- Over 3 million Medicare enrollees could be eligible for coverage of the anti-obesity drug Wegovy to lower the risk of heart disease and stroke.
- The news follows the FDA’s expanded the approval of Wegovy to include cardiovascular benefits.
- The Centers for Medicare and Medicaid Services (CMS) also updated its guidance to Part D prescription drug plans, which would allow coverage for Wegovy.
- A clinical trial showed that Wegovy lowered the risk of cardiovascular events such as heart attack and stroke in people with obesity or are overweight.
An estimated 3.6 million Medicare enrollees could be eligible for coverage of Wegovy, according to an analysis published April 24 by Kaiser Family Foundation (KFF).
The Food and Drug Administration’s
Even if just 10% of eligible enrollees are prescribed Wegovy — an estimated 360,000 people — it would cost Medicare nearly $3 billion annually in additional drug costs. The exact amount will depend in part on how many Part D prescription drug plans add coverage for Wegovy.
Some enrollees who pay a percentage of drug prices could face monthly out-of-pocket costs of $325 to $430 for Novo Nordisk’s Wegovy, which has a list price of $1,300.
While Part D annual out-of-pocket costs are capped at $3,300 in 2024 and $2,000 in 2025 — thanks to the Inflation Reduction Act — this may still be challenging for older adults on a fixed income.
In March, the Centers for Medicare and Medicaid Services (CMS) “issued guidance to Medicare Part D plans stating that anti-obesity medications (AOMs) that receive FDA approval for an additional medically accepted indication can be considered a Part D drug for that specific use,” the agency said in a statement.
This means that anti-obesity medications can be covered by Medicare when they are used to help reduce the risk of another medical condition such as a heart attack or stroke.
KFF said the heart-related approval for Wegovy applies to 7% of Medicare beneficiaries, or 3.6 million people, based on data from 2020. These are people with existing cardiovascular disease — a prior heart attack, prior stroke, or peripheral arterial disease — and who either have obesity or are overweight.
Congress passed a rule in 2003 that prohibits Medicare from covering drugs for chronic weight management when used only for weight loss.
But if the same drug receives FDA approval for a medically accepted use — such as cardiovascular disease or type 2 diabetes — it can be covered by Medicare prescription drug plans.
To ensure that Wegovy is being used for reducing the risk of cardiovascular disease, Part D plans can require enrollees to get advance approval (aka prior authorization) from the plan, CMS said in its statement.
Some Part D plans have already announced that they plan to cover Wegovy for people with heart-related conditions.
The agency also said state Medicaid plans would be required to cover Wegovy for reducing cardiovascular disease risks in people with obesity or overweight.
However, plans could require that people first try other medications or treatments.
The Wall Street Journal first reported the CMS guidance.
Wegovy is a type of medication called a GLP-1 receptor agonist, one of four drugs in this class on the market.
Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound were approved initially by the FDA only for chronic weight management. Wegovy’s approval has since been expanded to include cardiovascular benefits. Ongoing studies are evaluating the impact of Zepbound on cardiovascular disease.
The other two drugs in the same class — Novo’s Ozempic and Lilly’s Mounjaro — are approved to treat people with type 2 diabetes. Because of this, 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 contain tirzepatide and are dual-action drugs targeting both the GLP-1 and GIP hormones.
The FDA’s expanded
Beverly Tchang,MD, endocrinologist and Ro advisor said Medicare coverage of Wegovy for people with cardiovascular disease is a huge step in the right direction.
“Why wait for someone with obesity to develop diabetes and heart disease when you can treat earlier and prevent more complications?” she told Healthline. “I know many patients who will benefit from this and can only hope commercial insurers will follow suit.”
Angela Fitch, MD, chief medical officer at knownwell and current president of the Obesity Medicine Association, agreed.
“This is one of the most important populations to treat,” Fitch said. “If you can reduce somebody’s risk of another stroke or heart attack by 20%, that’s a pretty big deal.”
However, Fitch thinks Wegovy and other anti-obesity drugs should be covered by Medicare and private insurers even without FDA approval of its cardiovascular benefits.
“We have a medicine that can improve patients’ quality of life, improve their length of life, and decrease the risk of other diseases,” Fitch told Healthline. “So [doctors] should be able to get this drug to those who need it.”
There is a push among some lawmakers to make anti-obesity drugs more accessible to Medicare enrollees. The bipartisan Treat and Reduce Obesity Act (TROA) would allow Medicare to cover FDA-approved chronic weight management drugs, even if prescribed solely for weight loss.
Fitch said she hopes wider coverage of drugs like Wegovy will also help reduce stigma around obesity, which keeps some people from getting routine medical care.
“We have patients coming to us at knownwell who haven’t seen a doctor in 10 years and have several chronic diseases that they haven’t been addressing,” she said, “simply because they feel so stigmatized [about their weight], even if it’s unintentional stigma by the healthcare team.”
Both Novo and Lilly offer some discounts for these four medications. But the high list prices for the drugs puts them out of reach for many Americans unless their insurer covers them at a lower cost.
The Congressional Budget Office expects semaglutide to be selected for government price negotiations within the next few years under the Biden administration’s Inflation Reduction Act. This would only apply directly to Medicare, but this move might also influence decisions by private insurers.
Previously, CMS has said the prices it negotiates will apply to medications with the same active ingredient, rather than individual brand-name drugs — such as Wegovy and Ozempic.
Since the approval of these drugs by the FDA, there has been a large demand for them. The expanded coverage for Wegovy may worsen that unless drugmakers can increase their manufacturing supply.
However, Fitch said it will take more than insurers covering the drugs for a limited number of patients.
Some patients, she said, have had to skip doses because the pharmacy doesn’t have the medication or they can’t afford the cost. When patients miss a dose, they may have to start the drug again at the lower initial dose.
So “it’s not just about expanding access, from a coverage standpoint. It’s about delivering care efficiently and safely,” she said. “Because these are very expensive medications, and we shouldn’t be wasting doses.”
Medicare Part D prescription drug plans can now cover anti-obesity medications that have FDA approval for another medically accepted indication, such as treating type 2 diabetes or lowering the risk of heart attack or stroke.
As a result of this change, Part D plans can cover Novo Nordisk’s Wegovy, which received expanded approval from the FDA earlier this year for cardiovascular benefits.
This means an estimated 3.6 million Medicare enrollees could be eligible for coverage of this drug.
The decision comes after a clinical trial showed that Wegovy lowered the risk of major cardiovascular events such as heart attack and stroke in people who are living with obesity or overweight, and did not have type 2 diabetes.