The Institute for Clinical and Economic Review (ICER), a U.S. drug price watchdog, is out with its final multiple sclerosis med assessment—and drugmakers won’t much like its conclusions.
Most MS drugs cost more than their benefits are worth for patients, ICER said, after putting a range of drugs through its cost-effectiveness analysis. And the self-appointed pricing arbiter cited some market powerhouses in particular.
Based on the cost per additional quality-adjusted life year (QALY) it calculated for each med, ICER praised only Sanofi’s Lemtrada—with a QALY of $38,000—as a “good value” compared with best supportive care.
Every other med included in ICER’s evaluation—from Teva Pharmaceutical, Biogen and Bayer standbys to new oral meds from Biogen, Novartis and Sanofi—checked in above the $150,000 per QALY mark, which the organization pegged “above the range for reasonable value.” It flagged Biogen and AbbVie newcomer Zinbryta, in particular, for its $207,000 QALY estimate.
Pharma companies exactly responded favorably to the analysis. Novartis, which makes pill Gilenya, said in a statement that ICER's report "does not fully evaluate all the appropriate clinical data, including long-term effectiveness and safety data of Gilenya relative to other therapies, and therefore does not accurately reflect the value of Gilenya." Copaxone-maker Teva added that "we do not believe the final report, especially as it relates to cost per additional quality-adjusted life years, accurately reflects the real-world value" of its blockbuster.
Merck KGaA, maker of Rebif, agreed, noting in a statement that "value should be captured through long-term analysis and a broad, comprehensive examination of risks and benefits that the medicine brings, utilizing a robust incorporation of patient-centric measures."
And while Sanofi said it was "not surprised" by the favorable Lemtrada finding, it took issue with the report, too. "We believe the ICER analysis still contains a number of flaws and inaccuracies that result in mistaken and misleading conclusions," the French drugmaker said, arguing that ICER "undervalues the potential clinical and economic benefits" that its oral contender Aubagio can bring to patients and the healthcare system.
So what can drugmakers do to remedy the situation, in ICER’s eyes? The body has a few ideas. For one, companies can link their list prices at launch to the “added value they bring to patients compared to existing clinical options.” And knock off the annual price increases, too, ICER recommended.
Payers can help, ICER noted, suggesting they “increase access to therapies for which the cost aligns with the value brought to patients.”
One med that still has a chance to avoid ICER’s unwanted spotlight? Roche’s Ocrevus. The as-yet-unapproved candidate—along with Lemtrada and Biogen’s Tysabri—were the most effective at cutting relapse rates among patients with relapsing-remitting MS, ICER found. Ocrevus (ocrelizumab) is also the only med to show it can top best supportive care in patients with primary progressive forms of the disease.
But how ICER responds to Ocrevus will all depend on how Roche decides to price the med; the market will likely know more at the end of the month, when the Swiss pharma giant is due for an FDA verdict that’s already been once delayed.
Editor's note: This story has been updated with company statements.