The Institute for Clinical and Economic Review on July 3 released a Final Evidence Report and Report-at-a-Glance on three calcitonin gene-related peptide (CGRP) inhibitors for prevention of migraine attacks: erenumab (Aimovig, Amgen/Novartis), fremanezumab (Teva), and galcanezumab (Eli Lilly). Erenumab was approved in May, while the other two agents remain under FDA review.
ICER’s report was reviewed at a June public meeting of the California Technology Assessment Forum (CTAF).
Panel members voted that evidence was adequate to demonstrate a net health benefit of the CGRP inhibitors for individuals with chronic migraine and no other available treatment options.
While acknowledging the significant impact even infrequent migraine has on day-to-day life, a majority of panel members pointed to the unknown long-term risks in voting that current evidence is inadequate to show a net health benefit of the CGRP inhibitors for individuals with episodic migraine.
Panel members noted that the therapies may provide potential additional benefits beyond those studied in clinical trials, including reduced family/caregiver burden, a novel mechanism of action that may allow for successful treatment of patients without other options, and increased productivity.
Further, the high severity and lifetime burden of illness, along with the significant uncertainty around long-term risks and the magnitude and durability of benefit, were noted as key contextual considerations that factored into CTAF’s assessment of value.