IQWiG re-examination finds indication of added benefit in certain patients for Gilenya

The German Institute for Quality and Efficiency in Health Care (IQWiG) has reassessed Swiss drug major Novartis’ (NOVN: VX) Gilenya (fingolimod), a drug for the treatment of adults with highly active relapsing remitting multiple sclerosis (RRMS) that generated first-quarter 2015 sales of $638 million for the company.

The Federal Joint Committee (G-BA) had limited its decision on the first assessment from 2012 to three years because it considered the certainty of the data as insufficient. This obliged the drug manufacturer to submit a second dossier.

It did not submit any new studies, but reanalysed studies that were already available. On this basis, the IQWiG reached different conclusions: From the data, an added benefit was now derived for two instead of only one of a total of three patient groups. The IQWiG now found an indication where it had found a hint before.