[News follow-up from a friendly reporter]

The functional redundancies in the Cancer Disease Review Committee (CDRC) and Pharmaceutical Benefit Appraisal Committee (PBAC) arose as an issue at the NA Health and Welfare Committee audit recently. At the audit, the National Assembly Health and Welfare Committee member Sun-woo Kang of the Democratic Party of Korea had pointed out that a long-term delay has occurred in discussions on expanding reimbursement for a new anti-cancer drug due to the redundant functions of the two committees.

The new anti-cancer drug that Kang referred to was MSD Korea’s ‘Keytruda (pembrolizumab).’ ‘Keytruda is an immuno-oncology drug that was first approved reimbursement for NSCLC patients with ‘Opdivo (nivolumab)’ on August 21st, 2017.

The issue arose with the reimbursement for Keytruda in first-line in lung cancer delayed for 4 years. According to the data disclosed by Kang, MSD Korea applied to extend reimbursement of Keytruda to first-line NSCLC in September 2017, but the agenda finally passed the CDRC in July 2021.

Why the delay? The CDRC had delayed making the decision for 4 years due to concern over its fiscal sharing plan despite having no disagreement over the drug’s clinical usefulness. New anti-cancer drugs require CDRC review for setting reimbursement standards, but the fiscal sharing discussions that should be discussed at the PBAC were also conducted at the CDRC level. The CDRC has less than half the personnel of PBAC, and remarks of Ministry of Health and Welfare officials at public hearings or debates indicate that they expect CDRC to make decisions based on objectivity rather than expertise. In other words, objective reimbursement standards are set at the CDRC level without input from the pharmaceutical company. But Keytruda’s review was put on hold for 4 years over its ‘fiscal sharing’ at CDRC, not its reimbursement standards. That was why the drug was mentioned as an example at the NA audit.

What about HIRA? To what extent does the HIRA stipulate the scope of the work for CDRC? The scope of work for CDRC and PBAC are stipulated in the ‘Regulations on the Criteria for NHI Insurance Benefits.’ Article 5-2 of the regulation stipulates that ‘HIRA should organize a CDRC to deliberate the methods and standards for applying insurance benefit to medicines prescribed and administered to severe disease patients.’ The members of the committee should be comprised of 45 or fewer members with extensive experience and profound knowledge in the field of public health.’

In other words, under the regulations, the CDRC deliberates the standards and methods for drugs used for patients with rare, severe diseases or cancer. HIRA sees that the committee may assess a drug’s medical feasibility, alternative drugs and treatment cost, fiscal impact, etc. to deliberate its reimbursement standards. This was included in the written QA that was submitted after Kang’s NA audit, but the contents of the deliberation for setting the reimbursement standards could not be found.

However, DREC’s role is clearly stated in the regulations. Article 11-2 of the regulation is the basis for DREC, and it reviews insurance benefits of drugs that applied for assessment under Article 10-2(3). DREC has subcommittees for drug benefit standards, economic evaluation, RSA, fiscal impact assessment, herbal medicine, post-marketing evaluation, etc. The manpower pool for DREC is 102, and the members evaluate whether new drugs are eligible for medical care insurance benefits, reimbursement standards, and the price cap for drugs based on calculation standards.

The stipulated standards show that the functions of CDRC and DREC need not overlap. HIRA explained that a delay in deliberation had occurred at the CDRC level due to the fiscal burden that may arise in NHI finances due to the high price of new anticancer drugs. However, financial sharing is an agenda that needs to be reviewed by DREC or the NHI that has fiscal power, not the CDRC. Therefore the question that lies is whether the 45 non-expert members of the CDRC had the authority to neglect the patients’ 4 years’ worth of time over the fiscal sharing plan.