IQWiG encourages use of registry data in assessment

The Institute for Quality and Efficiency in Health Care (IQWiG) explains that data from registries are appropriate for use in assessments.

Medicines launched in Germany are generally subject to the early benefit assessment procedure carried out through the AMNOG process. However, in some cases (for example orphan drugs), data may be lacking at the time of market access to fully assess the benefit of a product. These evidence gaps can be filled by observing the use and effect of the drug in clinical practice – gathering real-world data (RWD) to create real-world evidence (RWE). One highly useful source of RWE is a patient registry.

Registries track the patient over time from diagnosis to treatment and eventual outcome. The data gathered can reveal many properties of a treatment unknown or unproven at time of market access, allowing decision makers to form a more accurate assessment later. A new report published by IQWiG explains that these data are appropriate for use in assessments, provided the appropriate quality checks are made. Jürgen Windeler, the Director of IQWiG, said of the new report:

“Extensive analyses of methodical specialist literature as well as intensive discussions with registry operators and external medical biometrics have led us to the opinion that it is possible for high-quality patient registries to set up studies on these registries and to use the healthcare data collected for the extended benefit assessment of medicinal products.”

Developments in the concept and design of registries has helped IQWiG form a positive view of their use, such as improvements to the quality of data they collect.

More information on the report is available here.

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Published on 27. January 2020 in News, News Germany