New amendments in the G-BA's Rules of Procedure

On February 20th, 2020, the Federal Joint Committee (Gemeinsamer Bundesausschuss; G-BA) resolved on clarifying updates in Chapter 5 of the Rules of Procedure, relating to the assessment of the benefit and costs of pharmaceutical products in accordance with paragraph 35a SGB V. These amendments are particularly induced by the "law for more safety in the provision of medicinal products" (Gesetz für mehr Sicherheit in der Arzneimittelversorgung; GSAV), which entered into force on August 9th, 2019. The changes associated with the G-BA resolution will become effective as soon as the Federal Ministry of Health (BMG) has given its approval and the publication in the Federal Gazette has taken place. The amendments to the Rules of Procedure are described in detail in our blog as of March 5^th, 2020. In a recently published article from APM Health Europe, Prof. Matthias Schönermark now provides professional insights on the changes in the G-BA Rules of Procedure and the related effects on the Benefit Assessment for the German pharmaceutical market. According to the interview, the amendments especially clarify critical aspects that opened room for interpretation in past Benefit Assessments and thus high potentials for conflict.

The interview refers to the following four clarifications of the G-BA resolution:

• For the approval of medicinal products with fixed combinations of known active substances in a new area of application, which entered the German market for the first time after January 1st, 2011 and for which data protection exists, a dossier obligation can also be requested at a later time than the first entry on the market.
• With regard to questions about the comparative therapy, scientific medical societies and the Drug Commission of the German Medical Association (AkdÄ) should be involved by providing written statements in order to take the current clinical care reality into account, in addition to medical guidelines.
• If the Benefit Assessment for an orphan drug shows a non-quantifiable added benefit, the G-BA will differentiate according to the specific reason. This may be due to a lack of scientific data or because the required evidence is not complete.
• In order to calculate the turnover threshold of 50 million euros with the statutory health insurance, revenues from the inpatient care must also be considered additionally to the sales from the outpatient care.n

Sources:

• https://www.g-ba.de/downloads/39-261-4182/2020-02-20_VerfO_Kapitel-5.pdf in German