at least the 30 days prior to LDL lab, or does the patient have a contraindication or intolerance to ezetimibe (Zetia)? * If yes, continue to #8. If no, do not approve.
8. Does the patient have a current LDL (LDL level drawn within the last 90 days) ≥100 mg/dL? If yes, continue to #9. If no, do not approve.
9. Will current (if currently on) statin therapy be continued with this medication? If yes, continue to #10. If no, do not approve.
10. Will this be used in combination with another PCSK9 inhibitor, Kynamro (mipomersen), or Juxtapid (lomitapide)? If yes, do not approve. If no, continue to #11.
11. Is the request for evolocumab (Repatha)? If yes, approve x 6 months at HICL (maximum of 2 syringes/pens or 1 Pushtronex per 28 days). If no, continue to #12.
12. Does the patient have a contraindication to, an allergy to, a history of adverse events to, or has the patient tried and failed an appropriate dose of evolocumab (Repatha)? * If yes, approve x 6 months at HICL (maximum of 2 pens per 28 days). If no, do not approve. The patient needs to try evolocumab (Repatha).
RENEWAL CRITERIA 1. Has the patient’s LDL decreased by at least 20% after starting PCSK9 inhibitor when compared to pre-PCSK9 inhibitor levels? If yes, approve x 1 year at HICL (maximum of 2 syringes/pens or 1 Pushtronex per 28 days). If no, do not approve.
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES *Requires documentation which may include, but is not limited to, chart notes, prescription claims records, prescription receipts, and laboratory data.
^^Includes: MI, ACS, CAD with intervention (e.g. PCI, stent, CABG), ischemic non- cardioembolic stroke, PAD with intervention (e.g. stent, surgery); Excludes: High CAC score, AAA, CAD finding on diagnostic cath without MI/ACS/intervention, CAD equivalents (e.g. DM, CKD), primary prevention patients regardless of CV risk score
** Must include all of the following: • Inability to tolerate at least 2 statins, with at least one started at the lowest starting daily dose • Statin dose reduction is attempted for symptom and biomarker abnormality resolution, rather than • discontinuation of statin therapy altogether • Intolerable symptoms or abnormal biomarker changes are reversible upon statin discontinuation, but reproducible by re-challenge of statins, if clinically appropriate (Statin re-challenge may be • appropriate for individuals who are: Symptomatic; Creatine kinase is less than 4 times the upper limit of normal per laboratory reference range; AST/ALT are less than 3 times the upper limit of normal per laboratory reference range • Symptoms or biomarker abnormalities are not attributable to established predispositions or conditions recognized to increase the risk of statin intolerance, such as: Hypothyroidism; Drug interactions; Concurrent illness; Significant changes in physical activity/exercise; Underlying muscle disease
Creation date: 5/25/2018 Effective date: 6/16/2020 Reviewed date: 5/1/2020 Revised date: 5/1/2020
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
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 (NOTE: FOR RENEWAL CRITERIA SEE BELOW)
For all requests for Multiple Sclerosis medications 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 medication will not be given in combination with other disease modifying therapies approved for the treatment of MS (See list in table below) AND
For Fingolimod (Gilenya) requests: the patient must meet ALL of 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 3. The patient has a significant prior intolerance to glatiramer acetate OR at least one interferon-beta (see table below) OR 4. 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
For Siponimod (Mayzent) requests: the patient must meet ALL the above criteria and the following criteria: 1. The patient does have a contraindication/serious precaution* with fingolimod that is not expected to occur with siponimod OR 2. 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 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) b. For genotypes CYP2C9 *1/*3 and *2/*3 only: prescriber will not exceed FDA labeled dose of 1 mg/day
