MOHW agrees to review current prior authorization system

to address the disparities in reimbursement approval rates of different indications of same drugs

Soliris approval rates, PNS 90%…aHUS 30%

Director Oh Chang-hyun "We will monitor the varying approval rates of the same drug by disease"

Director Chang-hyun Oh

Medical professionals are raising concerns about significant disparities in approval rates of the 'rare diseases drug prior authorization system,' which differ by patients and by diseases, and the ambiguity of the criteria.

 

The government appears to be failing to provide a direction for system improvement and address these concerns.

 

However, the government also agreed that significant disparities do exsit in the approval rates of prior authorization by diseases and by medical institutions.

 

Thus, it has expressed plans to improve the approval rate through case-by-case feedback.

 

On 11th, Oh Chang-hyun, Director of Pharmaceutical Benefits at the Ministry of Health and Welfare, spoke at the National Assembly roundtable discussion for the institutional improvement of the rare disease drug prior authorization system, saying, “We’re considering various systemic improvements to enhance patient access to high-cost drugs, and investigating why approval rates vary for the same drug in different diseases." The low approval rate of Soliris (eculizumab) for aHUS (atypical hemolytic uremic syndrome) sparked this issue of disparity in the reimbursement approval rate following prior authorization review.

 

aHUS is a severe genetic rare disease.

 

Up to 79% of patients die, require dialysis or experience permanent renal damage within 3 years of diagnosis.

 

The prior authorization system allows reimbursement eligibility decisions to be made for each individual patient prior to treatment so that high-priced rare diseases treatments can be provided to patients in need.

 

Individual cases are determined by an expert prior authorization subcommittee.

 

The review started in 1992 and was expanded to include medications in 2007.

 

The approval rate for Soliris, a treatment for aHUS (atypical hemolytic uremic syndrome), is currently below 30%.

 

In contrast, the approval rate for the same drug for Paroxysmal Nocturnal Hemoglobinuria (PNH) is around 90%.

 

Medical professionals and patients have consistently raised concerns that the disparities in prior authorization rates for the same medication by different diseases and by medical institutions, are causing difficulties in patient treatment.

 

In response, Shin Hyun-Young, a member of the Democratic Party of Korea, hosted a symposium to discuss improvements to the prior authorization system, gathering opinions from government agencies and experts.

 

Oh Chang-hyun, Director of Pharmaceutical Benefits at Ministry of Health and Welfare, who attended the symposium said that he is aware of the concern regarding the disparity in pre-approval rates, and is committed to finding solutions to the issue.

 

Director Oh revealed that out of the 18 new drugs approved this year (2023), only two are subject to the prior authorization system.

 

He explained, "The decision was not due to financial reasons, but because of the high cost, uncertainties, and misuse concerns.

 

The Health Insurance Review and Assessment Service (HIRA) is working on an improvement plan." "The prior authorization rate for most drugs is above 80%, but in the case of Soliris, its approval rate last year for PNH was 90.7%, while being below 50% for aHUS," said Director Oh, adding, “There is a need to scrutinize why there are disparities in approval rates by different diseases and to strictly enforce compliance requirements for medical institutions seeking approval.” Director Oh stated, “Approval rates would improve if we conduct a statistical analysis on the reasons behind the many rejections that were made, and providing this feedback to individual medical institutions and doctors." Oh stressed, “The reliability of the data will go up during the process, and the Ministry is considering transitioning drugs with a long-term stable approval rate from prior approval to post approval.” Likewise, the MOHW acknowledged the problem regarding disparities in the prior authorization system rates, but hadn't yet established a specific and finalized improvement plan.

 

However, improvements are expected soon, as the Ministry is working to address the issue quickly in collaboration with HIRA.

 

Panelist Choi Seungwon, Director of Doctors News, suggested that the MOHW should create and reinforce a channel for clear communication and discussion with medical professionals and patients about the reasons for rejections.

 

Director Choi said, “Patients should not suffer due to systemic uncertainties.

 

The prior authorization system should be based on the principle that it’s better that nine guilty ones escape, rather than let one innocent suffer,” he stressed, “It’s the doctor’s duty to their patients to provide an explanation.

 

The government should be able to explain how it will communicate its decisions in cases where medical professionals and patients find rejection decisions unacceptable." "A system that specifies which person and method of inquiry should be used to inquire about the government’s disapproval decision, is necessary and must be included as part of the prior authorization system," said Director Choi Seungwon, adding, “We ask Director Oh to preprare this."