Novartis' Xolair self-administration prescribed at GHs

Passed DC reviews at 8 medical institutions, including SNUH and Asan Medical Center

75mg solution to be reimbursed from January, 150mg from October

The self-administration formulation of the asthma treatment ‘Xolair’ can now be prescribed at general hospitals.

 

According to industry sources, Novartis Korea’s Xolair (omalizumab) prefilled syringe 75mg solution has passed the review of drug committees (DCs) in 8 general hospitals nationwide, including the Seoul National University Hospital, Seoul Asan Medical Center, and Cheonnam National University Hospital.

 

On December 20th, 2018, Novartis had abruptly withdrawn Xolair's application amid negotiations with the National Health Insurance Service (NHIS) after receiving the nod on its reimbursement feasibility.

 

The reason for the sudden withdrawal was the company's concern over its impact on the Chinese market, as the drug price set in Korea may negatively affect the drug price in China as well.

 

The incident made an exemplary case of the ‘Korea Passing’ phenomenon.

 

After launching Xolair in China in 2019, Novartis reconducted the pharmacoeconomic evaluation procedure to apply for reimbursement listing in Korea.

 

As a result, the Xolair injection was first listed in July last year.

 

The maximum reimbursed price for the Xolair injection and the Xolair prefilled syringe injection in 150mg is 271,700 won, and 143,000 won for the Xolair prefilled syringe injection in 75mg.

 

However, due to Novartis’s internal supply issues, the Xolair prefilled syringe 75mg solution started reimbursement in January of this year.

 

The prefilled syringe 150mg solution will be reimbursed from October.

 

Novartis's plan is to quickly proceed with the landing process in general hospitals as soon as the supply of pre-field syringe solutions begins.

 

Various trials on Xolair including the ASTERIA, GLACIAL, OPTIMA, XTEND-CIU, and X-ACT have demonstrated that Xolair ▲rapidly improves symptoms and quality of life of chronic idiopathic urticaria patients; ▲alleviates symptoms of patients who do not respond to antihistamine treatment or leukotriene receptor antagonists; ▲is safe and continuously effective for long-term use; ▲can manage symptoms when used for retreatment after discontinuation.

 

The clinical effect of Xolair in treating allergic asthma has been confirmed through the INNOVATE study conducted on 419 patients from 108 centers in 14 countries.

 

The rate of clinically significant asthma exacerbations, the primary efficacy endpoint in the INNOVATE trial, was 0.68 for the Xolair group and 0.91 for the placebo group, demonstrating a significant difference between the two groups.

 

Response of patients evaluated using the Global Evaluation of Treatment Effectiveness (GETE) showed that 64.3% of the patients responded favorably to Xolair, as reflected by a GETE rating of “excellent” or “good."