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Amendments to the Rules of Procedure of the Federal Joint Committee: Summary of the main changes

Thu, 2020 / 03 / 05
What changes will affect pharmaceutical companies in the assessment of the added benefit and costs of pharmaceutical products according to §35a SGB V (AMNOG)?

The expected amendments to the Rules of Procedure (VerfO) are now imminent. In a meeting on February 20, 2020, the Federal Joint Committee (G-BA) decided to revise the Rules of Procedure that lastly modified on September 19, 2019. These amendments mainly affect the 5th chapter of the Rules of Procedure and therefore have an impact on the assessment of the added benefit and the costs of pharmaceutical products according to §35a SGB V (AMNOG). Currently, these amendments are still under revision by the Federal Ministry of Health (BMG). However, rumors from Berlin suggest that the Federal Ministry of Health should have no objections to the planned changes. The current blog presents the main points of the changes:

  • For pharmaceutical products with fixed combinations of known active substances for which data protection exists and that entered the market for the first time after 1 January 2011, it may be requested to submit a dossier even later after their first entry on the market. As a pharmaceutical product with a fixed combination of known active substances is to be regarded as a separate entity under pharmaceutical law, so is its effect. Furthermore, the area of application of such pharmaceutical product may differ from those of the individual active substances. Therefore, the submission of a dossier may be required even at a later point in time after market entry. However, the submission of a dossier may be only be requested within the context of a new area of application.
  • Deviations in the evaluation of an added benefit for orphan drugs based on predefined categories provided by the Ordinance on the Benefit Assessment of Medicinal Products (AM-NutenV) will no longer be allowed. In addition, the attribution of a "non-quantifiable" added benefit will now become more transparent. In the future, the Federal Joint Committee will differentiate whether the "non-quantifiable" added benefit is due to lack of scientific data or due to incompleteness of the required evidence.
  •  In the context of an advice request, costs for services provided by the Federal Joint Committee as well as higher federal authorities (BfArm or PEI) involved in the process will be taken into consideration and charged to the pharmaceutical companies.
  • For questions related to the comparative therapy, the opinions of scientific medical societies as well as the Drug Commission of the German Medical Association (Arzneimittelkommission der deutschen Ärzteschaft, AkdÄ) will be sought. These bodies will be asked to provide a written statement, accompanied by a disclosure statement to the G-BA within four weeks after receipt of the advice request from the pharmaceutical company.
  • The evidence used to evaluate the added value of orphan drugs must be stated.
  • When calculating the turnover threshold of 50 million euros for orphan drugs, revenues generated in both outpatient and inpatient settings must be taken into account.
  • Amendment of Annex II to the 5th chapter of the Rules of Procedure: In order to generate a machine-readable version of the dossier according to the Electronic Drug Information Ordinance (Elektronische Arzneimittelinformations-Veordnung, EAMIV), information on the pharmaceutical product, the active substance, the ATC code, the ICD 10 GM code, the alpha ID and the ASK number will be provided in modules 1 and 2.

We at SKC directly implement the changes in our consulting activities for our clients. This applies both in the preparation of dossiers and the support in developing a suitable dossier and pricing strategy.

About the author

Ihr Ansprechpartner Univ.-Prof. Dr. med. Matthias P. Schönermark
Univ.-Prof. Dr. med. Matthias P. Schönermark
Gründer und Geschäftsführer
Fon: +49 511 64 68 14 – 0
Fax: +49 511 64 68 14 – 18
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