Early benefit assessment: Detailed analysis of all G-BA resolutions

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Resolutions May 2022

Dear AMNOG Monitor readers,

The draft of the GKV-Financial Stabilisation Act (GKV-FinStG) provides for massive savings on medicines in order to limit the expected increases in expenditure in the statutory health insurance system:

  • Free pricing for innovative medicines with AMNOG procedures is to be shortened to six months.
  • The manufacturer's discount, in particular for patent-protected medicines according to § 130a para. 1, is to be increased in a staggered manner as follows: 01.01.2023: 19%; 01.01.2024: 16%, 01.01.2025: 13%, 01.01.2026: 10%
  • For newly introduced, innovative medicinal products, a price reduction of 15% for combination products is to be introduced.
  • The price moratorium is to be extended until 31.12.2026.
  • Discarding due to uneconomical package sizes is to be reflected in the negotiated price in the form of a discount.
  • Quantity-related aspects, such as a quantity-related graduation or an annual total volume, are to become a mandatory part of the price negotiations according to § 130b SGB V.
  • The annual turnover threshold for the loss of orphan drug privileges in the AMNOG procedure is to be reduced from €50m to €20m.
  • The pharmacy discount is to be increased to €2.00 for a period of two years.
  • VAT is to be reduced to 7% for medicines from 2023 (as part of a separate law).

From May 2022 we add further innovations to the Interactive Analysis in the AMNOG Monitor, which until further notice will be available to you free of charge:

  • Revised interactive analysis for better overview and user-friendliness.
  • “G-BA endpoints (AIS)”: Summary of relevant clinical endpoints in the categories mortality, morbidity, quality of life and adverse drug reaction according to the Physician Information System (AIS) / G-BA resolution.
  • “G-BA endpoints (AIS↑↓)”: Direction of effect and reliability of the endpoint categories mortality, morbidity, quality of life and adverse reaction with arrow display
  • “Regulatory ICD-10 categories” Three-digit ICD codes such as "I21 - Acute myocardial infarction"
  • G-BA criterion "Relevant therapy option in individual cases" for the exception rule according to AM-VSG.
  • Reason for the procedure (special feature): Filter option for special constellations, e.g. known active substances with new dossier protection, reserve antibiotics, exceeding the de minimis limit, etc.
  • “Pharmaceutical company” and “Dossier: Pharmaceutical company”: Representation of the current MAH and the dossier submitter, so that acquisitions after the G-BA resolution can be easily tracked.

The G-BA has so far provided results on the AIS for approx. 70% of the subpopulations. For repealed G-BA resolutions there will be no subsequent assessment in the AIS.

In April, there were 5 new G-BA resolutions on early benefit assessments, the results of which are shown in the table below. The exemption for the reserve antibiotic Eravacyclin has not yet been included by the G-BA in the list of decisions.

Recent changes in reimbursement prices of AMNOG products in November 2021 can be seen here.
A list of current EMA Positive Opinions for new drugs is available here.

Kind regards,
Dr Johannes Hankowitz and Christian Rieke