Vyepti™

Drug - Vyepti™ (eptinezumab-jjmr) [Lundbeck Pharmaceuticals LLC.]

July 2020

Therapeutic area - Antimigraine Agents, Other

Initial approval criteria:

• Patient must be ≥ 18 years; AND
• Other causes of headaches have been ruled out; AND
• It will NOT be used in combination with other calcitonin gene-related peptide (CGRP) antagonists for migraine prevention (e.g., erenumab, galcanezumab, fremanezumab); AND
• Patient is NOT on concurrent treatment with a botulinum toxin (e.g., abobotulinumtoxinA, incobotulinumtoxinA, rimabotulinumtoxinB); AND
• Patient will continue to utilize prophylactic intervention modalities (e.g., pharmacotherapy, behavioral therapy, physical therapy); AND
• Patient has failed at least an 8-week trial of any 2 oral medications for the prevention of migraines prior to initiation of eptinezumab; AND
• Physician has assessed baseline disease severity utilizing an objective measure/tool (e.g., Headache Impact Test [HIT]; monthly headache day [MHD]; Migraine Disability Assessment [MIDAS]; Migraine Physical Function Impact Diary [MPFID]); AND
• Patient has a diagnosis of chronic migraines defined as ≥ 15 headache (tension-type-like and/or migraine-like) days per month for ≥ 3 months; AND
  • Patient has had 4-7 attacks with features consistent with migraine (with and/or without aura); AND
  • On ≥ 8 days per month for ≥ 3 months:
    • Headaches have characteristics and symptoms consistent with migraine; OR
    • Patient suspected migraines are relieved by a triptan or ergot derivative medication; OR
• Patient has a diagnosis of frequent episodic migraines defined as ≥ 5 headache attacks lasting 4 to 72 hours (when untreated or unsuccessfully treated); AND
  • Headaches have characteristics and symptoms consistent with migraine without aura§; AND
  • Medication overuse headache has been ruled out by trial and failure of titrating off acute migraine treatments in the past.

Renewal criteria:

• Patient must continue to meet the above initial criteria; AND
• Disease response as evidenced by the following:
  • Reduction in mean monthly headache days of ≥ 50% relative to the pretreatment baseline; OR
  • A clinically meaningful improvement in ANY of the following validated migraine-specific patient-reported outcome measures:
    • Reduction of ≥ 5 points when baseline score is 11 to 20 or reduction of ≥ 30% when baseline scores > 20 in the MIDAS scores; OR
    • Reduction of ≥ 5 points in the MPFID score; OR
    • Reduction of ≥ 5 points in the HIT-6 score; AND
  • Dose escalation (up to the maximum dose and frequency specified below) may occur upon clinical review on a case by case basis provided that the patient has:
    • Shown an initial improvement or response to therapy, as described above; AND
    • Had subsequent loss of response or no net decrease in frequency of headaches; AND
    • Received a minimum of 2 doses at the next stepped dose and interval specified below; AND
• Patients has NOT experienced any treatment-restricting adverse effects (e.g., severe hypersensitivity reactions); AND
• Patient must have a trial of 200 mg prior to escalating to the maximum dose of 300 mg.

Quantity limits:

• 3 vials (300 mg) per 84 days

Billing for Vyepti

• Vyepti must be billed as a medical claim

Questions?

MHCP Provider Call Center 651-431-2700 or 800-366-5411