Germany's IQWiG finds 'hint' of advantage for Novartis' Gilenya

The German Institute for Quality and Efficiency in Health Care (IQWiG) has assessed whether Swiss drug major Novartis’ (NOVN: VX) multiple sclerosis drug Gilenya (fingolimod) offers an added benefit compared with the present standard therapy, as required under the country’s recently enacted Act on the Reform of the Market for Medicinal Products” (AMNOG) for new drug reimbursement.The drug was approved in Europe last year and garnered fourth-quarter 2011 sales of $203 million (The Pharma Letters March 21, 2011 and January 25).

According to the findings of the early benefit assessment, patients with a rapidly progressive and severe course of disease who take fingolimod experience fewer flu-like symptoms. Under consideration of this advantage on the one hand and the uncertain evidence base on the other, IQWIG has concluded that the data provide a "hint” of a minor added benefit of fingolimod for this group of patients. Due to a lack of evaluable data, an added benefit is not proven for two further groups of patients.

Separate assessment in three groups of patients