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Pink Sheet – US FDA Has People Working At CMS To Help Implement Inflation Reduction Act

Pink Sheet – US FDA Has People Working At CMS To Help Implement Inflation Reduction Act

The US Food and Drug Administration now has employees working at the Centers for Medicare and Medicaid Services as part of the increased collaboration spurred by the 2022 Inflation Reduction Act.

FDA Commissioner Robert Califf indicated his employees are helping CMS implement the IRA, which among its many provisions includes the controversial Medicare price negotiation framework.

“We’ve really stepped up our communication and interchange and we’ve had folks from FDA helping out at CMS as they’re trying to figure out how to implement the IRA,” Califf said 10 February during an Alliance for a Stronger FDA webinar. “I can’t talk about exactly what the decisions are. That’s a CMS decision.”

Califf added that some of the implementation effort may be ensuring the law functions as intended.

“I think IRA is a big law,” he said. “There will be unanticipated consequences. There will be repair work that’ll need to be done to make it right. We’re all gonna watch with interest and track things.”

The FDA did not offer any additional detail on the agency employees helping at CMS, their expertise or tasks.

CMS told the Pink Sheet in a statement that it “regularly coordinates and communicates with the FDA on a variety of issues where the FDA has expertise, such as COVID-19 vaccines and biosimilar provider education materials.”

CMS “will continue to connect with FDA staff to tap their expertise on issues related to implementing the Inflation Reduction Act,” CMS said in the statement.

Calls for improved communications between the two agencies increased after divergent decisions on Biogen, Inc.’s controversial Alzheimer’s treatment Aduhelm (aducanumab-avwa). The FDA granted an accelerated approval for the product in 2021.  (Also see “The Conflicting Lessons Of Aduhelm” – Pink Sheet, 9 Feb, 2023.)

But CMS decided to implement a restrictive coverage plan for Aduhelm and other amyloid-directed monoclonal antibodies, even those that received a traditional approval. Reimbursement for accelerated approvals will only be allowed if the patients are part of a randomized clinical trial. Amyloid-directed agents receiving traditional approval will be covered if sponsors engaged in real world studies drawing from sources such as patient registries.  (Also see “Medicare Alzheimer’s Decision Varies Evidence Mandate For Accelerated vs. Traditional Approvals” – Pink Sheet, 7 Apr, 2022.)

The move hindered Aduhelm’s uptake, although providers and other payers were also wary of the relatively weak data supporting the drug’ approval. The launch of Biogen’s other Alzheimer’s treatment Leqembi (lecanemab-irmb) appears to be faring somewhat better, though Medicare coverage still is restricted.  (Also see “Eisai’s Leqembi Launch Bodes Well For Biogen In A Pivotal Year” – Scrip, 10 Feb, 2023.)

Another Way To Further FDA Access Mission?

The FDA by law cannot consider cost in its decision-making, but in recent years pricing issues have become more of a priority. Former Commissioner Scott Gottlieb was the first to openly suggest that access should be a priority for the FDA, suggesting when he took over in 2017 that the agency can help promote competition.  (Also see “Gottlieb Places Drug Pricing Out Front In First Speech To US FDA Staff” – Pink Sheet, 16 May, 2017.)

Insofar as access is related to pricing, more collaboration with CMS about coverage could connect with that part of its mission. For example, FDA officials could help inform CMS’ implementation of the Medicare price negotiation program established by the Inflation Reduction Act.

Industry already is attempting to limit the pool of potential products, arguing that novel technologies should be protected to avoid stifling innovation.  (Also see “Medicare Price Negotiation: Special Treatment For ‘Novel Technologies’ On PhRMA’s Advocacy Agenda” – Pink Sheet, 8 Feb, 2023.)

Califf recently offered some sympathy for pharma’s and investors’ concerns, indicating that innovation in the small molecule space will be hampered by the fact that the drugs could be subject to negotiated prices nine years after approval.

“I have a concern,” he suggested at the 13 February Prevision Policy/Friends of Cancer Research Biopharma Congress. “If you’ve got a small molecule that takes a six-year trial to get the answer that’s needed, I can understand why investors are looking at that … But it’s CMS’s call, not ours.”

Because of the timeline for negotiation eligibility, manufacturers also are likely to pay more attention to the date of an FDA approval. One strategy to limit the impact of price negotiations is to aim for a February FDA clearance, which would maximize a product’s time on the market before eligibility.  (Also see “US Medicare Price Negotiation: Gaming FDA Approval Dates Could Delay Drug Selection” – Pink Sheet, 27 Jan, 2023.)

CMS will involve industry in the price negotiation implementation process, but the timeframe is limited. The first list of drugs subject to price negotiation will be released in September.  (Also see “Medicare Price Negotiation: Sponsors Will Have A Say, But Likely Not Sway As Timetable Comes Into Focus” – Pink Sheet, 11 Jan, 2023.)

More CMS, As Well As PTO Collaboration

The increased attention also has spawned more collaboration between CMS and the FDA outside of the price negotiation program. Multiple FDA officials have said the agency wants to improve communications and the so-called “hand-off” between drug approval and reimbursement decisions.

The FDA already has indicated that it will try to help sponsors generate data CMS will need to make coverage decisions, but not serve as an middleman between the sponsor and payer.  (Also see “US FDA Wants To Help Sponsors Generate Evidence CMS Needs, But Won’t Be An Intermediary” – Pink Sheet, 24 Oct, 2022.)

FDA officials also will begin training Patent and Trademark Office examiners to help them best use FDA information in their decisions. The cross-training effort was created in response to an executive order on promoting competition in the American economy.  (Also see “US FDA Set To Begin Training Patent Examiners This Spring” – Pink Sheet, 16 Feb, 2023.)

Cathy Kelly contributed to this story.