Weight

Dec 27, 2023

US drug regulators are in talks with the Medicare agency about "what to do about obesity drugs," FDA Commissioner Robert M. Califf said Wednesday, potentially signaling a step toward increased coverage of the popular class of drugs.

The comments from the head of the Food and Drug Administration at a biotechnology conference indicate the Centers for Medicare & Medicaid is looking at ways to offer or expand a benefit that the agency's statute has long banned.

Right now, the CMS is prohibited from paying for obesity drugs, if that's the only indication, Califf said at the Biotechnology Innovation Organization convention in Boston. But he indicated that the data have to drive these decisions.

The commissioner's comments come as Novo Nordisk's Ozempic and Wegovy and Eli Lilly and Co's Mounjaro are leading to a booming obesity drug market that some analysts say could be worth up to $150 billion a year.

Medicare will pay for certain surgeries aimed at weight loss, but not for weight loss drugs or supplements. Sen. Thomas R. Carper (D-Del.) has introduced legislation that would allow Medicare coverage to include obesity drugs, but those bills haven't moved out of the Senate Finance Committee.

CMS did not address whether it's looking at ways to cover weight loss medications in its response. The agency reiterated that the law prohibits coverage under its prescription drug benefit known as Part D and under behavioral therapy under Part B, and that Medicare Advantage plans may offer additional benefits that aren't covered by Original Medicare, but not less. The agency said additional benefits, known as supplemental benefits, vary by plan.

Califf was using the weight loss drug talks as one example of many ongoing discussions between the two agencies in addition to the changes of Medicare's prescription drug benefit under the Inflation Reduction Act. Drug industry trade groups BIO and the Pharmaceutical Research and Manufacturers of America have decried the price negotiation provisions as a law that will stifle innovation.

"Most people acknowledge there are good parts," to the IRA, such as the $2,000 cap on out-of-pocket costs that starts in 2025, Nick Shipley, chief advocacy officer for BIO said in an interview. "Those are things that I think we very much want to, you know, see, stay, and work with. But right now the negotiating title—and all those kind of bells and whistles tacked on to it—really does blot out the sun in health-care policy.

BIO CEO Rachel King, who was on the panel with Califf, said "any society is trying to balance that support for innovation with the need for affordable access."

But Califf told the biotech industry, "I think the prices of drugs are too high."

"We have to come to grips with it. The impact on public health is substantial. Financial toxicity is something the cancer community has talked about a lot. People who suffer health consequences, because they don't take their drugs, because they’re trying to save money," he said. "We have to come up with a better system, and the IRA is an effort to do that."

Protecting the patent of these drugs in important, Califf acknowledged.

"When people criticize the FDA, one thing I love to say is, ‘Okay, name me a country that has a more rational system, and any country that is better in innovating in the medical products than the US."

At the same time, the US life expectancy has dropped behind other wealthy nations.

"How can it be that we’re inventing all the stuff that the rest of the world uses and they’re doing so much better than we are?" he said.

"There's something missing in the equation by which we translate all this amazing innovation into products and services that help the population."

To contact the reporter on this story: Jeannie Baumann in Washington at [email protected]

To contact the editor responsible for this story: Cheryl Saenz at [email protected]

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