FiercePharma, 22. Apr. 2015
Japan’s health regulators are in the midst of deciding how to conduct cost-effective assessments for drugs and medical devices with under the Central Social Insurance Medical Council, better known as Chuikyo.
The Government of Prime Minister Shinzo Abe adopted a plan last year that stipulates the trial rollout of cost-effective assessments in FY2016.
But industry officials are wary of the potential costs and worried the assessments will become highly complicated, especially as more novel therapies hit the market and are used in combinations for diseases like cancer.
Some experts say that if assessments become the main criteria for setting drug prices, innovation will suffer and that instead they should be used as one tool.
While Japan’s Ministry of Labour, Health and Welfare, or MHLW, plans to incorporate cost-effective assessments into the reimbursement framework, it is unclear how exactly it will do so–whether it will use the results of evaluations to make a go or no-go decision on reimbursements or it will use them to set NHI prices.