14 drugs apply for ‘100-day fast-track listing’

Numerous drugmakers, including Korean companies, seek to join pilot program

Strong turnout despite concerns over post-listing evaluation…raises expectations for full-scale rollout

The number of pharmaceutical companies throwing their hats into the ring for the pilot program aimed at listing rare disease drugs within 100 days, has exceeded expectations.

According to Dailypharm's coverage, a number of multinational pharmaceutical companies, including Leo Pharma Korea, Ipsen Korea, Novartis Korea, AstraZeneca Korea, MSD Korea and CSL Behring Korea, as well as Korean drugmakers G and S, submitted applications to participate in the pilot program by last month's deadline. Applications for a total of 14 products were confirmed to have been submitted.

Under the original plan, only 5 of the 14 products would be selected for the pilot. However, health authorities are reportedly considering selecting additional products if they meet the eligibility criteria.

The pilot program sets a target of 100 days for completing the reimbursement listing. It allows eligible drugs to be listed upfront without a pharmacoeconomic evaluation or price negotiation. Even negotiations over projected reimbursement claims are waived, with the initial reimbursement price set at around 90% of the lowest adjusted price among the A8 countries.

In other words, once a valid application is submitted and coordination with the government is completed, the system can enable drugs to obtain reimbursement listing substantially faster.

However, many had expected participation in the pilot to be limited, as several of its conditions were considered difficult for pharmaceutical companies to accept.

The biggest concern was the post-listing evaluation based on newly generated evidence. The government planned to establish real-world registries to generate real-world evidence (RWE) on clinical outcomes. At the 5-year mark, following reassessment, a drug could retain its existing reimbursement status, face a partial price reduction, or be switched to full out-of-pocket payment.

With debate over the reliability and use of RWE data still unresolved, a drug could therefore effectively lose reimbursement coverage after 5 years depending on the assessment outcome. For multinational companies, this raises the possibility of the Korean government effectively attaching an official label to one of their products suggesting that it ‘lacks efficacy.’

Furthermore, the newly introduced requirement to submit a ‘patient treatment continuity assurance plan’ was something never previously been part of Korea's reimbursement listing system. With no detailed guidance yet available, the unfamiliar requirement has added to companies' hesitation. There are also concerns over expenditure caps, given that the pilot is for rare disease therapies, whose patients generally have longer life expectancies than cancer patients.

Against this backdrop, applications for 14 products represent an encouraging result. Drugmakers appear to have been attracted primarily by the benefit of upfront reimbursement listing, while also placing expectations on how the program may evolve when it is rolled out on a full scale.

“Simply expressing our intention to participate in the pilot can help demonstrate our commitment to the government,” an official at one applicant company said. “It may also allow us to actively provide input as the program is refined and help find common ground that is acceptable to both the government and industry.”