A German Agency Says it has a Better Way to Assess Prescription Drug Value

Tuesday, March 10, 2015

Source: The Wall Street Journal

Seeking a better way to assess the value of a prescription drug? A German agency chartered with assessing cost effectiveness has a suggestion – require drug makers to provide complete dossiers, including clinical study reports, which it uses to assess benefits and risks. Why? The dossiers contain more complete information than is available otherwise publicly, according to a new study in BMJ.

Here’s the background: Four years ago, German regulators began requiring drug makers to submit dossiers to determine the value of newly approved medicines with comparative treatments. The idea was to make it easier for authorities to assess benefits and harms as they looked to negotiate pricing. The clinical study reports included in these dossiers may contain previously unpublished data.

And so, the Institute for Quality and Efficiency in Health Care, or IQWIG, which makes recommendations about drug effectiveness to German regulators, sought to determine whether this approach may yield more useful information about value than can be obtained from public sources. As part of its review, IQWIG publishes dossiers online and notes that no other country does so when assessing value.

So what IQWIG find?

IQWIG examined dossiers for 15 drugs it received between January 2011 and February 2013 containing study results and methods from 22 different clinical trials. The agency considered about 90% of the required dossiers to be complete. But other sources of information, such as publicly available journal publications and registry reports, were lacking compared with the dossiers submitted to IQWIG – only 75% had sufficient data on study methods and 52% had sufficient data on study results.

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