Will access to aHUS drugs improve in Korea?

Prior reimbursement approval system to be improved

The need to ease prior review standards for Soliris pointed out since last year’s NA audit

MOHW revises and clarifies reimbursement criteria… changes to take effect this October

The prior approval criteria for receiving reimbursement of atypical hemolytic uremic syndrome (aHUS) drugs, which had long been criticized for impeding patient access, have been improved.

 

This issue was raised during last year’s National Assembly audit as well.

 

At that time, Rep.

 

Yoon Kim (Democratic Party of Korea) pointed out the low approval rate for Soliris (eculizumab).

 

With approval rates hovering at only 30–40% annually, patient access was significantly limited, leading to calls for easing the pre-approval requirements.

 

The Ministry of Health and Welfare (MOHW) is currently collecting public opinion on the proposed partial amendment to the ‘Detailed Rules on the Standards and Methods for Applying Health Insurance Benefits (Drugs),’ from September 18 to 22.

 

The revised proposal specifies the criteria for insurance reimbursement and relaxes or adds detailed requirements on hemoglobin and haptoglobin levels, etc.

 

Previously, the reimbursement criteria required meeting all of the following: ▲ Platelet count below the lower limit of normal at the institution, ▲Presence of schistocytes, ▲ Hemoglobin < 10 g/dL, ▲and Lactate dehydrogenase (LDH) ≥ 1.5 times the upper limit of normal.

 

The revised criteria are as follows: ▲Platelet count < 150×10⁹/L, ▲ Presence of schistocytes, ▲ Hemoglobin < 12 g/dL (or < 11 g/dL for children under 5), ▲ LDH above the upper limit of normal, ▲Haptoglobin below the lower limit of normal.

 

For renal impairment, the wording was changed from “patients” to “cases,” but the thresholds remain the same: ▲≥20% decline in eGFR, ▲Serum creatinine above the age- and sex-specific upper limit of normal.

 

The ADAMTS-13 testing requirement was also specified.

 

Tests must be conducted before plasma exchange or plasma infusion, before the 4th treatment session, or at least 7 days after stopping treatment.

 

However, the criterion based on serum creatinine levels was removed.

 

In addition, a new criterion was added to allow reimbursement even if other requirements were not met.

 

Specifically, if end-stage renal disease due to aHUS is suspected and the drug is required before or after kidney transplantation, coverage may be granted on a case-by-case basis.

 

In addition, the following conditions were removed from the exclusion criteria: ▲  Hemolytic uremic syndrome caused by Shiga toxin, ▲Transplantation, ▲Fibrin thrombosis, ▲paroxysmal nocturnal hemoglobinuria, catastrophic hyperlipoproteinemia, ▲ Sepsis, ▲and other secondary hemolytic uremic syndromes.

 

The revised proposal applies identical detailed recognition criteria to eculizumab (Soliris) and ravulizumab (Ultomiris).

 

The MOHW plans to implement the revised criteria starting October 1, after completing the public opinion collection period.