German authorities have dealt a serious blow to French drug company Sanofi-Aventis after dubbing its new obesity medication, Acomplia, a "lifestyle" drug that should not be subsidised by health insurance companies.
Acomplia went on sale over the summer in seven European countries, including Ireland.
It was billed by its manufacturer as a treatment to aid weight loss as well as reduce the risk of developing diabetes and heart disease.
Germany's Federal Joint Committee (GBA) - a body of health insurance funds and doctors - rejected the diabetes and heart disease claims and ruled that German patients requesting the drug would not be subsidised by their insurer.
Sales of Acomplia across Europe - anticipated by analysts to reach up to €2.5 billion annually - could be hit if other European countries follow suit and force patients to cover the full cost of treatment.
The GBA said the high cost of the drug - €1,000 for a year's treatment in Germany - was not justified by the results.
It cited a study that found that overweight patients taking the drug were more likely to lose weight than those not taking the drug, but that weight loss did not exceed 5kg per year.
Dr Wolfgang Becker-Brüser, publisher of industry magazine Arznei-Telegramm, told German television the cost-benefit ratio of Acomplia was "absurd".
The cost of Acomplia, if placed on German health insurers' list of approved subsidised drugs, would drop to around €8 a month for the patient.
Instead, the GBA recommended that the drug be placed on a "negative" list of products that are not reimbursed.
A review of subsidised medicines two years ago in Germany - aimed at reducing health insurance costs - decided to no longer help cover the cost of drugs aimed at dieting, appetite control and weight loss.
A Sanofi-Aventis spokesman criticised the German ruling as "unlawful" and "misplaced".
He said the company intended to go to court if Germany's health ministry ratified the decision, something it usually does within 60 days.
"Sanofi-Aventis firmly stands behind the important clinical benefits Acomplia offers to patients who are obese and overweight and suffer from other serious risk factors which can put them at risk of heart diseases and diabetes," said the spokesman.
Acomplia's active ingredient, Rimonabant, works by blocking appetite-regulating receptors in the brain.
Sanofi-Aventis is hoping for a further sales boost if the drug is approved - as expected - for sale in the US before the end of the year.
