- Date2025-11-18
Publication of Review Result of the 7th Serious Illness (Cancer) Review Committee of 2025
□ The Health Insurance Review and Assessment Service (HIRA, President: Kang Jung-Gu) announces the results of the 7th Cancer Disease Deliberation Committee held on September 3, 2025, regarding the reimbursement criteria for drugs used in cancer patients.
○ New Drugs (Applications for Reimbursement) and Expanded Reimbursement Criteria
|
Type |
Product |
Manufacturer |
Indications |
Deliberation Results |
|
Applications for reimbursement |
Retevmo Capsule (Selpercatinib) |
Retevmo Capsule (Selpercatinib) |
1. Locally advanced or metastatic RET (REarranged during Transfection) fusion-positive non-small cell lung cancer (NSCLC) |
Reimbursement criteria established |
|
2. Advanced or metastatic RET-mutant thyroid medullary carcinoma requiring systemic therapy |
Reimbursement criteria established | |||
|
3. RET fusion-positive thyroid cancer requiring systemic therapy in patients previously treated with sorafenib and/or lenvatinib |
Reimbursement criteria established | |||
|
Rybrevant Injection (Amivantamab) |
Janssen Korea Ltd. |
1. First-line treatment in adults with locally advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations, in combination with carboplatin and pemetrexed |
Reimbursement criteria not established | |
|
2. Monotherapy in adults with locally advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations whose disease has progressed during or after platinum-based chemotherapy |
Reimbursement criteria established | |||
|
3. First-line treatment in adults with locally advanced or metastatic NSCLC harboring EGFR exon 19 deletion or exon 21 (L858R) substitution mutations, in combination with lazertinib |
Reimbursement criteria not established | |||
|
4. Combination with carboplatin and pemetrexed in adults with locally advanced or metastatic NSCLC harboring EGFR exon 19 deletion or exon 21 (L858R) substitution mutations, previously treated with EGFR TKIs |
Reimbursement criteria not established | |||
|
Expansion of reimbursement criteria |
Lynparza Tablets (Olaparib) |
AstraZeneca Korea Co., Ltd. |
1. Treatment of adult patients with BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC) whose disease progressed after prior novel hormonal therapy |
Reimbursement criteria established |
|
2. Combination with abiraterone and prednisolone in adult patients with mCRPC who have not received prior chemotherapy after diagnosis |
Reimbursement criteria established (BRCA mutation) | |||
|
3. Combination maintenance therapy in adults with homologous recombination deficiency (HRD)-positive (BRCA mutation or defined by genomic instability), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who responded (partial or complete response) to first-line platinum-based chemotherapy with bevacizumab |
Reimbursement criteria established | |||
|
Iclusig Tablets (Ponatinib Hydrochloride) |
Otsuka Korea Co., Ltd. |
Treatment in newly diagnosed adult patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy |
Reimbursement criteria not 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. |
