FDA Approves Treatment to Reduce Risk of Serious Heart Problems in Adults with Obesity
FDA Approves Treatment to Reduce Risk of Serious Heart Problems in Adults with Obesity
The following article is based on a press release from the U.S. Food and Drug Administration (FDA). To view the original press release, click here.
HUGE NEWS!
The U.S. Food and Drug Administration (FDA) approved Wegovy (semaglutide) to treat weight related risk of death for adult patients with cardiovascular disease. Semaglutide is also the same drug as Ozempic, used to encourage weight loss in Type 2 Diabetics.
This has FULL FDA approval, not accelerated or provisional approval. This means that there is a clear pathway now for Medicare to potentially cover these drugs for qualifying beneficiaries.
For Medicare to cover Wegovy, there still needs to be a National or Local Coverage Determination that indicates prescribing guidelines. If this comes to pass, it could be incredibly impactful to Part D costs in an already tumultuous market. The Congressional Budget Office (CBO) is already examining the cost implications of such coverage. Below, you can read about a recent discussion they had on the issue.
On January 31, 2024, the House Budget Committee convened to discuss the work of CBO. The question and answer below was addressed by Representative Buddy Carter, regarding the approval of Wegovy and Medicare. Click here to view the full record of the meeting, released by CBO.
Question
“In November, the Budget Committee sent CBO a letter asking the budget office to explain its approach to analyzing policies that impact patient access to new drugs. As follow-up on that letter, we would specifically, like to understand how CBO is considering GLP-1 prescriptions, in particular, new indications, for example, in cardiovascular diseases expected this year. As a result, patients with obesity and cardiovascular diseases will be able to access a GLP-1 under Medicare. How are you factoring new indications into developing CBO’s baseline? How are you factoring in new indications for GLP-1s that are considered medically accepted indications and not excluded under the current weight-loss prohibition?”
Answer
“CBO is incorporating information about treatments for cardiovascular conditions in its estimation of the effects of policies that would authorize coverage of medications for the treatment of obesity in Medicare. CBO expects that if the Food and Drug Administration (FDA) approves glucagon-like peptide-1 (GLP-1) agonists for cardiovascular indications, then Medicare will cover those drugs for the treatment of cardiovascular conditions among people with obesity. In that case, CBO would add the costs of covering GLP-1 agonists for Medicare patients with the newly approved indications to its baseline, and the cost of legislation to broaden coverage of those drugs for treating obesity would fall. The amount of spending that would be attributed to the baseline and would no longer be attributed to legislation would depend on the details of the indications approved by the FDA and on the language in any legislation. CBO is refining its baseline projection of what new indications are likely to be covered by Medicare under current law and will share more information when it is available.”
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