Pt management is required to provide high priced 1 shot tx

Performance-based benefit management is necessary

Emphasize the performance and financial management using the HIRA, the pre-approval system, and RSA

Starting with Kymriah of Novartis Korea, which recently passed the HIRA Drug Reimbursement Evaluation Committee, the search for management measures for ultra-high-priced one-shot treatments has begun with Zolgensma, which is expected to enter Korea.

 

In the end, the government's plan to manage the benefits of expensive drugs is a contract that uses treatments as DLBCL, but turns the benefits for patients who do not work into sharing by pharmaceutical companies.

 

Kymriah, which passed the Drug Reimbursement Evaluation Committee on the 13th, was also recognized for his eligibility, but conditions for applying DLBCL and Expenditure Cap have been attached, and all expensive drugs are likely to follow the contract in the future.

 

Byun Ji-hye, a deputy researcher at HIRA, announced domestic benefit plans such as expensive drugs using actual clinical grounds at the "Expensive Drug Benefit Management Forum" held on the 19th, saying, "We need to think about how to manage patients who have administered but are ineffective.

 

I think pharmaceutical companies should also bear the list." In the case of the SMA treatment Spinraza (Nusinersen), which is managed by the pre-approval system, Spinraza has been administered for two years, but there are several cases where the exercise function evaluation score continues to be "0".

 

She said, "In Korea, there are no specific standards for maintaining and improving exercise functions." She said, "We believe that performance-based benefit management is necessary by setting the minimum score for improving exercise function, which is clinically meaningful, and considering clinical improvement scores." Spinraza is an ultra-high-priced new drug with an insurance cap of 92.35 million won per bottle of 5ml, and nursing institutions that want to take it must apply for pre-approval and submit monitoring reports every four months after approval of benefit.

 

When drug price negotiations with the NHIS are completed soon, Kymriah, which is scheduled to be registered, and Zolgensma, which is expected to enter Korea, will have to use the pre-approval system like Spinraza.

 

The HIRA's high-drug benefit management plan also suggested approval and monitoring of patients subject to administration using the pre-approval system, financial management using risk-sharing systems (RSA), benefit standards based on revaluation results, and domestic clinical guidelines.

 

Deputy researcher Byun said, "Expensive drugs should be administered to optimal target patients for efficient use of limited resources.

 

Monitoring and re-evaluation should be conducted through patient-level data collection by establishing a disease-level registry." It also came up with financial management plans such as refunding patients' events during the monitoring period of pharmaceutical companies, adjusting the refund ratio reflecting the evaluation results after the end of the contract period, and setting the total amount considering the financial impact.

 

Deputy researcher Byun emphasized, "benefit standards and domestic clinical guidelines are also needed, such as collecting essential clinical information for screening and evaluation and analyzing it with related clinical societies when re-evaluating in connection with health care big data such as billing data."