[Reporter’s View] Expectations for the second pilot project

2nd Pilot Project for the Parallel Operation of the Drug Approval-Reimbursement System

Several drugs that were undergoing concurrent regulatory approval and reimbursement evaluations for improved patient access are now approaching commercialization.

 

However, whether these drugs will actually receive reimbursement coverage remains uncertain despite expedited approval timelines.

 

Since 2023, the Ministry of Health and Welfare has been running a pilot program integrating the drug approval, reimbursement evaluation, and pricing negotiation processes specifically for drugs treating life-threatening conditions and rare or intractable diseases.

 

The aim was to accelerate the timeline for new drug reimbursement under Korea’s National Health Insurance system.

 

In October last year, the government selected the first two candidate drugs under the initial pilot program: ‘Qarziba’ (dinutuximab), a pediatric rare disease treatment, and ‘Bylvay.

 

However, Bylvay failed to pass the Health Insurance Review & Assessment Service’s Drug Reimbursement Review Committee review.

 

Even Qarziba, which was eventually listed for reimbursement, faced a temporary setback during the review process.

 

Ten drugs applied for the second round of the pilot program in 2024, and three were selected: MSD Korea’s sotatercept (Winrevair) for pulmonary arterial hypertension, UCB Pharma Korea’s fenfluramine (Fintepla) for Dravet syndrome, and CuroCell’s anbal-cel (Rimqarto) for large B-cell lymphoma.

 

All three are expected to be commercialized in Korea within this year.

 

Eligibility criteria for the second round of the pilot program were as follows: ▲ drugs that can apply for both approval and reimbursement by June 2025, ▲ treatments for rare or life-threatening conditions with a life expectancy of less than one year with sufficient efficacy, ▲ drugs with no current alternatives or those that offer clinically significant improvements, and ▲ drugs designated or eligible for expedited approval under the GIFT program (Global Innovative Drug Fast Track) by the Ministry of Food and Drug Safety.

 

The criteria clearly specify drugs urgently needed in clinical settings.

 

While streamlining the reimbursement timeline for innovative drugs has long been discussed, and some procedural deadlines have indeed been shortened, doubts remain: Has the process truly become faster?

 

Even for Qarziba, the first pilot drug, it took over one year for the drug’s reimbursment listing.

 

The concurrent approval and pricing review system does not guarantee smooth or timely outcomes.

 

In other words, transparency and speed remain key concerns for the system.

 

New drugs must not be left in regulatory limbo – left to blindly await the government’s decision.

 

As the second pilot program unfolds, this reporter hopes that the combined efforts of all parties will result in a clearer and shorter listing process.