Medicaid, Medicare Part D to Provide Coverage of Wegovy, But Not for Weight Loss

The Centers for Medicare and Medicaid Services (CMS) has issued guidance that Medicare Part D plans can provide some coverage of Wegovy (semaglutide), but only if beneficiaries have an additional “medically accepted indication.”

But Wegovy or any other drug that receives FDA approval for chronic weight management alone would not be considered a Part D drug, according to a CMS spokesperson. “If this same drug also receives FDA approval to treat diabetes or reduce the risk of major adverse cardiovascular events in adults with established cardiovascular disease and either obesity or overweight, then it would be considered a Part D drug for those specific uses only,” the spokesperson said.

Within Medicaid, states are now required to cover Wegovy to prevent cardiovascular disease in people with obesity. But states can also use utilization management and step therapy.

This was first reported by the Wall Street Journal but confirmed with CMS.

The CMS spokesperson said Medicare Part D specifically excludes certain drugs and uses such as “agents when used for anorexia, weight loss, and weight gain.” Since the beginning of the Part D program in 2006, all drugs when used for weight loss have been excluded from basic coverage.

CMS is clarifying that if those same drugs are approved for medically covered condition, they can be considered a Part D for that new use only.

Related: FDA Approves Additional Indication for Wegovy

The decision to provide some limited coverage was made after Wegovy received FDA approval earlier this month to reduce the risk of cardiovascular death, heart attack and stroke in adults with cardiovascular disease and obesity. The approval is based on the SELECT cardiovascular outcomes trial, which demonstrated that Wegovy statistically significantly reduced the risk of MACE by 20% compared with placebo when added to standard of care.

Wegovy 2.4 mg, developed by Novo Nordisk, was approved first to treat obesity in adults in June 2021. It has a list price of $1,349.02 per package, which is a 28-day supply. Novo Nordisk also markets a lower-dose version of semaglutide as Ozempic to treat patients with diabetes. It is available in 0.5 mg, 1.0 mg and 2.0 mg doses. The list price of Ozempic 1.0 mg is $935.77 for one pen.

Additionally, Novo Nordisk announced that Ozempic 1.0 mg reduced kidney disease progression, major adverse cardiovascular events and death by 24%, according to topline results from the FLOW trial. The trial was stopped early on the recommendation from an independent data monitoring committee because an interim analysis found the study met the criteria for efficacy.