Monday, July 30, 2018

New Class of Migraine Drug May Drive Changes



For years, clinicians have mostly prescribed generic prescription drugs to treat migraines. But a new class of relatively high-cost specialty biologic products is threatening to upend payers' calm. Insurers and PBMs are proceeding with caution and focusing on utilization management to ensure the proper use of Aimovig (erenumab) from Amgen, Inc. and Novartis AG.

Current treatments supported by clinical evidence "include beta blockers, tri-cyclic anti-depressants and some seizure medications," according to Mesfin Tegenu, R.Ph., president of PerformRx, LLC. "These are utilized for prevention of migraine episodes only and not for stopping or reducing the duration of a current migraine. Most of these agents are relatively inexpensive generic medications."

The situation changed in mid-May, when Aimovig got the regulatory greenlight in the U.S., while two more calcitonin gene-related peptide (CGRP) inhibitors — Teva Pharmaceuticals' fremanezumab and Eli Lilly and Co.'s galcanezumab — are under FDA review, says an Institute for Clinical and Economic Review (ICER) report on migraine treatments.

ICER's recent report contended that it is reasonable for payers to develop prior-authorization criteria to ensure prudent use of CGRP inhibitors. Moreover, drug manufacturers should continue to exercise restraint in pricing and price negotiation so that net prices align with added benefits, following the example set by the first CGRP inhibitor, Aimovig.

PerformRx pays approximately $565 for the CGRP inhibitors to prevent one additional migraine per month, based on current published clinical trials, Tegenu says. That $6,900 annual price tag is "much higher than the generic products currently used for prevention," he says.

He adds that, like most specialty medications, CGRPs will require a prior authorization review prior to approval.

As of July 25, PerformRx has not seen many requests for Aimovig, according to Tegenu. "So far we have received only 24 total requests and 14 approvals."

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