AMNOG Process Supervision
We offer you company-specific services for early benefit assessment according to AMNOG. Early benefit assessment is the prerequisite for the long-term reimbursement of new drugs and indications. For each new active substance placed on the market in Germany, it is necessary to submit a beneficial dossier to the Joint Federal Committee at the time of market launch. Following the benefit assessment, price negotiations are held with the statutory health insurance funds, so that a reimbursement amount is agreed one year after the market launch.
Policy
Together with you we build your optimal market access and pricing strategy. Each product requires its own market access and pricing strategy, which must be developed in advance of the actual benefit assessment. Depending on the regulatory status and the indication (medicinal product. orphan drug, ATMP, fix price group, etc.), different conditions apply for market access resulting in different requirements of the AMNOG assessment. We support you in the development of the market access strategy and the compilation of the AMNOG dossier.
G-BA Hearing / Trainings
The G-BA scientific advice meetings is an important and necessary step for the definition of the market access strategy and the development of the AMNOG dossier. Most importantly, as part of the scientific advice meeting the appropriate comparative therapy for the benefit assessment of a new drug is essentially determined. The G-BA consultation is based on a written request, which is evaluated by the drug subcommittee of the G-BA. The written application for the advice meeting should be based on the G-BA criteria for the detemination of the appropriate comparative therapy and requires a systematic literature research of the available evidence. Within the meeting further aspects regarding population and patient-relevant endpoints are to be discussed. Our services include the preparation of the written consultation as well as the preparation and support during the consultation with the G-BA.
Negotiation Training
We prepare the AMNOG dossier with modules 1 – 5 according to the formal requirements of the G-BA. This includes a description of the mechanism of action, the comparable drugs in the area of application according to Module 2, the description of the disease, medical needs, prevalence and incidence, as well as the costs in Module 3, and the presentation of the medical benefit and additional benefit in Module 4.
