[ad_1]
Photo: Department of Health and Human Services headquarters sign in Washington, DC/iStock, JHVEPhoto
The Centers for Medicare and Medicaid Services on Thursday targeted Novo Nordisk’s blockbuster weight loss drug Wigovy (semaglutide) to reduce the risk of heart attack, stroke and other related cardiovascular problems in patients with pre-existing heart disease. Then he announced. This was reported by multiple media outlets.
Under this new guidance, private insurers operating Medicare prescription drug plans, known as Part D, will be eligible for Wegovy and other FDA-approved indications as long as these secondary conditions are covered. You can pay for anti-obesity drugs such as Lilly’s Zepbound (tirzepatide). By the Centers for Medicare and Medicaid Services (CMS).
“CMS provides for Medicare Part D plans that anti-obesity drugs that receive FDA approval for additional medically recognized indications may be considered Part D drugs for that specific use. We have issued guidance,” a department spokesperson said. Reuters on mail.
However, CMS still does not cover the use of these drugs for chronic weight management.
The new CMS guidance comes after the FDA approved Novo’s Wegovy earlier this month to reduce the risk of cardiovascular death, heart attack, and stroke in overweight and obese adults with heart disease. For this condition, the FDA recommends using his Wegovy while making lifestyle adjustments such as a low-calorie diet and exercise.
This approval was supported by data from the Phase III SELECT study, which evaluated 2.4 mg of Wegovy in more than 17,000 adults with cardiovascular disease but no history of diabetes.
SELECT demonstrated a 20% reduction in the risk of major cardiovascular events (MACE), the study’s primary endpoint, after Wegovy treatment. Novo’s GLP-1 receptor agonist also reduces the risk of heart attack and myocardial infarction by 28% compared to a placebo. These cardiac benefits became apparent much sooner after treatment started than if these effects were achieved through weight loss alone.
Novo is also positioning semaglutide for renal dilation. In March 2024, the company reported data from the Phase III FLOW trial (ended ahead of schedule due to strong signs of efficacy and ended in October 2023), which showed significant improvement in kidney disease progression, MACE, and demonstrated a 24% reduction in the risk of kidney death. Patients with type 2 diabetes and chronic kidney disease.
A Congressional Budget Office (CBO) report released Wednesday predicts that Medicare may choose Wegobee to negotiate prices “within the next few years.” This could lower the cost of semaglutide and other anti-obesity drugs, making coverage more financially viable for CMS.
According to the CBO, with current price ranges of $1,000 to $1,300 for a four-week supply, covering Wegovy and other obesity drugs is unsustainable for Medicare and will increase the federal deficit over the next 10 years. There is a possibility of a connection.
Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Contact him on LinkedIn or email tristan@tristanmanalac.com or tristan.manalac@biospace.com.
[ad_2]
Source link