Chuikyo adds 17 new drugs to Japan's NHI list, including seven NCEs

Japan's Chuikyo (the Central Social Insurance Medical Council) has approved the addition of 12 new active ingredients/17 products (seven New Chemical Entities, one new combination drug and two agents with new formulations, two products with new administration routes) to the National Health Insurance drug price list, with effect from December 1.

Among the NCEs is GlaxoSmithKline's Requip (ropinirole HCl), an orally-administered non-ergotamine dopamine D2 receptor agonist, for the treatment of Parkinson's disease. Its NHI prices for 0.25mg, 1mg and 2mg tablets were set at 59.50 yen ($0.51), 205.80 yen and 382.70 yen, respectively, and were based on the similar comparison method referring to Bi-Sifrol (pramipexole HCl) from Nippon Boehringer Ingelheim. No premiums were given. Sales of Requip for the first year and at its peak in the 10th are expected to reach 120.0 million yen and 10.90 billion yen, respectively.

For Dainippon Sumitomo's Replagal (agalsidase-alpha; recombinant), a treatment for Fabry's disease, the NHI price for a 3.5mg/2.5ml/vial was set at 357,307 yen, and was calculated by the similar comparison method using Genzyme Japan's Fabrazyme IV 35mg (agalsidase-beta) as a comparator. Turnover of Replagal for the first year and at its peak in the eighth year is expected to be 50.0 million yen and 2.03 billion yen, respectively.