Germany – IQWiG: ‘Quality’ Registry Data Suitable for Benefit Assessments

A new report from Germany’s Institute for Quality and Efficiency in Health Care (IQWiG) finds that patient registries can be used to conduct added benefit assessments for new drugs, especially in situations where there is limited evidence available at the time of market authorization.

“Extensive analyses of the methodological literature and intensive discussions with registry operators and external statisticians have led us to the conclusion that, in the case of high-quality patient registries, it is possible to base studies on these registries that use the routine practice data collected either with or without randomization,” said IQWiG Director Jürgen Windeler.

While the report found that data from patient registries can be used to assess a drug’s added benefit, the authors pour cold water on the notion that electronic health records and insurance claims data could be used to the same end.

“The collection and processing of routine practice data from electronic patient records and claims data from health insurance funds is currently not possible with regard to benefit assessment of drugs and will not be possible in the near future,” IQWiG writes, noting that important data are not collected through these sources…