Medicare to cover semaglutide for CV prevention for adults with overweight and obesity
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Key takeaways:
- The FDA approved once-weekly semaglutide 2.4 mg to reduce CV risk for adults with obesity and preexisting CVD.
- Semaglutide can be covered in Medicare Part D plans specifically to treat the new CV indication.
Medicare Part D plans can begin to cover semaglutide to lower risk for cardiovascular events among adults with overweight or obesity and preexisting CVD, according to new guidance from CMS.
Section 1860D-2(e)(2) of the Social Security Act prohibits medications used for anorexia, weight loss or weight gain from being covered under Medicare Part D, according to an emailed statement to Healio from a CMS spokesperson. However, as Healio previously reported, the FDA approved a new indication for semaglutide 2.4 mg (Wegovy, Novo Nordisk), on March 8 to reduce risk for major adverse CV events for adults with overweight or obesity and established CVD. Section 1927(k)(6) of the Social Security Act states an obesity medication can be considered a Part D drug if it receives an additional medically accepted indication, according to the email from CMS. Semaglutide’s expanded indication for lowering risk for major adverse CV events permits it to be covered specifically for that use.
“With the recent change in the FDA-approved use for [semaglutide], current Medicare Part D and Medicaid coverage rules apply,” the CMS spokesperson said. “To ensure Medicare prescription drug (Part D) plans have the flexibility to provide enrollees access to Part D drugs that reflect the latest developments and clinical guidelines, Part D plans may add drugs to their formularies, remove restrictions or move drugs to lower cost share tiers at any time during the plan year.”
As Healio previously reported, adults with overweight or obesity and preexisting CVD receiving once-weekly semaglutide in the SELECT trial had a 20% lower risk for CV death, nonfatal myocardial infarction or nonfatal stroke than those receiving placebo over a follow-up of nearly 40 months. Semaglutide was approved by the FDA for chronic weight management among adults with obesity or overweight with one weight-related comorbidity in June 2021.
“When an anti-obesity medication receives approval for an additional medically accepted indication mid-year, CMS will evaluate FDA labeling and updated treatment guidelines (if available) when reviewing formularies for the upcoming year,” the CMS spokesperson said.
In addition to Medicare Part D changes, states will also be required to include semaglutide as part of Medicaid coverage for the purpose of preventing CVD for people with obesity, according to the CMS spokesperson. Additionally, states will be allowed to use utilization management and step therapy in covering semaglutide for this purpose.
Perspective
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The emergence of semaglutide, which was approved by the FDA in 2021 at 1.7 mg and 2.4 mg for chronic weight management as Wegovy, was received with much enthusiasm by patients. The molecule had been approved for use in diabetes management as Ozempic in 2017 and is used at doses of 0.5 mg, 1.0 mg and 2.0 mg. The uptake of Ozempic increased dramatically as patient demand drove off-label prescribing, and shortages of both Ozempic and Wegovy occurred across the U.S. The emergence of tirzepatide (Mounjaro/Zepbound, Eli Lilly) only served to intensify popular demand in using these medications for chronic weight management.
It's hard to overstate the patient demand for Ozempic and Zepbound. Social media influencers, talk show hosts and word of mouth have all contributed to the buzz around these medicines. While some of the conversations about the drugs are strictly about cosmetic weight loss, we also hear mainstream conversations among lay people about obesity as a disease and the medications are proof that obesity is not one’s fault. That would be a positive thing in a society that stigmatizes people with obesity.
But all the buzz about the appetite and weight loss effects of semaglutide and tirzepatide creates a smoke screen, obscuring what is most important about these powerful medications. GLP-1 receptors are found throughout the body, and these long-acting peptides have effects not only on appetite centers in the brain. They are approved for diabetes treatment because they work in the pancreas to promote glucose-dependent insulin secretion, and in people with diabetes, semaglutide has been shown to reduce cardiovascular events. The SELECT CV outcome trial shows us that in persons without type 2 diabetes but with prior myocardial infarction, stroke or peripheral vascular disease, semaglutide was associated with a 20% reduction in secondary events.
The recent news that Medicare will allow payment for Wegovy for people with high CV risk is welcomed — patients with cardiovascular disease have high rates of overweight and obesity and many do not have established diabetes. Obesity is a newly identified modifiable risk factor that we can actually address, given access to Wegovy.
We are seeing evidence emerge that there are more benefits for GLP-1 receptor agonists beyond weight management, diabetes management and secondary prevention of CV events. The FLOW study with semaglutide was stopped early because of reduction in progress of chronic kidney disease. In patients with heart failure with preserved ejection fraction (HFpEF), semaglutide was shown in the STEP HFpEF trial to improve symptoms and function. The GLP-1 receptor agonists promote naturiesis and diuresis, they have anti-inflammatory effects, they reduce platelet aggregation and they improve post-prandial lipid levels. The potential for disease modification requires that we explore these agents in robust clinical trials.
I am delighted that we now have these medications for patients with overweight and obesity who need to lose weight for health improvement. The robust weight loss achieved with semaglutide and tirzepatide offers promise of modifying the course of the chronic diseases. But let’s not trivialize them by using them for cosmetic weight loss. These are serious and powerful medications. As with all medications, there are serious safety issues that make them inappropriate for cosmetic use. When medications produce weight loss that rivals bariatric surgery, prescribers need to know how to manage those patients during the weight loss phase. It’s more than writing a prescription. There are far too many medical spas providing what they propose to be “compounded semaglutide or tirzepatide” to young people who do not meet the indications for these medications.
That Medicare will provide coverage of Wegovy for heart disease prevention is welcome news. The evidence of safety and efficacy that supports this decision is the well-designed and well-executed SELECT CV outcome trial — it is evidence that we can trust. We need more studies of semaglutide and tirzepatide in other diseases. There is every reason to believe that these agents can be game changers in our approach to the chronic diseases. But let’s respect these medications as the powerful agents that they are.
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