Immuno-oncology Drug for 30,000 Bile Duct Cancer Patients May Receive Insurance Coverage This Fall

With more than 5,000 people losing their lives to bile duct cancer each year in Korea, it is expected that, as early as the second half of this year, health insurance coverage will be applied for the first time to an immuno-oncology drug for bile duct cancer.

AstraZeneca's immuno-oncology drug 'Imfinzi'. Korea AstraZeneca

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According to industry sources on May 27, there are expectations that health insurance coverage for AstraZeneca's immuno-oncology drug for bile duct cancer, Imfinzi (ingredient name: durvalumab), could be finalized as early as this fall. If this happens, Imfinzi will become the first immuno-oncology drug for bile duct cancer to be covered by insurance in Korea.

According to the Health Insurance Review and Assessment Service (HIRA), as of 2023, there were approximately 27,602 bile duct cancer patients in Korea, and 5,500 people died from the disease. Korea has the second highest incidence rate of bile duct cancer in the world and the highest mortality rate globally.

Targeted and immuno-oncology drugs for bile duct cancer have only emerged relatively recently. In Korea, AstraZeneca's Imfinzi received approval for bile duct cancer in November 2022, and MSD (Merck)'s Keytruda received approval for the same indication in April last year. Currently, Imfinzi is the only drug undergoing the health insurance application process.

Imfinzi passed the 'clinical usefulness' and 'coverage criteria' evaluations at HIRA's Cancer Disease Review Committee in November last year, and is currently undergoing a 'cost-effectiveness' evaluation by the Economic Evaluation Subcommittee. The industry consensus is that the results of this evaluation will be released around the middle of this year, as there is a set timeline for the insurance listing process for new drugs. If the results are positive, insurance coverage could be applied in the fall of this year, roughly 100 days from now.

The insurance listing process for new drugs is divided into seven main steps. First, HIRA reviews the following within 150 days: ▲clinical usefulness, ▲coverage criteria, ▲cost-effectiveness, and ▲appropriateness of coverage. Next, the National Health Insurance Service negotiates the drug price within 60 days, and the Ministry of Health and Welfare conducts the Health Insurance Policy Deliberation Committee review and the official drug price announcement within 30 days.

Initially, it was widely believed that insurance coverage for Imfinzi would be difficult due to its high cost. In the case of combination therapy using Imfinzi with Gemcis, the annual treatment cost reaches approximately 150 million won.

However, the situation changed after HIRA revised the 'Detailed Evaluation Criteria for Negotiated Drugs Including New Drugs' in August last year. The revision introduced flexibility in the insurance evaluation of new drugs that meet the 'innovation' requirement. As a result, in February, Trodelvy, a triple-negative breast cancer treatment, was recognized as appropriate for insurance coverage despite its high price. This was the first drug to which HIRA's revised system was applied.

If Imfinzi receives insurance coverage, there are high expectations that the relative survival rate for bile duct cancer (the probability that cancer patients survive for five years compared to the general population) will improve. This expectation is based on the fact that cancer types for which targeted and immuno-oncology drugs have been covered by insurance have seen increases in survival rates.

According to the National Cancer Information Center, in the case of lung cancer, the five-year relative survival rate improved from 27.7% (2011-2015) to 40.6% (2018-2022) after 15 targeted and immuno-oncology drugs were covered by insurance between 2011 and 2020. However, for bile duct cancer, which has no targeted or immuno-oncology drugs covered by insurance, the five-year relative survival rate remained almost unchanged, from 28.9% to 29.4% over the same period.

Hong Jungyong, a professor in the Division of Hematology and Oncology at Samsung Medical Center, explained, "The combination therapy using durvalumab, a representative immuno-oncology drug for bile duct cancer, improved the overall survival rate more than twofold after two years compared to the existing standard chemotherapy. Since this therapy is recommended as the global standard of care for bile duct cancer, lowering the barriers to its use will benefit many patients."

Currently, combination therapy with durvalumab for bile duct cancer patients is covered by insurance in major countries such as the United States, United Kingdom, Japan, Germany, and Australia. At the '2024 European Society for Medical Oncology (ESMO)' held in Barcelona, Spain last year, the Pan-Asian Bile Duct Cancer Patient Guideline was announced, strongly recommending this therapy as a first-line treatment for advanced bile duct cancer and calling for rapid insurance coverage.

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