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It’s a new drug, but the same old story.  The Institute for Clinical and Economic Review recently reported that preventive treatments for migraine may not, in their interpretation, be cost effective.   Known as CGGRP inhibitors, the drugs offer patients and health care providers the chance to not just treat but prevent debilitating migraine headaches.

The drugs’ benefits could be revolutionary – if patients can access them.

The Boston-based ICER, funded in part by health insurance companies and their foundations, estimates that as few as 16 percent of migraine patients could be treated without exceeding its budget threshold.  The group reported that one CGRP inhibitor, erenumab, may fall below its cost-effectiveness cap of $150,000 per quality-adjusted life year.  A second CGRP inhibitor, fremanezumab, may not.

ICER’s findings are tentative, however. The group’s economists are working from a manufactured price point – their best guess at what CGRP inhibitors might list for when they become publicly available.  “The placeholder price estimate for the drugs may not reflect actual market prices,” the report acknowledges.  ICER has attempted a cost-effectiveness analysis of a drug without a price before.

The group’s analysis of CGRP inhibitors’ effectiveness also has gaps.  Perhaps that’s because ICER has once again opted to evaluate the cost effectiveness of a drug that’s still in clinical trials.

Long-term effectiveness data for CGRP inhibitors doesn’t yet exist.  In fact, no real-world or post-marketing data is available, as CGRP inhibitors were still in Phase II or Phase III clinical trials when ICER undertook its analysis. As patients and health care providers know well, how drugs perform in a trial can vary from how they perform in the real world, where greater diversity of age, race, comorbidities and drug-to-drug interactions plays a role.

It’s little wonder, then, that ICER grades CGRP inhibitors’ net health benefit as “Inconclusive.”

Meanwhile, readers of ICER’s draft evidence report would be hard pressed to form an opinion of their own.  ICER has redacted the effectiveness data on how many fewer migraine days clinical trials participants experienced with CGRP inhibitors – a key data point in gauging the drugs’ effectiveness.

In short, the analysis of CGRP inhibitors follows the lead of past ICER reports, repeating the missteps described in the Institute for Patient Access’ recent white paper, “The ICER Myth.”  The paper notes that ICER repeatedly attempts to evaluate drugs too early, using incomplete data, and that its methods could not be fully replicated by other researchers, undermining the integrity of its findings.  ICER’s analysis of migraine treatments also reflects the organization’s modus operandi: a one-size-fits-all effort to reduce the immense, patient-specific value of innovative medicine into an exercise of economic number crunching.

To learn more, read the Institute for Patient Access’ response to ICER and the one-pager summarizing concerns about the ICER migraine report.

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