IQWiG publishes 1000th report
The IQWiG always follows its highly demanding methodological standards – especially during a reassessment of orphan drugs with annual sales of more than €50 million, there is a clear risk of an increase in the negotiated rebate.
Over the years, the spectrum of reports prepared by IQWiG has become increasingly broad. In particular, the tasks have been expanded by new legal requirements relating to the dossier assessment. These include, inter alia, assessments of the data on patient numbers and the costs in an orphan dossier.
"1000 reports from the IQWiG mean 1000 times strong written arguments to help the G-BA make good decisions on the quality and efficiency of medical services," comments Josef Hecken, impartial chairman of the G-BA. The G-BA can always rely on the independent scientific expertise of the IQWiG - "all SHI-insured people (statutory health insurance) in Germany benefit from this," says Hecken.
In its assessments and reports, the IQWiG always follows its standards of evidence-based medicine - evidence needs to be collected using objective and appropriate scientific methods and thus provide reliable results. However, during benefit assessment procedures, the high methodological standards in the IQWiG's approach are often perceived as too strict by pharmaceutical manufacturer.
In orphan procedures in particular, the evidence base is due to the small number of patients often insufficient with regard to the IQWiG's high standards. Here, however, the additional benefit for orphan drugs is considered proven (§ 35a (1) SGB V) - IQWiG only assesses the elaborations on size of the target population and the amount of the annual therapy costs. However, if the annual sales of an orphan drug exceed the limit of €50 million, the IQWiG is now involved in a regular benefit assessment procedure. Here, IQWiG has so far only been able to derive an additional benefit for about half of the drugs for rare diseases: There is a high risk of an increase in the negotiated price discount. According to an analysis by SKC, this risk exists even if the outcome of the re-assessment is better than the outcome of the first benefit assessment.
About the author
Director Market Access
M.Sc. Life Science
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