[Reporter’s View] Reform of reimb reevaluations

While it is difficult to predict whether the revision of reimbursement reevaluation standards lead to an expansion or contraction of the list of targeted products, a transparent selection process appears necessary to prevent unnecessary controversy.

Without proper discussion on the designation of active ingredients subject to re-evaluation, there is concern that wasteful debates will follow.

Even before today's (15th) discussion on revising the reevaluation criteria at the Drug Reimbursement Evaluation Committee, the Pharmaceutical Society for a Healthy Society (PSHS) has voiced opposition, stating, “The direction is tilting solely toward the convenience of the pharmaceutical industry.”

The group claims that the revised criteria lack clarity, particularly in cases where medicines are recommended by academic societies or experts, or where conflicting clinical data and efficacy evidence exist.

Compared to the previous system, under which old drugs were filtered annually based on overseas reimbursement status and reimbursement claims, the new standards are seen as more ambiguous. As a result, critics fear that the reform may be aimed at shrinking the scope of products subject to re-evaluation.

Conversely, however, this also means that any drug deemed necessary can be reevaluated, regardless of factors like listing countries or claim amounts.

For instance, even drugs with claims under 0.1% (approximately KRW 20 billion) or listed in at least one foreign country (A8) would no longer be completely excluded from reevaluations.

Last year, HIRA announced plans to revise the criteria, discussing expanding the scope to include items with claims under KRW 10 billion and fewer than three overseas countries listed.

If that original direction is maintained, the revision of reimbursement reevaluation criteria could actually lead to an expansion of reevaluation targets, contrary to the concerns raised by the Pharmaceutical Society for a Healthy Society.

Of course, industry backlash is expected even in this case. It will be difficult to accept the inclusion of ingredients that were not previously subject to reevaluation under the old criteria.

Ultimately, regardless of where the impact of the standard revision lands, mechanisms are needed to minimize unnecessary controversy.

At present, the revised criteria have not yet passed the Health Insurance Policy Deliberation Committee, nor has a concrete implementation plan been announced, making it too early to reach any firm conclusions. However, if a clear and broadly acceptable selection process is established, the reform could achieve meaningful progress in post-listing management of reimbursed drugs in Korea.