by Sabine Ohlenbusch
BERLIN, 31 May (APM) - Cost reduction is the main reason behind Germany's higher health technology assessment (HTA) body G-BA having the power, in a new bill, to request additional data collection on orphan drugs, an expert has told APM.
"Many pharma companies doubt that registry data collected as requested under the bill on 'better safety in drug supply' (GSAV) would meet the strict requirements for Germany's drug HTA procedures," Christian Stallberg, partner at Novacos lawyers, told APM in a phone interview ahead of his presentation at the 'Update on new drug supply bill - advanced therapies financing' seminar on 3 July in Berlin.
"It is feared, and I think this fear is not unfounded, that collecting data would cost all stakeholders a lot of effort and money, but in many cases, data would still not be convincing to HTA body G-BA and prices would be adjusted downwards" following pricing negotiations, he added.
Under the GSAV bill that is under discussion in Bundestag and could come into force in July, Germany plans to authorise G-BA to demand post-launch data that must be collected for orphan drugs, conditional approvals and approval under exceptional circumstances for a reassessment (APMMA 60657).
Moreover, G-BA could demand that physicians and hospitals record therapy administration of advanced therapy medicinal products (ATMPs) and submit the data to patient registries, for example, in order to be allowed to prescribe these therapies (APMMA 61670).
Orphan drugs currently have a special status in German HTA procedures - called 'orphan privilege' - and are automatically assumed to have an added benefit. The lowest possible G-BA rating for these drugs is 'unquantifiable added benefit'.
As negotiations on reimbursement prices with umbrella payer group GKV-Spitzenverband (GKV-SV) under drug pricing law AMNOG are mainly based on the level of added benefit, orphan drugs have a more favourable status than non-orphan ones.
The new bill would put an end to this advantage, as price reductions would be a systematic consequence of insufficient data in reassessment.
As GKV-SV is the strongest member within G-BA with five out of 13 votes, it is "imaginable how this could turn out", Stallberg said.
It is problematic that useful measures in German health policy, like gathering more evidence, are "improperly" used by G-BA to limit costs and trigger price cuts, he added.
However, market access conditions for orphan drugs seem very good in Germany, which is reflected in the high number of orphan drugs on the German market, Stallberg said.
European registries
Stallberg said that there would likely be difficulties to feed post-launch data collected in Germany into EU patient registries.German registries are set up with the goal of pricing and may, therefore, "vary widely" from registries for other purposes like healthcare research or drug safety, Stallberg said.
In general, German HTA procedures focus on data relevant for reimbursement issues, whereas European data collection on the European Medicines Agency's request focuses on safety issues, he said.
However, product safety is more relevant for data collection on ATMPs in Germany, too, as these are complex therapies with risks associated for patients, he added.
It would be good to have a centralised database - but this would require a central legislative power in the EU to align data requirements, Stallberg said.
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