WASHINGTON, March 21 (Reuters) - Heart patients insured
under the U.S. Medicare program would be covered for Novo
Nordisk's weight-loss drug Wegovy as long as it is
prescribed to reduce their risk of heart attacks and strokes,
the agency overseeing the program said on Thursday.
Medicare prescription drug plans administered by private
insurers, known as Part D, currently cannot cover obesity drugs.
Under the new guidance, however, such drugs would be paid for if
they receive U.S. approval for a secondary use that Medicare
does cover, the U.S. Centers for Medicare and Medicaid
Services(CMS) said.
Based on positive results from a large clinical trial, the
FDA approved Wegovy earlier this month for lowering the risk of
stroke and heart attack in overweight or obese adults who do not
have diabetes.
"CMS has issued guidance to Medicare Part D plans stating
that anti-obesity medications that receive FDA approval for an
additional medically accepted indication can be considered a
Part D drug for that specific use," a CMS spokesperson said in
an emailed statement.
Analysts have forecast the market for weight-loss drugs
could reach at least $100 billion a year by the end of the
decade, with production of Wegovy and Eli Lilly's ( LLY )
Zepbound and Mounjaro unable to keep up with astonishing demand.
A Novo spokesperson said the company was encouraged to see
the guidance, but more work was needed because Medicare still
does not cover obesity drugs for chronic weight management.
The CMS guidance on Wegovy was reported earlier by the
Wall Street Journal.
Medicare's coverage of Wegovy opens the drug up to
government price negotiations under President Joe Biden's
Inflation Reduction Act. CMS has said the prices it negotiates
will apply to drugs that share the same active ingredient rather
than specific brands.
Novo Nordisk last year told analysts it expected Medicare to
negotiate the price it will pay for diabetes drug Ozempic, which
has the same active ingredient as Wegovy, semaglutide, and
publish new prices for the drugs in 2027. It said it expected
Wegovy to be affected by the negotiations.
Medicare is barred from covering certain drugs including
those used to treat anorexia, weight loss, and weight gain,
under the Social Security Act. CMS said in its guidance that
weight loss drugs still cannot be covered when used solely to
treat obesity.
"A drug that receives FDA approval for chronic weight
management alone would not be considered a Part D drug," the CMS
spokesperson said. "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.
About 65 million people are enrolled in Medicare, the U.S.
government health insurance program for people aged 65 and older
or who are disabled.
State Medicaid programs for low income people and families
would be required to cover Wegovy when used to prevent heart
disease for people with obesity, the CMS spokesperson added.