AstraZeneca’s Imfinzi, Imjudo, and Ultomiris clear reimbursement panel review

AstraZeneca's anti-PD-L1 immune checkpoint inhibitor Imfinzi (durvalumab), the anti-CTLA-4 immune checkpoint inhibitor Imjudo (tremelimumab), and the C5 complement inhibitor Ultomiris (ravulizumab) were reviewed by the Health Insurance Review and Assessment Service (HIRA)’s Pharmaceutical Reimbursement Evaluation Committee (PREC). All three drugs passed the review.

HIRA held its 11th PREC meeting on Thursday and announced the results.

The head office of Health Insurance Review and Assessment Service (HIRA) in Wonju, Gangwon Province.

Imfinzi was approved for reimbursement for first-line treatment of hepatocellular carcinoma in combination with Imjudo (STRIDE therapy), and first-line treatment of cholangiocarcinoma in combination with gemcitabine and cisplatin (GemCis).

For liver cancer, the STRIDE regimen starts with Imfinzi and Imjudo, then switches to Imfinzi alone.

AstraZeneca received PREC reimbursement approval two-and-a-half years after MFDS approved STRIDE in June 2023.

According to industry sources, the STRIDE regimen was evaluated using a cost-minimization approach compared to the existing treatment (atezolizumab + bevacizumab). Its incremental cost-effectiveness ratio (ICER) was recognized based on the “mean duration of treatment (DoT).”

AstraZeneca received approval from the MFDS in November 2022 for the combination therapy of Imfinzi and GemCis for the treatment of bile duct cancer. The company passed the PREC after three years.

However, since last March, the HIRA has only partially reimbursed GemCis (5/100), meaning patients have been using Imfinzi under full out-of-pocket conditions (100/100).

Both combination therapies will likely be covered by insurance. In particular, this coverage would begin once they pass the National Health Insurance Service (NHIS) price negotiations and receive approval from the Health Insurance Policy Deliberation Committee.

“We welcome the PREC’s decision to expand treatment access for patients with bile duct and liver cancer,” an AstraZeneca Korea official said. “We will engage in price negotiations with the NHIS to ensure patients get optimal treatment as soon as possible. We are committed to enabling tangible treatment benefits within the first quarter of next year.”

Additionally, although not included in the deliberation list released by HIRA, the PREC also discussed and approved expanding the reimbursement criteria for Ultomiris, a treatment for myasthenia gravis. Beyond AstraZeneca's therapies, several other drugs were also reviewed at the meeting.

Specifically, Ultomiris is indicated as adjuvant therapy to standard treatment in adults with generalized myasthenia gravis (gMG) who are positive for anti-acetylcholine receptor (AChR) antibodies.

AstraZeneca voluntarily lowered the drug price to secure coverage approval for Ultomiris, thereby bypassing price negotiations with the NHIS.

In such cases, coverage usually begins next month after a report to the Health Insurance Policy Review Committee.

The PREC also approved Janssen's Balversa (erdafitinib), Takeda's Takhzyro Prefilled Syringe (ranadelumab), and Antengene's Xpovio (selinexor).

Balversa was approved for adults with FGFR3-mutated advanced or metastatic urothelial carcinoma after PD-(L)1 therapy.

Takhzyro was approved for adults and adolescents 12 or older to prevent hereditary angioedema attacks.

Xpovio was approved for expanded coverage, provided that payments do not exceed the assessed value for the bortezomib and dexamethasone combination in adults with multiple myeloma who have received at least one prior therapy.