Ubrogepant (Ubrelvy) Form

Ubrogepant (Ubrelvy™) is a calcitonin gene-related peptide (CGRP) receptor antagonist. FDA Approved Indication(s) Ubrelvy is indicated for the acute treatment of migraine with or without aura in adults. Limitation(s) of use: Ubrelvy is not indicated for the preventive treatment of migraine. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Ubrelvy is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Migraines (must meet all):

1. Diagnosis of migraine headaches;
   2. Age ≥ 18 years;
   3. Failure of at least TWO formulary generic 5HT1B/1D-agonist migraine medications (e.g., sumatriptan, rizatriptan, zolmitriptan) at up to maximally indicated doses, unless clinically significant adverse effects are experienced or all are contraindicated;
   4. For requests for monthly quantities > 1 box of 10 tablets per month, member meets all of the following (a, b, and c): a. Failure of TWO oral migraine prophylactic therapies from different therapeutic classes, each for 8 weeks, unless clinically significant adverse effects are experienced or all are contraindicated (see Appendix B); Prior authorization may be required.
      b. Failure of a 3-month trial of ONE CGRP inhibitor used for migraine prophylaxis, unless clinically significant adverse effects are experienced or all are contraindicated (see Appendix B); *Prior authorization may be required.
      c. Member is being treated by or in consultation with a neurologist, headache, or pain specialist;
2. Ubrelvy is not prescribed concurrently with other CGRP inhibitors (e.g., Aimovig™, Ajovy™, Emgality™, Nurtec® ODT, Qulipta™, Vyepti™);

3. Dose does not exceed 200 mg (2 tablets) per day and 8 days per month. Approval duration: 6 months Page 1 of 7

   CLINICAL POLICY Ubrogepant B. Other diagnoses/indications (must meet 1 or 2):

4. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.PMN.16 for Medicaid; or
5. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.PMN.53 for Medicaid.
   II. Continued Therapy A. Migraines (must meet all):
6. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
   2. Member is responding positively to therapy;
   3. For dose increase requests to quantities > 1 box of 10 tablets per month, member meets all of the following (a, b, and c): a. Failure of at least TWO oral migraine prophylactic therapies from different therapeutic classes, each for 8 weeks, unless clinically significant adverse effects are experienced or all are contraindicated (see Appendix B); Prior authorization may be required.
      b. Failure of a 3-month trial of ONE CGRP inhibitor used for migraine prophylaxis, unless clinically significant adverse effects are experienced or all are contraindicated (see Appendix B); *Prior authorization may be required.
      c. Member is being treated by or in consultation with a neurologist, headache, or pain specialist;
7. Ubrelvy is not prescribed concurrently with other CGRP inhibitors (e.g., Aimovig™, Ajovy, Emgality, Nurtec ODT, Qulipta, Vyepti);This requirement does not apply to CA if member was previously approved via Centene benefit and is currently stable on therapy with both oral and injectable CGRP inhibitors

8. If request is for a dose increase, new dose does not exceed 200 mg (2 tablets) per day and 8 days per month. Approval duration: 12 months Page 2 of 7

   CLINICAL POLICY Ubrogepant B. Other diagnoses/indications (must meet 1 or 2):

9. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.PMN.16 for Medicaid; or

10. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.PMN.53 for Medicaid.
    III. Diagnoses/Indications for which coverage is NOT authorized:
    A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.PMN.53 for Medicaid, or evidence of coverage documents IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key 5-HT: serotonin AAN: American Academy of Neurology
    CGRP: calcitonin gene-related peptide
    FDA: Food and Drug Administration Appendix B: Therapeutic Alternatives
    This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization.
    Drug Name
    Dosing Regimen Abortive Migraine Therapy Triptans naratriptan (Amerge®) One tablet (1 or 2.5 mg) PO at onset; almotriptan (Axert®) frovatriptan (Frova®) can be repeated in 4 hours 6.25 to 12.5 mg PO QD May repeat dose in 2 hours 2.5 mg PO QD May repeat dose in 2 hours One spray (5 to 20 mg) at onset into one nostril; can be repeated in 2 hours sumatriptan (Imitrex® nasal spray)
    sumatriptan (Imitrex®) One tablet (25 to 100 mg) PO at onset; rizatriptan (Maxalt® /Maxalt MLT®) can be repeated in two hours One tablet (5 or 10 mg) PO at onset of migraine headache; can be repeated in two hours Page 3 of 7 Dose Limit/ Maximum Dose 5 mg/day 25 mg/day 7.5 mg/day 40 mg/day 200 mg/day 30 mg/day

