WILL NEW LAW PROVIDE GREATER OPPORTUNITIES FOR REAL-WORLD DATA COLLECTION IN GERMANY?

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BACKGROUND

On March 27, the German Ministry of Health published a draft revision to the Act for Greater Safety in the Pharmaceutical Supply System (GSAV ­– Gesetz für mehr Sicherheit in der Arzneimittelversorgung, Drucksache 19/8753). The draft legislation proposes a range of reforms intended to improve drug safety which, among other things, affect the market access of orphan medicinal products and pave the way for patient-reported real-world evidence (RWE) collection in rare diseases.

IMPLICATIONS

If the legislation is enacted, the Federal Joint Committee (G-BA) will be able to mandate the collection of observational RWE as a condition of the reimbursement of orphan products. The G-BA will determine the parameters of data collection, with manufacturers responsible for conducting or financing studies.

The new law could lead to the prescription of orphan products being restricted to physicians and hospitals that participate in data collection programs. Also, product prices may be reduced if manufacturers do not comply with data collection requirements, or if, on the evidence gathered, products are found to have a non-quantifiable level of additional benefit. Additionally, as data will be reviewed by the G-BA annually, product benefit assessments could be revised on the basis of updated evidence.

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OPPORTUNITIES FOR REAL-WORLD EVIDENCE

The law is likely to provide opportunities for the pharmaceutical industry. Until now, RWE has generally been viewed less favorably than that collected through clinical trials, but the new law has brought RWE to the fore, opening the door to wider acceptance and use. This could be of considerable value for orphan products, where demonstration of benefit via the clinical trial route has traditionally been a challenge.

If the G-BA’s existing approach to RWE is an indication of how the new law will be implemented, we should expect to see requests for disease – rather than product – focused registries, which reflect the German healthcare setting, and prioritize patient-centric endpoints. Registries established before product launch, to provide comparisons with current practice, are also likely to be of value.

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The GSAV legislation is expected to be enacted at the start of July. If it comes into law without major amendments it could have a substantial effect on the market access environment and the design of data collection programs for orphan products.

HOW VITACCESS CAN HELP TO ADDRESS G-BA CHALLENGES

Here at Vitaccess, we know the value of RWE. Our pioneering digital RWE platform, MyRealWorld™, helps researchers understand the impact of treatments and diseases in the real-world. The MyRealWorld™ platform comprises modules such as demographics and treatment pathways that can be combined and customized to create tailored study apps that are accessed by participants on their phones, in any country, and in any language. Data gathered via the platform can also be linked with existing patient registries to enhance the breadth of information gained. We have already collected vital information from patients with several orphan diseases, including transfusion-dependent β-thalassemia and Charcot-Marie-Tooth disease. Real-time RWE could be a vital tool to meet the G-BA's new requirements for orphan drugs, as part of an effective German market access strategy.