Post Launch Data Collection
The Federal Ministry of Health restricts the G-BA’s requirements for post launch data collection
A major topic that has increasingly become the focus of health care debates in recent years is the generation of evidence for new drugs through 'real world evidence'. In response to the debate, the German legislator passed the law for more safety in the provision of medicinal products (Gesetz für mehr Sicherheit in der Arzneimittelversorgung - GSAV) in 2019, enabling the G-BA to demand the collection of routine treatment data, if the G-BA identifies evidence gaps at the time of approval (for more information please refer to our white paper). The G-BA subsequently specified the exact course of procedure in its Rules of Procedure. Although the BMG has officially approved the course of procedure, it mitigates essential methodological requirements of the G-BA regarding the type of evidence generation and its consideration in the benefit assessment.
On the one hand, the BMG specifies that an application-accompanying data collection should not be linked to the requirement of a randomized controlled trial – a position that the G-BA and the IQWiG followed so far to ensure a sufficient evidence generation for the quantification of the additional benefit. The BMG justifies this with the physician's therapeutic freedom in medical care, so that no provisions on the use of drugs and obligations for randomization should be defined. A post launch data collection can, thus, be conducted in the context of observational studies, case-control studies or registry studies.
On the other hand, the BMG clarifies that, if the G-BA requests a post launch data collection and the pharmaceutical company fulfills the requirements specified thereby, additionally collected data then also needs to be considered in the benefit assessment and may not be rejected by the G-BA due to methodological deficiencies. This cirsumstance is clearly regulated in § 7 para. 2a of the German Drug Benefit Assessment Regulation (Arzneimittel-Nutzenbewertungsverordnung – AM-NutzenV). Therefore, the scope of interpretation for the G-BA is narrowed and the possibility of non-recognition of registry data despite compliance with the previously defined requirements, as in the case of Strensiq®, is excluded in future.
The BMG, thus, reinforces the path taken by the legislator through the GSAV to take greater account of real world evidence in the benefit assessment of orphan drugs and new active ingredients, which have been approved by the EMA, to close evidence gaps. At SKC, we continuously monitor the regulatory changes as well as amendments of the G-BA's Rules of Procedure and, as a result, we support to develop the best possible German benefit assessment strategy for each of our clients individually. Due to numerous market access and price negotiation projects in the field of Orphan Drugs, SKC has an extensive expertise in this area and would be delighted to support you. We look forward to your request.