UPDATE 2-Novo ready to seek German insurance coverage of Wegovy for heart use
(Adds detail on German market, regulatory review, background on Lilly from paragraph 6)
By Ludwig Burger
FRANKFURT, March 25 (Reuters) - Novo Nordisk said it plans to seek coverage by Germany's public health insurance scheme for the use of its Wegovy drug to cut the risk of strokes and heart attacks, if the drug's extended indication wins European approval.
German health agency G-BA said in guidance documents last week that regulation banning Germany's health system from paying for weight-loss drugs such as Wegovy would not apply in the case of other approved uses of the weekly injection, a boost for Novo Nordisk's efforts to convince governments of its wider medical benefits.
G-BA evaluates the benefits of drugs after they win approval from the European regulator, part of an effort by EU member states known as health technology assessment, or HTA, which typically plays a big role in drug price negotiations.
"We are looking forward to demonstrating the value of Wegovy in an official HTA process," Novo said on Monday in response to a question from Reuters about whether it would seek German coverage.
Novo added that Wegovy would first need EU approval for use in cardiovascular risk reduction and the drug would have to "officially fall into the area of reimbursable conditions", in Germany.
The country is Europe's largest drug market, and its public health insurance scheme, which has been trying to contain rising medical costs, covers 90% of Germans.
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 its approved use to tackle obesity.
While U.S. regulatory approval to reduce heart risk was granted earlier in March, Novo has said it expects Chinese and European Union regulators to decide on an expanded heart risk label during the second half of the year.
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.
The favourable guidance by G-BA is 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 weight-loss drug Mounjaro, also known as tirzepatide.
(Reporting by Ludwig Burger; editing by Kirsten Donovan and Jason Neely)
