Considering economic analyses in the revision of the preventive vaccination law: a new direction for health policy-making in Japan?

Evidence of a significant vaccine policy shift can be witnessed not only in the number of new vaccines available in Japan but also in the way that vaccine policy is being formulated. In 2010, policy makers decided for the first time ever to commission economic analyses as a reference in their consideration of subsidy allocation. This research offers a first hand account of the recent changes in vaccine policies by examining the decision-making process from the perspective of the researchers commissioned to perform the economic evaluations. In order to understand the vaccine policy-making process, a review was made of all the documents that were distributed and discussed during the government committee meetings from February 2010 when the revision of the Preventive Vaccination Law was initially proposed to May 2012 when the final recommendations were made. Economic evaluations were conducted for seven vaccines under consideration in the routine immunization program (Haemophilus influenzae type b or Hib, pneumococcal disease for children and adults, human papillomavirus, varicella, mumps, and hepatitis B). All were cost-effective options, except the Hib and hepatitis B vaccines. Nonetheless, all the vaccines were recommended equally for inclusion in the routine immunization program. While it is significant that policy-makers decided to commission economic assessments at all, various issues remain regarding the influence of external pressure, the choice of evaluation methods and the implications of using cost-effectiveness analyses on the future of Japanese health policy-making.