Multiple sclerosis drug Ocrevus may soon be reimbursed

Roche completes pricing negotiations with the National Health Insurance Service

Started process promptly after receiving approval in May last year

The new multiple sclerosis drug Ocrevus is expected to be listed for reimbursement in Kore.

 

According to industry sources, Roche Korea has completed negotiations with the National Health Insurance Service on the drug price of Ocrevus (ocrelizumab) for relapsing multiple sclerosis (MS).

 

As a result, the drug is expected to be reimbursed once it passes the Health Insurance Policy Review Committee review.

 

The company is moving quickly to finalize the reimbursement process, given that it submitted the application for reimbursement after its domestic approval in May last year.

 

Ocrevus targets CD20-expressing B cells that affect the demyelinating process that causes neurological disorders in MS patients.

 

MS is a chronic disease in which myelin is damaged by an autoimmune inflammatory response.

 

Damage to the myelin sheath causes symptoms such as muscle weakness, fatigue, and vision impairment, and can lead to non-traumatic disability.

 

As of 2022, an estimated 2,674 patients in Korea are known to be suffering from MS, with those in the 20-40 age group accounting for more than 62% of the total.

 

Antibody therapies such as Tysabri (natalizumab), Gilenya (fingolimod), and Mabthera (rituximab) have been utilized in the disease area, but there has been a steady demand for additional high-efficacy drugs.

 

Various new drugs have been developed overseas, including Novartis' Kesimpta (ofatumumab) and TG Therapeutics' Briumvi (ublituximab), but Roche's Ocrevus is the only one introduced in Korea.

 

Ocrevus also has the advantage of offering a shorter dosing period.

 

Ocrevus can be administered once every 6 months, which is more convenient than Kesimpta (administered once every month).

 

The approval was based on the Phase III OPERA-I and II studies.

 

The studies evaluated the efficacy and safety of Ocrevus versus Biogen's interferon therapy Plegridy (interferon beta-1a) in patients with relapsing MS.

 

In the trial, Ocrevus reduced the annualized relapse rate (ARR) by nearly half compared to Plegridy.

 

Specifically, in the OPERA I study, the ARR was 0.156 for 96 weeks of Ocrevus versus 0.292 for the control arm, and in OPERA II, the ARR was 0.155 for 96 weeks of Ocrevus versus 0.290 for the control arm.

 

Ocrevus also showed efficacy in the Phase III ORATIORIO study in patients with primary progressive MS.

 

In this study, Ocrevus reduced the risk of confirmed disability progression (CDP) by 24% over 12 weeks compared to the control group.

 

Ho Jin Kim, professor of Neurology at the National Cancer Center, said, “In MS, even small differences in the early stages can have huge cumulative consequences.

 

This is why the benefits of early access to highly effective therapies are significant.

 

These treatments will not only improve patients’ quality of life but also help reduce the cost of the disease to society and the economy.

 

Ocrevus is well positioned to be utilized because it has sufficient data established not only in terms of efficacy but also on long-term treatment administration.”