How Tevimbra was reimbursed in Korea first

than in the A8 countries

Considered the high prevalence of esophageal cancer in Korea... proposed a reasonable drug price

First esophageal cancer drug to be reimbursed... Only one year and four months after approval

BeiGene Korea's Tevimbra will be reimbursed in Korea from next month as a second-line treatment for esophageal squamous cell carcinoma, a type of esophageal cancer.

 

It is the first immuno-oncology drug to be covered for esophageal cancer.

 

In particular, the drug is drawing attention as it was covered in South Korea before the A8 countries (the United States, the United Kingdom, Germany, France, Italy, Switzerland, and Japan) known as the government’s reference countries for reimbursement coverage.

 

The reason why the drug received prompt reimbursement in Korea is that the insurance authorities have taken into account Korea’s situation, where the prevalence of esophageal cancer is relatively higher than in other countries, and that the pharmaceutical company, BeiGene Korea, also presented a reasonable drug price.

 

According to industry sources on the 21st, Tevimbra (tislelizumab, BeiGene Korea) will be reimbursed starting next month for unresectable, recurrent, locally advanced, or metastatic esophageal squamous cell carcinoma that has relapsed or progressed during or after previous platinum-based chemotherapy.

 

It is the first PD-1 inhibitor-based immuno-oncology drug to be covered by the National Health Insurance for esophageal cancer.

 

Squamous cell carcinoma accounts for the largest proportion of esophageal cancer, accounting for 91% of esophageal cancer cases.

 

In particular, its prevalence is reportedly higher in East Asia compared to that in North American and European countries.

 

Its prognosis is also poor.

 

Most cases are detected when the disease has progressed to a significant degree, so the survival rate is not high.

 

According to data from the Korea Central Cancer Registry, the 5-year relative survival rate for esophageal cancer from 2017 and 2021 was only 42.8%.

 

Platinum-based chemotherapy is mostly used as the first-line treatment for esophageal cancer, and docetaxel is used as the second-line or later treatment.

 

Compared to existing anticancer drugs, immuno-oncology drugs have shown significant improvements in overall survival but are not widely used because they are not reimbursed by the National Health Insurance.

 

Due to this situation, the health authorities reportedly have given high scores for Tevimbra in terms of its clinical utility.

 

Experts at the Drug Reimbursement Evaluation Committee said, “Compared to the chemotherapy group, Tevimbra showed a significant improvement in overall survival and is safer with a lower risk of side effects than chemotherapy.

 

Currently, there are no immuno-oncology drugs reimbursed for esophageal squamous cell carcinoma in Korea, and due to the many limitations in treatment options, Tevimbra’s introduction is necessary.” Such expert opinions were heavily reflected in the review of the drug's adequacy of reimbursement.

 

“The fact that the number of esophageal cancer patients in Korea is higher than in the US and Europe and that the prognosis is poor was taken into consideration,” said a HIRA official.

 

“It was difficult to assess the drug because it was not listed for reimbursement in the A8 countries and was not mentioned in major reference textbooks, but the review was conducted with a focus on the drug’s clinical aspects.” Of course, there were results from clinical studies that showed significant improvements in overall survival and progression-free survival, but there were relatively few references to textbooks or other such materials.

 

However, there was a clinical practice guideline - the NCCN guidelines in the United States – which recommended the drug as a second-line or higher monotherapy.

 

The company’s proposal of a reasonable drug price was also granted for the drug’s prompt reimbursement.

 

BeiGene Korea was recognized for its cost-effectiveness by submitting the results of a pharmacoeconomic evaluation compared to docetaxel and the results of a cost-utility analysis using RSA plans (refund and expenditure cap type).

 

BeiGene Korea has announced that it will offer a low drug price to ensure the rapid supply of Tebipembrolizumab.

 

It is reported that the drug will be supplied at a 10% discount from existing treatments in the United States.

 

Currently, the only immuno-oncology drugs that are undergoing the reimbursement process for esophageal cancer are Keytruda and Opdivo.

 

They have been approved as first-line treatments, not second-line treatments.

 

However, unlike these drugs, Tevimbra has the advantage of being able to be used regardless of PD-L1 expression.

 

Tevimbra is an anticancer drug developed in China in 2019.

 

The domestic approval was granted in November 2023, and the drug was successfully listed for reimbursement in 1 year and 4 months.

 

Its price is KRW 1,206,000 per bottle, and it is expected to cost about KRW 9.65 million per year.

 

If the 5% co-insurance rate is applied, the annual drug cost for the patients will be reduced to about KRW 480,000, which is a relatively low price for an immuno-oncology drug.