Less than two weeks after Novo Nordisk’s weight-loss drug Wegovy gained expanded FDA approval for cardiovascular event risk reduction, CMS issued a new Medicare Part D guidance that allows coverage of obesity drugs for senior patients with “an additional medically accepted indication”… like cardiovascular disease.
- Medicare Part D is administered through private payers, and is intended to help Medicare beneficiaries pay for self-administered prescription drugs.
- The program technically isn’t allowed to cover drugs that treat anorexia, weight loss, or weight gain, although the new guidance allows for the coverage of obesity drugs for “additional” medical indications.
- Medicare Part D already covered diabetes-targeted GLP-1s (Ozempic & Mounjaro), and this guidance paves the way for on-label coverage for their obesity counterparts.
Given that Wegovy is the only GLP-1 approved for cardiovascular event reduction (or any “additional indication”), that should mean that Medicare Part D is about to pay for a significant number of Wegovy prescriptions, as long as the patients are obese or overweight and are taking the GLP-1 for CVD event risk reduction (not weight loss).
- To make sure of that, CMS specified that they might require prior authorizations to ensure that GLP-1s are only covered for the approved additional indications.
Wegovy’s recent FDA approval expansion for CVD events and last week’s Medicare Part D policy expansion both come in response to the SELECT trial, which found that Wegovy slashed patients’ major cardiac event risks by 20% over five years, while cutting non-fatal heart attacks by 28% and reducing cardiovascular mortality by 15%.
The new guidance will also likely drive more prescriptions beyond Medicare, noting that the guidance also applies to state Medicaid plans, and it could lead to coverage by commercial payers.
- In fact, the guidance could lead to coverage beyond Wegovy and cardiovascular disease, potentially including Lilly’s tirzepatide (Zepbound) once its cardiovascular trials become public, and for GLP-1s’ other cardiovascular and cardiometabolic benefits (HFpEF, MASLD/MASH, diabetes, OSA, PAD, etc.)
The Takeaway
Although this new coverage only impacts a smaller subset of potential GLP-1 patients, March 2024 appears to represent a key milestone for both obesity and CVD care, showing that if obesity drugs can improve other key health outcomes they stand a good chance of achieving both FDA approval and Medicare coverage.
