With Medicare now providing coverage for semaglutide for those with obesity and cardiovascular issues, even if they do not have diabetes, a recent study investigates who exactly may qualify for this aid, based on the criteria applied by prescription plans.
Millions of older individuals dealing with obesity could potentially receive assistance from Medicare to offset the significant expense of a weight-loss medication, aimed at lessening their elevated risk of heart-related ailments.
However, what specific level of cardiovascular risk qualifies a person for coverage, how many individuals might be eligible, and what would the financial implications be for the nation?
A recent study addresses these questions, revealing a broad spectrum of potential outcomes that vary by millions of individuals and billions of dollars, contingent on how private insurance plans that collaborate with Medicare may be permitted to operate.
The research indicates that around 3.6 million individuals might typically qualify. This estimate is based on the assumption that plans permit coverage solely for those with obesity who have previously experienced a heart attack or stroke, or who have been diagnosed with coronary artery disease or angina.
This figure does not account for the 7 million individuals who might already qualify due to having both diabetes and obesity.
The study, published in the Annals of Internal Medicine, was led by Alexander Chaitoff, M.D., M.P.H., a researcher from the VA Ann Arbor Healthcare System and the University of Michigan Medical School.
But what about older individuals with obesity who do not have diabetes and have not yet faced a significant cardiovascular diagnosis, although they are at an increased risk of a heart attack or stroke within the next decade?
If prescription drug plans allow those with the highest cardiovascular risk scores to receive full or partial coverage for semaglutide, an additional 5.1 million Americans might qualify, according to the findings. Furthermore, if plans extend coverage to individuals with intermediate risk, an extra 6.5 million people could be eligible.
Medicare coverage of semaglutide — but for whom?
Chaitoff and his former colleagues at Harvard initiated the study after the spring announcement that Medicare would begin covering semaglutide for drug plan enrollees with established cardiovascular disease. The medication is marketed as Wegovy for weight management and Ozempic for diabetes treatment.
With no clear definition from Medicare regarding “established cardiovascular disease,” Chaitoff stated, “it’s uncertain exactly who qualifies now, who may qualify in the future, and whether certain high-risk individuals might be excluded.”
It is likely that Medicare plans will adhere to a limited list of diagnoses required for eligibility based on the clinical trials that led to the approval of semaglutide for tackling cardiovascular disease and obesity.
Conversely, they could adopt a more preventive stance similar to other medications that aim to lower the risk of a heart attack or stroke.
Chaitoff notes that Medicare Part D and Medicare Advantage plans have the option to establish criteria for determining which high-risk individuals might qualify for semaglutide treatment. They could also impose a greater share of costs on patients.
He highlights that veterans with obesity and at least one obesity-related condition can access coverage for Wegovy through the Veterans Health Administration if they engage in the MOVE weight management program over several months or years.
However, for others above 65 years old, the onus falls on the plan selected during Medicare Open Enrollment to provide prescription drug coverage.
“If those plans concentrate on coverage for individuals with the same conditions as those in the clinical trial, 1 in 7 Medicare participants with obesity would gain access, representing a significant expansion,” Chaitoff remarked. “However, the remaining 6 out of 7 would not qualify, most of whom also exhibit elevated cardiovascular risk based on their overall health.”
Risk assessment for future cardiovascular issues
The researchers utilized data from the National Health and Nutrition Examination Survey, which samples the U.S. population annually. This enabled them to assess cardiovascular risk scores for every Medicare enrollee with a body mass index of 27 kg/m² or above who lacked a history of heart attacks, strokes, coronary artery disease, or angina.
The risk scoring tool known as ASCVD takes various factors into account, assisting clinicians in determining appropriate preventive treatments. Those with a score of 20% or above are categorized as high risk for heart issues or strokes, whilst individuals scoring between 7.5% and just under 20% are identified as intermediate risk.
Chaitoff emphasizes that individuals scoring above 20% should receive immediate treatment to mitigate their risks, which generally encompasses medications to manage blood pressure, cholesterol, and potentially elevated blood sugar levels, alongside support for quitting smoking, enhancing physical activity, improving diets, and losing weight as needed.
He mentions that this approach mirrors the treatment for those who have experienced a heart attack, stroke, or have a diagnosis of CAD or angina.
Those scoring between 7.5% and 20% should also receive assistance in addressing their risk factors, which often involves medication.
“In practice, our approach to treating both groups with heightened risk scores is quite similar — we aim to make medical management decisions and lifestyle adjustments to avert future incidents,” Chaitoff elaborated. “Weight loss is recommended in clinical guidelines for both groups due to the established link between obesity and cardiovascular risk. However, the only criterion for Medicare coverage of weight loss medications might not be linked to risk, but strictly to historical diagnoses.”
Providing coverage for medications proven to support sustained weight loss — like several medications that include semaglutide — could empower more individuals facing obesity and heightened cardiovascular risk to meet the standards outlined in clinical guidelines, he added.
“Ultimately, we need to consider the level of evidence we are asking for to secure coverage for specific drugs compared to what is needed for other treatments,” said Chaitoff. “Given what we understand about the relationship between obesity and cardiovascular risk, it may be wise to recognize that a sustained weight reduction is a reasonable criterion for coverage. This approach is implemented for other health issues, yet remains inconclusive for obesity. We must question why this is the case and whether it is appropriate.”
Potential expenditures for Medicare
The negotiations regarding semaglutide costs for Medicare plans will likely involve the Centers for Medicare and Medicaid Services and the manufacturer of FDA-approved versions of the drug, with any agreements made only taking effect the following year.
Meanwhile, if only those with a history of heart attacks or strokes are permitted to receive the drug under the non-diabetes approval, and merely 30% of that group initiate the treatment and continue for one year, the expenditure for Medicare could exceed $10 billion at current pricing, the researchers estimate.
