Japan's Chuikyo to increase premium for pediatric use and orphan drugs

Japan's Chuikyo (the Central Social Insurance Medical Council) has begun discussing the premium rate and requirements for pharmaceuticals for pediatric use and orphan drugs in the National Health Insurance system at its Expert Committee on NHI Drug Prices, which was held in Tokyo earlier this month .

Currently, the premium rate for pediatric medicines use is a range between 3% and 10%, while that for orphan drugs (a marketability premium) is either 10% or 3%. However, it has been pointed out that the requirements for obtaining the premium are strict and these do not give drug manufacturers strong incentives to develop such medicines because these premiums are, firstly, not sufficient and, secondly, they are not awarded in some cases, despite the products qualifying for pediatric or orphan status.

In addition, notes the Marketletter's local correspondent, there is no system to appropriately evaluate an additional indication for pediatric use. Therefore, the Expert Committee will discuss the details of the premiums with a view to raising the amount offered and alleviating the situation at future meetings.