Germany's health insurance could cover Wegovy for strokes, heart conditions, agency says

By Ludwig Burger

FRANKFURT (Reuters) -Germany's public health insurance scheme can cover certain patients with a risk of heart disease or strokes to take the weight-loss Wegovy drug, a big boost for Novo Nordisk's efforts to convince governments of its wider medical benefits.

The European Union's drug regulator has been reviewing wider use of the highly popular weight-loss drug Wegovy to include reducing the risk of strokes and heart attacks, adding to the previously-approved use to tackle obesity.

Guidance posted online late on Thursday by health agency G-BA for Europe's largest national drug market said that regulation banning Germany's health insurance system from paying for weight-loss drugs such as Wegovy would not apply in the case of other approved uses of the weekly injection.

Novo Nordisk has been pushing to widen insurance coverage in Europe by showing health benefits beyond weight loss.

In a similar ruling on Thursday, the U.S. agency overseeing the Medicare programme for the elderly said that heart patients under its remit would be covered for Wegovy as long as it is prescribed to reduce their risk of heart attacks and strokes.

While U.S. regulatory approval to reduce heart risk was granted two weeks ago, Novo has said it expects Chinese and European Union regulators to decide on an expanded heart risk label in the second half of the year.

U.S. Medicare prescription drug plans administered by private insurers currently also cannot cover drugs for obesity.

The EU's review is based on a trial known as Select, which showed that the drug can reduce the risk of heart attacks, strokes or death from heart disease by 20% in certain overweight people who have already had serious cardiovascular problems.

G-BA formally confirmed that Germany's statutory health plans are not to pay for Wegovy when prescribed for weight-loss, but added a caveat.

"In case that the requested extension of approval is granted, it should be noted for clarity that the use of Wegovy to reduce the risk of cardiovascular events after prior cardiovascular disease ... is not subject to the regulation," the committee said in its guidance.

The guidance by G-BA and Medicare are likely to have repercussions beyond the use of Wegovy because Novo's rival Eli Lilly has also been running trials to show additional health benefits of its highly effective weight-loss drug Mounjaro, also known as tirzepatide.

G-BA is a committee made up of representatives of physicians, medical insurances and hospitals, which plays a key government-assigned role in setting standards for treatment and financial coverage.

The German policy declaring weight-loss drugs lifestyle products that people need to pay for themselves affects statutory health plans overseen by the state that cover 90% of people in Germany.

Many other European countries have kept a restrictive stance when it comes to health system coverage.

Ballooning demand for Wegovy, and for diabetes drug Ozempic which is based on the same active ingredient, has more than doubled Novo's share price over the past two years but it has also overwhelmed the company's ability to ramp up production of the weekly injections.

For now, people paying for slimming drugs out of their own pockets have been a major driver of Novo and Lilly's sales growth but insurers in the public sector could underpin the longer-term momentum, analysts have said.

If Novo decides to seek German insurance coverage of Wegovy for the heart risk indication, it would have to consult with G-BA and file a request dossier, G-BA has said.

A price setting procedure typically takes 12 months.

Novo did not immediately respond to a request for comment.

(Reporting by Ludwig Burger; editing by Matthias Williams and Elaine Hardcastle)