ICER Releases Final Evidence Report on Efficacy, Cost Effectiveness of CGRP Inhibitors for Migraine

The Institute for Clinical and Economic Review (ICER) has released their final evidence report evaluating the effectiveness and value of calcitonin gene-related peptide (CGRP) inhibitors as preventive treatments for patients who suffer from episodic or chronic migraine.

In order to assess the clinical effectiveness, the report compared the tolerability and safety of CGRP inhibitors—erenumab, fremanezumab, and galcanezumab—to no preventive treatment or commonly-used preventive therapies.

For chronic migraine, the report considered 11 trials—1 erenumab trial, 2 fremanezumab trial, and 8 trials of onabotulinum toxin A or topiramate. Following the meta-analyses of the trial results, there were greater reductions in monthly migraine days, monthly headache days, and days using acute medication per month for all interventions versus the placebo; however, there was not a significant difference when comparing CGRP inhibitors to active therapies.

Eighteen trials were considered for episodic migraine, with 8 placebo-controlled trials of CGRP inhibitors assessing erenumab (Sun 2016, STRIVE, ARISE), fremanezumab (Bigal 2015b, HALO-EM), or galcanezumab (Skljarevski 2018, EVOLVE-1, EVOLVE-2), and 10 trials assessing oral preventive therapies.

Overall results showed greater reductions in monthly migraine days, higher odds of 50% response, and greater reductions in days using acute medication per month for all of the interventions versus placebo. The results that compared CGRP inhibitors to oral preventive therapies were found to not be statistically different.

The report also considered cost effectiveness, finding that erenumab and fremanezumab fell under the $150,000 per quality-adjusted life year (QALY) threshold in chronic migraine and were nearly equivalent to the threshold in episodic migraine. The report noted that the analysis results were sensitive to the costs of medication and to scenarios that took a societal perspective.

The final report also included results of the California Technology Assessment Forum Panel, which deliberated on June 14, 2018. The meeting discussed issues regarding the evidence available to help patients, clinicians, and payers address the questions surrounding CGRP inhibitors for the treatment of migraine.

The panel determined that there is not enough evidence to distinguish the net health benefits among the CGRP inhibitors, between treatment with CGRP inhibitors and oral preventive therapies, or between treatment with CGRP inhibitors and onabotulinum toxin A.

For patients who have no other options for preventive therapy, the panel was split on whether there is adequate evidence demonstrating a net health benefit for treatment with CGRP inhibitors compared with no treatment. However, the majority said there was.

"At the June 14 public meeting, clinical experts indicated that uptake is unlikely to exceed levels that would threaten access and affordability, as CGRP inhibitors use a novel mechanism of action with an unknown long-term safety profile, are injectable, and patients who do not benefit from therapy are likely to discontinue treatment,” the ICER concluded. “As such, ICER is not issuing an access and affordability alert at this time. However, given the budget impact potential, all stakeholders should closely monitor the use of CGRP inhibitors in the event that actual uptake exceeds expectations.”