- Date2025-07-29
Publication of Review Result of the 3rd Serious Illness (Cancer) Review Committee of 2025
□ The Health Insurance Review and Assessment Service (President Kang Jung-Gu) releases the result of the deliberations of the 3rd Cancer Review Committee in 2025 on ‘Reimbursement criteria for drugs used for cancer patients (Improvement of reimbursement standards reflection clinical reality)’ as follows.
○ New pharmaceuticals (application for reimbursement) and expansion of reimbursement criteria
|
Category |
Products |
Pharmaceutical company |
Efficacy and Effectiveness |
Deliberation Results |
|
Application for reimbursement |
Balversa Tab. (Erdafitinib) |
Janssen Korea |
Treatment for adult patients contracting surgically unresectable, topically advanced or metastatic urothelial carcinoma with FGFR3 gene mutations, whose disease has progressed after (or during) prior systemic therapy including at least one PD-1 or PD-L1 inhibitor |
Establishing reimbursement criteria |
|
Tibsovo Tab. (Ivosidenib) |
Servier Korea |
Monotherapy for adult patients contracting topically advanced or metastatic cholangioma previously treated, with a IDH1-mutant disease |
Establishing reimbursement criteria | |
|
Expansion of reimbursement criteria |
Xpovio Tab. (Selinexor) |
Antengene |
Combination therapy (Bortezomib and Dexamethasone) for adult patients with multiple myeloma previously treated by at least one therapy |
Establishing reimbursement criteria |
|
Enhertu Inj. (Trastuzumab deruxtecan) |
Daiichi Sankyo Korea |
Treatment for patients contracting unresectable or metastatic non-small lung cancer previously treated by systemic therapy including platinum-based chemotherapy, with tumors harboring an activating HER2 (ERBB2) mutations |
Not establishing reimbursement criteria | |
|
Treatment for patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+ / ISH-negative) breast cancer that has recurred within 6 months of completing (or during) adjuvant chemotherapy, or has progressed after systemic therapy in the metastatic setting Patients with hormone receptor-positive (HR+) breast cancer having underwent additional endocrine therapy or having been deemed ineligible for it. |
Not establishing reimbursement criteria | |||
|
ARTA(Anti-androgen Receptor Target Agent) + ADT, etc |
Treatment for patients with hormone-sensitive metastatic prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT) |
Change in reimbursement criteria | ||
○ Improved benefit criteria proposal in the clinical setting
- The Healthcare Review Assessment Committee of HIRA has reviewed and deliberated requests that were made on December 2024 for benefit criteria improvement from various medical associations such as the Korean Medical Association (KMA) and the Korean Hospital Association (KPA) and the following items fall under consideration:
|
Main Requests |
Deliberation Result |
|
As regards partial reimbursement for anticancer drugs combination therapy |
Preparation of the draft revised notice |
|
As regards a reimbursement request for shifted combination therapy to trastuzumab, oxaliplatin (from cisplatin), and capecitabine or 5-FU for HER2-high (IHC 3+ or IHC 2+ / FISH or SISH-positive) metastatic adenocarcinoma or gastroesophageal junction (GEJ) cancer |
Establishing reimbursement criteria |
|
Relaxation of eligibility criteria for administration as regards the standard of patients who has progressed after administering all three drugs-anthracycline, taxane, and trastuzumab-in breast cancer combination therapy (Lapatinib and Capecitabine) |
Change in reimbursement criteria |
|
As respects continuous administration of immune checkpoint inhibitors (ICIs) in the case of brain oligoprogression occurrence when the inhibitors are administered to non-small lung cancer |
As is |
