With Ultomiris, 9 items require prior approval for reimb.

Systemic improvement being considered by authorities

No items were excluded since the introduction of the prior approval system…raises the need to change the system to a post review system

5,785 among the 6,001 applications that were filed last year were approved for reimbursement… 79 applications disapproved

Improvements are expected to be made to the ‘pre-approval' system that may be actively used in the process of reimbursement listings for ultra-high-priced drugs.

 

Starting with the stem cell transplantation procedure in 1992, the Health Insurance Review and Assessment Service (HIRA) has been operating the pre-approval system to deliberate in advance whether an insurance benefit should be applied to high-risk, high-cost, irreplaceable drugs and procedures.

 

With the most recent addition of ‘'Ultomiris inj.,’ a total of 9 items are on the list for deliberation for pre-approval of insurance benefits.

 

The other 8 include ▲ Stem Cell Transplantation; ▲ Immune Tolerance Induction; ▲Soliris Inj.

 

▲ Implantable Cardioverter Defibrillator& Cardiac Resynchronization Therapy ▲ Ventricular Assist Device therapy ▲Spinraza inj.

 

▲Strensiq inj.

 

▲Clinical studies A total of 6,001 cases applied for pre-approval last year, 5,785 of which were approved for reimbursement.

 

The approval rate is high at 96.4%.

 

Among all the cases filed, 79 were disapproved, and 137 were dropped.

 

Excluding Ultomiris, which was added this year as a pre-approval item, the medical and pharmaceutical expenses spent on pre-approval items last year recorded 231.43 billion won.

 

Despite the increase in medical care benefits caused by the added items and the increase in the number of applications, no item has been removed from the list since the system was implemented in 1992.

 

Also, no dedicated department exists for the pre-approval system, raising the need for systemic improvements.

 

Jin-Su Lee, Chair of HIRA who met with the Korea Special Press Association reporters on the 10th, said, “As of last year, the number of applications seeking for pre-approval increased to 6,001 cases for 26,910 people.

 

Therefore, we would need to review adding or removing items subject to the pre-approval, and systemize the approval process.” In other words, HIRA will analyze and review the whole operation process of the pre-approval system and collect the stakeholders' opinions for reflection to come up with a plan for improving the operation of the prior approval system.

 

Kim Moo-sung, director-general of HIRA's Committee Operations, said, “Since the system was implemented in 1992, no items were excluded (removed) from the list.

 

Opinions that items that have been constantly reviewed without change should be switched from pre-approval to the post-approval system have been raised, and we plan to discuss this with the Ministry of Health and Welfare after collecting expert and internal opinions." Regarding newly establishing a department for pre-approvals, Kim said, “Currently, 10 people in 2 teams are in charge of the prior approval review.

 

With the government requesting more items to be added to the pre-approval list this year, the committee agrees on the need for a dedicated department that manages the pre-approval system.” Kin added, “We will discuss newly establishing an independent department for the pre-approval system with relevant departments during the next reorganization process."