A law designed to help lower the cost of Germany’s drugs budget has also had another effect – helping open up pharma’s data to the public.
This is according to new analysis from the country’s health technology assessment (HTA) body IQWiG, published in the British Medical Journal.
It found that the strict 2011 AMNOG law, which forces pharma companies to prove the worth of their new medicines against tough – and often cheaper – comparators, has had the unexpected result of making more clinical trial data available for public scrutiny.
This is because in order for a new drug to be assessed in Germany, pharma must submit a ‘standardised dossier’ containing all available evidence of the drug’s added benefit over an appropriate comparator treatment.
The dossier is generally assessed by the country’s Institute for Quality and Efficiency in Health Care (IQWiG), and then published online. It contains all relevant study information, including data from unpublished clinical study reports contained in the dossiers.
The BMJ study looked at all the dossier assessments conducted by IQWiG between 1 January 2011 and 28 February 2013, and all European public assessment reports, journal publications, and registry reports referring to these studies and included in the dossiers and compared to studies published in other places, but not via the AMNOG route.
The study found that 15 out of 27 dossiers were eligible for inclusion and contained 22 studies. A registry report in the US government-run ClinicalTrials.gov website was available for all drugs and studies; however, only 11 contained results.
In the analysis of total study populations, the authors say that the AMNOG documents reached the “highest grade of completeness”, with about 90% of methods and results items completely reported.
In non-AMNOG documents, the rate was 75% for methods and 52% for results items; journal publications achieved the best rates, followed by European public assessment reports and registry reports.
The study concluded that conventional, publicly available sources of data “provide insufficient information on new drugs”, especially on patient relevant outcomes in approved sub-populations.
This type of information is largely available in AMNOG documents, albeit only partly in English.
The authors state that the AMNOG approach could be used internationally to develop a comprehensive publication model for clinical studies and thus “represents a key open access measure”.
Beate Wieseler, head of IQWiG’s drug assessment department (pictured), and a co-author of the report, explained: “The early benefit assessment reveals a large amount of additional information from clinical studies: This is beneficial for research, physicians, and patients, and can thus improve healthcare.”
IQWiG’s director, Jürgen Windeler, added: “The fact that data and documents on new drugs today do not disappear in some drawer is not owed to voluntary self-commitments of pharmaceutical companies, but to the law.
“AMNOG also shows that clinical study reports can be nearly fully published without damaging pharmaceutical companies.”