by Hélène Mauduit
BERLIN, Jan 19 (APM) - Including a biosimilar in a fixed-price group, meaning the originator and its biosimilars have the same capped reimbursement, is "problematic", German lobby Pro Biosimilars told APM.
Germany's higher health technology assessment (HTA) body G-BA has launched a consultation on putting infliximab into a fixed price group (Festbetrag), meaning a capped reimbursement for all infliximab products in Germany. (APMMA 51367).
In Germany, infliximab originator Merck Sharp & Dohme's Remicade faces competition from three biosimilars: Pfizer's Inflectra, Celltrion's Remsima (marketed by Mundipharma) and Biogen's Flixabi.
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"Since the consultation has just started, we can only speculate on the reasons why G-BA has initiated the procedure" and what the decision will be, said Pro Biosimilars in an email statement on Wednesday.
The amount of the capped reimbursement is not yet known and will be determined by umbrella payer group GKV-Spitzenverband after G-BA's decision is made and published.
"Pro Biosimilars will take the opportunity to give an opinion" to G-BA during the consultation, the lobby said.
"Fixed-price groups are problematic for biosimilars because they are aimed at setting the same price for all drugs in the groups and thus they remove the key competitive advantage" of biosimilars, it pointed out.
The issue was raised in 2010 by the Glaeske report on oncology drugs commissioned by the German health ministry. In the report, experts recommended waiting until biosimilars have reached a 50% market share before introducing a Festbetrag, said Pro Biosimilars. (APMMA 21843)
In the case of infliximab, the market is "still developing", Pro Biosimilars said.
Overall, the prescription share of the infliximab biosimilars is 34% but there are significant gaps between regions, from 17% in Saxony to 62% in Westphalia-Lippe, according to last available statistics dating from November 2016, Pro Biosimilars said.
Moreover, "the bulk of the market is already under discount agreements" negotiated between major insurers and manufacturers, so that the real prices for these payers, which are kept confidential, are already lower than the listed prices.
Pro Biosimilars favours regional target agreements as "the key to success" both to making biosimilars' prescriptions standard in everyday care and to making savings for the healthcare system.
The highest rate of biosimilars' prescription is in Westphalia-Lippe, a region in which such agreements have been widely promoted, it said.
In September, Pro Biosimilars argued in favour of prescription targets at regional level and gain-sharing agreements (APMMA 49649).
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