Expanded reimbursement criteria for 'Enspryng'

Eased to one or more relapses within one year

First incidence of improved administration scope since Enspryng's listing in 2023

Product photo of Enspryng

As the insurance reimbursement criteria for 'Enspryng' have been eased, the drug is expected to be more utilized.

 

The Ministry of Health and Welfare (MOHW) recently announced an administrative announcement regarding the partial revision to the "Detailed Standards and Methods of Application for Health Insurance Benefits (Pharmaceuticals)," which includes expanding the reimbursement criteria for Roche Korea's Neuromyelitis Optica Spectrum Disorder (NMOSD) treatment, Enspryng (satralizumab).

 

Accordingly, starting in August, the eligibility for Enspryng will be broadened from patients with two or more relapses within two years to those with one or more relapses within one year.

 

Yet, unmet needs still exist.

 

The reimbursement criteria for Enspryng are primarily for '4th-line treatment or later.' Currently, for NMOSD, azathioprine, an immunosuppressant, is used as first-line maintenance treatment.

 

Following azathioprine treatment failure, mycophenolate or rituximab are reimbursed as second-line treatments, but these are off-label drugs without an NMOSD indication.

 

In other words, Enspryng can only be used by patients who have failed rituximab treatment as a 3rd-line treatment.

 

Therefore, future developments, including whether Enspryng will pursue further reimbursement expansion, remain to be seen.

 

Enspryng is an officially approved treatment for adult aquaporin-4 antibody-positive NMOSD.

 

It is a drug that selectively targets the Interleukin-6 (IL-6) receptor, a key pathogenic factor of the disease, to inhibit IL-6 signaling.

 

A novel recycling antibody technology was used, enabling the drug to recirculate in the bloodstream, thereby extending the duration of its IL-6 inhibitory effect.

 

Moreover, as the only subcutaneous injection formulation, it can be self-administered once every four weeks during maintenance therapy, enhancing patient convenience.

 

Meanwhile, the efficacy of Enspryng was demonstrated through the SAkuraStar and SAkuraSky clinical trials conducted in adult aquaporin-4 (AQP4) antibody-positive NMOSD patients.

 

In the AQP4 antibody-positive group of the SAkuraStar monotherapy trial, 76.5% of Enspryng-treated patients prevented relapse for 96 weeks, compared to a relapse prevention rate of 41.1% for the placebo group.

 

Additionally, in the SAkuraSky trial, which evaluated the concomitant use of Enspryng with standard immunosuppressant therapy, the relapse prevention rate was 91.1% at 96 weeks, compared to 56.8% for the placebo.