- Date2025-11-18
Publication of Review Result of the 6th Serious Illness (Cancer) Review Committee of 2025
□ The Health Insurance Review and Assessment Service (HIRA, President: Kang Jung-Gu) announces the results of the “deliberation on reimbursement criteria for drugs used in cancer patients,” reviewed at the 6th Cancer Disease Review Committee meeting held on July 23, 2025.
○ New Drugs (Applications for Reimbursement) and Expanded Reimbursement Criteria
|
Type |
Product |
Manufacturer |
Indications |
Deliberation Result |
|
Applications for reimbursement |
Darzalex SC Injection (Daratumumab) |
Janssen Korea Ltd. |
1 Combination with bortezomib, melphalan, and prednisolone for newly diagnosed multiple myeloma patients ineligible for autologous stem cell transplant. 2. Combination with bortezomib, thalidomide, and dexamethasone for newly diagnosed multiple myeloma patients eligible for autologous stem cell transplant. 3. Combination with lenalidomide and dexamethasone for newly diagnosed transplant-ineligible or previously treated multiple myeloma patients. 4. Combination with bortezomib and dexamethasone for previously treated multiple myeloma patients. 5. Treatment of relapsed or refractory multiple myeloma after at least three prior therapies, including a proteasome inhibitor and an immunomodulatory agent. |
Reimbursement criteria not established |
|
Applications for reimbursement |
Darzalex SC Injection (Daratumumab) |
Janssen Korea Ltd. |
Combination with bortezomib, cyclophosphamide, and dexamethasone for newly diagnosed light-chain (AL) amyloidosis patients. |
Reimbursement criteria established |
|
Polivy Injection (Polatuzumab Vedotin) |
Roche Korea Co., Ltd. |
For previously untreated adult patients with diffuse large B-cell lymphoma (DLBCL), in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone/prednisolone (R-CHP). |
Reimbursement criteria established | |
|
Polivy Injection (Polatuzumab Vedotin), Roche Korea Co., Ltd. For adult patients with relapsed or refractory DLBCL who are ineligible for stem cell transplantation and have failed at least one prior therapy, in combination with bendamustine and rituximab. |
Reimbursement criteria not established | |||
|
Expansion of reimbursement criteria |
Neulasta Prefilled Syringe Injection (Pegfilgrastim) and others |
Kyowa Kirin Co., Ltd., etc. |
Reduction of the incidence and duration of febrile neutropenia in patients receiving cytotoxic chemotherapy for malignant tumors. |
Reimbursement criteria established |
|
Verzenio Tablets (Abemaciclib) |
Eli Lilly Korea Co., Ltd. |
As adjuvant therapy in combination with endocrine therapy for adult patients with early-stage breast cancer at high risk of recurrence, hormone receptor (HR)-positive, HER2-negative, and lymph node-positive. |
Reimbursement criteria not established | |
|
Tecentriq Injection (Atezolizumab) |
Roche Korea Co., Ltd. |
As adjuvant therapy following surgery and platinum-based chemotherapy for patients with stage II–IIIA non-small cell lung cancer whose tumor cells (TC) express PD-L1 ≥50%. |
Reimbursement criteria established | |
|
Blincyto Injection (Blinatumomab) |
Amgen Korea Co., Ltd. |
As consolidation therapy for adult and pediatric patients with Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (ALL). |
Reimbursement criteria established |
|
※ In accordance with Articles 5 and 5-2 of the “Regulations on Standards for National Health Insurance Benefits,” the President of the Health Insurance Review and Assessment Service (HIRA) may announce detailed standards and methods for applying coverage to drugs prescribed or administered to patients with severe diseases, for drugs designated and notified by the Minister of Health and Welfare, following deliberation by the Severe Disease Review Committee. The coverage criteria for such drugs may be set differently within the range of approved indications by the Ministry of Food and Drug Safety, based on clinical literature, domestic and international guidelines, and expert opinions. The coverage decision and criteria may change during subsequent procedures. |
