On March 8, 2024, the FDA approved Wegovy (semaglutide) to treat cardiovascular disease risk (heart attack, stroke, death) in obese or overweight adults with a history of cardiovascular disease. It became the first anti-obesity drug (AOM) to receive such approval. Studies have shown that semaglutide, when combined with blood pressure and cholesterol management and healthy lifestyle counseling, reduces the risk of heart disease. The FDA said the approval was a “major advance in public health.”

Less than two weeks after the FDA approved the new indication (semaglutide is also approved for chronic weight management and type 2 diabetes), CMS issued a memorandum that allows Medicare Part D plans to AOM could be covered if approved by the FDA as an additional indication. Weight management only. CMS’s guidance is forward-looking and is not limited to semaglutide. This guidance applies to all AOMs that may be approved in the future to treat other conditions. To ensure that AOMs are used for medically recognized indications, CMS is clarifying that Part D sponsors can use common utilization management tools such as step therapy and prior authorization. did.

Of note, FDA approval of semaglutide for cardiovascular disease, along with Medicare coverage, is likely a precursor to similar approval in the near future. While the benefits are significant, as more drugs and patients become covered, costs can increase as well.

obesity and public health

Obesity is an urgent public health crisis that requires robust, multifaceted solutions that include medical interventions. The CDC considers obesity to be an epidemic, and in 2013 the American Medical Association also recognized obesity as a disease. Although there is no consensus in the scientific community as to whether obesity is a disease, one thing is clear: medical interventions (including AOM), along with other public health measures, are key to addressing obesity. about it.

Obesity prevalence in the United States is 41.9%, and obesity rates are higher among black and Hispanic adults, the very people who face the greatest socioeconomic barriers to accessing health care and medications. AOM provides significant public health benefits, but ensuring equitable and affordable access is essential.

economic impact

Our analysis revealed that Wegovy’s prices were unusually high, with a list price of up to $1,349 and a net price (as received by the manufacturer) of $701 for a four-week supply. It is estimated that 6.6 million Americans would benefit from drugs such as semaglutide to reduce cardiovascular events. Because AOMs are very expensive, increasing their coverage and usage could significantly increase Medicare spending as well as increase premiums and cost-sharing for enrollees.

In 2022, total Medicare spending for semaglutide and tirzepatide for diabetes reached $5.7 billion, up from $57 million in 2018. With FDA approval of these drugs as AOMs, Medicare spending for new indications is expected to increase dramatically in the coming years.

In March 2024, the Congressional Budget Office (CBO) found that Medicare coverage of AOM could result in significant demand for and use of AOM by enrollees. CBO expects that generic competition, which could ease prices and lead to increased rebates, will not begin in earnest until 20 years after the policy allowing Medicare Part D coverage of AOM. There is. But even that assumption is far from certain, as drug companies aim for “evergreen” patent protection and exclusive sales. The CBO also acknowledged the potential for new drugs that are more effective, have fewer side effects, or need to be taken less frequently, which could lead to higher prices. Additionally, discontinuing AOM will cause weight gain, so you may need to take these medications for the rest of your life.

Presumably, reducing obesity rates could have a net benefit in the long run by reducing the incidence of many chronic diseases such as diabetes and heart disease. And in the short term, the Inflation Control Act (IRA) could help contain costs.

CBO and other reports suggest that semaglutide is likely to be selected by CMS for price negotiations under the IRA within the next few years. If selected in 2025, negotiated Medicare pricing will be available to him by 2027. Successful CMS price negotiations could resolve some of the cost concerns.

IRAs also have other mechanisms that may help address high costs. For example, the IRA’s rebate program ensures cost containment by requiring non-competitive drug manufacturers to pay rebates to HHS if drug prices rise faster than the rate of inflation. . The IRA also limits out-of-pocket costs for prescription drugs to $2,000 starting in 2025. (While the $2,000 cap helps limit costs, spending that amount is still a burden, especially for people of lower socioeconomic status, who are disproportionately affected by obesity.) )

In other words, IRAs may alleviate Medicare spending concerns, but they cannot eliminate them. The IRA’s ability to address the cost issues of his AOM coverage depends on a variety of factors, and these cost containment measures may take years to materialize. AOMs continue to be approved for new uses, and the high demand and high costs of these drugs are likely to put pressure on Medicare spending for years to come.

Take-out

CMS has made clear that Medicare should cover semaglutide and other AOMs only when necessary to avoid cardiovascular disease or other serious conditions. This regulation must be strictly enforced and monitored.

Smart Medicare enrollees could try to game the system by using drugs primarily for weight loss purposes, but that would be inconsistent with CMS approval. Some doctors may prescribe dishonestly. Also, given racial and ethnic disparities in access to obesity treatment, marginalized groups are unlikely to receive equal benefits from AOM. For this reason, strong and thoughtful strategies are needed to ensure that such drug coverage is not abused. Without clear limits on the use of AOMs, the costs to Medicare could be significant.

Beyond Medicare spending, there are broader capital concerns regarding access to drugs to treat obesity-related conditions. Even if medicines become available to marginalized populations, obtaining the optimal health benefits of AOM is likely to remain a challenge. The FDA notes that semaglutide is most effective when taken in conjunction with other lifestyle and behavioral changes, such as diet and exercise. Healthy lifestyles and behaviors are primarily influenced by broader social and commercial determinants, so those most at risk may not be able to fully reap the health benefits of AOM there is. To harness the public health benefits, AOM must be viewed as part of a broader approach to addressing the health risks associated with obesity. It should not undermine interventions that target the social structural determinants of health that shape individual and population health outcomes.

For some, semaglutide and other AOMs are miracles of modern science. But miracle solutions to deep and complex health threats warrant a degree of skepticism. Medicare should expand AOM coverage on a basis that meaningfully considers competing concerns and tradeoffs. Meanwhile, public health professionals and clinicians continue to use all tools available to reduce the burden of disease caused by overweight and obesity, and address the widespread stigma, shame, and discrimination in society. need to be fought against.

Andrew Tzwinamatzko, J.D., is director of the Health Policy and Law Initiative at the O’Neill Institute in Washington, DC. Sheila Ranganathan, J.D., is a collaborator in the O’Neill Institute’s Health Policy and Law Initiative. Lawrence O. Gostin, J.D.; He is a Distinguished University Professor, Georgetown University’s highest degree, and directs the O’Neill Institute. He is also Director of the World Health Organization’s Collaborating Center for National and Global Health Law. he is the author of the book Global health security: A blueprint for the future.