Amendments to the Rules of Procedure – Part 2: Overview of the most important changes

Thu, 2019 / 04 / 25
What has changed for pharmaceutical companies planning to submit a dossier for the benefit assessment according to §35a SGB V (AMNOG)?

Part 2: Overview the most important changes

In our previous blog no. 1, we presented an overview of the previous resolutions, their amendments and the documents involved in the benefit assessment according to §35a SGB V. Blog no.2 refers to the amended contents of the dossier.

The amendments regarding Annex II to Chapter 5 of the Rules of Procedure (Annexes 2-6) set in place in March 2018 largely relate to information used to prepare and submit a dossier for benefit assessment in accordance with § 35a SGB V and to the checklist for checking the formal completeness of the dossier. Here, in contrast to the more far-reaching changes to the clinical section, module 4, mostly editorial adjustments were made. Modules 1 and 2 have also remained unaffected by complex adjustments. The authors of a dossier will face an initial additional effort in preparing module 3 - "Appropriate comparative therapy, number of patients with significant therapeutic additional benefit, costs of therapy for the SHI system, requirements for a quality-assured application". For better traceability and transparence, the calculations for determining the number of patients in the target population must be made available to the G-BA in form of an excel table, which is attached to module 3. With the resolution of September 20th, 2018, further formal adjustments were made, mostly within Annex 1 "Request form for a G-BA consultation". The amendments to Annex I to Chapter 5 of the Constitution (Request form for a G-BA consultation) adopted in accordance with the resolution of March 16th and September 20th, 2018 already entered into force on January 17th, 2019.

The new dossier template requirements, especially in module 4, call for a more concrete data analysis and presentation in order to increase the transparency of the available data and to align the quality of the information presented between submitted dossiers. In some cases, data density is increased due to the adjusted specifications, as in the case of the supplementary data cuts and respective data that have to be described as of now. In addition to the data cut-offs pre-specified in the study protocol, the presentation of results of all additionally performed data cuts is now also required, if these provide a gain in information for the dossier. In addition, separate Kaplan-Meier curves will be required for all endpoints with survival time analyses; for endpoints collecting and demonstrating their results with scales (such as PROs, QoL, symptoms) the entire course of the study will have to be mapped. Significant concretizations were made with regard to the preparation and presentation of subgroup analyses and the requirements regarding the presentation of safety endpoints. The predictive factor for a potentially higher additional effort for the authors of a dossier is the respective "company-specific-practice" of how to present data in the dossier (for companies that have already submitted at least one dossier to the G-BA). Amongst others, Prof. Schönermark recently commented on this in an interview with APM Health Europe. Companies which have previously received good advice on the selection of data to be presented, will not face any major problems with the conception and processing of the now updated dossier template and the associated new requirements.

SKC Beratungsgesellschaft mbH has been successfully supporting pharmaceutical companies in the initial conception and compilation of the value dossier for several years and also assists you to deal with the new requirements of the German market access in a targeted manner to establish your product on the German market in the long term with a best possible start. We are happy to be the partner of your choice.

BY Prof. Matthias P. Schönermark, M.D., Ph.D., managing director and Dr. Alexandra Kuhn


G-BA: Beschluss Verfahrensordnung (German only) 

About the author

Ihr Ansprechpartner Prof. Matthias P. Schönermark, M.D., Ph.D.
Prof. Matthias P. Schönermark, M.D., Ph.D.
Founder and Managing Director
Fon: +49 511 64 68 14 0 – 0
Fax: +49 511 64 68 14 18
to the top