'Tevimbra' can be prescribed at general hospitals

First immunotherapy for esophageal cancer

Has passed the drug committees of the 'Big 5'-designated tertiary general hospitals

Has passed the Cancer Disease Review Committee (CDRC) meeting, expecting to be considered for the DREC review

'Tevimbra,' a type of immune checkpoint inhibitor, is becoming more widely available for prescription at general hospitals.

 

According to industry sources, BeiGene's PD-1 inhibitor Tevimbra (tislelizumab), which has applied for reimbursement for its esophageal cancer indication, has passed the drug committees (DC) of tertiary general hospitals, including Samsung Medical Center, Seoul National University Hospital, Seoul St.

 

Mary's Hospital, and Asan Medical Center.

 

Tevimbra is a PD-1 inhibitory immune checkpoint inhibitor that demonstrated clinical usefulness as the second-line therapy for esophageal squamous cell carcinoma.

 

It was approved in South Korea in November 2023.

 

The drug passed the Cancer Disease Review Committee (CDRC) of the Health Insurance Review and Assessment Service (HIRA) in August in its second attempt and is awaiting consideration for the Drug Reimbursement Evaluation Committee (DREC) review.

 

Since there haven't been any immune checkpoint inhibitors with reimbursement for esophageal cancer, it remains to be watched whether Tevimbra will become available as the new treatment option.

 

Currently, seven immune checkpoint inhibitors have been approved or authorized for marketing in South Korea, including ▲Keytruda ▲Opdivo ▲Tecentriq ▲Imfinzi ▲Bavencio ▲Jemperli ▲Tevimbra.

 

The number of indications for these drugs totals 64.

 

However, only 21 therapies are reimbursement-listed (about 33%).

 

None of these drugs are included on the reimbursement list for the treatment of esgophageal cancer.

 

In South Korea, platinum-based anticancer chemotherapy is approved for reimbursement as both first-line therapy and second-line therapy or higher for esophageal squamous cell carcinoma.

 

The low reimbursement rate for immune checkpoint inhibitors in each indication, such as esophageal cancer, is due to drug price and finance.

 

It has been known that after drugs were reimbursed for treating several cancer types, such as lung cancer, the overall claim amount for immune checkpoint inhibitors and the percentage of anticancer agents under the National Health Insurance significantly increased, resulting in a financial burden.

 

Based on the 2023 report, the claim amount of anticancer agents was KRW 2.4 trillion.

 

The claim amount for immune checkpoint inhibitors was about KRW 500 billion, accounting for 20% of the anticancer agents' claims.

 

Patients have high hopes for BeiGene's Tevimbra because the company announced the drug supply at a relatively lower price.

 

BeiGene has already demonstrated its 'Fair pricing of innovative new drugs' philosophy to eliminate potentially excluded patients through the reimbursement procedure for the blood cancer treatment, 'Brukinsa (zanubrutinib).' Meanwhile, the global Phase 3 clinical RATIONALE-302 study showed Tevimbra prolonged the median overall survival (OS) by 2.3 months compared to chemotherapy (8.6 months vs.

 

6.3 months), statistically reducing the death risk by 30%.

 

The response rate was twofold higher in Tevimbra compared to chemotherapy (20% vs.

 

10%), and Tevimbra extended the median duration of response (DOR) by approximately three months, from 4.0 months to 7.1 months.

 

As a result, the National Comprehensive Cancer Network (NCCN) Guidelines were revised, detailing Category 1 recommendation for Tevimbra as a favorable option for second-line therapy for esophageal squamous cell carcinoma.