AZ Achieves dual milestone in liver and biliary tract cancers

AZ completes price negotiations with NHIS for immunotherapy ‘Imjudo’

Second successful case of flexible ICER application following ‘Trodelvy’

AstraZeneca has achieved a significant milestone. AstraZeneca’s immunotherapy-based combination regimens in both hepatocellular carcinoma (HCC) and biliary tract cancer (BTC) are expected to be simultaneously listed for reimbursement in Korea.

According to Dailypharm coverage, AstraZeneca Korea recently concluded price negotiations with the National Health Insurance Service for the combination therapy of the PD-L1 inhibitor ‘Imfinzi (durvalumab)’ and the CTLA-4 inhibitor ‘Imjudo (tremelimumab)’ as first-line treatment for adult patients with advanced or unresectable hepatocellular carcinoma.

In parallel, reimbursement pricing was also concluded for Imfinzi in combination with gemcitabine and cisplatin for first-line treatment of patients with locally advanced or metastatic biliary tract cancer.

This achievement comes approximately 3 months after Imfinzi and Imjudo passed the Drug Reimbursement Evaluation Committee (DREC) review in November last year. For biliary tract cancer, this marks the emergence of a new treatment option in nearly a decade.

The journey toward reimbursement listing for the Imfinzi-based combination regimens was not smooth. In November 2024, the Imfinzi + chemotherapy regimen for HCC, and the Imjudo combination regimen for BTC successfully passed the Cancer Drug Review Committee. However, when submitted to DREC 10 months later in September of the following year, both regimens received a redeliberation decision.

In this context, passing the DREC review in November and concluding the price negotiation demonstrates the pharmaceutical company's efforts. The government's second flexible application of the ICER threshold, following the antibody-drug conjugate (ADC) anticancer drug Trodelvy (sacituzumab govitecan), also played a significant role.

The Imfinzi and Imjudo combination therapy involves administering the combination only once initially, followed by maintenance therapy with Imfinzi alone. This approach reduces the burden of administration compared to existing standard therapies that include VEGF antibodies and offers the advantage of being suitable for patients with vascular invasion.

This therapy demonstrated improved overall survival (OS) in the HIMALAYA study, which became the first Phase III clinical trial targeting patients with unresectable hepatocellular carcinoma receiving first-line treatment to show such benefit.

There had been virtually no treatment option that demonstrated safety and efficacy through a large-scale Phase 3 clinical trial in first-line biliary tract cancer. Imfinzi, which had been partially non-reimbursed in this area, became the new standard of care after over a decade, based on the improved overall survival in the TOPAZ-1 study when used in combination with gemcitabine and cisplatin.