ATMPs are approved as biological drugs by the EMA. In Germany, market access and reimbursement of these drugs is generally equivalent with innovative drugs or, in case of an orphan drug status, with orphan drug regulations. As a result, ATMPs used in outpatient care are also subject to the early benefit assessment procedure. For ATMPs used only for inpatient purposes, an exemption application can be submitted to the Federal Joint Committee at least 3 months before market entry. This applies only, if the expected sales volume is of minor importance, i.e., less than 1 Mio Euro.
However, it emerged that ATMPs were not always treated as drugs by the G-BA, but rather, depending on the extent and proportion of medical services involved in the use of ATMPs, were evaluated as a new examination and treatment method in accordance with § 135 SGB V (Social Code, Book V). Three examples are the gene therapy C-Cure® and the biotechnological tissue products Holoclar® and Maci®. ue to the novelty of the ATMPs, it should be noted that different legal bases have been applied reagrding the reimbursement of the products. Consequently, ATMP manufacturers are faced with different requirements, time constraints and price negotiation options for each procedure. From this point of view, the early benefit assessment according to § 35a SGB V provides benefits for the companies in terms of clear formal guidelines for the AMNOG dossier and a defined time-line for the evaluation as well as the price negotiations. The process of early benefit assessment according to § 35a SGB V provides clear formal guidelines for the AMNOG dossier, which defines the time frame. Moreover, the benefit assessment leads to price negotiations for the new product, which result in an agreement on the reimbursement amount after 12 months. The new product is immediately reimbursable upon market launch, the product price can be freely set by the pharmaceutical company and is transferred to the negotiated reimbursement amount following the early benefit assessment procedure with subsequent price negotiations.
If an ATMP is assessed according to the early benefit assessment, the new product is immediately reimbursable at market entry, the price can freely be freely chosen by the pharmaceutical entrepreneur and the final reimbursement price is negotiated within 6 months. The price negotiations are based on the outcome of the benefit assessment and the comparators.
However, if an ATMP is classified as a new examination and treatment method, its reimbursement is not initially possible, as the outpatient area is subject to the so-called reservation of authorisation. The reservation of authorisation states that examination and treatment methods are not covered by statutory health insurance (GKV) and thus shall not be applied or prescribed by physicians on behalf of the GKV until the G-BA has voted in favour for them. The G-BA evaluates whether a certain examination or treatment method is available for an adequate, appropriate and economical care of the insured, considering the current state of medical knowledge. Article § 135 SGB V differs from the early benefit assessment according to AMNOG regarding the eligible applicants, the time frame and pricing. Applications for the assessment of new examination and treatment methods in accordance with § 135 SGB V may only be submitted by impartial members of the G-BA, a Federal Association of Statutory Health Insurance Physicians, a Statuory Health Insurance Fund or the hospital association.