Imfinzi denied reimb for bile duct cancer for the 3rd year

Will the drug make it to reimbursement in the second half of the year

Expected to be submitted to the Drug Reimbursement Evaluation Committee... Attention focused on listing discussions

Major developed countries apply flexible ICER considering disease characteristics

Attention is focused on whether there will be progress in the reimbursement process for Imfinzi for bile duct cancer, which has remained non-reimbursed for three years now.

 

According to industry sources, the Health Insurance Review and Assessement Service's Drug Reimbursement Evaluation Committee may likely review the agenda of expanding the reimbursement of AstraZeneca Korea's PD-L1 inhibitor immunotherapy Imfinzi (durvalumab) for bile duct cancer in the second half of the year.

 

In the harsh environment of bile duct cancer, where the average survival period was just over seven months, the emergence of Imfinzi brought about a change in the treatment landscape.

 

Imfinzi demonstrated more than a twofold improvement in overall survival rate compared to the standard chemotherapy regimen at the three-year mark, and in a subgroup analysis of Korean patients, it proved to provide even better survival benefits than the overall patient population.

 

Countries such as Canada, the United Kingdom, Australia, Japan, and Taiwan quickly reimbursed Imfinzi in recognition of its clinical innovation.

 

In the case of the United Kingdom, considering the poor reality of bile duct cancer treatment and the fact that Imfinzi is the first first-line treatment for bile duct cancer, the ICER threshold was applied flexibly by exceptionally weighting the quality-adjusted life years (QALY) during the pharmacoeconomic evaluation process.

 

However, in South Korea, reimbursement barriers remain, limiting patients' access to treatment.

 

It has been three years since Imfinzi was approved by the Ministry of Food and Drug Safety as a first-line treatment for metastatic bile duct cancer.

 

The indication for bile duct cancer was approved by the Cancer Review Committee in November 2024, but there has been no significant progress to date.

 

Jung-yong Hong, Professor of Hematology and Oncology at Samsung Medical Center, said, “The ultimate goal of the government, pharmaceutical companies, and medical professionals is to provide Imfinzi’s treatment benefits, proven as standard therapy, to bile duct cancer patients as quickly as possible.

 

Measures to strengthen institutional flexibility must be explored to enhance treatment access for bile duct cancer patients.”