Nurtec ODT (Rimegepant) Quantity Override

UnitedHealthcare Pharmacy Clinical Pharmacy Programs

Program Number 2021 P 1333-3 Program Supply Limit Medication Agents for Migraine – Nurtec ODT* (rimegepant), Ubrelvy (ubrogepant) P&T Approval Date 10/2020; 2/2021, 7/2021 Effective Date 9/1/2021; Oxford: 9/1/2021

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. 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 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

(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

Ubrelvy 8 tablets 8 tablets per fill AND a maximum of 16 tablets per month

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

1. One of the following:

a. All of the following:

1) Used for acute treatment of migraine

-AND-

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

a) Neurologist b) Pain Specialist c) Headache Specialista

-AND-

3) One of the following:

a) Patient is currently treated with one of the following prophylactic therapies: i. Amitriptyline (Elavil) ii. A beta-blocker (i.e., atenolol, metoprolol, nadolol, propranolol, or timolol) iii. 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)] iv. Divalproex sodium (Depakote/Depakote ER)

v. OnabotulinumtoxinA (Botox) [Note: Coverage of onabotulinumtoxinA (Botox) may be subject to additional benefit and coverage review requirements] vi. Topiramate (Topamax) vii. 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: i. Amitriptyline (Elavil) ii. A beta-blocker (i.e., atenolol, metoprolol, nadolol, propranolol, or timolol) iii. 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)] iv. Divalproex sodium (Depakote/Depakote ER) v. OnabotulinumtoxinA (Botox) [Note: Coverage of onabotulinumtoxinA (Botox) may be subject to additional benefit and coverage review requirements] vi. Topiramate (Topamax) vii. 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

-OR- b. All of the following:

1) Diagnosis of episodic migraines with greater than or equal to 4 migraine days per month

-AND-

2) Used for preventive treatment of migraines

-AND-

3) History of failure (after a trial of at least two monthsb), contraindication or intolerance to two of the following prophylactic therapies (document name and date tried):

a) Amitriptyline (Elavil) b) One of the following beta-blockers: atenolol, metoprolol, nadolol, propranolol, or timolol c) Divalproex sodium (Depakote/Depakote ER) d) Topiramate (Topamax) e) Venlafaxine (Effexor/Effexor XR)

-AND-

4) History of failure (after a trial of at least three monthsb), contraindication or intolerance to both of the following (document date tried):

a) Aimovig b) Emgality 120 mg

-AND-

5) Prescribed by or in consultation with one of the following specialists with expertise in the treatment of migraine:

a) Neurologist b) Pain Specialist c) Headache Specialista

-AND-

6) Medication will not be used in combination with another CGRP antagonist or inhibitor used for the preventive treatment of migraines (e.g. Aimovig, Ajovy*, Emgality, Vyepti)

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 Acute treatment of migraine: 8 tablets per fill AND a maximum of 18 tablets per month Preventive treatment of migraine: 16 tablets per fill AND a maximum of 18 tablets per month

* Ajovy, and Nurtec ODT are typically excluded from coverage a Headache specialists are physicians certified by the United Council for Neurologic Subspecialties (UCNS). b For Connecticut and Kentucky business, only a 30 day trial will be required.

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.; May 2021. 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. 7/2021 Updated to allow for preventive treatment of migraines for Nurtec ODT and updated override criteria to allow for up to 18 tablets per month.