“Impartiality of reimbursement review system undermined"

with the clinical head of a competitor drug reviewing reimbursement for a lung cancer drug

NA member Jung-sook Suh, “refusing to participate or make statements at the review are causes for exclusion”

HIRA president Sun-Min Kim, “Difficult to regulate members’ participation in competitor drug’s clinical trials”

HIRA president Sun-Min Kim (left) is answering to People Power Party member Jung-sook Suh’s inquiry (Pic provided by National Assembly Press Corps)

The principal investigator of the clinical trial of lung cancer drug B participated in lung cancer A drug’s reimbursement assessment meeting.

 

Isn’t this a conflict of interest and cause for the member’s exclusion from the committee?” (People Power Party Jung-sook Suh) “There are operational regulations set for the Cancer Disease Deliberation Committee, however, it is difficult to regulate the members’ participation in competitor drug’s clinical trials” (HIRA president Sun-Min Kim) Controversy over the fairness and expertise of the Health Insurance Review and Assessment Service and its Cancer Disease Deliberation Committee has risen in the course of providing health insurance benefits for non-small cell lung cancer treatments.

 

The issue was that a professor of a medical school who is in charge of the clinical trial of lung cancer drug B, a competitor drug, had participated in the reimbursement review of the lung cancer drug A, which is a conflict of interest that undermines the impartiality of HIRA and the expertise of CDDC.

 

On the criticism, HIRA’s president Sun-Min Kim expressed the service’s position that it would be difficult to exclude all professors who participated in clinical trials of competitors' drugs from the reimbursement reviews.

 

NA member Jung-sook Suh of the People Power Party had inquired so to HIRA president Sun-Min Kim at the NHIS·HIRA’s NA audit on the 15th.

 

Suh had pointed out that it is inappropriate for the principal investigator of a competing company to participate in the drug reimbursement review of its competitor drug.

 

Suh's point of view was affected by the appeal made by a lung cancer patient group that visited the National Assembly to ask for the extended reimbursement of the lung cancer drug A.

 

With lung cancer drug A failing to receive reimbursement for several years, some have been criticizing that this was an infringement of the patients’ right to accessibility.

 

Currently, the lung cancer drug A has been approved for reimbursement as a second-line treatment and applied to extend its reimbursement to first-line.

 

The competitor drug B is currently conducting clinical trials to assess its efficacy in the first line.

 

Suh said that professor K, principal investigator of the clinical trial of lung cancer drug B, participating in lung cancer drug A’s reimbursement review raises the issue of fairness.

 

The professor had participated in the Cancer Disease Deliberation Committee meeting in April that reviewed the reimbursement of lung cancer drug A as first line.

 

Suh used the committee’s exclusion, recusal, and avoidance regulations to point out that the situation has greatly undermined the objectivity of the reimbursement review for lung cancer drug A.

 

According to Article 13-2 of the Operating Regulations of the Cancer Disease Deliberation Committee, if a person who attends the committee and makes a statement is deemed not to be fair or objective due to family relations or personal and economic interest under the civil law, the committee shall refuse the participation and statement of the committee member.

 

Seo said, “It is very inappropriate for the principal investigator of the competitor lung cancer drug B’s clinical trial, professor K, to participate and deliberate on lung cancer drug A’s first-line reimbursement.

 

According to the Operating Regulations of the Cancer Disease Deliberation Committee, professor K should have refused to participate or provide an opinion on the matter.

 

A serious and clear flaw in the committee’s operations have been revealed, and HIRA should explain why this has happened and come up with measures to prevent recurrence “ While expressing some agreement to Suh’s argument, HIRA president Sun-min Kim expressed the service’s position that it would be difficult to regulate the member’s participation in other drugs’ clinical trials as exclusion criteria in the operating regulations.

 

Kim said, “Operating Regulations for the Cancer Disease Deliberation Committee does exist, however, it is difficult to regulate the members’ participation in competitor drug’s clinical trials.”