NHRC issues ‘expedited listing of Kymriah’ opinion to MOHW

Agenda to be deliberated at DREC meeting on the 13th… Korea Leukemia Patients Organization “Novartis should submit a reasonable fiscal-sharing plan”

The National Human Rights Commission of Korea urged the Ministry of Health and Welfare on the need to expedite insurance listing of the CAR-T therapy ‘Kymriah’ that is used to treat leukemia and lymphoma.

 

The NHRC’s position is that the government should set a temporary drug price with NHI coverage for drugs that are directly related to life immediately upon its sale for the patients’ benefit.

 

In this case, Kymriah will be again put on the agenda and discussed by the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee on the 13th.

 

On the 12th, the NHRC turned down the complaint filed by leukemia patients and patients preparing to use Kymriah against the Minister of Health and Welfare, and issue an opinion to the MOHW to expedite insurance listing of the drug.

 

Kymriah is awaiting deliberation by DREC on the 13th.

 

The petition was filed by KLPO last year to the NHRC to urge for the expedited reimbursement listing of Kymriah, and NHRC turned down the petition but issued its opinion on the need for an expedited listing of the drug to the Minister of Health and Welfare.

 

For the reason why the NHRC rejected the petition, the NHRC pointed to the fact that the reimbursement standards that are set for specific treatments are an area that requires high-level expertise, and that NHRC is not capable of comprehensively considering and making a decision on Kymriah based on approval cases in Korea and abroad, clinical trial results, and academic and expert opinions.

 

In addition, the NHRC said it is difficult to say that the ‘petitionee’ MOHW had made no effort for the prompt insurance listing of Kymirah.

 

In addition, the NHRC told the Minister of Health and Welfare that it is necessary to allow patients to first receive treatment at a temporary drug price that is covered by health insurance as soon as Kymriah is sold post-MFDS approval.

 

NHRC’s request is that a system needs to be prepared to expedite insurance listing of new drugs directly related to life.

 

The KLPO agreed to the opinion issued by NHRC, criticizing Korea’s reality in which no system is available for prior use of NHI finances even for new drugs that are directly related to life.

 

In other words, the KLPO also pointed to the need for an added expediated NHI listing system for new drugs that are directly related to life.

 

Also, the KLPO pointed to Novartis Korea’s high-price request as the cause of the delay in Kymriah’s CDDC and DREC review.

 

According to KLPO, a non-reimbursed patient should pay around ₩460 million to be treated with Kymirah.

 

Therefore, KLPO believes that the company should prepare a reasonable fiscal sharing plan while the health authorities make efforts to promptly introduce an expedited listing system.

 

KLPO said, “The unceasing tug-of-war between Novartis, which is trying get a high price, and the government, which is trying to save NHI finances, is hurting the patients who cannot bear the high cost of the drug.

 

The due procedures for Kymriah’s listing, including deliberation and vote by DREC, the drug pricing negotiations between NHIS and the Novartis, as well as deliberation by HIPDC, should be proceeded in a prompt manner.”