What's Kymriah's procedure after passing the Committee?

The HIRA completed setting the standard on the 13th

It is a difficulty such as sharing household finances

It seems that it will take time for the ultra-high-priced one-shot treatment Kymriah (Tisagencleucel) to be registered.

 

In particular, it is because the setting of additional financial sharing conditions for pharmaceutical companies, which was not easy in the Cancer Drugs Benefit Appraisal Committee, may pass the Drug Reimbursement Evaluation Committee evaluation.

 

The HIRA (Director Kim Sun-min) conducted the second Kymriah's standard review at the 7th The Cancer Drugs Benefit Appraisal Committee held on the 13th.

 

Kymriah's standard, which were not set at the 6th Cancer Drugs Benefit Appraisal Committee held on September 1, were set at the 7th Cancer Drugs Benefit Appraisal Committee.

 

Kymriah, which entered Korea in March using Drug Approval-Linkage Systems, is a one-shot treatment, but it took about seven months to set the standard as an ultra-high-priced new drug with a single dose cost of 500 million won.

 

Even so, it was said that the period was shortened even a little due to the influence of one-man protests and national petitions as well as the parliamentary audit of the National Assembly's Health and Welfare Committee on the 15th, urging patients to pay Kymriah.

 

The standard set after about seven months of meeting requires additional financial sharing by Novartis Korea.

 

Novartis applied for benefits for both indications, including "adult diffuse giant B-cell lymphoma" and "B-cell acute lymphocytic leukemia in children and young adults," approved by the MFDS.

 

The Cancer Drugs Benefit Appraisal Committee was concerned with indications for adult diffuse giant B-cell lymphoma.

 

This is why the setting of salary standards was put on hold at the 6th Cancer Drugs Benefit Appraisal Committee.

 

Finally, the Cancer Drugs Benefit Appraisal Committee established standards under these provisions like ▲ higher level of risk-sharing by pharmaceutical companies considering overseas drug prices ▲ in the case of diffuse giant B-cell lymphoma with insufficient clinical performance compared to acute lymphocytic leukemia, addition of risk-sharing system according to treatment performance at a patient level ▲ benefit can be applied.

 

After reviewing the risk-sharing plan for cancer screening in detail, making a final draft, putting the agenda on the committee for review and resolution, and then negotiating drug prices with the NHIS.

 

It has also been conducting drug price negotiations with the MOHW and the HIRA for 60 days, and will come up with a plan to share finances between the government and pharmaceutical companies.

 

Therefore, since it is applied after deliberation and notification by the Risk Sharing Subcommittee, the Drug Reimbursement Evaluation Committee, the NHIS negotiations, and the Health Insurance Policy Review Committee of the MOHW, it must be at least next year for actual patients to receive Kymriah benefits.