Cost-Effectiveness Analysis / Health Technology Assessment (CEA/HTA)

The expansion of price adjustment scope by HTA significantly impairs predictability with regard to prospective drug prices, thereby undermining the position of the Japanese pharmaceutical market in the globe.


  • Results of HTA should not impede or delay patients access to new medicines. Thus, the principle set out when the HTA system was introduced in 2019, which complements the NHI pricing system, should be maintained.
  • The evaluation system should embrace assessments for additional benefits and values of new medicines, as the current system relies heavily on cost/QALY values, which cannot adequately address the value of new innovation.
  • For HTA selection criterial, the scope of products subject to assessment should be limited, as Japan is still developing the system itself, which does not have an enriched capability of evaluating a large number of products. Especially, medicines for rare diseases, including designated incurable diseases, should be thoroughly excluded from the scope.
    • In addition, there is absolutely no need for additional HTA selections for post-listing designation due to market expansion and/or additional indications, as multiple recalculation systems are already implemented.
    • If the post-listing designation mechanism were to be implemented, price adjustments beyond the initial additional usefulness premiums or equivalent could be possible, which would deviate from the principle of complementing the drug price system and should be strictly forbidden.