NA criticizes HIRA's low prior approval of specific drug

HIRA states that there is ‘no problem’

NA points to the low approval rate of Soliris for aHUS

HIRA states that the disapprovals are mostly due to the low understanding of the reimbursement standards

Doctors raise concern over how it ‘impedes patient access to treatment’

In response to the criticism that the prior review approval rate of certain drugs is low, the Health Insurance Review and Assessment Service said that the low rate is due to a lack of understanding of the reimbursement standards and that it will maintain the current standards.

 

The response was made regarding the low approval rate of Soliris for aHUS (atypical hemolytic uremic syndrome) disease.

 

On the 18th, Rep.

 

Sun-Woo Kang of the Democratic Party of Korea made a written inquiry about the low prior approval rate of certain drugs used for aHUS during the NA audit of the Health Insurance Review and Assessment Service.

 

aHUS is a severe and rare hereditary disease in which 79% of patients die or require dialysis within 3 years of onset and suffer permanent renal failure.

 

Also, patents with aHUS experience 'thrombotic microangiopathies (TMA)' (a condition in which blood clots and inflammation damage small blood vessels throughout the body), and major organs such as the kidneys, heart, and brain become damaged, bringing about various complications such as acute renal failure, heart failure, and stroke.

 

In acute cases, the disease can tear internal organs within 1 week, especially the walls of the kidneys, which severe cases lead to death.

 

The prior approval system was implemented in 1992 as a system that allows a prior review subcommittee, which consists of several experts, to decide whether or not to allow reimbursement for each case before treatment to allow patients in dire need of treatment with high-priced rare disease treatments.

 

The system has been applied to pharmaceuticals since 2007.

 

This is not the first time Soliris' low approval rate for aHUS has been raised as an issue.

 

According to the data presented by Yong Kyun Won, Professor of Radiation Oncology at Soonchunhyang Univ.

 

Cheonan Hospital, Soliris’s prior approval rate for aHUS was only 21.6%.

 

None of the 6 new applications filed in July that were disclosed by the HIRA passed expert review.

 

This is why experts in the field have expressed concerns saying, "If the prior review approval rate is low, the prescribing doctor may give up use of the drug in advance, impeding patient access to treatment." However, HIRA has been arguing that the low approval rate is not a concern, rather, it is due to a lack of understanding of the reimbursement standards.

 

In a response to Rep Kang’s written inquiry, HIRA stated, "The approval rate for aHUS is low because medical institutions have been filing many applications to receive help from experts in the prior review subcommittee on determining the reimbursement adequacy of their patients or apply with a lack of knowledge about the reimbursement standards, rather than clearly determining the eligibility and exclusion criteria themselves based on each patient’s medical records.

 

In addition, regarding the criticism about the strict reimbursement standards, HIRA answered, “A reimbursement t expansion request has been filed recently, asking for ‘'ease of the TMA requirements in the aHUS salary standards.’” After discussing the request at an advisory meeting, including experts from related societies such as the Korean Society of Nephrology, they concluded that the current standards should be maintained, as no new clinical evidence has been generated to warrant a change, and the prior review subcommittee has been reviewing the situation of each patient in consideration of the comprehensive situation of each patient for cases that require medical judgment.” Despite so, concerns have continued to rise in the field.

 

In a survey conducted on relevant societies in the ‘Current Status and Improvement Plan for Medical Benefit Prior Approval System (2022)’ that was conducted by HIRA, the relevant societies said that the criteria for selecting target drugs for the prior review system have not been specified, and the varying composition of the expert committee members that discuss each reimbursement can bring different results.

 

Related academic societies said, “Although the prior review application process in itself is complicated, there is a lack of sufficient explanation regarding the progress or reasons for disapproval.

 

Patients miss out on the appropriate treatment period due to the prior review meeting schedule, which is held once or twice a month.

 

Therefore, flexible operation may be necessary to review cases that arise by case." In addition to Rep Kang, Rep Chounsook Jung from the same party had also raised the issue of the prior review approval rate of a specific drug.

 

Jung made a written inquiry to the health authorities regarding the cases of disapproval of Spinraza, which is used to treat spinal muscular atrophy (SMA), and the need for their improvement.

 

Spinraza’s scope of administration has been expanded starting in October.

 

Its subjects have been expanded from those under the age of 3 to those under the age of 18 who show onset of symptoms.

 

Rep.

 

Jung pointed out that measures are needed for patients who were not approved before the change of the standards.

 

Regarding this, HIRA said, "Patients who were previously disapproved because they did not meet the existing age requirements may be able to receive reimbursement if they meet all the reimbursement requirements after evaluation through the prial approval process in line with to the expansion of the age requirement.

 

However, patients who were disapproved while receiving other drugs after review would need to consider that their decision was made based on the expert opinion that ‘after a close and careful review of the medical records (progress record, test results, video, etc.), the members of the ‘prior review subcommittee’ that consist of many experts made the professional medical judgment that ‘it cannot be determined whether the motor function can be maintained or improved with administration of the medication.” HIRA added, “We also have a relief procedure that allows patients and caregivers to file an appeal to the prior review results, and committee members rediscuss the rejected cases based on the submitted explanatory material.

 

If the patient or institution has an objection to the appealed results, they may seek relief for the patient’s rights through administrative adjudication by the Health Insurance Dispute Mediation Committee." HIRA added that 10 administrative adjudications have been filed, 8 of which were rejected, and 2 are under review.