Pharmaceutical companies participating in the equivalence re-evaluation of Artemisia princeps extract are weighing whether to proceed, with some expected to withdraw before making final contract payments.

According to industry sources on August 11, the companies—initially committed to the re-evaluation—were unsettled by the Health Insurance Review and Assessment Service (HIRA)’s first reimbursement appropriateness review. The Pharmaceutical Benefit Evaluation Committee (PBEC) concluded there was “no evidence” of clinical usefulness, rather than the anticipated “unclear” classification.

In past re-evaluation cases, HIRA has considered cost-effectiveness and social demand when clinical usefulness was unclear before determining reimbursement eligibility. However, a “no evidence” finding could lead directly to delisting.

“We did not expect a ‘no evidence’ conclusion,” said a representative from one participating company. “We anticipated a possible price cut, but now delisting is on the table. An appeal is almost certain. Depending on the second review, if the product becomes non-reimbursable, we will need to reconsider the equivalence study. Some may withdraw before paying the final contract fee.”

Because participants share the costs, withdrawals would increase the financial burden for those remaining, forcing a recalculation of break-even points. Another industry official noted that companies which had already discontinued Artemisia products or shifted them to export-only “might have made the right decision,” given the $144,000–$215,000 cost of a comparative clinical trial.

Lead company Mothers Pharmaceutical, along with other participants, plans to file an appeal and will decide on further participation after the second PBEC review.

Even if the PBEC ultimately removes the product from the reimbursement list, the change would not take effect until January next year, leaving time to prepare countermeasures. “Even if a generic of Stillen passes the comparative trial, it would be meaningless without reimbursement,” a South Korean pharma representative said. “We need to see whether the second review offers any chance of a price reduction instead.”