In contrast, classifying an ATMP as a new treatment method means that the product is not reimbursable for the time being, since the so-called authorization reservation applies for the outpatient sector. The reservation of authorization states that new treatment methods are not
covered by statutory health insurance (SHI) and cannot therefore be used or prescribed by doctors at the expense of the SHI until the Joint Federal Committee (Gemeinsame Bundesausschuss – G-BA) has voted in favor of them. GBA examines whether a certain examination or treatment method is available for a sufficient, expedient and economical care of the insured, taking into account the generally recognised state of medical knowledge. The regulation according to § 135 SGB V differs from the early benefit assessment according to AMNOG with regard to the entitled applicants, the time requirements and pricing. Applications for the evaluation of new examination and treatment
methods according to § 135 SGB V can only be submitted by impartial members of the G-BA, a Federal Association of Statutory Health Insurance Physicians, the Statutory Health Funds, or the Hospital Association.
Price Negotiations for ATMPs
As long as ATMPs fall into the scope of the early benefit assessment, price negotiations follow the logic of innovative drugs. The systematic and framework of the price negotiations is outlined in § 130b SGB V.
Price negotiations are determined by the results of the benefit assessment, the price level of comparative therapies, and European reference prices.
Especially gene therapies as one-time treatments create new challenges for the price negotiations between companies and payers. Annual therapy costs for chronic diseases have to be compared in terms of benefits, risks and costs to new ATMPs. The mechanism and duration of action offers the chance to negotiate new pricing and payment models.