With the Inflation Reduction Act's Medicare price negotiations moving ahead (PDF) rapidly, one party not officially involved in the talks is the Institute for Clinical and Economic Review (ICER).
Formed in 2006, the organization seeks to illuminate the debate around the often controversial topic of drug pricing and access. And, as the IRA commands more and more attention within the biopharma industry, ICER could end up playing a growing role in the process.
Still, one key condition would need to be met for that to happen, the cost watchdog’s new president said in a recent interview.
“I think we would need some direction from [the Centers for Medicare & Medicaid Services] that they wanted the drug price negotiation program to be about value, and not just about a lower price,” ICER’s president, Sarah Emond, told Fierce Pharma on the sidelines of the 2024 J.P. Morgan Healthcare Conference.
ICER produces value-based pharmaceutical economics analyses. The organization’s drug cost-effectiveness reports are based on clinical data, comparative clinical effectiveness and long-term benefits plus medicines' impacts on patients’ quality of life and the overall healthcare system.
“There’s parts of the statute that look a lot like a value assessment,” Emond said of the IRA. “Therapeutic advance, unmet need, cost and cost offset, … [they] sound an awful lot like what you do in a value assessment. But we’ll have to wait and see.”
The biopharma industry should know soon what goes into the CMS’ pricing assessments. By Feb. 1, the agency is set to send its initial offers for the 10 drugs involved in the first round of negotiations, laying out what it considers to be the maximum fair prices for those products.
The offers are expected to include the methodology used to reach the numbers, and the government plans to set the final prices by Aug. 1.
Before the CMS publishes its findings, ICER has voluntarily conducted evaluations of two oral anticoagulants affected by the IRA—Bristol Myers Squibb and Pfizer’s Eliquis and Johnson & Johnson and Bayer’s Xarelto. Rather than spelling out specific prices, ICER calculated the premiums that the two factor Xa inhibitors could command over what Medicare pays for two older comparator meds, warfarin and dabigatran.
Meanwhile, ICER has spoken with officials at the CMS to volunteer some ideas on the negotiation process. The CMS team was happy to listen, Emond said, but it’s not clear how much of the feedback it’s taken in.
Looking forward, Emond said she hasn’t decided whether ICER will routinely produce reports for IRA-picked drugs in the future. For now, the organization remains focused on scrutinizing new launches.
“If it turns out these reports are having important impact and are working towards the goal of better access and fairer prices for Medicare recipients, then, yes, that might work into our portfolio,” she said.
While the IRA targets 10 medicines for negotiations at first, the number of affected drugs will increase to up to 20 drugs annually for 2029 and beyond. If ICER commits to routine IRA-related assessments, it would have to scale up, Emond said. It took six ICER staffers about six months to complete the first project on Eliquis and Xarelto.