Sanofi-Aventis’ problems with the obesity pill Acomplia are continuing as a court in Germany rejected a legal challenge by the firm which wanted to change its ‘lifestyle’ drug status and make the treatment reimbursable.
The Social Affairs Court in Berlin upheld a decision made by the German Ministry of Health which had stated that Acomplia (rimonabant) will not be reimbursed. By taking that position, the ministry had been following a recommendation from the German Federal Joint Committee, the G-BA, which said in October that it believes funding treatment with rimonabant is inappropriate because it is a 'lifestyle' drug.
This is a viewpoint which Sanofi disagrees with vigorously and it can still appeal the Berlin court’s ruling. The Franco-German drugmaker had argued that Acomplia should be covered by insurers because it helps lower the risk of developing diabetes and cardiovascular disease, in addition to aiding weight loss. Despite the lack of coverage, however, Germany is still Sanofi’s best market for Acomplia, as figures released last week showed that 50,000 people were prescribed the drug in the country between June and November last year, which suggests that few Germans have been put off by the 100 euro price tag.
Reimbursement has proved to be a problem elsewhere in Europe for Acomplia, however those difficulties seem less important now. Last week the US Food and Drug Administration's Endocrinologic and Metabolic Drugs Advisory Committee voted 14-0 against approving rimonabant, saying that the benefits do not outweigh the risk of psychiatric adverse effects seen in patients taking the drug, including suicide and seizures. Sanofi had previously made peak sales forecasts for Acomplia of around $3 billion a year with no approval likely now from the USA, that estimate has been rendered obsolete.