Linking 'Prior review-performance evaluation-reevaluation'

To manage the reimbursement of high-priced drugs

HIRA’s HCRAC Administration Division establishes a virtuous cycle for the preliminary review system

5 of the 12 preliminary review items were converted to post-review

HIRA

The Health Insurance Review and Assessment Service announced that it has been reviewing a measure that links preliminary review, performance evaluation, and reevaluation for newly listed high-priced drugs.

 

In other words, for newly listed high-priced drugs, the authorities will conduct a proper cost-effectiveness evaluation through a preliminary review process.

 

In this way, the new system will build a virtuous cycle with the existing preliminary review system.

 

HIRA's Healthcare Review and Assessment Committee (HCRAC)’s Review Department and Review Division explained so at a press conference with press corp reporters on the 3rd.

 

The Review Department and the Review Division are TF-type departments that were established this year to improve HIRA’s review standards.

 

Min-Sun Kim, Head of the HCRAC Department, said, “The HCRAC Department was newly established earlier this year when a new task of overseeing and improving the general review standards was added to the committee’s preliminary review task.” Kim explained that the HCRAC's key achievements this year were the voluntary efforts it had made to improve the review standards and the establishment of a virtuous cycle of the preliminary review system.

 

“As the need for preliminary review has increased with the increase in the number of high-priced drugs, we have established and operated a monitoring and return system that switches items that have been under review for a long time to post-review and quickly introduce newly listed high-priced drugs through preliminary review,” explained Kim.

 

Of the 12 preliminary review items, 5 items, including a treatment for paroxysmal nocturnal hemoglobinuria, were stably transitioned to items for post-review, and a new treatment for the inherited retinal disease was introduced.

 

In addition, the committee improved and expanded the reimbursement standards for 6 items through analysis of the review status and expert discussions.

 

This year, HIRA switched the preliminary review status of Strensiq, Soliris Inj (paroxysmal nocturnal hemoglobinuria), Ultomiris Inj, ICD (implantable cardioverter-defibrillator), and CRT (cardiac resynchronization therapy) as subject to post review.

 

Kim added, “In the case of preliminary review, we will promote the introduction of high-priced new drugs, and consider ways to utilize data that can be linked from preliminary review to performance evaluation and re-evaluation for a solid reimbursement management system of high-priced drugs." Jung Gu Kang, President of HIRA who also attended the conference, added, “Drugs whose data has not been verified at the time of their introduction should be objectively verified for cost-effectiveness through post-evaluations.

 

Newly introduced drugs should undergo preliminary review to reduce unnecessary spending.” However, he said there are no plans to move the atypical hemolytic-uraemic syndrome treatment, which has been receiving many requests to transition the item to post-review due to its low pre-approval rate.

 

“The reason we switched paroxysmal nocturnal hemoglobinuria treatments to post-review is because they are stable in terms of reimbursement coverage, but atypical hemolytic uremic syndrome treatments are not so,” added Kim, ”The Anti-Corruption & Civil Rights Commission did not recommend abolishment of the drug’s preliminary review status.” In addition to the reorganization of the preliminary review system, the HCRAC’s review office said it has improved the review standards for 114 applications.

 

Kim explained, “At the end of last year, we reviewed a total of 410 cases, including spine surgeries that clinical societies and associations filed appeals and opinions on improving the review criteria and revised and reflected their opinion on 114 cases into review guidelines and notices, and improved the review process.

 

We met and discussed with academic societies and held advisory meetings more than 50 times.” “Of the 410 cases, 58%, or 238 cases, were resolved within the year.

 

For 124 cases where the medical community misunderstood the review and criteria, we provided detailed guidance to clinical societies and associations for better understanding of the medical community, and 114 cases with medical grounds were reflected in the review guidelines and notices.” “For the other 172 cases that have not yet been resolved, some cannot be resolved immediately due to lack of clinical evidence, while others need to be improved, but may take several months to a year or more to resolve due to equity issues between medical departments or financial requirements.

 

We have shared these situations with clinical societies and associations, and we ask for the understanding and cooperation of the medical community and the government for their resolution.”