Medicare coverage expands to millions of people with heart disease

KFF Said Based on 2020 data, Wegovy's cardiac approval applies to 7% of Medicare beneficiaries, or 3.6 million people. These people have pre-existing cardiovascular disease, such as a history of heart attack, stroke, or peripheral artery disease, and are: You have obesity or are overweight.

Congress passed 2003 rules This prohibits Medicare from covering chronic weight management medications that are used solely for weight loss purposes.

However, if the same drug receives FDA approval for medically accepted uses such as cardiovascular disease; type 2 diabetes — Can be covered by Medicare prescription drug plans.

CMS said in a statement that to ensure that Wegovy is used to reduce the risk of cardiovascular disease, Part D plans may require enrollees to receive prior approval (also known as preapproval) from the plan.

Some Part D plans already announced They said they plan to cover Wegovy for people with heart-related illnesses.

The agency also said state Medicaid plans will be required to cover Wegobee to reduce cardiovascular disease risk for people who are obese or overweight.

However, your plan may require you to try other drugs or treatments first.

of wall street journal We were the first to report the CMS guidance.

Wegovy is a type of drug called a GLP-1 receptor agonist and is one of four drugs in this class on the market.

Novo Nordisk's Wegovy and Eli Lilly's zep bound It was originally approved by the FDA for chronic weight management only. Wegovy's approval was subsequently expanded to include cardiovascular effects. Ongoing research is evaluating her Zepbound's impact on cardiovascular disease.

Two other drugs in the same class – Novo's Ozempic And Lily's Munjaro — Approved to treat patients with type 2 diabetes. Therefore, Medicare Part D plans and commercial insurance plans are more likely to cover these drugs when used for diabetes management.

Wegovy and Ozempic share the same active ingredient; Semaglutide. Similarly, Mounjaro and Zepbound both include: Tirzepatide It is a dual-acting drug that targets both the GLP-1 and GIP hormones.

FDA expansion approval The Wegovy study is based on a clinical trial of 17,600 patients, which showed that people taking Wegovy had an almost 20% lower risk of major cardiovascular events such as heart attacks and strokes. I did. The study included adults living with obesity or overweight but who did not have type 2 diabetes.

beverly chang,MDEndocrinologist and Advisor Ro said Wegovy's Medicare coverage for people with cardiovascular disease is a big step in the right direction.

“Why should we wait for obese people to develop diabetes or heart disease when we can treat them early and prevent further complications?” she told Healthline. “I know many patients who would benefit from this, and I hope private insurance companies will follow suit.”

Angela Fitch, MD, Chief Medical Officer well known and the current president Obesity Medical Societyagreed.

“This is one of the most important populations to treat,” Fitch said. “If we can reduce someone's risk of having another stroke or heart attack by 20 percent, that's a pretty big deal.”

However, Fitch believes that Wegovy and other anti-obesity drugs should be covered by Medicare and private insurance companies even without FDA approval for their cardiovascular effects.

“We have drugs that can improve patients' quality of life, extend their lives and reduce their risk of other diseases,” Fitch told Healthline. “So [doctors] We should be able to get this medicine to people who need it. ”

Some lawmakers are pushing to make anti-obesity drugs more accessible to Medicare enrollees.bipartisan Obesity Treatment and Abatement Act (TROA) This would allow Medicare to cover FDA-approved chronic weight management drugs, even if they are prescribed solely for the purpose of weight loss.

Fitch said he hopes expanding coverage of medicines like Wegoby will also reduce the stigma associated with obesity, which prevents some people from receiving regular medical care.

“At Knownwell, we have patients who come to us who haven't seen a doctor in 10 years and who have several chronic conditions that we can't treat,” she said. [about their weight]Even if it's an unintentional bias by the medical team. ”

Both Novo and Lilly offer several discounts on these four medications.but high list price That's because the drugs are out of reach for many Americans unless insurance companies cover them at low cost.

of Congressional Budget Office We expect semaglutide to be selected for government price negotiations within the next few years under the Biden administration. inflation control law. Although this only applies directly to Medicare, the move could also impact decisions by private insurers.

Previously, CMS said negotiated prices would apply to drugs. same active ingredientrather than individual branded drugs such as Wegovy or Ozempic.

Since the FDA's approval of these drugs, large-scale request for them. Wegovy's expanded coverage could make the situation even worse unless drug companies increase manufacturing supply.

However, Fitch said it will take longer for insurers to cover the drugs for a limited number of patients.

He said some patients have had to skip their doses because pharmacies don't have them or they can't afford to pay for them. If a patient misses a dose, they may have to start the drug again at a lower initial dose.

So, “from a coverage perspective, it's not just about expanding access. It's about delivering care efficiently and safely,” she said. “Because these are very expensive drugs and no doses should be wasted.”

Medicare Part D prescription drug plans can now cover anti-obesity drugs that are FDA-approved for other medically recognized indications, such as treating type 2 diabetes and reducing the risk of heart attack and stroke. became.

As a result of this change, Part D plans can now also cover Novo Nordisk's Wegovy, which received expanded approval from the FDA for its cardiovascular effects earlier this year.

This means an estimated 3.6 million Medicare enrollees could be eligible for coverage for the drug.

This decision comes after clinical trials showed that Wegovy reduced the risk of major cardiovascular events such as heart attack and stroke in people living with obesity or overweight and who did not have type 2 diabetes. It was done after being shown.