UPDATED: Germany gives an initial 'no additional benefit' on Biogen Idec's Tecfidera

Biogen Idec's ($BIIB) multiple sclerosis blockbuster Tecfidera for a second time has hit a roadblock in its effort to replicate in Europe the kind of runaway success it has had in the U.S. Germany's price watchdog, IQWIG, says it has found "no additional benefit" for the treatment compared to existing options, a preliminary decision that could deny it premium pricing there.

IQWIG compared the drug to interferon β-1a. As ISI Group analyst Mark Schoenebaum pointed out in a note to investors today, this is not a final decision. IQWIG and other cost-determining groups in Europe often make an initial denial and then negotiate better pricing with companies.

The U.K. price watchdog, NICE, did just that last month, reversing its earlier recommendation against Tecfidera. When Biogen initially presented the drug with a price of £16,000, or $26,680, NICE said it didn't justify its benefits. But it relented when Biogen said it would offer the drug under a so-called patient access scheme--a price break drugmakers often need to offer up to get past the cost-effectiveness gatekeeper.

In an emailed statement, spokesperson Shanon Altimari said, "Biogen Idec will conduct a thorough review of the IQWIG assessment, and will provide a written response to G-BA. An oral hearing will follow shortly after that. We will await the final recommendation this fall, at which time pricing negotiations will commence. A final price in Germany is expected by mid-2015."

Schoenebaum said that Biogen has the drug priced in Germany at $30,000 right now, with drugs in the treatment area ranging from $22,000 to $35,000. Its own Tysabri is at the high end, along with competitor Gilenya from Novartis ($NVS). In a "worst case scenario," Schoenebaum said, Biogen would need to cut that price up to 25% to compete in the first-line category.

But doctors want the drug for their patients, and that also may influence a final decision. Approved just last year, it's racked up more than $700 million in the second quarter, allowing Biogen to raise its forecast for the year. Of that $585 million was in U.S. and $115 million in other markets. It has already reached blockbuster levels in the first 6 months, racking up $1.2 billion so far.

- here's a Google translated version of the decision

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