Vabysmo pays attention to entry into reimbursement

Negotiate drug prices with NHIS

July Acceptance of 'below the evaluation amount' presented by the Pharmaceutical Reimbursement Evaluation Committee

Vabysmo, a treatment for macular degeneration, stood in front of the final gateway to being listed as an insurance benefit.

 

According to industry sources, Roche Korea's first bispecific antibody treatment Vabysmo for the ophthalmic disease is in negotiations with NHIS.

 

Last month (July), this drug accepted the conditions below the evaluation amount proposed by the Pharmaceutical Reimbursement Evaluation Committee and received the final reimbursement adequacy decision.

 

Vabysmo, licensed as a treatment for neovascular or wet age-related macular degeneration and vision loss caused by diabetic macular edema, is a significant disease pathogenesis pathway, vascular endothelial growth factor-A (VEGF-A) and angiopoietin-2 (Ang-2) ), it is a new drug with a differentiated mechanism that targets all.

 

It is the first intraocular injection that enables administration at 4-month (16-week) intervals through licensed clinical research based on a new mechanism, and it can reduce the patient's treatment burden with fewer injections.

 

Vabysmo is administered by intravitreal injection once monthly (4 weeks) at the recommended dose of 6 mg (0.05 ml) for the first 4 doses.

 

After that, nAMD patients without disease activity are administered once every 4 months (16 weeks).

 

In patients with DME, the administration interval can be increased by 4 weeks and extended up to 4 months (16 weeks) according to the judgment of the medical staff.

 

Meanwhile, Vabysmo proved its effectiveness through four phase 3 studies, including clinical studies related to nAMD treatment, TENAYA and LUCERNE, and clinical studies related to DME treatment, YOSEMITE, and RHINE studies.

 

The double TENAYA and LUCERNE studies were non-inferiority trials comparing Vabysmo and Eylea in nAMD treatment.

 

As a result of the study, in the first year of treatment, Vabysmo treatment at intervals of up to 4 months (16 weeks) showed a non-inferior level of visual acuity improvement to Eylea treatment at intervals of 2 months (8 weeks).

 

In particular, in the first year of treatment, about 80% of the Vabysmo-administered group maintained a dosing interval of 3 months (12 weeks) or more.

 

In the recently announced results of the second year of treatment, it was found that more than 60% of patients maintained a 4-month (16-week) dosing interval, raising expectations that continuous clinical benefits will be provided to patients.