Joint Advice through the BfArM and the Federal Joint Committee (G-BA)
Consultation for early benefit assessment of medicinal products in accordance with SGB V section 35a
Since the introduction of the Act on the Reform of the Market for Medicinal Products (AMNOG) in Germany in 2011, new medicinal products with the new active substances are required to undergo an early benefit assessment immediately after market entry.
Pharmaceutical companies can request consultation by the G-BA on documents and studies to be submitted (SGB V, section 35a, paragraph 7). A consultation before the start of phase 3 authorization studies should involve the BfArM or PEI. The pharmaceutical company must pay the costs of the consultation.
Conversely, upon request experts from the G-BA can be involved in the consultation meeting at the BfArM or PEI.
More information about the procedure and relevant documents can be found on the webpage of the G-BA and in the Guidance for Applicants.
Exemption of reserve antibiotics from benefit assessment according to § 35a SGB V
Update of the list of criteria and pathogens for classification as a reserve antibiotic in 2024
An amendment to § 35a of the SGB V (German Social Code, Book V) enables the Federal Joint Committee (G-BA) to exempt new antibiotics designated as reserve antibiotics within the meaning of the law from the additional benefit assessment requirement.
For antibiotics classified by the G-BA as reserve antibiotics in accordance with §35a SGB V, the additional benefit is considered to be proven compared to possible treatment alternatives without the pharmaceutical company (MAH) having to prove this through corresponding studies. The resulting financial and economic incentives are intended to promote the research, development and market launch of new antibiotics with efficacy against multi-resistant bacterial pathogens (MRE) ("push-pull mechanisms").
The Robert Koch Institute (RKI), in collaboration with the Federal Institute for Drugs and Medical Devices (BfArM), has developed criteria for classifying an antibiotic as a reserve antibiotic and has compiled a non-exhaustive list of MRE for the first time in 2021 and updated it in 2024.
The non-exhaustive list of multi-resistant bacterial pathogens (pathogen list) currently contains 25 multi-resistant bacterial pathogens or pathogen-resistance combinations that are considered relevant for Germany.
The World Health Organisation's Pathogen Priority List (WHO PPL) served as the basis for the selection of pathogens for the non-exhaustive pathogen list. In addition to the criteria used in the WHO PPL (such as treatability, mortality, transmissibility), national data from the Antibiotic Resistance Surveillance (ARS) database were used for the adaptation to the national context - focussing on the resistance situation (prevalence and trend) - in order to assess the relevance of the individual MRE for Germany.
The main criteria for classifying a new antibiotic as a reserve antibiotic were defined as its proven suitability for the treatment of in particular serious bacterial infectious diseases caused by at least one of these relevant multidrug-resistant pathogens with limited alternative, clinically equivalent treatment options.
As part of the 2024 update, the non-exhaustive list of pathogens was reviewed again based on the latest available data and the requirements for the data to be submitted for classification by the G-BA were further specified based on the list of criteria.
The non-exhaustive list of multi-resistant bacterial pathogens and the criteria for classifying an antibiotic as a reserve antibiotic in accordance with § 35a para. 1 SGB V dated 01.02.2024 can be found here: