Heart claims unlock Medicare coverage of obesity drugs

Medicare has loosened restrictions on the reimbursement of obesity drugs, thanks to clinical data showing they can improve cardiovascular outcomes, but their price could be up for negotiation.

The Centers for Medicare & Medicaid Services (CMS) has published guidance that instructs Medicare Part D drug benefit plans – a voluntary outpatient prescription drug benefit provided through private plans contracted to Medicare – to cover obesity drugs that are approved for an additional healthcare indication.

That would include Novo Nordisk’s Wegovy (semaglutide), which was cleared by the FDA earlier this month to reduce the risk of serious cardiovascular conditions in people who are overweight or obese.

Reimbursement of all medicines used simply for weight loss remains prohibited under Medicare Part D, a situation that dates back to a safety scandal over obesity drugs that emerged in the 1990s, but Wegovy’s new label means that “current […] Medicaid coverage rules [now] apply,” according to a CMS statement.

At the same time, a new report from the Congressional Budget Office (CBO) has predicted that Wegovy will “be selected for price negotiation by the Secretary of Health and Human Services within the next few years,” adding that this would lower its price and potentially the cost of other drugs in the anti-obesity medicine (AOM) class, such as Eli Lilly’s Zepbound (tirzepatide).

The CBO said it is also looking for information on take-up rates and patient adherence for AOMs currently on the market, along with their long-term clinical benefits or complications.

Novo Nordisk and Lilly’s drugs are already generating direct-to-consumer (DTC) sales, and the former said last month that it expects AOMs to be “mostly out-of-pocket” in the US market.

Meanwhile, there are efforts underway by lawmakers to expand Medicare coverage of AOMs to include simply weight loss, along with expanding access to other measures, like intensive behavioural therapy. The bipartisan Treat and Reduce Obesity Act (TROA) introduced last year is one such measure and has been supported by Novo Nordisk and Lilly.

Wegovy’s approval for cardiovascular risk reduction came on the back of the SELECT trial, which showed that it reduced major adverse cardiovascular events (MACE) – cardiovascular death, non-fatal heart attack (myocardial infarction), or non-fatal stroke – by 20% compared to placebo in overweight or obese patients who had underlying cardiovascular disease.

Lilly, meanwhile, is running its own cardiovascular outcomes study called SURMOUNT-MMO, with results due in 2027.