German upper house of parliament warns of 'considerable problems' in HTA

BERLIN, Feb 10 (APM) - Germany's upper house of parliament, the Bundesrat, wants a change in the way comparator therapies used in health technology assessment (HTA) are selected, intimating pharmas are left at a disadvantage when seeking a positive rating for their drugs.
Because of the selection process, companies often do not have the appropriate dossier for German HTA, through no fault of their own, it added in a position paper, commenting on a new health bill moving through the legislature.
In the Friday paper, the Bundesrat specifically called on the German government to change the process because the choice of comparator has a "significant influence" on the outcome.
According to the Bundesrat, the expertise of German drugs regulator, BfArM, or the regulator for vaccines and biomedicines, the Paul Ehrlich Institute, should be used "more intensively" when selecting comparator therapies and an agreement should be sought between the regulators and Germany’s highest HTA body, the G-BA, on the ultimate choice using "international standards of evidence-based medicine".

Pharmas struggle to provide required data

Comparator therapies set by the G-BA, often differ from those set by regulatory bodies - and, therefore, those used in pivotal clinical trials - meaning pharmas face "considerable problems" in providing the necessary data for German HTA, said the Bundesrat.
"If pharmas diverge from the G-BA’s requirements, then added benefit is usually not recognised for technical reasons" but the choice of comparator therapy has a "significant influence" on the added benefit rating given to new drugs, said the lawmakers.
"Approval studies are, therefore, often rarely considered in the added benefit process. On the other hand, the Institute for Quality and Efficiency in Healthcare (IQWiG) does not accept indirect comparative studies for methodological reasons, as a rule," said the Bundesrat.

Drugs being pulled

Pharmas and analysts have repeatedly highlighted the perceived problems with comparator therapies in German HTA (APMHE 38972). Last year, the German Diabetes Society attacked the G-BA for a no added benefit ruling for AstraZeneca diabetes drug Xigduo (dapagliflozin+metformin), saying it had deliberately rejected trial data showing the drug in a good light because of dosing problems, although those dosages were agreed with U.S. and European regulators. (APMHE 39412)
Johnson & Johnson subsidiary Janssen also pulled its Invokana (canagliflozin) in type 2 diabetes from Germany in September following a no added benefit ruling based on the pharma’s failure to provide "appropriate" comparisons. (APMHE 39868)



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