Novo Nordisk pulls Tresiba from Germany in protest at pricing

Novo Nordisk has become the latest drugmaker to refuse to supply one of its diabetes products in Germany after failing to agree a price with the national body representing health insurance funds.

The company said it has decided to stop distributing its once-daily basal insulin Tresiba (insulin degludec) in Germany – Europe’s largest pharmaceutical market – in the wake of a “negative outcome of price negotiations with the GKV-Spitzenverband.”

The company says it will maintain supplies until September 2015 in order to allow patients currently taking the drug to be switched to another product.

Novo Nordisk said it refuses to make the drug available at the price demanded by the national body, which wanted to set it at the same level as standard human insulin that has been available in Germany since the 1980s.

“If we were to accept this price, we would undermine our ability to research and develop medical innovations for people with diabetes,” said the company in a statement.

“That would not be in the best interest of the millions of people with diabetes for whom current treatments are insufficient to control their disease.”

Germany has become a focal point for pharma industry pricing dissatisfaction since the passage of the AMNOG legislation in 2011, which requires new drugs to show additional benefit over an established therapy in order to command a proportional premium on price.

Other companies that have opted not to make drugs available in Germany include AstraZeneca, which withdrew diabetes therapy Forxiga (dapagliflozin) towards the end of 2013, as well as Eisai which suspended sales of its epilepsy therapy Fycompa (perampanel) in Germany earlier that year.

Almirall also threatened to withdraw its Sativex (nabiximols) drug for moderate to severe spasticity in multiple sclerosis patients, although it remains on the market there according to the company’s website.

Business Monitor International (BMI) recently downgraded Germany in the Western European index for pharma and healthcare markets to fourth place out of 15 countries, relinquishing its earlier third-placed rank to France.

“Potential industry rewards are capped by increasingly burdensome reimbursement and pricing regulation and the potential for a sharp economic correction to Germany’s dependence on the export of high value manufactured goods,” according to BMI.

The decision to withdraw is a blow to Tresiba, which along with combination drug Ryzodeg (insulin degludec and insulin aspart) is one of Novo Nordisk’s core growth product and saw sales rise 7 percent to 70 billion Danish kroner ($10m) last year.

It still has a long way to go before it is mounting a significant challenge to $8bn-a-year market leader Lantus (insulin glargine) from Sanofi, especially as the US FDA declined to approve the drug without additional data in 2013, forcing the company to re-file earlier this year.

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