Will multiple-product listing rule apply to 14th drug transfers?

Will not affect transfer of products already exceeding the 14th generic introduced

New rule to take effect on Aug. 1 next year after the implementation of relevant regulations

Will the multiple-product listing management rule apply when a product belonging to the same-ingredient group that already exceeds 14 listed products is transferred before August next year?

The answer is no. Because the multiple-product listing management rule did not exist under the previous regulations, it will not affect the reimbursement price of a transferred product.

According to the Health Insurance Review and Assessment Service (HIRA) and industry sources on Aug. 12, products that already exceed the 14-product threshold will be exempt from the multiple-product listing management rule when ownership is transferred before Aug. 1 next year, as implementation of the revised reimbursement recalculation rule for transfers has been deferred until then..

The multiple-product listing management system was newly introduced through this month's revision to the relevant notice. Under the system, drugs in a same-ingredient group that exceeds 14 listed products will have their reimbursement prices reduced to 85% of the lowest price one year later.

Based on the rule, one may assume that a product beyond the 14th listing would become subject to the multiple-product listing management rule if it is transferred.

However, until August next year, when the previous transfer rules continue to apply, the multiple-product listing management provision will not be applied.

Under the previous rules governing transfers, “the reimbursement price was to be set at the lower of the final ceiling price and the amount calculated under Item 2.” At the time, however, Item 2 (Pricing calculation criteria) did not include any provision on multiple-product listing management.

A HIRA official said, “The reimbursement price must be determined under the rules that were in effect before the revised provisions take effect, and those rules contained no provisions on multiple-product listing management. The previous rules did not require comparison with a revised calculated price incorporating the multiple-product listing management rule, so the rule has no bearing on such transfers.”

In other words, products belonging to groups that already exceed the 14-product threshold may be transferred until August next year without concern that the transfer itself will trigger a price reduction under the multiple-product listing management system.

How, then, will the rule apply to product transfers after August next year? A transfer made while a same-ingredient group contains 13 listed products (the 13th product) will still avoid the impact of multiple-product listing management.

So if a large number of additional products are listed and the group exceeds 14 products at the time the 13th-listed product is transferred, the transferred product will remain exempt from the rule. This is because it retains its status as the 13th product in the listing order at the time of transfer, meaning the multiple-product listing management rule does not apply.