    CLINICAL POLICY Ubrogepant Drug Name
    Dosing Regimen Abortive Migraine Therapy eletriptan (Relpax®) zolmitriptan (Zomig®/Zomig® ZMT) 20 or 40 mg PO QD May repeat dose in 2 hours 1.25 or 2.5 mg PO QD May repeat dose in 2 hours Drug Name Dosing Regimen Prophylactic Migraine Therapy 500 to 1,000 mg/day PO 500 to 1,000 mg/day PO 100 mg/day PO Antiepileptic Drugs divalproex sodium (Depakote) divalproex sodium ER (Depakote ER) topiramate (Topamax) Beta-Blockers metoprolol (Lopressor) 200 mg/day PO propranolol (Inderal) timolol (Blocadren) atenolol (Tenormin) nadolol (Corgard) Serotonin Reuptake Inhibitors venlafaxine XR (Effexor XR) Tricyclic Antidepressants amitriptyline (Elavil) CGRP Inhibitors Aimovig (erenumab) 150 mg/day PO 80 to 240 mg/day PO 20 to 30 mg/day PO 100 mg/day PO 80 to 240 mg/day PO 30 to 150 mg/day PO Ajovy (fremanezumab) Emgality (galcanezumab) Vyepti (eptinezumab- jjmr) Nurtec ODT (rimegepant) 70 mg SC once a month; may be increased to 140 mg SC once a month 225 mg SC once a month or 675 mg SC every 3 months
    240 mg SC as a single loading dose, followed by 120 mg SC once a month The recommended dosage is 100 mg IV every 3 months. Some patients may benefit from a dosage of 300 mg IV every 3 months. Acute migraine treatment: 75 mg PO as needed Dose Limit/ Maximum Dose 40 mg/dose 80 mg/day 5 mg/dose 10 mg/day Dose Limit/ Maximum Dose 1,000 mg/day 1,000 mg/day 100 mg/day 200 mg/day 240 mg/day 30 mg/day 100 mg/day 240 mg/day 150 mg/day 150 mg/day 140 mg/month 225 mg/month or 675 mg/3 months 120 mg/month 300 mg every 3 months See dosing regimen Qulipta (atogepant) Migraine prophylaxis: 75 mg PO every other day 10 mg, 30 mg, or 60 mg PO QD 60 mg/day Page 4 of 7

    CLINICAL POLICY Ubrogepant Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. **FDA approved. Appendix C: Contraindications/Boxed Warnings • Contraindication(s): concomitant use with strong CYP3A4 inhibitors, hypersensitivity • Boxed warning(s): none reported Appendix D: General Information
    • The AAN recommends that prophylactic migraine medications should be considered if the patient experiences 2 or more attacks per month that produce aggregate disability of 3 or more days/month. • The AAN and the National Headache Foundation recommend that prophylactic migraine medications should be considered if one or more of the following are present: greater than 2 migraine headaches per week; migraines cause significant impairment in daily routine even with abortive treatment; contraindication to, adverse effects, overuse or failure of abortive migraine medications, presence of uncommon migraine condition (e.g., basilar migraine); or patient requesting prophylactic therapy. V. Dosage and Administration
    Indication Dosing Regimen Migraines 50 or 100 mg PO, as needed. If needed, a second dose may be administered at least 2 hours after the initial dose. The maximum dose in a 24-hour period is 200 mg. Maximum Dose 200 mg/day VI. Product Availability
    Tablets (package size 10, 16, 30): 50 mg, 100 mg VII.