AstraZeneca and Bristol-Myers Squibb have pulled their diabetes drug Forxiga (dapagliflozin) from pharmacy shelves in Germany after failing to reach an agreement on price.
The drugmakers released a joint statement on Friday warning that from December 15 the drug would no longer be for sale in the country, although it will continue to be available by prescription until the current supply in the market is exhausted.
The move to withdraw the drug comes after the companies were unable to reach an agreement on first-in-class Forxiga's reimbursement from the country's National Association of Statutory Health Insurance Funds (GKV-SV).
According to the firms, Forxiga, the first of the sodium-glucose cotransporter (SGLT2) inhibitors to win approval for diabetes type II, is an innovative agent that can help improve glyceamic control as well as offering additional benefits of weight loss and blood pressure lowering.
But an analysis by Germany's Federal Joint Committee (G-BA) concluded that Forxiga does not offer any benefit over other diabetes therapies on the market, thus preventing AZ and B-MS from slapping a higher price tag on its drug.
In recent years Germany has constructed a new pricing system to ensure that, by directly pitting new drugs against a comparator already on the market, costs can be centred on benefit and thus better kept under control.
But the system, considered by many to be overly confusing, has already led to a number of clashes between pharma and cost regulators in the country, giving rise to a growing number of products being pulled back as a result - such as Eisai's epilepsy therapy Fycompa (perampanel) and Eli Lilly/Boehringer Ingelheim's diabetes drug Trajenta - leaving patients unable to access these innovative medicines.