Research to Improve the Operation of New Drug Price Calculation: Toward Extending the Applicability of the Comparator Method

Abstract

With the aim of considering improved operation of reimbursement price calculation for new drugs in Japan, the status of selection of a comparator drug in the recent price calculation process was investigated and summarized. For newly listed drugs whose price was calculated by the comparator method (Ⅰ), nearly 80% of the new drugs had different characteristics from the comparator either in the indication, mode of action, type of substance, or route of administration, which are four items to be considered in selecting a comparator. In the cases in which the indication was different between the new drug and the comparator, the two drugs had a commonality such as their target symptoms were overlapped, or their indications belonged to a same family of diseases. Also, the two drugs had a strong similarity in the mode of action, type of substance, and route of administration. In the cases in which the type of substance was different between the new drug and the comparator, their indications were identical or overlapped, although the mode of action and the route of administration were different in most cases due to the difference in the type of substance. Poor transparency in the breakdown of the price has been pointed out for products whose price was calculated by the cost accounting method, and it would be important to consider a system to extend the scope of “comparators” with a view to enhance the transparency and reasonability in price calculation. The information on the products to which the comparator method was applied in the face of the relatively low similarity with the comparator will be of help in the future discussion on extending the scope of application of the comparator method.