House committee backs some Medicare cover for obesity drugs

 The House Ways and Means Committee in the US voted in favour of a new bill which would end a two-decade-long restriction on the coverage of drugs to treat obesity under Medicare.

The Treat and Reduce Obesity Act of 2023 (TROA) was originally intended to overturn the restriction completely, but has been hugely scaled back in its scope.

It now only covers new enrollees in Medicare Part D – which helps cover the cost of prescription drugs for the over-65s – who have already taken weight-loss medicines for at least a year. Furthermore, TROA allows rather than requires coverage, leaving a route for patients to be denied reimbursement.

Medicare’s block on obesity medication coverage can be traced back to a safety scandal in the 1990s when a widely-used weight-loss regimen called ‘fen-phen’ was shown to cause potentially fatal pulmonary hypertension and heart valve problems.

TROA was first tabled more than a decade ago – prompted by the American Medical Association’s reclassification of obesity as a disease – and, while it has been introduced at every Congress since then, has not made much headway.

The bill has re-emerged in the wake of the explosion in the use of a new generation of incretin-based weight-loss therapies like Novo Nordisk’s Wegovy (semaglutide) and Eli Lilly’s Zepbound (tirzepatide), which generally have to be paid for out-of-pocket as many private health insurers have followed the federal plan’s line.

This is the first time it has come up for a committee vote in Congress, clearing by 36 votes to four, although it remains to be seen whether it will progress to a full floor vote.

The Senate Finance Committee is also due to consider TROA, but at the moment they are looking at the original draft, rather than the scaled-down version, so the path forward for that is also unclear.

While TROA may only open the door for a small proportion of potential obesity therapy patients, the recent approval of Wegovy’s label to reduce the risk of serious cardiovascular conditions in people who are overweight or obese could usher in more widespread coverage.

Its co-sponsors, Representatives Brad Wenstrup (R-OH) and Gwen Moore (D-WI), have said they are determined to expand coverage of obesity therapies, arguing that they can reduce the risk and cost of costly chronic conditions linked to being overweight.

Impact modelling has suggested that, as it stands, TROA would cost Medicare $1.7 billion over 10 years, a fraction of the overall market for these drugs. The Congressional Budget Office (CBO) has previously estimated that they could cost $40 billion to $60 billion over the same period, according to Wenstrup.

There was also an attempt during the markup session to require obesity drugs to be subject to Medicare pricing negotiations, which did not make it into the final draft, but there have been suggestions that Wegovy is likely to be included in the next round of negotiations.

“The bill is an important step forward to ensure that seniors in Medicare do not lose access to vital treatment and paves the way for future expanded coverage of these treatments in Medicare,” original Wenstrup. “Tackling obesity head-on can help prevent numerous additional diseases, such as heart disease and diabetes, and help keep Americans healthier for much longer. Not only a longer lifespan, but a longer health span.”

Moore also remarked: “Why would we punish these folks and likely create a setback in their fight against obesity? And if I understand obesity – a fight that they have been having for some time. A fight for their lives.”

After the vote, the patient organisation Obesity Action Coalition (OAC) said in a statement that it is an “important first step” in improving access to these drugs, adding that it is “encouraged by the bipartisan support and the commitment demonstrated by both sides of the aisle to expand coverage in the future.”

https://pharmaphorum.com/news/house-committee-backs-some-medicare-cover-obesity-drugs