Swiss pharma giant Novartis is pulling its freshly approved drug Rasilamlo off the German market due to the new rules regulating the pricing and reimbursement landscape in Germany.
IHS Global Insight Perspective | |
Significance | Novartis has pulled Rasilamlo from the German market, as the firm is unable to provide the Federal Joint Committee (G-BA) with extensive data required as part of the new pricing process. |
Implications | This is the second reported case of companies not willing to maintain their product on the German market due to the new pricing process introduced in January 2011. |
Outlook | The German Association of Research-Based Pharmaceutical Companies (VFA) has called for fairer pricing rules, but their lobbying power is this time very unlikely to be sufficient to convince the government to backtrack. |
Swiss pharma giant Novartis has discontinued the marketing of Rasilamlo (aliskiren + amlodipine) in Germany due to the new pricing regulation, reports Deutsche Apotheker Zeitung. Rasilamlo was approved by the European Commission in April 2011 for the treatment of high blood pressure in patients whose condition is not adequately controlled by either aliskiren or amlodipine alone. The withdrawal is due to the fact that Novartis was unable to provide data requested as part of the early benefit assessment.
Rasilamlo was launch in May 2011 in Germany. Manufacturers of (most) new drugs launched after January 2011 must provide the Federal Joint Committee (G-BA) with a reimbursement dossier composed of extensive data and information about the clinical benefit of their drug. Novartis' decision to withdraw its drug suggests that the firm failed to provide the requested data because these data were not part of clinical studies conducted during Rasilamlo's development programme.
Novartis stopped marketing its drug as of 1 September in Germany, but still plans to launch its drug in the Netherlands, Greece, Switzerland, Belgium and Finland in 2011, and in France, Spain, Portugal and Austria in 2012, according to Scrip.
Outlook and Implications
The decision to withdraw Rasilamlo does not prevent Novartis from maintaining its drug on the private market in Germany and to reapply for reimbursement once/if it is able to provide the requested data. This is the second reported case of companies not willing to maintain their product on the German market due to the new pricing process introduced in January 2011. German firm Boehringer Ingelheim and US partner Eli Lilly recently decided not to launch their new type 2 diabetes treatment, Trajenta (linagliptin) in Germany due to the negative pricing prospect for their drug. In pre-discussions, the G-BA indicated that Trajenta would not be compared to other gliptins as expected by the two partners. The suggested comparator remains unnamed but may well be a generic diabetes drug, and would in that case put the drug at risk of obtaining a generic price (see Germany: 5 September 2011: Boehringer, Eli Lilly Choose Not to Launch Trajenta in Germany). Discussions between the G-BA and Boehringer Ingelheim are still ongoing.
The German Association of Research-Based Pharmaceutical Companies (VFA) is, in parallel, calling for a fairer pricing system which does not block innovation in Germany. The lobbying group fears that price negotiations with the statutory health insurance body disadvantage the industry, even if a positive innovation score is granted by the G-BA after early benefit assessment. The VFA and the statutory health insurance are still discussing the framework regulating pricing negotiations in Germany. The decision related to which countries will be used by the arbitrary body for European reference pricing is particularly awaited.