NMOSD drug Enspryng’s reimbursement expanded in KOR

Reimbursement criteria eased to once relapse within a year, improving patient access

The eased reimbursement criteria allow reimbursement even if the patient experiences only one relapse with existing treatment

Pic of Enspryng

Roche Korea announced on the 31st that the reimbursement criteria for Enspryng (satralizumab), a treatment for neuromyelitis optica spectrum disorder (NMOSD), will be expanded from August 1st per a notification from the Ministry of Health and Welfare.

 

Enspryng is indicated for the treatment of adult patients with anti-aquaporin(AQP4) antibody-positive NMOSD.

 

It selectively targets the interleukin-6 (IL-6) receptor, a key pathogenic factor in the disease, to inhibit IL-6 signaling.

 

As the only subcutaneous injection formulation approved for NMOSD, it allows for maintenance therapy with a single subcutaneous injection every four weeks.

 

This revision of the reimbursement criteria comes about a year and a half after Enspryng was first listed for reimbursement in December 2023.

 

Under the revised notification, the criteria for Enspryng’s reimbursement, which previously required at least two symptom relapses within the last two years, have been relaxed to allow reimbursement only after at least one symptom relapse within the past year.

 

Under the previous reimbursement criteria, patients had to wait for their second relapse of symptoms, even if they experienced their first relapse during initial treatment, before they could be prescribed Enspryng.

 

However, with the revision, the treatment environment has been improved so that patients can quickly receive reimbursement for Enspryng even if they experience only one relapse during existing treatment.

 

The expansion is expected to allow more patients with relapsing NMOSD to enjoy Enspryng’s treatment benefits.

 

NMOSD is an inflammatory autoimmune disorder of the central nervous system that can cause lifelong physical weakness.

 

Eight to nine out of ten patients experience recurrent relapses, and as even a single relapse can cause severe neurological deficits, early and aggressive relapse prevention treatment is crucial.

 

Enspryng’s safety and efficacy in reducing the risk of relapse were demonstrated through two global Phase III trials - SAkuraStar and SAkuraSky - that were conducted on adult NMOSD patients.

 

Study results showed that in anti-aquaporin-4 antibody-positive patients, approximately 9 out of 10 patients receiving combination therapy with immunosuppressants and approximately 7 out of 10 patients receiving monotherapy with Enspryng remained relapse-free at approximately 2 years (96 weeks).

 

No cases of death or anaphylaxis (hypersensitivity reactions) were reported following Enspryng administration in either clinical study, and most adverse reactions were mild to moderate in severity.

 

In particular, recently published real-world data from Japan showed that 96.6% of patients treated with Enspryng did not experience recurrence at 6 months (26 weeks).

 

"Enspryng is an innovative treatment that has demonstrated its effect in reducing the risk of recurrence in patients with NMOSD in multiple clinical studies,” said Ezat Azem, General Manager of Roche Korea.

 

“With the reimbursement expansion, patients who experience relapse with existing treatments will be able to use Enspryng more quickly without unnecessary delays, which will contribute to improving treatment outcomes and quality of life for patients.”