SEOUL — South Korea’s Ministry of Health and Welfare has announced that five innovative rare disease medications have been selected for a newly introduced fast-track health insurance reimbursement pilot program.

The initiative aims to dramatically reduce the official health insurance listing period from the current 240 days down to a maximum of 100 days. Under this streamlined pathway, treatments will bypass traditional economic evaluations and drug price negotiations, with prices set at 90 percent of the lowest price among the A8 reference countries.

The Ministry stated that the program transitions the conventional upfront cost-effectiveness evaluation into a post-evaluation system. This adjustment is designed to ensure that patients suffering from severe conditions gain much faster access to vital therapies.

The pilot program was specifically created to address the hurdles faced by rare disease treatments—such as small patient populations that make gathering clinical evidence difficult—while resolving a lack of viable therapeutic alternatives. The core mechanism shifts the evaluation of cost-effectiveness from pre-registration to a post-marketing phase based on actual clinical outcomes and pre-agreed evaluation plans.

Following a public call for applications between July and August, document supplemental reviews, patient advocacy group meetings, and academic consultations, a selection evaluation committee met on November 4 to review in-person presentations from participating pharmaceutical companies.

As a result, five specialized treatments were chosen:

*Spevigo (LEO Pharma) for generalized pustular psoriasis
*Agamree (NexMed Pharma Korea) for Duchenne muscular dystrophy
*Joenja (Berto Korea) for activated phosphoinositide 3-kinase delta syndrome (APDS)
*Qalsody (Biogen Korea) for amyotrophic lateral sclerosis (ALS)
*Iqirvo (Ipsen Korea) for primary biliary cholangitis

The selection committee rigorously evaluated the severity of the diseases, current availability of alternative treatments, therapeutic efficacy, and the adequacy of post-evaluation plans along with patient care guarantees following the evaluation.

The selected pharmaceutical companies are required to finalize their post-evaluation frameworks, submit compliance agreements, and complete their official reimbursement applications by January 2027 at the latest. By applying predetermined pricing and expected claim caps, the government expects to secure rapid and efficient market access for these crucial medicines.

Yoo Joo-heon, Director General for Health Insurance Policy, noted that the Ministry will closely monitor the outcomes of this pilot project to institutionalize the fast-track system permanently, while actively considering a second pilot phase to further enhance treatment accessibility for patients with severe rare diseases.

[ⓒ Global Economic Times. 무단전재-재배포 금지]