The German Institute for Quality and Efficiency in Health Care (IQWiG) has found that Celgene’s new psoriasis pill Otezla gives no added benefit to patients, and is minded not to recommend paying full price for the medicine.
IQWiG said it has examined the drug in two dossier assessments to decide whether it offers an added benefit over a comparator drug, but concluded that such an added benefit “cannot be derived from any of the dossiers, because they contain no relevant data”.
The cost assessor added that Celgene itself did not claim an added benefit as it presented no studies in which Otezla (apremilast) was tested against what it deems an appropriate comparator therapy for its licence in patients with moderate to severe plaque psoriasis, or active psoriatic arthritis.
The Institute said Celgene only described data from placebo-controlled studies, but did not use them for indirect comparisons.
There was also no systematic search for studies with the appropriate comparator therapy, which might be suitable for an indirect comparison with the drug.
“It therefore remains unclear whether an indirect comparison would have been possible and whether this comparison would have shown an added benefit or lesser benefit of apremilast in comparison with the drugs already available”, IQWiG said in a statement.
This dossier assessment is part of the early benefit assessment according to the 2011 drug pricing reform legislation known as the Act on the Reform of the Market for Medicinal Products (AMNOG).
This law is supervised by a ruling body called G-BA – this body will now make a final decision on the extent of the added benefit, and decide on what price the country will be pay for the treatment.