BRIEF—ICER draft scoping document for acute migraine treatments

The US medicines cost-effectiveness watchdog, the Institute for Clinical and Economic Review (ICER), has posted a Draft Scoping Document outlining a planned review of the comparative clinical effectiveness and value treatments for acute migraine.

Included in the review are: two oral CGRP receptor antagonists, rimegepant, from Biohaven, and ubrogepant, from Allergan; and a 5-HT1f agonist lasmiditan, from Eli Lilly.

All three of these agents are under Food and Drug Administration review with an anticipated decision in the final quarter of 2019, according to the ICER statement.

However, while ubrogepant is expecting an FDA decision in the final quarter of 2019, rimegepant was submitted to the FDA in the second quarter of 2019.  Also, lasmiditan was filed in November 2018, so the PDUFA could be in fourth-quarter 2019, but Lilly has never publicized the expected PDUFA date, The Pharma Leter has been advised.

All interested stakeholders are encouraged to submit comments and suggested refinements to the scope to ensure all perspectives are adequately considered.

Comments can be submitted by email to publiccomments@icer-review.org and must be received by 5 PM ET on July 19, 2019.

All comments submitted must meet ICER’s formatting specifications.