Abstract

The purpose of the cost-effectiveness evaluation introduced by MHLW in Japan is to verify the appropriateness of the products that are priced based on the NHI drug price calculation rules and reimbursed by the insurance, and the price will be adjusted partially depending on the results of the evaluation. Since HTA is not used to determine reimbursement, it is guaranteed to access patients as soon as the price is set. Industries consider it as a reasonable system introduced. On the other hand, in many foreign countries, it takes a considerable amount of time for a drug to be reimbursed through the HTA process before it can be accessed. For the medical community, Japan's system should be sustained because it allows for the prompt administration of new drugs. We are concerned that the introduction of this system has been discussed without sufficient involvement of healthcare professionals and patients, and we believe that stakeholders need to be involved in the policy development process. The value of a drug is not as simple as an “incremental cost-effectiveness ratio” (ICER*) value or a mathematical formula that can be mechanistically demonstrated. In order to determine that the cost of cancer treatment is not cost-effective if it exceeds XXX million yen, a discussion involving the public is essential, such as the question of what medical care should be. It should also reflect not only direct numerical effects, but also social and ethical contributions and indirect economic effects in the medium to long term. The value of medicines should be comprehensively assessed by stakeholders.

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