Posted by Michael Wonder on 17 Sep 2016
Selexipag in pulmonary arterial hypertension: additional clinical benefit is not proven
16 September 2016 - Limited comparator therapy and division of population inadequate/the only study compared the medicine with placebo.
Selexipag (Uptravi) is approved for long-term treatment of pulmonary arterial hypertension (PAH) in adults with moderate to severe symptoms. The drug can be used either as combination therapy with other blood-pressure lowering drugs or as monotherapy in patients who are not candidates for these therapies. Selexipag has been on the market in Germany since May 2016. In an early benefit assessment, the German IQWiG has now examined whether this drug has advantages or disadvantages in comparison with the appropriate comparator therapy.
The limitation of the comparator therapy to a specific drug and the subsequent division of the population in the dossier were inadequate. The only study cited by the drug manufacturer for one of its subpopulations compared selexipag with placebo. However, no added benefit can be inferred from such a comparison.
Hence the manufacturer presented no suitable data for the assessment of the added benefit of selexipag, and IQWiG concluded: An added benefit of selexipag in comparison with the appropriate comparator therapy is not proven.
