G-BA specifies procedure for the post-launch data collection

The GSAV, which entered into force in August 2019, authorizes the G-BA to demand an additional, structured data collection to close evidence gaps for a novel pharmaceutical product as part of the early German benefit assessment according to the Act on the Reform of the Market for Medicinal Products (AMNOG) in order to evaluate a drug's added benefit. A post-launch data collection requested by the G-BA is associated with high methodological standards and several formal procedural steps specific for the German healthcare context.

Pursuant to § 35a (3b) SGB V, the G-BA just recently determined the detailed formal procedure for the request and evaluation of a post-launch data collection: If an additional data collection is deemed necessary, a draft concept including requirements for the type, duration and extent, the research question, patient-relevant endpoints as well as the methodology and evaluation of the data collection is to be developed by the G-BA or the Institute for Quality and Efficacy in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen; IQWiG) within six months after publication of the resolution. The draft concept will then be evaluated in written form by the federal authorities BfArM and PEI, scientific-medical societies, the Drug Commission of the German Medical Association (AkdÄ) and, if necessary, other experts such as registry operators. In this context, the pharmaceutical entrepreneur will also have the opportunity to submit a written statement. All parties must submit their statements within four weeks after release of the draft concept. The final concept may also include information on interim evaluation dates, which are to be carried out at least every 18 months to evaluate the progress of the requested post-launch data collection for the benefit re-assessment, as well as limitations in authorization for treatment to those physicians participating in the post launch data collection.

Together with the information about the formal procedure the G-BA announced the first registry requirement under GSAV conditions for the gene therapy Zolgensma® for the treatment of spinal muscular atrophy in the resolution as of July 16th, 2020. According to the G-BA, conclusive study data on the long-term (added) benefit and harm in the approved patient population, on the comparison with current alternative therapies and on patients who are older than six months as well as six weeks are missing. Concept development was assigned to the IQWiG and is to be finalized by October 1st, 2020.

This blog is the initiation of a blog series about important aspects regarding post-launch data collection and registry requirements, which we will release over the next few weeks. Moreover, SKC analyzed the implications and risks of the GSAV and provides an overview of related post-launch data collection requirements in a comprehensive Whitepaper. If you would like to learn more about the implications of the GSAV for the benefit assessment and price negotiations in Germany, please feel free to request a free copy of the Whitepaper below.

• https://www.g-ba.de/presse/pressemitteilungen/874/
• https://www.g-ba.de/beschluesse/4378/