Imjudo, Imfinzi, Xpovio in reimb discussions with NHIS

NHIS negotiating prices for three new drugs and two indication expansions

AstraZeneca nearing reimbursement for two products, listing expected early next year

Imjudo (tremelimumab) and Imfinzi (durvalumab) are in price negotiations with Korea’s National Health Insurance Service (NHIS), bringing the drugs closer to reimbursement listing.

Once they clear the final hurdle with the NHIS, Imjudo will be newly reimbursed for use in combination with Imfinzi in hepatocellular carcinoma, while Imfinzi is expected to secure a reimbursement expansion for use in combination with gemcitabine and cisplatin in biliary tract cancer.

According to industry sources on the 26th, the NHIS is conducting price negotiations for three new drugs and two coverage expansion items.

These drugs all passed the Drug Reimbursement Evaluation Committee in November. AstraZeneca Korea is negotiating the reimbursement of both Imjudo and Imfinzi simultaneously.

If negotiations conclude as expected, Imfinzi will secure reimbursement for two combination regimens at once: combination therapy with Imjudo and the GemCis (gemcitabine + cisplatin) regimen.

AstraZeneca is expected to expand Imfinzi’s use beyond its previous focus on lung cancer into liver cancer and biliary tract cancer.

AstraZeneca is expected to expand Imfinzi prescriptions, previously focused on lung cancer, to include liver and bile duct cancers.

Additionally, new drugs under negotiation include Janssen Korea's Balversa Tab 3, 4, 5mg (erdafitinib) and Takeda Korea's Takhzyro Prefilled Syringe 300mg (lanadelumab).

Balversa Tab, a new targeted therapy for bladder cancer, received reimbursement adequacy approval for treating adult patients with locally advanced or metastatic urothelial carcinoma. Takhzyro Prefilled Syringe received reimbursement adequacy approval for preventing attacks of hereditary angioedema in adults and adolescents. Both products are now awaiting final price agreements.

Xpovio 20 mg Tab (selinexor) from Antengene, which received reimbursement expansion approval alongside Imfinzi in November, has also entered price negotiations. Xpovio was approved for reimbursement expansion for use in combination with bortezomib and dexamethasone in adult patients with multiple myeloma who have received at least one prior therapy.

However, unlike the other products, Xpovio’s approval came with a conditional clause stipulating that reimbursement expansion is deemed appropriate only if the company accepts a price at or below the evaluated price. If the company is unable to accept the proposed price, there remains a possibility that negotiations could break down.