Eisai pulls Fycompa in Germany to protest pricing

Eisai is fed up with Germany's pricing authority. The Japanese drugmaker is so fed up, in fact, that it plans to stop selling its new seizure drug there. It's just the latest example of a pharma company loath to market its meds in Germany, now that cost regulators have raised new hurdles.

Fycompa's case is a textbook example of how Germany's cost cuts are playing out. Approved in Europe last year, Fycompa went up for review by the German Institute for Quality and Efficiency in Healthcare (IQWiG) as required. Under the new rules, Fycompa would have to prove superior to existing drugs to deserve premium pricing. But the agency said its additional benefits, compared with older drugs such as GlaxoSmithKline's ($GSK) Lamictal, were unproven. Hence, no brand-level price.

Eisai said it was "appalled" by IQWiG's determination. And now, the drugmaker has put that emotion into action by suspending Fycompa marketing. It appears to be an arm-twisting move; the company says it hopes the suspension will be temporary. Whether German authorities will reconsider remains to be seen.

They haven't in other cases, at least not yet. Novartis ($NVS) pulled its blood pressure drug Rasilamlo three months after its German launch. And Eli Lilly ($LLY) and Boehringer Ingelheim chose not to launch their diabetes treatment Trajenta at all. Industry groups have protested the country's pricing moves. And more than one Big Pharma has blamed the changes for layoffs in the country, directly or indirectly. In announcing 400 job cuts late last year, AstraZeneca ($AZN) cited "massive state intervention in the pricing of innovative medicines" as one reason.

Other recent drug launches have hit IQWiG blockades, too. Just last week, Sanofi's ($SNY) new oral multiple sclerosis drug Lyxumia received the "no additional benefit" tag, and in February, Pfizer's ($PFE) targeted lung cancer drug Xalkori got the same treatment. So did Bristol-Myers Squibb ($BMY) and AstraZeneca's combination diabetes drug Komboglyze. If those assessments stick, then expect more companies to pull their drugs out of Germany. Pfizer, for one, would not be excited to sell Xalkori, priced above $100,000 per year in other markets, at the same price as older, non-targeted treatments.

But there is hope. One problem drugmakers are having is that IQWiG takes issue with the choice of comparators. The agency has even pounded on dosing and dosing schedules, as in the case of Bayer's vision treatment Eylea. In a few cases, the agency has reversed itself after drugmakers provided more data.

- see the story at PMLive

Special Report: Jürgen Windeler - The Institute for Quality and Efficiency in Health Care (Germany) - The 25 most influential people in biopharma today - 2013