The more applications for pre-screening drugs, the higher

the approval rate

Benefit standards are also an issue

The strict reimbursement criteria for Soliris aHUS treatment, which has an approval rate of 30%, is also the cause. Currently under review for improvement

..

 

Lee Jin-soo, chairman of the Medical Review and Evaluation Committee, "If the number of applications increases, the understanding of the benefit standards also increases." It was found that the higher the number of applications for pre-screening drugs, the higher the approval rate.

 

It is an interpretation that the approval rate increases as the understanding of the salary standards accumulates.

 

However, there is an interpretation that the salary standard is strict in the first place, so there is a high probability of disapproval of the salary in the pre-screening.

 

Among pre-screening drugs, Soliris, which treats 'atypical hemolytic uremic syndrome (aHUS)', has a meager initial approval rate.

 

The Health Insurance Review and Assessment Service presented an interpretation at the Korea Special Press Association meeting on the 18th that the understanding of the benefit standard was poor.

 

In response to a question about the cause of Soliris' aHUS initial review approval rate and improvement plans, Chairman Lee Jin-soo explained, "I think the approval rate will increase if the clinical site fully understands the benefit standard and applies for it." He explained, “When we analyzed the status of approvals by the institution by 2022, we confirmed that the more cumulative applications there are, the more often they are approved.” According to the table released by the Clinical Review and Evaluation Committee, a total of 47 institutions applied for prior approval of Soliris in aHUS disease, and 51 cases (20.3%) out of 251 cases were approved.

 

However, agency A, which applied the most, was approved for 10 out of 35 cases, with an approval rate of 28.6%, higher than the average.

 

On the other hand, all 15 institutions that applied for prior approval were rejected.

 

Regarding this, Chairman Lee explained, "As the number of applications for Solily increases, the understanding of the salary standard increases." Even so, it is pointed out that the approval rate of Soliris aHUS is too low compared to other drugs with an initial approval rate of more than 50%.

 

In response, the Medical Review and Assessment Committee also said, "The expansion of the Soliris reimbursement standard was discussed at a recent advisory meeting, and the review results have been reported to the Ministry of Health and Welfare." In fact, it is pointed out that the Soliris aHUS salary standard is more difficult than overseas.

 

In Korea, the benefit is approved only when all four criteria are satisfied: platelet count, mitotic red blood cell count, hemoglobin, and LDH, but the medical community says that the standard is higher than overseas.

 

The Korean Society of Nephrology also submitted an opinion asking for relief standards to be relaxed.

 

In March, Yoo Mi-young, head of the drug management office at HIRA, said, "A number of academic societies, including the Society for Nephrology, have submitted proposals for revising the reimbursement standards (for Soliris aHUS), including discontinuation of administration, administration standards, and evaluation methods." "We are currently reviewing the salary standards by identifying the reasons for pre-approval and disapproval and referring to expert opinions," she explained.

 

It is noteworthy whether the pre-examination approval rate of Soliris will increase through the improvement of the benefit standard.