Over 52,000 citizens petition National Assembly for access to bile duct cancer immunotherapy

Despite proven clinical benefits, immunotherapy for bile duct cancer has remained uncovered by Korea’s national health insurance for nearly three years, leaving patients without access while other advanced countries have already adopted reimbursement.

As Korean patients remain unable to access treatment for a protracted period, calls are mounting for improving this situation.

The Korea Blood Disease and Cancer Association (KBDCA) visited the National Assembly on Tuesday and presented an opinion paper, urging the application of insurance coverage for immunotherapy drugs to enhance the treatment environment for patients with bile duct cancer. It also carried a petition, signed by 52,291 people who agreed with improving the treatment environment for bile duct cancer, and delivered it to the office of Rep. Suh Myung-ok of the People Power Party.

KBDCA also held a protest rally in front of the National Assembly building, holding pickets reading, “The last hope for bile duct cancer patients: We urge the inclusion of immunotherapy drug ‘Imfinzi’ in insurance coverage.” It requested the Ministry of Health and Welfare and the Health Insurance Review and Assessment Service to expedite their review and implementation.

The KBDCA conducted the “Bile Duct Cancer Clarity Campaign” from May 28 to July 5, a period of approximately one month, to raise awareness about the reality of bile duct cancer patients and the need to improve their treatment environment. As a result, 52,291 citizens participated and expressed their support.

Participants sent messages, such as, “We hope society will not turn a blind eye to others' suffering,” “Patients are not alone, and we will join forces to ensure that better treatment environments and support are provided.”

The KBDCA emphasized that these messages of solidarity are evidence of the high level of public demand for the reimbursement of immunotherapy drugs for bile duct cancer.

Bile duct cancer is a deadly cancer, with Korea marking the second-highest incidence rate and the highest mortality rate worldwide. Unlike other cancers, where survival rates have steadily improved, the five-year survival rate for bile duct cancer is 28.9 percent, significantly lower than that of stomach cancer (77.9 percent) and colorectal cancer (74.3 percent). Additionally, the average survival period for patients with inoperable bile duct cancer is only seven months. However, no immunotherapy drugs have been approved for insurance coverage for bile duct cancer to date.

In a clinical study led by Korean researchers, immunotherapy demonstrated efficacy, including a more than doubling of the overall survival rate at three years and a 26 percent reduction in the risk of death compared to standard therapy. However, despite receiving approval from the Ministry of Food and Drug Safety in November 2022, immunotherapy has not been covered by insurance for nearly three years, severely limiting patient access. In contrast, major countries, including Canada, the United Kingdom, Australia, and Japan, have recognized the clinical innovation and urgent need for reimbursement of immunotherapy drugs, improving patient access to treatment through rapid reimbursement.

“Bile duct cancer is a deadly form of cancer that is difficult to detect early and has limited treatment options. Therefore, the reimbursement of immunotherapy for bile duct cancer is a realistic hope that sustains the lives of patients and their families,” said Lee Chul-hwan, secretary-general of the KBDCA. “We cannot leave immunotherapy, which has shown the possibility of long-term survival to patients with an average survival period of just seven months, as an unattainable dream.”

Given that the proposal for reimbursement of immunotherapy for bile duct cancer is expected to be reviewed by the Health Insurance Review and Assessment Service’s Pharmaceutical Reimbursement Evaluation Committee in the second half of the year, the KBDCA urges the government and National Assembly to seriously consider the voices of 52,291 citizens and expedite the reimbursement process, Lee emphasized.