The result of the benefit assessment of the G-BA has consequences for the price negotiations on the reimbursement amount. Within 6 months after the benefit assessment, the price negotiations are conducted between the pharmaceutical entrepreneur and the GKV Spitzenverband. For this purpose, the GKV Spitzenverband specifies 4-5 negotiation dates in order to reach an agreement on the reimbursement amount within the time frame. Price negotiations above the price of the appropriate comparative therapy are in general only possible for drugs with an additional benefit. New drugs for which no additional benefit is available or cannot be proven are agreed at the level of the most economical comparative therapy. According to the law, deviations from this rule are only possible in exceptional cases.
For new drugs grouped in a reference price group, the benefit assessment is performed according to the reference price system. In the absence of any additional benefit, these medicinal products are assigned directly to the existing reference amount group, thus the reference amount is the maximum reimbursable amount. The reimbursement amount will apply 12 months after market entry. In case no agreement can be reached on the reimbursement amount, arbitration will take place within 3 months to determine the reimbursement amount retrospectively.
The new reimbursement amount therefore always takes effect 12 months after market entry / submission of the dossier. For drugs evaluated for a new indication, the already negotiated reimbursement amount applies first – for a period of 12 months – or for drugs placed on the market before the introduction of AMNOG, the existing price. During the negotiations, the reimbursement amount / price may be adjusted.