Boehringer-Lilly won’t launch Trajenta in Germany
pharmafile | September 5, 2011 | News story | Sales and Marketing | Drug pricing, Germany, Tradjenta, Trajenta, price cuts
Boehringer Ingelheim and Lilly have decided not to launch their new diabetes drug Trajenta in Germany and say the country’s new pricing controls are to blame.
The companies are preparing to launch Trajenta in other European countries later this month, but came to the decision that Germany’s pricing policy would not reflect the “the positive benefits” of their medicine.
Trajenta was approved by the EMA last month for use as a monotherapy in type II diabetics whose sugar levels are inadequately controlled by diet and exercise alone, and for whom metformin is inappropriate due to intolerance, or contraindicated due to renal impairment.
The debate centres on Germany’s new pricing policy, the Reorganisation of the Pharmaceutical Market (AMNOG), which was established in January this year to regulate the pricing of newly approved drugs within their first year.
This means that Germany’s NICE equivalent IQWiG and a new Federal Joint Committee (G-BA) now assess a drug’s cost-effectiveness against a suitable comparator and if the drug fails to demonstrate its cost-effectiveness, then its manufacturer may be liable to refund the government’s Statutory Health Fund, which originally paid for the treatment.
Both Boehringer and Lilly say they want to open a dialogue with the German government over the AMNOG process in order to reach a mutually beneficial agreement.
But Engelbert Gunster, country manager for Germany by Boehringer Ingelheim, said that the drug could become available only if there was more transparency regarding Germany’s pricing process.
“We want to offer patients with diabetes our drug at a reasonable price. We believe Trajenta is an innovative therapy that may improve their standard of care and their long-term health,” Gunster said.
The drug is part of the new class of oral DPP-4 drugs that includes Merck’s blockbuster Januvia, but Trajenta should have an edge over its competitors because patients with kidney damage are able to use the drug – something they cannot do with other DPP-4 treatments.
Both firms said that in Germany around 6.8 million people have type II diabetes, of whom 67% are at an increased risk of declining kidney function, all of whom could potentially benefit from Trajenta.
This company’s decision not to launch it in Germany forms part of a wider debate between the pharma industry – which is looking to increase its profits – and governments that are imposing strict austerity measures to help offset their budget deficits.
However, it is unlikely that the firms would not eventually launch Trajenta in Germany, which is Europe’s largest and most lucrative market.
Ben Adams
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