Ultomiris is reimbursed for aHUS in Korea

“Will contribute to improving access to treatment for patients”

Will be reimbursed for thrombotic microangiopathy with renal impairment aHUS starting this month

Demonstrated efficacy in both adult and pediatric patients...sustained terminal complement inhibition

Dr.

 

Jinseok Kim, professor of hematology at Severance Hospital.

 

Ultomiris has been reimbursed in Korea for atypical hemolytic uremic syndrome (aHUS) since January.

 

While experts have welcomed the news of its reimbursement, they have also raised the need for systematic improvements to the stringent conditions for reimbursement, including the preliminary review requirement.

 

On the 10th, AstraZeneca Korea held a press conference at JW Marriott Dongdaemun Square Seoul to celebrate the reimbursement coverage of Ultomiris for aHUS in Korea.

 

Starting this month, Ultomiris will be reimbursed by health insurance for patients with aHUS with thrombotic microangiopathy (TMA) and kidney damage.

 

This is expected to improve access to treatment for patients with aHUS whose symptoms can worsen rapidly and lead to end-stage renal disease (ESRD).

 

Ultomiris is a next-generation C5 complement inhibitor with a half-life approximately four times longer than Soliris.

 

While Soliris requires dosing every 2 weeks, Ultomiris has an extended dosing interval of 8 weeks, improving treatment convenience.

 

When complement C5 is activated on the surface of bacteria, it produces a membrane-attacking complex that causes holes in the cell membrane.

 

If the normal immune system process of complement activation continues, vascular endothelial cells are disrupted, causing related diseases.

 

Ultomiris has a mechanism of action that inhibits this process.

 

aHUS is an acute rare disease in which the immune system's complement is overactivated due to a genetic defect and causes thrombotic microangiopathy, which can lead to severe damage to multiple organs, especially the kidneys.

 

aHUS refers to hemolytic uremic syndrome not associated with E.

 

coli.

 

The efficacy and safety of Ultomiris were confirmed in Phase III Study 311 in adult patients who were not previously treated with complement inhibitors.

 

At 26 weeks of treatment, Ultomiris demonstrated improvement in TMA-related markers, including platelet and LDH levels, in 53.6% of patients.

 

The treatment also demonstrated sustained terminal complement inhibition by maintaining serum-free C5 concentrations of < 0.5 μg/ml.

 

In the Phase III Study 312 in pediatric patients, Ultomiris demonstrated complete resolution of TMA in 94.4% of patients at 50 weeks of treatment.

 

“In a study of pediatric aHUS patients who switched from Soliris to Ultomiris, the renal and hematologic parameters remained stable over one year, confirming the efficacy of the switch,” said Dr.

 

Jinseok Kim, professor of hematology at Severance Hospital.

 

“As clinicians, we are excited to be able to offer hope to our patients with the introduction of this new treatment option.” Ultomiris and Soliris are currently available for aHUS in Korea, but both agents are only available to patients who have been approved through the prior review process.

 

Clinicians have called for improved reimbursement, including moving to a post-review process, as patients' conditions can worsen if they are not properly dosed.

 

The coverage of aHUS was implemented in 2018 with the introduction of Soliris.

 

However, according to an analysis of the results of the preliminary review system from July 2018 to October last year, 56 out of 321 cases were approved, showing an average approval rate of 18%.

 

Kim added, “Although Ultomiris has been reimbursed, like Soliris, it is subject to the same restrictions as Soliris, which requires preliminary review.

 

We hope that systemic improvements are also made so that aHUS patients can receive treatment in a timely manner.”