가. 검토배경 ○ 비소세포폐암에서 pembrolizumab(품명: 키트루다주)을 2년간 요양급여 투약하고 장기간 안정 병변 유지 중, 질병진행 소견 확인되어 동일 약제를 재투여(rechallenge)한 사례의 의학적 타당성 및 요양급여 인정여부에 대하여 논의하고자 부의함. 나. 관련근거 ○「국민건강보험 요양급여의 기준에 관한 규칙」[별표1] 요양급여의 적용기준 및 방법(제5조 제1항 관련) ○ 식품의약품안전처 허가사항 ○「암환자에게 처방？투여하는 약제에 대한 요양급여의 적용기준 및 방법에 관한 세부사항」(건강보험심사평가원 공고) ○ NCCN(National Comprehensive Cancer Network) clinical practice guidelines in Oncology(NCCN Guidelinesⓡ) ○ L.E.Hendriks, et al. Non-oncogene-addicted metastatic non-small-cell lung cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. ANNALS of ONCOLOGY. 2023. ○ NICE Guideline, Lung cancer: diagnosis and management. 2019. ○ Kluger H, et al. Society for Immunotherapy of Cancer (SITC) consensus definitions for resistance to combinations of immune checkpoint inhibitors. J Immunother Cancer. 2023. ○ Langer CJ, et al. Carboplatin and pemetrexed with or without pembrolizumab for advanced, non-squamous non-small-cell lung cancer: a randomised, phase 2 cohort of the open-label KEYNOTE-021 study. Lancet Oncol. 2016. ○ Reck M, et al. Pembrolizumab versus chemotherapy for PD-L1-positive non-small-cell lung cancer. N Engl J Med. 2016. ○ Gandhi L, et al. Pembrolizumab plus chemotherapy in metastatic non-small-cell lung cancer. N Engl J Med. 2018. ○ Paz-Ares L, et al. Pembrolizumab plus chemotherapy for squamous non-small-cell lung cancer. N Engl J Med. 2018. ○ Mok TSK, et al. Pembrolizumab versus chemotherapy for previously untreated, PD-L1-expressing, locally advanced or metastatic non-small-cell lung cancer (KEYNOTE-042): a randomised, open-label, controlled, phase 3 trial. Lancet. 2019. ○ Herbst RS, et al. Five-year survival update from KEYNOTE-010: pembrolizumab versus docetaxel for previously treated, programmed death-ligand 1-positive advanced NSCLC. J Thorac Oncol. 2021. ○ Novello, et al. Pembrolizumab Plus Chemotherapy in Squamous Non？Small-Cell Lung Cancer: 5-Year Update of the Phase III KEYNOTE-407 Study. J Clin Oncol by ASCO. 2022. ○ Cai Z, et al. Safety and efficacy of retreatment with immune checkpoint inhibitors in non-small-cell lung cancer: a systematic review and meta-analysis. Transl Lung Cancer Res. 2022. ○ Huang et al. Clinical definition of secondary resistance to immunotherapy in non-small cell lung cancer. Thorac Cancer. 2023. ○ Feng Y, et al. Efficacy and safety of immune checkpoint inhibitor rechallenge in non-small cell lung cancer: A systematic review and meta-analysis. Thorac Cancer. 2023. ○ Musaelyan AA, et al. Predictive markers of response to immune checkpoint inhibitor rechallenge in metastatic non-small cell lung cancer. Explor Target Antitumor Ther. 2024;5:1271-88. ○ Ding et al. Optimal immunotherapy duration in advanced NSCLC: defining the ideal treatment window. Cancer Biol Med 2025. 다. 분과위원회 결정사유 및 결정 ○ 항암요법에 사용되는 약제(이하 ‘항암요법’이라 함)는 식약처 허가사항 범위 내에서 사용함을 원칙으로 하며, 「암환자에게 처방？투여하는 약제에 대한 요양급여의 적용기준 및 방법에 관한 세부사항」(건강