Cinqair’s quicker reimb renders reimb difficult for others

renders reimbursement difficult for the other 2 asthma drugs

Whether the other 2 drugs can be reimbursed through RSA gains attention...RSA track virtually impossible if Cinqair is listed first

Attention is rising on the progress of the two new asthma drugs that chose to receive reimbursement through the RSA track, unlike Cinquair.

 

According to industry sources, GSK Korea’s ‘Nucala (mepolizumab)’ has recently been reviewed by the Health Insurance Review and Assessment Service’s Risk Sharing Agreement (RSA) subcommittee for reimbursement.

 

However, no news has been heard for AstraZeneca Korea’s Fasenra (benralizumab)’ yet.

 

Unlike Teva-Handok’s Cinqair (reslizumab), which opted to take the general reimbursement listing track, the two drugs faced difficulties after passing the Drug Reimbursement Evaluation Committee review in July.

 

If Cinqair completes drug pricing negotiations and is listed with reimbursement, it becomes virtually impossible for the other two drugs to receive reimbursement through the RSA track.

 

Although the RSA subcommittee reviewed Nucala’s reimbursement, whether it can continue on the reimbursement discussions for RSA also remains to be seen.

 

No other drug has been reimbursed for severe asthma since the reimbursement approval of Novartis Korea’s ‘Xolair (omalizumab)’ in 2020 Although the three drugs seem similar to Xolair as all are indicated to treat ‘asthma,’ Xolair can only be used for allergic asthma.

 

Therefore, the drugs’ indications do differ.

 

However, the government used Xolair as a comparator for reimbursement review, and the drug price set using Xolair was too low for the three new biological agents to accept.

 

This is why the companies had foregone the reimbursement listing process.

 

Nucala’s efficacy was demonstrated through the Phase III DREAM, MENSA, and SIRIUS studies.

 

Among these, MENSA is the main trial for the drug, and its results were published in the NEJM in 2014.

 

The MENSA study was conducted on patients with severe asthma who experienced exacerbations despite the use of various controller medications including high-dose inhaled corticosteroids (ICS).

 

In particular, patients whose blood eosinophil count was ≥150 cells/μL at screening (≥300 cells/μL in the previous year) enrolled in the study.

 

The patients received mepolizumab or placebo and were assessed for the annualized rate of clinically significant exacerbations.

 

Results showed that at Week 32, the rate of exacerbations was reduced by 47% among patients receiving intravenous mepolizumab 75mg and by 53% among those receiving subcutaneous mepolizumab 100mg, as compared with those receiving placebo.

 

At week 32, patients receiving Nucala had also shown significant improvement in quality of life and showed higher levels of satisfaction in terms of asthma control.