The result of the benefit assessment of the G-BA has consequences for the price negotiations on the reimbursement amount. Price negotiations are conducted within 6 months following the benefit assessment between the pharmaceutical contractor and the GKV central association. To this end, the GKV central association has set 4-5 negotiation dates in order to reach an agreement on the reimbursement amount within the period. In principle, price negotiations above the price of appropriate comparative therapy are only possible for drugs with an additional benefit. Innovative medicines for which no additional benefit is available or cannot be proven are agreed at the level of the most economical CTC. The law designates that this requirement can only be deviated from in exceptional cases.
For new drugs that can be assigned to a reference price group, the benefit assessment is carried out using the reference price system. If no additional benefit can be determined here, these medicinal products are directly allocated to the existing reference price group, so that the reference price is regarded as the maximum reimbursement amount. The reimbursement amount comes into force 12 months after market entry. If no agreement can be reached in the negotiations on the amount of the refund, arbitration will be held within 3 months, in which the amount of the refund will be determined retrospectively.
The new reimbursement amount therefore always takes effect 12 months after market entry / submission of the dossier. For medicinal products for which a new indication is evaluated, the already negotiated reimbursement amount applies first – for a period of 12 months – or for medicinal products that were placed on the market before the introduction of AMNOG, the existing price. During the negotiations, the refund amount / price can be adjusted.