Japan's Drugmakers Petition On Pricing

Japanese pharmaceutical companies, through their trade association the JPMA, have petitioned the Ministry of Health and Welfare (Koseisho), seeking clarification of its various recommendations, particularly on National Health Insurance pricing of new drugs and repricing of existing products. Japan's biennial NHI price cuts, for implementation April 1, are due to be announced shortly.

The JPMA argues that the Koseisho should not implement new rules without a consensus being reached with the industry, reports Pharma Japan, and it should apply the new NHI price calculation method for new drugs starting with the new drugs that will be listed in the NHI price list in May of this year. It also calls for the deletion of a provision added by the Central Social Insurance Medical Council (Chuikyo) that NHI prices of me-too drugs will not exceed those of the lowest-priced new drug approved during the past six years. This last provision, which took the industry by surprise, would have too damaging an impact on drug companies, says the JPMA.

On the pricing of already-listed drugs, the JPMA asks the Koseisho to explain the definition of: - drugs subject to repricing; - products listed in the NHI drug list within a period of 10 years; - drugs with no peak-time sales forecast; - and situations in which repricing may be carried out for reasons such as approval of additional indications. The JPMA is especially concerned about the second point, repricing within 10 years, claiming it is a gross deviation from the Chuikyo's recommendations. It is also strongly opposed to the use of market size of comparative drugs at the time of NHI drug price listing as the baseline for drugs whose NHI prices are determined on the basis of NHI prices of comparative drugs.