Nucala retries insurance benefits for the first time in five

Attention to respiratory biomedical options

Nucala, a respiratory antibody drug, is seeking to register insurance benefits again.

 

According to related industries, GSK Korea recently submitted an application for the salary of Nucala, a severe eosinophilic asthma treatment.

 

It is the first re-challenge in about five years since the non-reimbursed decision of the Drug Benefit Evaluation Committee of the Health Insurance Review and Assessment Service in 2017.

 

At that time, the committee decided that the cost effectiveness was unclear as a result of Nucala's PE data analysis.

 

Nucala is an interleukin (IL)-5 antagonist that reduces eosinophilic levels, a type of white blood cell involved in asthma triggers.

 

Currently, it can be used as an additional maintenance treatment for asthma treatment in adult patients suffering from severe eosinophilic asthma with 150 cells/㎕ or more in the blood or 300 cells/㎕ or more in the blood within 12 months before the start of ▲ treatment, and is prescribed as a non-reimbursement.

 

Nucala proved its validity through phase DREAM, MENSA, and SIRIUS studies.

 

Among them, MENSA was published in the NEJM in 2014 as a representative study of this drug.

 

This study was conducted on patients with severe asthma who developed exacerbations despite the use of several regulators, including high-dose inhaled corticosteroids (ICS), and in particular, patients with increased eosinophils by more than 150 cells/㎕ (more than 300 cells/㎕ a year ago) were recruited in the initial screening.

 

They were administered Mepolizumab and placebo, and the annual incidence of exacerbation was observed.

 

As a result, the annual incidence of exacerbation in the Mepolizumab 75mg intravenous treatment group at 32 weeks decreased by 47% compared to the placebo group, and the Mepolizumab 100mg subcutaneous injection treatment group also decreased by 53%.

 

In addition, the quality of life was improved, and asthma control satisfaction was higher than placebo.

 

The SIRIUS study observed dose changes in OCS after 20–24 weeks when Mepolizumab was administered in patients with oral corticosteroids (OCS).

 

As a result, the dose of OCS in the Mepolizumab 100 mg subcutaneous injection group was reduced by 50% compared to the placebo group, and asthma control satisfaction and quality of life evaluation were significantly improved.

 

This study was published in the ERJ in 2014 as the first to demonstrate a decrease in the dose of OCS when administering antibody drugs.

 

In addition, various sub-analysis confirmed the effect of improving the incidence rate of deterioration and quality of life according to the eosinophil level.