Expanded reimb for Imfinzi will be available next month

First-line treatment criteria have been established for use in combination with Imjudo

For biliary tract cancer, reimbursement criteria are applicable up to 1 year of treatment…can be extended for up to 2 years

AstraZeneca Korea's Imfinzi 

New reimbursement criteria for anticancer drugs will be established ahead of the expanded insurance coverage for AstraZeneca Korea's Imfinzi (durvalumab), an immunotherapy used to treat cancer.

Starting in March, Imfinzi combination therapy will be added for both liver cancer and biliary tract cancer. Notably, in liver cancer, the drug achieved dual success by simultaneously proving its combination therapy with Imjudo (tremelimumab).

On the 23rd, the Health Insurance Review and Assessment Service (HIRA) announced that it is currently conducting an opinion survey regarding the revision of the "Application criteria for National Health Insurance reimbursement for drugs prescribed and administered to cancer patients." After the survey ends on the 25th, the revised contents will be applied starting in March.

For liver cancer, the combination therapy with Imjudo will be newly established. Reimbursement is limited to patients with advanced hepatocellular carcinoma who are ineligible for surgery or local treatment and who meet specific criteria.

The reimbursement criteria are appliable up to 1 year of treatment. However, if clinical results for the administration period within that year have not been published, reimbursement will be automatically extended for up to 2 years.

For biliary tract cancer, the combination therapy of Imfinzi (durvalumab) + gemcitabine + cisplatin will be newly established. Insurance coverage will apply to patients with unresectable locally advanced or metastatic biliary tract cancer. This is limited to adenocarcinoma and excludes ampullary Vater carcinoma.

Gemcitabine and cisplatin will not be administered after the initial 8 cycles of combination therapy. The reimbursement period is the same as that for the liver cancer combination therapy.

Imfinzi is becoming reimbursed for two combination therapies. Consequently, Imfinzi prescriptions, which had been concentrated on lung cancer, are expected to expand into liver cancer and biliary tract cancer.

In particular, it will emerge as a new treatment option for biliary tract cancer. Imfinzi is the second drug to receive a flexible Incremental Cost-Effectiveness Ratio (ICER) for an innovative new drug.

In this revision, Janssen Korea's Balversa (erdafitinib) monotherapy for urothelial carcinoma was also newly established. It is indicated for second-line or later use, and the target population is "patients with unresectable locally advanced or metastatic urothelial carcinoma with FGFR3 genetic alterations whose disease has progressed during or following at least one prior systemic therapy, including a PD-1 or PD-L1 inhibitor."

For multiple myeloma, a second-line or later combination therapy of Antengene's Xpovio (selinexor) + bortezomib + dexamethasone was newly established. It can be administered to patients with multiple myeloma who have failed previous treatments.

Xpovio received a decision on reimbursement expansion conditions from the Drug Benefit Evaluation Committee meeting last November, which required the company to accept a price below the evaluated amount.