CNN
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Medicare may begin overlaying Wegovy for sure senior residents and different beneficiaries with a historical past of coronary heart illness now that the US Meals and Drug Administration has authorised drugmaker Novo Nordisk’s utility to add cardiovascular benefits to the drugs’s label.
The Facilities for Medicare and Medicaid Providers mentioned it has knowledgeable insurers that present Medicare Half D drug plans that they may cowl the medicine after the FDA expanded the approval this month.
“CMS has issued steering to Medicare Half D plans stating that anti-obesity drugs (AOMs) that obtain FDA approval for a further medically accepted indication may be thought of a Half D drug for that particular use,” CMS mentioned in an announcement.
Medicare just isn’t allowed by legislation to cowl medication for persistent weight administration, though Congress is going through stress to vary that. But when the identical medicine additionally receives FDA approval to cut back the chance of coronary heart assaults, strokes and different main adversarial cardiovascular occasions, it could possibly be added to Half D formularies for individuals with established coronary heart illness, the company mentioned.
Insurers might use prior authorization – or advance approval – to make sure that Wegovy is getting used for a medically accepted indication, CMS mentioned. The FDA approval applies to adults with heart problems and who’re both overweight or chubby.
The Wall Avenue Journal first reported the CMS steering.
Wegovy is one among 4 wildly widespread – and tremendous costly – drugs known as GLP-1 receptor agonists. Two of them, Novo Nordisk’s Ozempic and Eli Lilly’s Mounjaro, are authorised to deal with individuals with diabetes. They’re extra more likely to be lined by Medicare Half D plans and by business insurers for diabetes sufferers.
However Wegovy and Eli Lilly’s Zepbound had been authorised solely as anti-obesity medication, till the FDA’s latest expanded approval for Wegovy. So they’re much much less more likely to be lined by insurers in business plans and had been lined by just a few state Medicaid packages.
CMS additionally mentioned that states could be required to cowl Wegovy of their Medicaid plans to forestall heart problems in individuals with weight problems however may additionally take steps to regulate utilization, comparable to requiring sufferers to strive different drugs or therapies first.
Although the drugmakers present some reductions for all 4 drugs, their high list prices put them out of reach for a lot of People. Wegovy prices $1,349 for a four-week provide, whereas Zepound is priced at $1,060. The record value for Ozempic is $969 for a four-week provide, and Mounjaro prices $1,069.
The FDA approval was primarily based on a 17,000-patient examine that confirmed that individuals taking Wegovy had a 20% decrease threat of a cardiac occasion than these taking a placebo.
“Wegovy is now the primary weight reduction medicine to even be authorised to assist forestall life-threatening cardiovascular occasions in adults with heart problems and both weight problems or chubby,” Dr. John Sharretts, director of the FDA’s Division of Diabetes, Lipid Issues, and Weight problems, mentioned in a information launch.
Though protection of Wegovy and related medication may scale back different well being care spending, these drugs at their present costs would in all probability nonetheless value the federal authorities greater than they might save, in line with a Congressional Funds Workplace evaluation launched Wednesday. A number of the value could be borne by Medicare enrollees via greater premiums and out-of-pocket prices.
CNN’s Meg Tirrell contributed to this report.