Agents for Migraine – Nurtec ODT (Rimegepant), Ubrelvy (Ubrogepant) P&T Approval Date 10/2020; 2/2021 Effective Date 4/1/2021; Oxford: 5/1/2021

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UnitedHealthcare Pharmacy Clinical Pharmacy Programs

Program Number 2021 P 1333-2 Program Supply Limit Medication Agents for Migraine – Nurtec ODT (rimegepant), Ubrelvy (ubrogepant) P&T Approval Date 10/2020; 2/2021 Effective Date 4/1/2021; Oxford: 5/1/2021

1. Background:

Nurtec ODT (rimegepant) and Ubrelvy (ubrogepant) are calcitonin gene-related peptide receptor antagonists indicated for the acute treatment of migraine with or without aura in adults.

2. Coverage Criteria:

A. Nurtec ODT, Ubrelvy requests exceeding the maximum quantity per month will be approved to the ceiling limit based on the following criteria:

1. Used for acute treatment of migraine

-AND-

2. Prescribed by or in consultation with one of the following specialists with expertise in the acute treatment of migraine:

a. Neurologist b. Pain Specialist c. Headache Specialista

-AND-

3. One of the following:

a. Patient has is currently treated with one of the following prophylactic therapies: 1) Amitriptyline (Elavil) 2) A beta-blocker (i.e., atenolol, metoprolol, nadolol, propranolol, or timolol) 3) A biologic calcitonin gene-related peptide receptor (CGRP) antagonist for preventive treatment of migraine [i.e., Aimovig © 2021 UnitedHealthcare Services Inc.

(erenumab), Ajovy (fremanezumab), Emgality (galcanezumab), Vyepti (eptinezumab-jjmr)] 4) Divalproex sodium (Depakote/Depakote ER) 5) OnabotulinumtoxinA (Botox) [Note: Coverage of onabotulinumtoxinA (Botox) may be subject to additional benefit and coverage review requirements] 6) Topiramate (Topamax) 7) Venlafaxine (Effexor/Effexor XR)

- OR –

b. Patient has >/ = 4 migraine days per month and has contraindication or intolerance to one of the following prophylactic therapies: 1) Amitriptyline (Elavil) 2) A beta-blocker (i.e., atenolol, metoprolol, nadolol, propranolol, or timolol) 3) A biologic calcitonin gene-related peptide receptor (CGRP) antagonist for preventive treatment of migraine [i.e., Aimovig (erenumab), Ajovy (fremanezumab), Emgality (galcanezumab), Vyepti (eptinezumab-jjmr)] 4) Divalproex sodium (Depakote/Depakote ER) 5) OnabotulinumtoxinA (Botox) [Note: Coverage of onabotulinumtoxinA (Botox) may be subject to additional benefit and coverage review requirements] 6) Topiramate (Topamax) 7) Venlafaxine (Effexor/Effexor XR)

-AND-

4. One of the following:

a. Member has more than four migraines per month each requiring more than one dose (provide number of migraines per month).

-OR-

b. Member has more than eight migraines per month (provide number of migraines per month).

-AND-

5. Physician acknowledges that the potential benefit outweighs the risk associated with the higher dose or quantity

Authorization will be issued for 12 months and allow for the quantities noted in the table below

Migraine Agent Limits (Maximum Quantity per Duration AND Maximum Prescription Fills per Month) _ Medication Maximum Quantity per Maximum prescription fills Duration (Supply Limit) per month (Ceiling Limit) Nurtec ODT 8 tablets 8 tablets per fill AND a maximum of 16 tablets per month Ubrelvy 8 tablets 8 tablets per fill AND a maximum of 16 tablets per month

* Nurtec ODT is typically excluded from coverage a Headache specialists are physicians certified by the United Council for Neurologic Subspecialties (UCNS).

3. Additional Clinical Rules: • Notwithstanding Coverage Criteria, UnitedHealthcare may approve initial and re- authorization based solely on previous claim/medication history, diagnosis codes (ICD-10) and/or claim logic. Use of automated approval and re-approval processes varies by program and/or therapeutic class.

4. References: 1. Nurtec ODT [package insert]. New Haven, CT: Biohaven Pharmaceuticals, Inc.; March 2020. 2. Ubrelvy [package insert]. Madison, NJ: Allergan USA, Inc.; June 2020.

Program Supply Limit – Migraine agents Change Control Date Change 10/2020 New program 2/2021 Removed moderate to severe migraine requirement. Simplified criteria for >/= 4 migraines per month. Removed Reyvow from the override criteria. Added biologic CGRP to prophylactic therapies.