Recently, I have written about RWE collection, that can be mandated by the G-BA as part of their benefit assessment. Now, the IQWiG has proposed a concept for gathering RWE for products of the same active ingredient class.
Request by G-BA
The G-BA commissioned the IQWiG on 1 April 2021 to assess how RWE should be collected for different products from the same class of active ingredients. Separate data collections for each product would not be efficient, and depending on the size of the target population, may also not be achievable. Therefore, the G-BA wants to develop a structure to accelerate the collection of the RWE and to generate high-quality consistent data for the specific therapy areas.
IQWiG’s proposal
The IQWiG published their rapid report on 28 April 2022, and proposes the use of platform studies with a master study protocol due to its adaptive design.
The data collection in the study would be established once up-front (i.e. the platform). Then, new products can be gradually introduced as new study arms. This can speed up the data collection for follow-on products. In addition, one comparator group can be used for different agents, which means that fewer patients need to be included.
Platform trials can be conducted with or without randomization. However, the law currently requires non-randomized RWE collection. But without a randomized design, the data will be less meaningful for the benefit assessment. For example, one needs to adjust for differences in the risk of patients, i.e. confounders, to compare different interventions from different trials.
Benefit assessment within platform trials
The overall data collection follows one master protocol. This means the data are generated consistently and are therefore comparable and suitable for benefit assessments.
The benefit assessment for the products is based on the platform trial. If one agent shows an additional benefit, this will then become the ACT. The comparator group in the study will be amended respectively.
Furthermore, the study design allows for the controlled discontinuation of one study arm when the study generated sufficient data for the benefit assessment.
Timing of platform studies
The IQWiG proposal describes platform trials after the launch of a product in the German markets.
However, platform studies can be started already before the regulatory approval, and thereby provide comparative RWE from clinical routine practice already at the point of launch in Germany. This would accelerate patient access to evidence-based medicine.
RWE for haemato-oncology
The reason for the development of the concept was the launch of several new agents for haemato-oncological diseases. The EMA has already approved several CAR T-cell therapies for the treatment of adult patients with B-cell lymphomas; other active ingredients are likely to follow.
The IQWiG report concluded that a platform study for the RWE collection would be suitable for CAR-T cell therapies in this indication.
Further reading related to RWE
- IQWiG finds problems with the use of RWE in manufacturers’ dossiers
- What’s important to know about real-world evidence data collection in Germany?
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