'Tevimbra' applies for reimbursement for five indications

following successfully obtaining the first reimbursement

Has applied for reimbursement on the day of additional approval for esophageal cancer, gastric cancer, and lung cancer

Attention has been gathered to BeOneMedicines, which announced reasonable drug pricing, for its subsequent actions

Product photo of Tevimbra

'Tevimbra' is quickly expanding following its successful inclusion in the insurance reimbursement for esophageal cancer.

 

BeOneMedicines Korea has been confirmed to have applied for reimbursement on the day of approval for five new indications for its PD-1 inhibitor immunotherapy Tevimbra (tislelizumab), which received additional approval in June.

 

In April, Tevimbra became the first immunotherapy to receive reimbursement for esophageal cancer.

 

Following this, it has added five new indications for solid tumors, including esophageal cancer, gastric cancer, and non-small cell lung cancer.

 

The specific expanded indications are ▲first-line combination therapy for unresectable, locally advanced, or metastatic esophageal cancer ▲first-line combination therapy for unresectable or metastatic, HER2-negative gastric or gastroesophageal junction adenocarcinoma ▲two types of first-line combination therapy, and second-line monotherapy for non-small cell lung cancer.

 

Tevimbra has already received approval from the U.S.

 

FDA for first- and second-line treatment of unresectable or metastatic esophageal squamous cell carcinoma, as well as for first-line treatment of advanced gastric cancer.

 

The European Medicines Agency (EMA) has also approved it for first- and second-line treatment of esophageal squamous cell carcinoma, first-line treatment of advanced gastric cancer, and first- and second-line treatment of non-small cell lung cancer.

 

Tevimbra is receiving various expanded indication in the global market.

 

Since the company, BeOne Medicines, has been quick to proceed with reimbursement procedures for additional indications, Tevimbra's role is expected to expand across various cancer types in Korea.

 

Expectations are particularly high due to BeOne Medicines' previous track record of successfully concluding negotiations with the government by advocating for 'reasonable drug pricing' since its initial listing.

 

The reason for the low reimbursement rate by indication for immunotherapies, including esophageal cancer, is, as expected, related to drug pricing and financial burden.

 

After reimbursement was applied to some cancer types, like lung cancer, the total amount claimed for immunotherapies and their share of the total cancer drug claims within the health insurance system significantly increased, raising concerns about the financial burden.

 

As of 2023, cancer drug claims totaled KRW 2.4 trillion, with immunotherapy claims accounting for approximately KRW 500 billion, or 20% of the total cancer drug claims.

 

It remains to be seen whether BeOne Medicines can uphold its company philosophy of 'providing innovative new drugs at a reasonable price and leaving no patient behind.' Meanwhile, the efficacy and safety of Tevimbra were proven in various indications through the RATIONALE clinical trial series (RATIONALE-303, 304, 305, 306, 307).

 

In esophageal squamous cell carcinoma and gastric or gastroesophageal junction adenocarcinoma, Tevimbra demonstrated clinical benefits in the overall patient population.

 

The trials showed consistent results in pre-specified subgroups based on PD-L1 expression.