FRANKFURT, March 22 (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.
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 ( LLY ) 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.