- Date2025-11-18
Publication of Review Result of the 9th Pharmaceutical Reimbursement Evaluation Committee of 2025
□ The Health Insurance Review and Assessment Service (HIRA, President: Kang Jung-Gu) announces the results of the 9th Drug Benefit Evaluation Committee deliberations.
○ Deliberation Results on the Appropriateness of Reimbursement for the Requested Drug
|
Product |
Manufacturer |
Indications |
Deliberation Results |
|
Petrozac Injection 1 g (Cefiderocol Tosilate Sulfate Hydrate)) |
Jeil Pharmaceutical Co., Ltd. |
Complicated urinary tract infections, hospital-acquired pneumonia, including ventilator-associated pneumonia |
Reimbursement deemed appropriate |
|
Rezurok 200 mg (Belumosudil Mesylate [undifferentiated]) |
Sanofi-Aventis Korea Co., Ltd. |
Treatment of adult and pediatric patients aged 12 and older with chronic graft-versus-host disease who have failed two or more prior systemic therapies |
Reimbursement deemed appropriate |
|
Tyvaso Inhalation Solution 0.6 mg/mL (Treprostinil) |
Antrogen Co., Ltd. |
Improvement of exercise capacity in pulmonary hypertension associated with interstitial lung disease |
Not reimbursed |
|
Imudo Injection (Tremelimumab) |
AstraZeneca Korea Co., Ltd. |
First-line treatment in combination with Durvalumab for adult patients with advanced or unresectable hepatocellular carcinoma |
Subject to re-evaluation |
○ Deliberation Results on the Appropriateness of Expanded Use for Risk-Sharing Agreement Drugs
|
Product |
Manufacturer |
Indications |
Deliberation Results |
|
Impfinzi Injection 120, 150 mg (Durvalumab) |
AstraZeneca Korea Co., Ltd. |
First-line treatment in combination with gemcitabine and cisplatin for patients with locally advanced or metastatic cholangiocarcinoma |
Subject to re-evaluation |
|
Dupixent Prefilled Injection Pen 200, 300 mg (Dupilumab, recombinant) |
Sanofi-Aventis Korea Co., Ltd. |
Treatment of severe type 2 inflammatory asthma in adults and adolescents. |
Expansion of the reimbursement coverage deemed appropriate |
|
Keytruda Injection (Pembrolizumab, recombinant) |
MSD Korea Co., Ltd. |
⦁ First-line monotherapy for patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) who are PD-L1 positive (CPS ≥ 1). ⦁ First-line treatment in combination with platinum and 5‑fluorouracil (5‑FU) chemotherapy for the same patient population. |
Expansion of the reimbursement coverage deemed appropriate |
|
First-line treatment in combination with trastuzumab, fluoropyrimidine, and platinum-based chemotherapy for patients with PD-L1 positive (CPS ≥ 1), unresectable locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma |
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|
First-line treatment in combination with fluoropyrimidine and platinum-based chemotherapy for patients with unresectable locally advanced or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma | |||
|
First-line treatment in combination with platinum and fluoropyrimidine-based chemotherapy for patients with PD-L1 positive (CPS ≥ 10), unresectable locally advanced or metastatic esophageal cancer | |||
|
Treatment in combination with lenvatinib for progressive advanced endometrial cancer after prior systemic therapy, MSI-H (microsatellite instability high) or dMMR (mismatch repair deficient) negative, and unsuitable for surgery or radiotherapy | |||
|
Treatment of progressive advanced endometrial cancer after prior therapy, MSI-H or dMMR positive, unresectable or metastatic, with no satisfactory alternative treatment options | |||
|
Treatment of progressive advanced small intestine cancer after prior therapy, MSI-H or dMMR positive, unresectable or metastatic, with no satisfactory alternative treatment options | |||
|
Treatment of progressive advanced cholangiocarcinoma after prior therapy, MSI-H or dMMR positive, unresectable or metastatic, with no satisfactory alternative treatment options | |||
|
Treatment of progressive advanced colorectal cancer, MSI-H or dMMR positive, unresectable or metastatic | |||
|
Treatment of locally recurrent or metastatic triple-negative breast cancer with PD-L1 positive (CPS ≥ 10), in combination with chemotherapy, for patients who are not eligible for surgery | |||
|
Treatment of persistent, recurrent, or metastatic cervical cancer with PD-L1 positive (CPS ≥ 1), in combination with chemotherapy with or without bevacizumab |
|
※ In accordance with Article 11-2 of the “Regulations on Standards for National Health Insurance Benefits,” the President of the Health Insurance Review and Assessment Service (HIRA) evaluates the appropriateness of drug coverage through deliberation by the Drug Benefit Evaluation Committee. The detailed coverage scope of the drug may differ from its indications, and the final evaluation results may change in the event of changes to standard items, modifications, or withdrawal (cancellation) of the approved specifications of the requested drug, or other relevant circumstances. |