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES c. For all other genotypes: prescriber will not exceed FDA labeled maximum dose of 2 mg/day 4. This drug will NOT be given in combination with moderate CYP 2C9 and strong CYP3A4 inducers OR moderate CYP2C9 and moderate or strong CYP3A4 inhibitors
For Ozanimod (Zeposia) requests: the patient must meet ALL of the above criteria and the following criteria: 1. The patient does have a contraindication OR serious precaution* with fingolimod that is not expected to occur with ozanimod AND 2. 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 AND 3. The patient does NOT have severe untreated sleep apnea 4. The drug will NOT be given in combination with strong CYP2C8 inhibitor (e.g., gemfibrozil) OR Breast Cancer Resistance Protein (BCRP) Inhibitors (e.g., cyclosporine, eltrombopag) OR strong CYP2C8 inducers (e.g., rifampin)
APPROVAL GUIDANCE: Gilenya - Approve x 1 year, max daily dose 1cap/day Mayzent for CYP2CP GENOTYPES *1/*1, *1/*2, or *2/*2 - Approve #12 tablets only of 0.25mg for a 5 day titration to 2mg/day, and approve 2mg tablets for max daily dose of 1/day and x 1 year Mayzent for CYP2CP GENOTYPES *1/*3, *2/*3 - Approve #7 tablets only of 0.25mg for a 4 day titration to 2mg/day, and approve 2mg tablets for max daily dose of 1/day and x 1 year Zeposia - Approve the Zeposia Starter Kit x 1 year
RENEWAL CRITERIA ALL of the following criteria must be met: 1. The requesting provider is a CPMG neurologist or an affiliated network neurologist with active referral, if needed AND 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) AND 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) AND 4. The patient has had a CBC and LFT’s checked within prior 12 months AND 5. The patient does not have new onset cutaneous malignancies (for example, basal cell carcinoma, melanoma, squamous cell carcinoma, etc) AND 6. The patient does NOT have a new or existing contraindication/ serious precaution* to siponimod (Mayzent) or fingolimod (Gilenya) or ozanimod (Zeposia)
See above for Approval instructions
* Contraindications & Serious Precautions to Gilenya:
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES 1) angina, unstable; within the last 6 months 2) Concomitant Class Ia or Class III anti-arrhythmic drugs (beta-blockers, diltiazem, verapamil, quinidine, disopyramide, procainamide, amiodarone, dofetilide, ibutilide, dronedarone, sotalol) 3) heart failure, Class III/IV within the last 6 months 4) heart failure, decompensated; requiring hospitalization within the last 6 months 5) Mobitz type II second-degree or third-degree atrioventricular block (history or current), unless the patient has a functional pacemaker 6) myocardial infarction within the last 6 months 7) QTc interval at baseline 500 milliseconds or greater 8) sick-sinus syndrome (history or current), unless the patient has a functional pacemaker, or heart rate less than 55 bpm 9) irregular heartbeat 10) stroke within the last 6 months 11) TIA within the last 6 months 12) diabetes 13) opportunistic infection 14) history of posterior reversible encephalopathy (PRES) 15) new or existing diagnosis of uveitis or macular edema 16) (specific to ozanimod) severe untreated sleep apnea ** High risk features defined as meeting at least 1 of the following criteria (MRI obtained within past 12months): 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
Creation date: 5/4/2020 Effective date: 6/16/2020 Reviewed date: Revised date:
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
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: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
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.
Creation date: 5/12/2019 Effective date: 6/16/2020 Reviewed date: 5/1/2020 Revised date: 5/1/2020
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES INTERFERON BETA-1B
Generic Brand HICL GCN Exception/Other INTERFERON BETASERON 70023 BETA-1B
GUIDELINES FOR USE 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: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
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
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES 5. Is there a contraindication or serious precaution to Extavia and/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?
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.
