Amendments to the Rules of Procedure of the Fed. Joint Committee: History

Within the last year, the Joint Federal Committee (G-BA) passed three resolutions which affect the submission of a dossier for the benefit assessment according to §35a SGB V (AMNOG). In this blog series, SKC consulting presents the most important contents and effects of these decisions.

Resolution of 16^th March 2018:

• Amendment of Annex I to Chapter 5 of the Rules of Procedure (VerfO) (Annex 1 to the resolution)
• Amendment of Annex II to Chapter 5 of the Rules of Procedure (Annexes 2-7 to the resolution)

This resolution was entailed by a letter from the Federal Ministry of Health (BMG) dated 30^th May 2018 requesting additional comments to the resolution, following an interruption of the deadline for approving the decision of 16^th March 2018 . The currently available modules in the version of 18^th April 2013 were to be used further on for the submission of a dossier according to Annex II to Chapter 5 of the Rules of Procedure.

Resolution of 20^th September 2018:

• Amendment of the resolution of 16^th March 2018: Renewal of Annex I (Annex 1 to the resolution) - Annex 1: Annex I to Chapter 5 - Request for a consultation

The amendment to Annex I to Chapter 5 of the Rules of Procedure by the G-BA (Annex 1 to the resolution) adopted pursuant to the resolution of 16^th March 2018 and 20^th September 2018 entered into force on 17^th January 2019.

Resolution of 21^st February 2019:

• Amendment of the resolution of 16^th March 2018: Renewal of Annex II (Annex 7 to the resolution) - Annex 7: Annex II to Chapter 5 - Module 4: Medical benefit and additional medical benefit, patient groups with therapeutically significant additional benefit

The amendment to Annex II to Chapter 5 of the Rules of Procedure (Annex 7 to the resolution) regarding Module 4 in the version dated 21^st February 2019, which was adopted in accordance with the amendment resolution of 21^st February 2019, can already be assessed on the G-BA homepage, however, the document is subject to approval by the BMG and publication in the Federal Gazette pursuant to Section 91 (4) SGB V. The transitional regulation allows the application of the templates in the previous version of 18^th April 2013 or of 16^th March 2018 and 21^st February 2019 until 31^st December 2019 for the submission of a dossier for the benefit assessment according to §35a SGB V.

We are going to report on the changes in the content of the dossier documents and to what extent these will have an influence on the benefit assessment for pharmaceutical companies in our upcoming blog of the series "Amendments to the Rules of Procedure of the Federal Joint Committee - What has been changed for pharmaceutical companies planning to submit a dossier for the benefit assessment according to §35a SGB V (AMNOG)?".

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

Sources:

G-BA: Beschluss Verfahrensordnung (German only)