In final report, ICER appears to have a change of heart on new acute migraine therapies
ICER appears to have reversed course on its assessment of two acute migraine therapies.
The cost-effectiveness watchdog in November issued a draft report suggesting that existing generic medicines are more effective and cheaper than Allergan’s December-approved CGRP ubrogepant, Biohaven rival molecule, rimegepant (which is under FDA review), and Lilly’s October-sanctioned lasmiditan, which binds to 5-HT1F receptors.
On Tuesday, however, ICER’s chief medical officer David Rind said the institute had worked with Allergan and found that additional “high quality” evidence supporting the use of ubrogepant, and by extension rimegepant, led to a “near doubling” of ICER’s health-benefit price benchmark.
“For patients who are unable to take triptans or who don’t get adequate benefit from those more affordable options, these new migraine therapies appear to relieve migraine symptoms in 10-20% more patients than who respond to placebo,” he said in a statement.
Biohaven chief Vlad Coric said he felt vindicated by the decision, in an emailed statement to Endpoints News. “It is unusual to see such a reversal from ICER, but we believe we speak on behalf of clinicians and patients when we say they got it right.”
For migraine, patients are largely treated with a host of drugs including a class of drugs called triptans (which constrict blood vessels and are therefore risky in patients with CV disease), anti-depressants and hypertension medicines.
A class of injectable biologics — CGRP (calcitonin gene-related peptide) inhibitors — target the CGRP protein that transmits pain signals into the brain, and is believed to be instrumental in generating and maintaining headaches associated with migraine. A raft of such preventative treatments was sanctioned for approval last year.
But acute treatments for as-needed use are the next frontier. The three newer acute therapies from Allergan, Biohaven and Lilly do not exhibit the vasoconstrictive impact triptans have on cranial and coronary blood vessels. Rimegepant and ubrogepant provide comparable net health benefits to each other, and while lasmiditan likely confers similar efficacy to the other two — it is also linked to significantly higher rates of dizziness and discontinuation, according to ICER.
After the draft report was published by ICER, a panel of independent advisors deliberated on its findings before a final report was issued.
Although the evidence showed the trifecta of acute therapies did confer benefit over no treatment, it was not enough to support the finding of superior net health benefits in comparison to triptans, the panelists said. However, when taking into account the therapies’ other benefits and contextual considerations, the reviewers agreed the three drugs will allow for the successful treatment of many patients for whom other treatments have failed.
ICER estimated a health-benefit price benchmark of between $2,800-$3,200 per year for lasmiditan, lower than the treatment’s annual list price of $4,610. For rimegepant and ubrogepant, the benchmark was set at $4,200-$4,600 annually — ubrogepant’s list price is a smidge higher at $4,896/year, while rimegepant’s price is unknown since it has not yet been approved.
ICER’s health-benefit price benchmarks reflect a list price range — net of any discounts and rebates — that align fairly with a treatment’s added benefits for patients over their lifetime, the institute contends, saying that the ranges reflect commonly cited cost-effectiveness thresholds between $100,000 and $150,000 per Quality-Adjusted Life Year (QALY) gained. (QALYs are a measure of the state of health of a person or group in which the benefits — in terms of length of life — are adjusted to reflect the quality of life.)
Akin to NICE in the UK, ICER is an independent body that analyzes the cost-effectiveness of drugs and other medical services in the United States. Unlike NICE, though, ICER is not government-affiliated, but its determinations are increasingly gaining traction with payers and policymakers. Manufacturers frequently attack the methodologies the institute employs in its analyses.
Endpoints News has contacted Allergan and Lilly for comment on the final report.