- July 8, 2018
- Posted by: PharmaScroll
Report notes the significant remaining uncertainty about the long-term safety of CGRP inhibitors given their new mechanism of action, highlights that their clinical and economic value hinges on use among patients for whom other available treatments have not been successful
The Institute for Clinical and Economic Review 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 of 2018, while the other two agents remain under FDA review.
ICER’s report was reviewed at a June 2018 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.
Voting on the long-term value for money of erenumab, the only CGRP drug with a publicly-available price, a majority of the panel voted that erenumab represents an intermediate value in adults with chronic migraine, and votes were split between intermediate and low long-term value for money when the drug is used for patients with episodic migraine.
“Although there is a wide spectrum of disease severity, in some people migraine can have a very large impact on quality of life, and these therapies offer hope to patients who have not seen new treatments in a long time,” noted David Rind, MD, MSc, ICER’s Chief Medical Officer. “At the same time, these therapies work on a novel pathway, and we do not yet have adequate evidence to know if the treatments will be associated with long-term, uncommon side effects. Given this, as well as the high price of these therapies relative to oral preventive treatments and uncertainties around long-term efficacy, it is reasonable for insurers to develop evidence-based prior authorization criteria to ensure prudent use of CGRP inhibitors.”
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News Source: https://icer-review.org/announcements/cgrp-final-report/
Image Source: https://vitals.lifehacker.com/the-new-drug-for-migraines-has-some-drawbacks-1826201295