In the current draft of the Act on the Stabilisation of Finances for the Statutory Health Insurance in Germany, the threshold for orphan drugs shall decrease from currently €50 to €20m. A déjà vu? But wasn’t it €30m last time this was mentioned? Would €25m be a compromise? While this might sound like a negotiation at a bazaar, the aim is to cut the national incentives faster for orphan drugs in Germany. The ones currently reimbursed and the ones assessed in the future.
The AMNOG assessment procedure without orphan privilege foresees a comparison of a drug over an appropriate comparator previously determined by the G-BA. The assessment of an orphan drug on the other hand considers no national appropriate comparator until it reaches a specific value of sales. The price of the appropriate comparator is a reference price for the negotiations between the National Association of Statutory Health Insurance Funds and pharmaceutical companies that take place after the publication of the G-BA benefit assessment resolutions.
The comparison over an appropriate comparator is an instrument to provide more power for payers in negotiations. In its published statement, the G-BA even qualifies it as “the basis for a fair reimbursement price negotiation” for orphan drugs. It may be no surprise that the draft of the new act also foresees negotiation instruments for non-orphan drugs. Powerlessness of payers in front of advanced negotiation skills of pharmaceutical companies?
Fair negotiation, fair reimbursement?