Will Uplizna be reimbursed this time?

Previously failed to pass pricing negotiations— will it be listed this time?

Mitsubishi Tanabe Pharma Korea reapplies for reimbursement

Process previously halted due to supply issues… attention rises on whether coverage will be expanded for NMOSD

Discussions have resumed regarding the inclusion of the twice-yearly administered new drug ‘Uplizna’ for neuromyelitis optica spectrum disorder (NMOSD) in the national health insurance reimbursement list, which had previously been rejected.

 

According to industry sources, Mitsubishi Tanabe Pharma Korea has resubmitted an application for reimbursement of Uplizna (inebilizumab), a treatment for adult patients with AQP4 antibody–positive NMOSD, which is currently under review by the Health Insurance Review and Assessment Service.

 

The drug’s listing process was suspended in October last year during price negotiations with the National Health Insurance Service (NHIS) due to supply issues.

 

At the time, Uplizna accepted the evaluation price set by HIRA’s Drug Reimbursement Review Committee and entered into negotiations.

 

However, no conclusion was reached within the 60-day negotiation period.

 

NHIS attempted to extend negotiations, but the manufacturer was unable to secure a domestic supply, preventing further talks.

 

It remains to be seen whether Uplizna, as a new treatment option for NMOSD, will succeed in being listed this time.

 

NMOSD is caused when disease-specific AQP4 autoantibodies, produced by B cells, bind to AQP4 antigens on astrocytes in the central nervous system, triggering immune responses that lead to neural damage.

 

Uplizna is a novel CD19-targeted humanized monoclonal antibody that selectively binds to the CD19 antigen on B cells, depleting those that produce AQP4 antibodies and thereby preventing disease relapse.

 

The safety and efficacy of Uplizna were demonstrated in the N-MOmentum trial, a monotherapy study involving 230 patients without concomitant immunosuppressants.

 

Study results showed that 89% of patients receiving Uplizna experienced no relapse during the 197-day follow-up period, demonstrating a 77.3% reduction in relapse risk compared to the placebo group.

 

Safety assessments also showed a comparable rate of adverse events to the placebo group.

 

Furthermore, in an extension study of this clinical trial, Uplizna continuously reduced the risk of relapse for at least 4 years, with a relapse-free rate of 87.7%.

 

The long-term safety profile demonstrated generally good tolerability, and there was no increase in infection rates due to B-cell depletion.

 

Meanwhile, NMOSD is a serious autoimmune disease in which most patients experience persistent relapses with incomplete recovery, leading to accumulated nerve damage that causes vision loss, gait impairment, and even death from respiratory failure.