Implementation of fast-track listing pilot project imminent

Pilot program for select rare disease drugs to be prioritized this year

Post-evaluation follow-up measures to be specified in contracts…implementation plan outline expected in 1H

The list of drugs eligible for the fast-track listing pilot project for rare disease treatments, along with contract terms, is expected to take shape in the first half of this year.

Among rare disease treatments, certain drugs will be selected for initial application, and follow-up measures reflecting reimbursement after post-evaluation will be included in contract terms.

According to industry sources and relevant agencies on the 27th, the National Health Insurance Service (NHIS) and the Health Insurance Review and Assessment Service (HIRA) have begun working-level preparations for implementing the fast-track listing pilot project.

Fast-track listing is a government plan to reform the drug pricing system by reducing the listing period for rare disease treatments from 240 days to 100 days, with the aim of improving patient access to treatment.

The Ministry of Health and Welfare announced at the end of March, through the Health Insurance Policy Deliberation Committee, that it will prioritize the pilot project this year and institutionalize it starting next year. From 2028, it will be expanded to innovative new drugs.

The pilot project is expected to include selected drugs among rare disease treatments, considering factors such as patient population. NHIS and HIRA are reviewing detailed selection criteria and negotiation contract conditions.

Since there are already designation criteria for orphan drugs set by the Ministry of Food and Drug Safety, additional conditions are expected to be added to these existing standards.

HIRA and NHIS need to significantly simplify the existing listing process. Since it is not possible to accommodate all rare disease treatments, HIRA is carefully reviewing the criteria for selecting items.

In addition, HIRA is conducting a research project through the end of the year to evaluate clinical efficacy using real-world evidence (RWE). The results will be reflected in the institutionalization of the fast-track listing system next year.

Both HIRA and NHIS share the view that post-listing mechanisms must be strengthened as the listing period is significantly shortened.

NHIS is focusing on strengthening follow-up measures based on post-evaluation. While reducing the drug price negotiation period with pharmaceutical companies from 60 days to one month, fast-track listing negotiations will focus mainly on expenditure caps and supply obligations.

NHIS is also reviewing including clauses in negotiation contracts with pharmaceutical companies that allow for price adjustments or the re-establishment of reimbursement criteria after post-evaluations.

Consequently, reaching a concrete agreement on post-listing adjustment conditions during negotiations with pharmaceutical companies is expected to be a key issue.