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BMS and AZ pull diabetes drug in Germany

Unable to agree price with health authorities
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Bristol Myers Squibb (BMS) and AstraZeneca (AZ) intend to withdraw their diabetes drug Forxiga from the market in German after they were unable to agree a suitable price with health authorities.

Under Germany's drug reimbursement system, the companies had been able to market sodium-glucose co-transporter 2 (SGLT2) inhibitor Forxiga (dapagliflozin) as soon as it was approved in the EU in November 2012, with authorities given a year to determine if it was a cost-effective use of healthcare resources.

However, earlier this year Germany's cost-effectiveness assessment body IQWiG decided data provided by BMS and AZ for Forxiga was insufficient to demonstrate the drug provided added benefit over current type 2 diabetes treatments.

This decision has now been ratified by Germany's Federal Joint Committee (G-BA), which provides guidance based on IQWiG recommendations, preventing the drug from being publicly funded in the country.

AZ and BMS also said they were unable to agree a price with Germany's private health-insurance administrators, which could have provided another route for use in the country.

As a result, the partners have made a decision to withdraw supply of the drug, commencing this week, according to Bloomberg.

The news agency quoted a statement from AZ and BMS, which said: “The product will continue to be available by prescription until the current supply in the market is exhausted.

“AstraZeneca and Bristol-Myers Squibb will reassess the decision to stop supplying Forxiga in Germany once the arbitration process is completed.”

Forxiga has also faced troubled market access plans in other countries, being turned down by the UK's National Institute for Health and Care Excellence (NICE) in draft guidance and being knocked back by the US Food and Drug Administration (FDA) on its first attempt to win approval in the US.

However, BMS and AZ were able to provide data that helped reverse both decisions, with NICE later recommending Forxiga for NHS use and an FDA panel last week backing Forxiga as a treatment in the US.

Article by
Thomas Meek

16th December 2013

From: Sales

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