* 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
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES 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
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: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
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: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
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: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES 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
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: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES CGRP ACUTE ACTING AGENTS MD SPEC
Generic Brand HICL GCN Exception/Other RIMEGEPANT NURTEC ODT NONFORM - SPECIALTY TIER LASMIDITAN REYVOW NONFORM UBROGEPANT UBRELVY NONFORM - SPECIALTY TIER
GUIDELINES FOR USE MD Specialty restriction
• Prescribing provider must be Neurology specialist
Quantity Limits based on FDA approval for dosing. Lasmiditan 50mg - 4 tablets per 30 days Lasmiditan 100mg - 8 tablets per 30 days Ubrogepant 50mg, 100mg - 16 tablets per 30 days Rimegepant 75mg ODT - 8 tablets per 30 days
MUST meet medical necessity and within FDA and Clinical evidence to obtain more
Creation date: 5/7/2020 Effective date: 6/16/2020 Reviewed date: Revised date:
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES AUBAGIO (TERIFLUNOMIDE)
Generic Brand HICL GCN Exception/Other TERIFLUNOMIDE AUBAGIO 39624 33262, 33259
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 an 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 Aubagio with another disease modifying treatment (see table in attachment)
If yes, do not approve. If no, continue to #4.
4. Has the patient failed, demonstrated intolerance, or demonstrated significant non- adherence to interferon-beta AND glatiramer acetate therapy?
If yes, continue to #6. If no, continue to #5.
5. Does the patient have a contraindication/serious precaution to both interferon-beta AND glatiramer acetate therapy?
If yes, continue to #6. If no, do not approve.
6. Was a baseline CBC and LFTs completed within the last 3 months?
If yes, continue to #7. If no, do not approve.
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES 7. Does the patient have a documented history of neuropathy, diabetes (type 1 or 2), or other medical condition that would suggest patient is at an increased risk of developing neuropathy?
If yes, do not approve. If no, go to #8
8. Is the patient a female and between 12-50 years old with a negative pregnancy test AND on highly effective contraception? (highly effective contraception = oral birth control, medroxyprogesterone, IUD, implant, surgical intervention, same sex partner, partner with vasectomy)
If yes or male & not applicable, continue to #9. If no, do not approve.
9. Does the patient have a significant intolerance or allergy to inactive ingredients with leflunomide that is not expected to occur with Aubagio?
If yes, continue to #10. If no, do not approve. (suggest leflunomide 10mg (as alternative to teriflunomide 7mg) or 20 mg (as alternative to teriflunomide 14mg) once daily)
10. 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 Gilenya, Tysabri, or Rituxan or biosimilar and determine response. If unwilling to change or unresponsive, approve Tecfidera x 2 years) . If no, approve x 2 years, recommending Aubagio 14 mg daily.
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.
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES
3. Is the patient currently using or will the patient be using Aubagio with another disease modifying treatment (See table in attachment)?
If yes, do not approve. If no, continue to #4.
4. Is the patient a female and between 12-50 years old and on highly effective contraception? (highly effective contraception = oral birth control, medroxyprogesterone, IUD, implant, surgical intervention, same sex partner, partner with vasectomy)
If yes, continue to # 5. If no, do not approve. If n/a, continue to # 5.
5. Has the patient had an LFT checked within the last year?
If yes, go to #6. If no, do not approve.
6. Does the patient have a documented history of neuropathy, diabetes (type 1 or 2), or other medical condition that would suggest patient is at an increased risk of developing neuropathy?
If yes, do not approve. If no, approve x2 years.
* High risk features defined as meeting at least 1 of the following criteria (MRI obtained within past 12months): 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
Creation date: 5/12/2019 Effective date: 6/16/2020 Reviewed date: 5/1/2020 Revised date: 5/1/2020
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES MIXED LONG-ACTING INSULIN/GLP-1 AGONIST PENS
Generic Brand HICL GCN Exception/Other INSULIN XULTOPHY 41880 DEGLUDEC/LIRAGLUTIDE INSULIN SOLIQUA 43944 GLARGINE/LIXISENATIDE
GUIDELINES FOR USE INITIAL CRITERIA (NOTE: FOR RENEWAL CRITERIA SEE BELOW)
1. Does the patient have a diagnosis of diabetes mellitus type 2?
If yes, continue to #2. If no, do not approve.
