First Price Negotiation Successful As Product Withdrawals Multiply in Germany

Brilique Receives First AMNOG Negotiated Price

Germany's statutory health insurance fund, the GKV, on 31 May announced that a discounted price has been successfully negotiated with United Kingdom-based firm AstraZeneca for the blood thinner Brilique (ticagrelor). The drug is the first to go through the new pricing process introduced in January 2011. No information was given relating to the exact price negotiated but more details should be unveiled in coming days.

Both IQWiG and the G-BA acknowledged the innovative profile of Brilique by granting a significant incremental benefit score to the medicine in patients with non-ST-elevation myocardial infarction (NSTEMI) or unstable angina compared with clopidogrel plus aspirin (see Germany: 5 October 2011: IQWiG Delivers Positive Opinion After Early Benefit Assessment of Brilique). Price negotiations initiated in January 2012 were based on the following innovation scores.

The "important additional benefit" rating granted to Brilique in NSTEMI/UA is the second highest innovation score that a medicine can achieve under AMNOG. So far, no medicine has been deemed to bring a considerable incremental benefit, the highest innovation score, under early benefit assessment.

Trobalt Withdrawn from Market

Although innovative medicines can expect a price premium over alternatives, products deemed to bring no additional benefit have high chances to see their price aligned to an alternative generic under the internal reference pricing system. This has prompted a series of product withdrawals that does not bode well for market access in Germany. The latest being UK-based GlaxoSmithKline which yesterday (31 May) announced that it has decided to withdraw its epilepsy drug Trobalt (retigabine) after "careful consideration" due to a negative pricing prospect, reports the German newspaper Deutschen Apotheker Zeitung. The drug will be pulled out of the German market on 1 July. The decision comes after the G-BA ruled in favour of an inclusion of Trobalt into the reference pricing system; a decision which would have resulted in the granting of a reference price similar to that of appropriate comparators lamotrigine and topiramate, which both have generic price levels (see Germany: 9 May 2012: Trobalt, Rasilamlo Bring No Added Benefit According to G-BA).

Outlook and Implications

GlaxoSmithKline now has one year to provide comparative data against the appropriate comparators selected by the G-BA: lamotrigine and topiramate. Under AMNOG, a re-assessment can be asked for if a poor innovation score has been obtained due to a lack of comparative data versus the appropriate comparator. In its dossier, GSK provided data against a different comparator than that selected by the G-BA, without sufficiently justifying the deviation. This has ruined its chances to obtain a positive innovation score. GlaxoSmithKline will keep Trobalt out of the German market until a re-assessment of its medicine is performed by the G-BA. The manufacturer will re-launch its epilepsy medicine if it obtains an innovation score that qualifies it for price negotiations with the GKV.

The withdrawal of Trobalt is the fourth product removal since the introduction of the new pricing process. It follows the removal of US-based Pfizer's Dupuytren's contracture treatment Xiapex (collagenase clostridium histolyticum) and Swiss pharma Novartis' high blood pressure treatment Rasilamlo (aliskiren + amlodipine; see Germany: 18 May 2012: Pfizer Announces Withdrawal of Xiapex from German Market). Another example of the negative impact of the new pricing process on market access is Boehringer Ingelheim (Germany)'s decision not to launch its Type 2 diabetes medicine Trajenta (linagliptin) due to a disagreement on the appropriate comparator. Boehringer is so far the only firm known to have not launched its product because of AMNOG. The four freshly approved medicines have gone through early benefit assessment and were granted negative innovation scores qualifying them for reference pricing.

As for Brilique, more details will be unveiled soon but it remains uncertain whether the GKV will provide the exact price negotiated under price negotiation. The government seems indeed in favour of a confidentiality clause that would prevent the disclosure of the discounted price. Such amendment of the present law would mean that the negotiated prices would not be considered as list prices, especially in the context of international reference pricing (see Germany: 30 May 2012: German Cabinet in Talks with Manufacturers on Confidentiality of Pricing Negotiations).