Medicare Will Cover AOM Semaglutide for Cardiovascular Risk Reduction: A First

The US Centers for Medicare and Medicaid Services (CMS) on Thursday published a guidance to Medicare Part D programs instructing them to cover antiobesity medications (AOM) that are approved for an "additional accepted indication," reports the AP¹ and other news sources.

The indication of note currently is for cardiovascular risk reduction among those with overweight or obesity and preexisting cardiovascular disease (CVD) that was granted to semaglutide (Wegovy, Novo Nordisk) via approval of a label expansion from the US Food and Drug Administration (FDA) on March 8, 2024.² The approval is the first of its kind but could set the stage for “thousands of new prescriptions,” according to the AP.¹ Semaglutide is also approved as an adjunct to diet and exercise to reduce hyperglycemia in type 2 diabetes.

Part D plans are voluntary and provide outpatient prescription drug benefits through private plans that are contracted to Medicare.¹ Prohibition of "weight loss" medications under part D is rooted in safety issues that predate the evolution of the glucose-like peptide-1 receptor agonist (GLP-1 RA) medications when a number of drugs were forced off the market for serious—and and fatal—side effects, such as fenfluramine-phentermine (Fen-Phen) in 1997, according to reporting in PharmaForum.³

In contrast, semaglutide, a once-weekly injectable GLP-1 RA, was shown in the large SELECT clinical trial⁴ to reduce the risk of major adverse cardiovascular events by up to 20% compared with placebo when added to therapy considered standard of care in people with overweight (BMI 25.0 to <30 kg/m² or obesity (BMI ≥30 kg/m²).⁴

Speaking with the AP, Tricia Neuman, a Medicare policy specialist at the nonprofit health policy organization KFF, said that part D plans could begin coverage for semaglutide “some time this year.”¹

However, “Medicare plans may be reluctant to move quickly to cover Wegovy given its relatively high price, particularly because they won’t be able to adjust premiums before next year,” Neuman added.¹

The average cost to a patient without coverage for the drug is $1300 per month, which translates to roughly $16 000 per year.

Coverage will be up to the discretion of individual insurance plans, given their license to “pick and choose from among available drugs” that treat a specific condition, Juliette Cubanski, deputy director of the Program on Medicare Policy at KFF, told FirstWord Pharma. ⁵ Moreover, there are long-established treatments for CVD and to reduce risk for heart attack or stroke, many of which are now available generically and so are relatively inexpensive, said Cubanski.⁵

In fact, the CMS guidance sent to part D plans suggests “certain utilisation management tools,” to help reduce potential cost.⁵ Specifically, the agency wrote that “Part D sponsors may consider using prior authorisation for [AOMs] to ensure they are being used for a medically accepted indication.”⁵ Other “tools” could include higher out of pocket fees, a requirement for step therapy, ie, failure to achieve results on potentially lower cost drugs that treat the same condition before moving on to the new treatment¹ and placing limits on refill quantity or length of time coverage will be provided.⁵

According to the most recent data from the Centers for Disease Control and Prevention, approximately 40% of the nearly 66 million adults enrolled in Medicare had obesity.⁶ That proportion essentially reflects the US population at large, where obesity affects approximately 42% of adults.⁶

"This patient population has a higher risk of cardiovascular death, heart attack, and stroke," John Sharretts, MD, director of the Division of Diabetes, Lipid Disorders, and Obesity at FDA's Center for Drug Evaluation and Research, said in a statement reviewed by MedPage Today.⁷ "Providing a treatment option that is proven to lower this cardiovascular risk is a major advance for public health."⁷

"CMS is committed to ensuring that people have access to treatments and treatment options that improve health outcomes," an agency spokesperson told MedPage Today in an email. "With the recent change in the FDA approved use for Wegovy (semaglutide), current Medicare Part D and Medicaid coverage rules apply."⁷

Eli Lilly, manufacturer of competing AOM tirzepatide (Zepbound) is conducting a cardiovascular outcomes trial similar to the SELECT study, called SURMOUNT-MMO (NCT05556512). The the company anticipates results in 2027.

References

1. Aleccia J. Medicare can pay for obesity drugs like Wegovy in certain heart patients. AP. March 21, 2024. Accessed March 22, 2024. https://apnews.com/article/wegovy-medicare-part-d-heart-attack-stroke-288e551eb69914cb9803644290e01faf

2. Halsey G. Semaglutide 2.4 mg (Wegovy) wins expanded indication to include reduced risk of MACE. Patient Care. March 8 2024. https://www.patientcareonline.com/view/semaglutide-2-4-mg-wegovy-wins-expanded-indication-to-include-reduced-risk-of-mace

3. Taylor P. Heart claims unlock Medicare coverage of obesity drugs. Pharma Forum. March 22, 2024. https://pharmaphorum.com/news/heart-claims-unlock-medicare-coverage-obesity-drugs

4. Halsey G. Semaglutide cuts cardiovascular risk by 20% in adults with obesity, CVD and without diabetes. Patient Care. November 13, 2023. https://www.patientcareonline.com/view/semaglutide-cuts-cardiovascular-risk-by-20-in-adults-with-obesity-cvd-and-without-diabetes

5. Eaton ES. Medicare to cover some weight loss meds, but high price sets stage for future negotiation. First Word Pharma. March 21, 2024 https://firstwordpharma.com/story/5839220

6. Adult obesity facts. US Centers for Disease Control and Prevention. Last reviewed May 17, 2022. https://www.cdc.gov/obesity/data/adult.html

7. Frieden J. Medicare to cover weight-loss drug Wegovy for certain patients. Medpage Today. March 21, 2024. https://www.medpagetoday.com/publichealthpolicy/medicare/109305