Drug - Ubrelvy™ (ubrogepant) [Allergan, Inc..]
Therapeutic area - Anitimigraine Agents, Other
Initial approval criteria:
- Patient must be ≥ 18 years of age; AND
- Patient must have a diagnosis of migraine, with or without aura; AND
- Patient must NOT have headache frequency ≥ 15 headache days per month during the prior 6 months; AND
- Provider must provide an attestation to all of the following:
- Provider has completed a comprehensive review of all of the patient’s concurrent medications to determine if dosage adjustment of Ubrelvy is necessary; AND
- Provider has evaluated patient’s hepatic and renal function to determine if dosage adjustment of Ubrelvy is necessary; AND
- If applicable, provider has completed a review of patient’s adherence of any medications used to prevent migraine and address any patient’s adherence issue; AND
- Patient must NOT be concurrently using a strong CYP3A4 inhibitor; AND
- Patient must NOT have end-stage renal disease (creatinine clearance [CrCl] < 15 mL/min); AND
- Patient must have tried and failed ≥ 1 of the following: NSAID, non-opioid analgesic, acetaminophen, OR caffeinated analgesic combination; AND
- Patient must have tried and failed, or have contraindication to, ≥ 2 preferred triptans.
- Patient must continue to meet the above criteria; AND
- Patient must demonstrate resolution in headache pain or reduction in headache severity, as assessed by prescriber; AND
- Patient has not have experienced any treatment-restricting adverse effects (e.g., nausea, somnolence, dry mouth).
- 16 doses per 30 days
- Any request for quantities exceeding those recommended by the FDA will not be approved
FDA-approved label states:
- The maximum dose in a 24-hour period is 200 mg.
- The safety of treating more than 8 migraines in a 30-day period has not been established.
MHCP Provider Call Center 651-431-2700 or 1-800-366-5411