HIRA to reinforce staff for post-listing evaluation

President Jung-gu Kang, “Shorten listing timelines, but reinforce post-listing evaluation”

Pharmaceutical Performance Assessment Department reorganized and expanded into Rare & Severe Disease Pharmaceutical Performance Assessment Department

RWE-based outcome evaluation guidelines prepared… ICER-related research to be contracted in 1H

The Health Insurance Review and Assessment Service (HIRA) has begun reinforcing post-listing evaluation by expanding personnel and restructuring its organization in preparation for shortened listing timelines for rare disease drugs.

The existing Pharmaceutical Performance Assessment Department has been reorganized into the Rare & Severe Disease Pharmaceutical Performance Assessment Department within the Health Insurance Innovation Center, accompanied by staffing reinforcements.

As evaluation procedures must be streamlined to shorten listing periods, post-listing assessment of clinical outcomes will be intensified.

On the afternoon of the 4th, HIRA President Jung-gu Kang explained the plan to shorten the listing period for rare disease treatments, included in the proposed drug pricing reform plan, during a briefing with press corps reporters.

The drug pricing reform plan reported to the Health Insurance Policy Deliberation Committee (HIPDC) in January includes a policy to enable fast-track reimbursement listing of rare disease drugs within 100 days.

Kang stated, “We will simplify reimbursement appropriateness evaluation and negotiation procedures to shorten listing timelines and improve patient access. Conversely, to strengthen post-listing evaluation and ensure internal scalability, we have reorganized the existing Pharmaceutical Performance Assessment Department into the Rare & Severe Disease Pharmaceutical Performance Assessment Department within the Health Insurance Innovation Center and increased staffing.”

In the first half of this year, HIRA also plans to commission research projects aimed at establishing cost-effectiveness evaluation criteria for new drugs.

Kang said, “Through these research projects, we will develop an ICER threshold and adjustment framework suited to the Korean context, thereby building a rational and sustainable cost-effectiveness evaluation system.”

Furthermore, to strengthen post-market evaluation for new drugs with unclear clinical evidence, plans are underway to utilize Real-World Data (RWD) and Real-World Evidence (RWE).

Guidelines were developed based on the results of a research project conducted from March to November last year. Currently, registries for 12 drugs are being established to conduct performance assessments.

The drugs under evaluation include Kymriah, Zolgensma, Spinraza, Evrysdi dry syrup, Luxturna, Qarziba, Bylvay capsules, Livmarli oral solution, Ilaris, Pemazyre, Zepzelca, and Isturisa film-coated tablets.

Kang stated, “We revised detailed evaluation criteria to establish a solid foundation that enables outcome assessment using RWD. We will enhance the utilization of RWE generation guidelines, systematically manage registry quality to continuously verify clinical value, and strive to ensure patient safety.”

Advancing health insurance payment reform… reviewing introducing a parallel fee schedule

Beyond drug-related issues, HIRA also outlined plans to develop a roadmap for reforming the national health insurance payment system. HIRA is reviewing a parallel payment model that combines fee-for-service and diagnosis-related group (DRG) payment system.

For example, fee-for-service reimbursement would be maintained for physicians’ specialized surgical procedures and interventions, while hospital system usage fees, such as hospitalization charges or examination fees, would be compensated under a bundled payment system by DRG.

HIRA also plans to further refine the Clinical Practice Evaluation Panel (CPEP) system, which precisely measures physician effort and equipment costs associated with individual medical services. The goal is to reassess and appropriately revalue services that have been historically undervalued.

Kang explained, “Based on research recommendations, we are reviewing relative value payment reforms, including further refinement of CPEP to reform the current fee-for-service system. We are also considering the introduction of parallel payment models in relation to bundled payments.”

He added, “We will shorten the cycle of the relative value score adjustment structure, which is a national policy task, and ultimately transition to a continuous adjustment system. This will help break away from the structure where profits increase only by performing many tests, and instead support a more realistic and sustainable reimbursement system.”