Medicare coverage for obesity drug raises questions

Millions of older Americans who suffer from obesity could potentially have the high cost of a weight-loss drug covered by Medicare, thereby reducing their high risk of heart problems.

But at what level of cardiovascular risk does someone exactly have to be entitled to such insurance, how many people could be entitled to it and what could this cost the state?

A new study examines these questions and finds a wide range of answers that differ by millions of people and billions of dollars – depending on how private health insurers that contract with Medicare may be allowed to proceed.

Most likely, 3.6 million people will be eligible. This assumes that reimbursement for semaglutide injections is only given to people with obesity who have already suffered a heart attack or stroke or who have been diagnosed with coronary heart disease or angina, the study said.

This figure does not include the 7 million people who may already qualify because they have diabetes in addition to being obese.

The study was led by Alexander Chaitoff, MD, MPH, a researcher at the VA Ann Arbor Healthcare System and the University of Michigan Medical School, and published in the Annals of Internal Medicine.

But what about older people with obesity who do not have diabetes or a serious cardiovascular diagnosis but who are at increased risk of heart attack or stroke in the next ten years?

If prescription drug coverage plans allow people with the highest cardiovascular risk scores to cover all or part of the cost of semaglutide, the study found, an additional 5.1 million Americans could be eligible. And if the plans also allow people with moderate risk to cover the cost, an additional 6.5 million people could be eligible.

Medicare coverage of semaglutide – but for whom?

Chaitoff and his former colleagues at Harvard University launched the study after it was announced in the spring that Medicare would allow semaglutide to be covered by drug plans for people diagnosed with cardiovascular disease. The drug is sold under the name Wegovy when used for weight loss and Ozempic when used for diabetes.

Without a concrete definition from Medicare of what constitutes “established cardiovascular disease,” Chaitoff said, “it's unclear exactly who qualifies now, who might qualify in the future, and whether certain high-risk individuals will be left out.”

Medicare plans may be more likely to consider the short list of diagnoses that participants had to meet to be eligible for the clinical trial that led to the approval of semaglutide for the treatment of cardiovascular disease and obesity.

However, they may be able to take a more preventative approach – as is the case with many drugs that reduce the risk of heart attack or stroke.

Chaitoff, who cares for veterans at VAAAHS, notes that Medicare Part D and Medicare Advantage could set conditions to determine which high-risk patients are eligible for semaglutide treatment and could require them to contribute more to the cost.

He points out that veterans with obesity and at least one related condition may be eligible for Wegovy insurance from the Veterans Health Administration if they participate in the MOVE weight management program for months or years.

However, for everyone else over age 65, coverage of their prescription drugs depends on the plan they chose during Medicare open enrollment.

If these plans focus on covering people with the same conditions as in the clinical trial, one in seven Medicare enrollees with obesity would now have access, which is an important expansion. But the other six of the seven would not have access, and most of them also have an increased cardiovascular risk due to their overall health.”

Alexander Chaitoff, Michigan Medicine – University of Michigan

Risk assessment for future cardiovascular diseases

The researchers used data from the National Health and Nutrition Examination Survey, which is conducted each year in samples of the U.S. population, to calculate cardiovascular risk scores for every Medicare-insured person with a body mass index of 27 kg/m2 or more who had no history of heart attack, stroke, coronary artery disease or angina.

The assessment tool is called ASCVD, and it takes into account many factors to help doctors decide what preventative treatments a person may need. People who score 20% or more are considered high-risk for heart disease or stroke, while people who score 7.5% to just under 20% are considered moderately at risk.

Chaitoff points out that people whose levels are above 20% should receive immediate treatment to reduce their risk. This typically includes medications to lower blood pressure, cholesterol and even to treat potentially prediabetic blood sugar levels, as well as help with smoking cessation, increasing physical activity, improving diet and, if necessary, weight loss.

In fact, he says, this is the same approach used in patients who have survived a heart attack or stroke or who have been diagnosed with coronary heart disease or angina.

But even people with values ​​between 7.5% and 20% should receive help in reducing the risk factors that affect their value. This often includes taking medication.

“In practice, the way we treat both groups of people with elevated risk scores is not dissimilar — we make medical treatment decisions and lifestyle recommendations to prevent a future event,” Chaitoff explained. “Weight loss is listed as recommended in clinical guidelines for both groups because there is a general association between obesity and cardiovascular risk. But the only way Medicare allows coverage of weight loss drugs may have nothing to do with risk, just the earlier diagnosis.”

Covering drugs that have been shown to produce sustained weight loss – and several drugs do, including semaglutide – would enable more people with obesity and increased cardiovascular risk to achieve the goals set out in clinical guidelines, he added.

“Ultimately, we have to ask ourselves what level of evidence we require for coverage of certain drugs compared to the level of evidence we require for coverage of other treatments,” Chaitoff said. “Given all that we know about the impact of obesity on cardiovascular risk, perhaps it is best to accept that a surrogate outcome of sustained weight loss is sufficient evidence for coverage. We do this for other conditions but not for obesity, and the questions are why and whether it is appropriate.”

Potential Medicare Costs

The cost of semaglutide for Medicare plans will likely be the subject of negotiations between the Centers for Medicare and Medicaid Services and the manufacturer of the FDA-approved versions of the drug, but the price agreed upon in those negotiations will not take effect until the following year.

Meanwhile, if the drug were allowed only to patients with a history of heart attack or stroke under the non-diabetes label, and only 30 percent of them started taking the drug and took it for a year, the cost to Medicare at current prices could exceed $10 billion, the researchers estimate.