Novo aims to seek German insurance coverage of Wegovy heart use
The drugmaker needs an EU nod for use in cardiovascular risk reduction and the drug would have to fall under reimbursable conditions
25 March 2024 - 16:58
byLudwig Burger
Support our award-winning journalism. The Premium package (digital only) is R30 for the first month and thereafter you pay R129 p/m now ad-free for all subscribers.
Frankfurt — Novo Nordisk 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 (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 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 EU’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 US regulatory approval to reduce heart risk was granted earlier in March, Novo has said it expects Chinese and EU 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.
Support our award-winning journalism. The Premium package (digital only) is R30 for the first month and thereafter you pay R129 p/m now ad-free for all subscribers.
Novo aims to seek German insurance coverage of Wegovy heart use
The drugmaker needs an EU nod for use in cardiovascular risk reduction and the drug would have to fall under reimbursable conditions
Frankfurt — Novo Nordisk 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 (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 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 EU’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 US regulatory approval to reduce heart risk was granted earlier in March, Novo has said it expects Chinese and EU 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.
Reuters
Would you like to comment on this article?
Sign up (it's quick and free) or sign in now.
Please read our Comment Policy before commenting.
Most Read
Related Articles
Eli Lilly signs deal with Amazon to deliver medicines
Novo Nordisk to present updates on trial drug and Wegovy supply issue
Indian pharma firms start making generic versions of weight-loss jabs
Published by Arena Holdings and distributed with the Financial Mail on the last Thursday of every month except December and January.