COLORADO - MEDICATION AUTHORIZATION GUIDELINES DROXIDOPA Generic Brand HICL GCN Exception/Other DROXIDOPA NORTHERA 40936 INITIAL CRITERIA (NOTE: FOR RENEWAL CRITERIA SEE BELOW) 1. Is this being prescribed by a neurologist or cardiologist? If yes, continue to #2. If no, do not approve. 2. Is the patient 18 years of age or older? If yes, continue to #3. If no, do not approve. 3. Does the patient have a confirmed diagnosis of neurogenic hypotension due to Parkinson’s disease, pure autonomic failure, multisystem atrophy, non-diabetic autonomic neuropathy, or dopamine-β-hydroxylase deficiency? If yes, continue to #4. If no, do not approve. 4. Does the patient have ischemic heart disease, arrhythmias, congestive heart failure, or sustained, severe hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg sitting or supine)? If yes, do not approve. If no, continue to #5. 5. Does the patient have aspirin hypersensitivity or a yellow dye allergy? If yes, do not approve. If no, continue to #6. 6. Does the patient have severe renal impairment (CrCl less than 30 mL/min)? If yes, do not approve. If no, continue to #7. 7. Is the patient currently breastfeeding? If yes, do not approve. If no, continue to #8. Effective: July 2021 NOTE: these guidelines may change at any time COLORADO - MEDICATION AUTHORIZATION GUIDELINES 8. Is the patient currently utilizing a non-selective MAO inhibitor, linezolid, or tedizolid*? If yes, do not approve. If no, continue to #9. 9. Is the patient symptomatic despite using non-pharmacological interventions (getting up slowly, wearing elastic stockings, adequate salt and fluid intake, elevating the head of the bed, leg-crossing, thigh contraction, etc.)? If yes, continue to #10. If no, do not approve. 10. Has the patient tried and failed fludrocortisone and midodrine individually and as a combination? If yes, approve GENERIC only x3 months, max daily dose #6. If no, do not approve. RENEWAL CRITERIA 1. Has the patient developed symptoms of neuroleptic malignant syndrome; ischemic heart disease; arrhythmias; congestive heart failure; sustained, severe hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg sitting or supine); severe renal impairment (CrCl less than 30 mL/min); or has the patient started a non-selective MAO inhibitor, linezolid, tedizolid*, or breast-feeding? If yes, do not approve. If no, continue to #2. 2. Have the patient’s symptoms improved? If yes, approve GENERIC Only x6 months, max daily dose #6. If no, do not approve. *Possible theoretical interaction for tedizolid. Creation date: 11/16/2016 Effective date: 1/1/2017 Reviewed date: 7/1/2020 Revised date: 11/1/2016 Effective: July 2021 NOTE: these guidelines may change at any time COLORADO - MEDICATION AUTHORIZATION GUIDELINES BECAPLERMIN Generic Brand HICL GCN Exception/Other BECAPLERMIN REGRANEX 17028 Becaplermin will be provided as a plan benefit within the following guidelines: 1. Is the patient diagnosed with diabetes mellitus? If yes, continue to #2. If no, continue to #4. 2. Is the prescription written by a vascular surgeon, podiatrist, or endocrinologist? If yes, continue to #3. If no, continue to #4. 3. Is there a diagnosed neoplasm (i.e., cancer), necrotic tissue, infection, or osteomyelitis at site of application? If yes, continue to #4. If no, approve for 3 months for two (2) tubes per month maximum. 4. Is the prescription a hospital discharge prescription per the member, prescriber, or pharmacy? If yes, approve for 3 months for two (2) tubes per month maximum. If no, do not approve. RENEWAL CRITERIA 1. Has there been at least a 30% decrease in wound size? If yes, approve for a period of time necessry to complete a 20 week course, including the previous approvals, for two (2) tubes per month maximum If no, do not approve Creation date: 11/16/2016 Effective date: 1/1/2017 Reviewed date: 9/1/2020 Revised date: 11/1/2017 Effective: July 2021 NOTE: these guidelines may change at any time COLORADO - MEDICATION AUTHORIZATION GUIDELINES INSULIN GLARGINE (VIALS) Generic Brand HICL GCN Exception/Other INSULIN LANTUS (VIALS) 13072 GLARGINE Approval for the use of insulin glargine vials is based upon meeting one of the following criteria: • Patient has type 1 diabetes. • Prescription is written by CPMG affiliated Endocrinology (Pediatric or Adult) specialist. • Patient has type 2 diabetes with severe hypoglycemia despite appropriate insulin management (i.e., basal insulin, bolus/mealtime insulin, hypoglycemia management). Severe hypoglycemia can be defined as: o 2-3 episodes <70 mg/dl on separate days in a week o Any event resulting in coma/seizure o Any event requiring the assistance of another person with glucagon or emergency services. Creation date: 5/25/2018 Effective date: 6/11/2018 Reviewed date: 5/1/2020 Revised date: 5/1/2018 Effective: July 2021 NOTE: these guidelines may change at any time COLORADO - MEDICATION AUTHORIZATION GUIDELINES LAMOTRIGINE, EXTENDED-RELEASE Generic Brand HICL GCN Exception/Other LAMOTRIGINE, LAMICTAL XR 24703, EXTENDED- 24739, RELEASE 24693, 30787, 29725, 24697, 24851, 24856, 24869 GUIDELINES FOR USE Note: The 200 mg and 300 mg strength are formulary. All other strengths are 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? If yes, approve open-ended. If no, go to #6. Effective: July 2021 NOTE: these guidelines may change at any time COLORADO - MEDICATION AUTHORIZATION GUIDELINES 6. Can the patient’s daily dose be achieved by a formulary strength of lamotrigine XR/SR? If yes, approve the appropriate formulary strength of lamotrigine open-ended. If no, approve the non-formulary strength of lamotrigine x 1 year. RENEWAL CRITERIA 1. Can the patient’s daily dose be achieved by a formulary strength of lamotrigine XR/SR? If yes, approve the appropriate formulary strength of lamotrigine open-ended. If no, approve the non-formulary strength of lamotrigine x 1 year. Creation date: 7/25/2018 Effective date: 8/15/2018 Reviewed date: 7/1/2020 Revised date: 7/1/2018 Effective: July 2021 NOTE: these guidelines may change at any time COLORADO - MEDICATION AUTHORIZATION GUIDELINES LUMACAFTOR/IVACAFTOR Generic Brand HICL GCN Exception/Other LUMACAFTOR/IVACAFTOR ORKAMBI 42235 GUIDELINES FOR USE (RENEWAL CRITERIA BELOW) 1. Is the patient 2 years old or older? If yes, continue to #2. If no, do not approve. 2. Is this medication prescribed by a pulmonologist? If yes, continue to #3. If no, do not approve. 3. Does the patient have a diagnosis of cystic fibrosis, and is the patient homozygous for the F508del mutation (as verified by testing)? If yes, continue to #4 If no, do not approve. 4. Is the patient of age 6 years or older? If yes, continue to #5. If no, approve x12 months at HICL, maximum daily dose of two. 5. Does the patient have a baseline FEV1 of at least 40% as documented by lab report or chart notes (not required for patients younger than 6 years of age)? If yes, approve x1 fourteen-day fill (#56 tablets). Also, enter an approval x1 year @ HICL, max daily dose #4 to start the day the fourteen-day supply ends. If no, do not approve. RENEWAL CRITERIA 1. Is there documentation of improvement in the patient’s CF as indicated by a maintained or improved FEV1 or BMI, reductions in pulmonary exacerbations, or improved quality of life as demonstrated by Cystic Fibrosis Questionnaire-Revised (CFQ-R) respiratory domain score? If yes, approve x 2 years at HICL. If no, do not approve. Creation date: 9/15/2018 Effective date: 10/12/2018 Effective: July 2021 NOTE: these guidelines may change at any time COLORADO - MEDICATION AUTHORIZATION GUIDELINES Reviewed date: 7/1/2020 Revised date: 9/1/2018 Effective: July 2021 NOTE: these guidelines may change at any time COLORADO - MEDICATION AUTHORIZATION GUIDELINES IVACAFTOR Generic Brand HICL GCN Exception/Other IVACAFTOR KALYDECO 38461 GUIDELINES FOR USE INITIAL CRITERIA (see below for renewal criteria) 1. Is this medication prescribed by a pulmonologist? If yes, continue to #2. If no, do not approve. 2. Is the patient 6 months old? If yes, continue to #3. If no, do not approve. 3. Does the patient have a diagnosis of cystic fibrosis (CF) with documentation of at least one of the following mutations in the CFTR gene that is responsive to ivacaftor (Kalydeco)? E56K, P67L, R74W, D579G, G1069R, D1270N, G178R, E193K, L206W, A1067T, S1255P, R117H, S549R, G551D, G551S, S1251N, R117C, S549N, 711+3A→G, F1052V, K1060T, D110H, A455E, S945L, 3272-26A→G, D1152H, G1244E, R352Q, E831X, R1070W, 2789+5G→A, D110E, R347H, G1349D, R1070Q, S977F, 3849+10kbC→T, F1074L If yes, continue to #4. If no, do not approve. 4. Is the patient homozygous for the F508del-CFTR mutation? If yes, do not approve. If no, continue to #5. 5. Is the patient of age 6 years or older? If yes, continue to #6. If no, approve for 12 months at HICL with a quantity limit of #2 per day. 6. Does the patient have a baseline FEV1 of at least 40% as documented by lab report or chart notes (not required for patients younger than 6 years of age)? If yes, approve for 12 months at HICL with a quantity limit of #2 per day.