Novartis gains NIH listing in Japan for Ilaris

Swiss drug major Novartis’ (NOVN: VX) Ilaris (canakinumab), a treatment for cryopyrin-associated period syndrome (CAPS) which gained marketing approval in Japan a couple of months ago (The Pharma Letter September 28), has now received National Health Insurance (NIH) price listing from the Central Social Insurance Medical Council (CSIMC; Chuikyo).

The NHI price listing was delayed by the CSIMC on November 16 due to an insufficient explanation of its clinical efficacy by the Ministry of Health, Labor and Welfare (MHLW; Korosho), but at later deliberations members who had criticized the lack of a sufficient explanation at the previous meeting were satisfied with the additional information presented by the MHLW, reports Pharma Japan. Ilaris was priced using the cost calculation method. Its NHI price will be 1,435,880 yen ($18,671) per 150mg vial, according to Pharma Japan.

In a non-blinded, non-controlled clinical trial conducted in 19 patients in Japan, 18 patients (94.7%) achieved complete remission within 24 weeks. In a double-blind, placebo-controlled Phase III trial conducted in 31 subjects overseas, none of the 15 patients who received Ilaris experienced a recurrence of symptoms, while 13 of 16 (81.3%) of those who received a placebo experienced a recurrence.