What's the outcome of the 2nd reimb attempt for 'Uplizna'?

Mitsubishi Tanabe Pharma Korea has accepted a conditional price evaluated by the Health Insurance Review and Assessment Service (HIRA)

Attention has been drawn to whether the treatment option for neuromyelitis optica spectrum disorders (NMOSD) will be expanded

Attention has been drawn to whether 'Uplizna,' a new treatment for neuromyelitis optica spectrum disorders (NMOSD), will successfully gain insurance reimbursement listing at its second attempt.

 

According to industry sources, Mitsubishi Tanabe Pharma Korea has accepted the conditional price that Health Insurance Review and Assessment Service (HIRA)'s Drug Reimbursement Evaluation Committee (DREC) suggested for Uplizna (inebilizumab), a treatment for adult patients with anti-aquaporin-4 (AQP-4) antibody-positive neuromyelitis optica spectrum disorder (NMOSD).

 

The Ministry of Health and Welfare (MOHW) has ordered the National Health Insurance Service (NHIS) to initiate drug price negotiation.

 

Therefore, the company is expected to begin discussions with the NHIS.

 

The listing process for Uplizna was halted in October of last year during the drug price negotiation stage due to a supply issue.

 

At that time, the company accepted a price below the amount evaluated by the HIRA's DREC and began drug price negotiations.

 

However, a conclusion was not reached within the 60-day negotiation period.

 

Although the National Health Insurance Service (NHIS) intended to enter into an extension negotiation, the renegotiation could not commence because the pharmaceutical company was unable to secure a domestic supply.

 

NMOSD occurs when AQP4 autoantibodies, which are disease-specific markers produced by B cells, bind to the target antigen Aquaporin 4 (AQP4) on astrocytes in the central nervous system, thereby activating an immune response that leads to neurological damage.

 

Uplizna is a CD-19-targeting humanized monoclonal antibody, developed using a novel mechanism, that prevents disease relapse by selectively binding to CD19, a B-cell-specific surface antigen, to deplete AQP4 antibody-producing B cells.

 

Uplizna's safety and efficacy were demonstrated in the N-MOmentum clinical study, a monotherapy study conducted in 230 patients without concomitant immunosuppressants.

 

The study results showed that 89% of patients who received Uplizna did not experience a relapse during the 197-day follow-up period, demonstrating a 77.3% reduction in relapse risk compared with the placebo group.

 

The safety evaluation also showed a similar rate of adverse events to the placebo group.