2. Is the patient 2 percentage points or less from their designated HgbA1c goal? (Ask for the patient’s HgbA1c goal and an HgbA1c result drawn in the last 3 months to determine the answer to this question.)
If yes, continue to #3. If no, do not approve.
3. Will the patient use this medication with a DPP-4 inhibitor (medications like Januvia, Tradjenta, Onglyza, and Nesina)?
If yes, do not approve. If no, continue to #4.
4. Will this combination product be used in addition to a separate insulin product?
If yes, do not approve. If no, continue to #5.
5. Does the patient have active, or a past history of, pancreatitis?
If yes, do not approve. If no, continue to #6.
6. Does the patient have a family or personal history of medullary thyroid carcinoma, or does the patient have multiple endocrine neoplasia syndrome type 2?
If yes, do not approve. If no, continue to #7.
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES 7. Does the patient have severe gastrointestinal disease (i.e., colitis, Crohn’s disease, GI obstruction, GI perforation, gastroparesis, ileus, etc.)?
If yes, do not approve. If no, continue to #8.
8. Is the patient inadequately controlled on a total daily dose of 60 units or more of a long-acting insulin?
If yes, continue to #9. If no, do not approve.
9. Has the patient tried and failed an exenatide product?
If yes, continue to #10. If no, do not approve. Patient needs to try Bydureon or Byetta first.
10. Does the total daily dose requested fall in the range below for the matching drug?
Xultopy—between 16 units and 50 units of insulin component Soliqua—between 15 units and 60 units of insulin component
If yes, approve x6 months. If no, do not approve.
RENEWAL CRITERIA
1. Is the patient at HgbA1c goal?
If yes, continue to #2. If no, do not approve.
2. Is the patient using this combination product in addition to a separate insulin product?
If yes, do not approve. If no, continue to #3.
3. Is this medication being used with a DPP-4 inhibitor (medications like Januvia, Tradjenta, Onglyza, and Nesina)?
If yes, do not approve. If no, continue to #4.
4. Has the patient developed severe gastrointestinal disease (i.e., colitis, Crohn’s disease, GI obstruction, GI perforation, gastroparesis, ileus, etc.) or pancreatitis?
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES If yes, do not approve. If no, continue to #5.
5. Does the total daily dose requested fall in the range below for the matching drug?
Xultopy—between 16 units and 50 units of insulin component Soliqua—between 15 units and 60 units of insulin component
If yes, approve x1 year. If no, do not approve.
Creation date: 5/4/2017 Effective date: 6/16/2020 Reviewed date: 5/1/2019 Revised date: 5/1/2020
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
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)?
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES
If yes, continue to #8. 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.
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
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: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES INSULIN DETEMIR PENS
Generic Brand HICL GCN Exception/Other INSULIN DETEMIR LEVEMIR 22836 FLEXTOUCH
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. 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.
*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 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.
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
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: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES INSULIN DETEMIR (VIALS)
Generic Brand HICL GCN Exception/Other INSULIN DETEMIR LEVEMIR (VIALS)
GUIDELINES FOR USE 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: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
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: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
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.
*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 date: 6/16/2020 Reviewed date: 5/1/2020 Revised date: 5/1/2020
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
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 70/30 DEGLUDEC/INSULIN FLEXTOUCH ASPART 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.
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 x indefinitely
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES If no, do not approve.
Creation date: 5/25/2018 Effective date: 6/16/2020 Reviewed date: 5/1/2020 Revised date: 5/1/2020
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES NPH INSULIN PENS
Generic Brand HICL GCN Exception/Other INSULIN NPH HUMULIN N 18488 HUMAN ISOPHANE KWIKPEN
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.
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: 5/4/2017 Effective date: 6/16/2020 Reviewed date: 5/1/2020 Revised date: 5/1/2020
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
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.
Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
COLORADO - MEDICATION AUTHORIZATION GUIDELINES If no, do not approve.
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: June 2020 NOTE: These guidelines are subject to change at any time throughout the year
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: June 2020 NOTE: These guidelines are subject to change at any time throughout the year