HIRA plans to improve the overall management system

of the pre-approval system

Lee Jin-soo, chairman of HIRA's medical review and evaluation committee, considered excluding hematopoietic stem cell transplantation

Lee Jin-soo, chairman of HIRA

With the launch of Zolgensma, the HIRA plans to improve the overall management system of the pre-approval system.

 

Accordingly, it has been confirmed that internal research is being carried out.

 

The HIRA allows benefits for ultra-high-priced drugs such as Soliris and Spinraza or some medical procedures through a pre-approval system.

 

However, some items have been pre-approved for a long time, and as ultra-high-priced drugs subject to pre-approval are expected to increase in the future, they are reportedly considering adjusting the target items.

 

Lee Jin-soo, chairman of the HIRA Medical Review and Assessment Committee, made the announcement at a meeting with the Korea Special Press Association on the 17th.

 

Chairman Lee explained, "Recently, demands for higher-priced drugs have continued to increase, and medical institutions are also expected to actively use the pre-approval system," adding, "We will improve the overall management system of the pre-approval system." Currently, hematopoietic stem cell transplantation, Soliris (subject to PNH, aHUS diseases) 'ICD&CRT, VAD, and Spinraza are allowed to administer or perform pre-approval systems.

 

Among them, hematopoietic stem cell transplantation is under consideration.

 

Chairman Lee said, "In the case of hematopoietic stem cell transplantation, the pre-approval system has been applied since 1992.

 

At the beginning, it was a high-risk and high-cost act, but now it is cheaper than other expensive drugs, so I think we can go to a post-examination." However, in the medical community, there is a high opinion that it should be maintained.

 

Hematopoietic stem cell transplantation benefited 3,323 people through preliminary screening last year, costing a total of 127.6 billion won.

 

This is a much higher cost than other items.

 

Soliris, an ultra-high-priced drug, cost 36.7 billion won and Spinraza 41.6 billion won last year.

 

The number of people subject to approval is also higher.

 

Chairman Lee said, "Hematopoietic stem cell transplantation has been a learning training for medical institutions since pre-examination was introduced for 30 years, so the approval rate is far higher than other items.

 

However, we are considering withdrawing internally in consideration of manpower and screening capacity." The new drug to which the pre-approval system will be applied is Zolgensma, a treatment for spinal muscular dystrophy.

 

Zolgensma was recognized of benefits on the condition of prior approval of medical care benefits at a review of the Drug Benefit Evaluation Committee held on the 12th.

 

The Medical Review and Assessment Committee is currently considering coordinating the Spinraza review division with the same indication if Zolgensma is confirmed to be subject to the pre-approval system.

 

"In order to improve the system, the review and evaluation laboratory is conducting internal research on the systematic operation of the pre-approval system," Chairman Lee said.

 

"We will analyze the operation status and collect domestic and foreign cases to come up with specific improvement measures." The preliminary review department of the Medical Review and Assessment Committee plans to expand the application of the pre-approval system for severely incurable diseases who need high-risk and high-cost medical services and strengthen management.

 

Chairman Lee said, "Last year, the number of pre-approval items increased from eight to nine, and we received about 280 billion won in medical expenses."