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美보건당국, “CAR-T 치료제 보험적용” 최종결정 - 바이오스펙테이터

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美보건당국, “CAR-T 치료제 보험적용” 최종결정

입력 2019-08-09 18:11 수정 2019-08-11 18:45

바이오스펙테이터 봉나은 기자

이 기사는 '프리미엄 뉴스서비스 BioS+' 기사입니다.
FDA의 안전성 규정(REMS)에 등록된 의료기관에서 CAR-T 치료받은 환자 보험 적용가능

미국 보건복지부 산하 메디케어 및 메디케이드 서비스 시스템(Centers for Medicare and Medicaid Services, CMS)은 FDA의 승인을 받은 CAR-T 치료제에 보험을 적용할 수 있도록 최종 결정을 내렸다고 7일(현지시간) 발표했다.

CAR-T 치료제에 대한 보험 적용은 2017년 FDA로부터 처음 승인받은 CAR-T 치료제인 노바티스의 ‘킴리아(Kymriah)’가 출시된 이후부터 계속해서 언급되어 왔지만, 2년이 지나서야 보험적용이 이루어지게 됐다.

CMS는 미국 의료보험 시스템인 메디케어(65세 이상 대상의 노인의료보험제도) 프로그램을 운영하고, 메디케이드(저소득층 및 장애인 대상의 공공보험제도)나 CHIP(어린이 건강보험 프로그램) 및 건강보험 호환 기준 등을 관리하는 조직이다.

CMS는 FDA에 승인받은 적응증에 대한 안전성 규정으로 위해성 관리계획(Risk evaluation and mitigation strategies, REMS)을 따르는 의료기관에서 CAR-T 치료제를 처방받는 경우 보험이 적용될 수 있다고 설명했다. 다만, FDA가 승인하지 않은 질환에 대한 CAR-T 치료제는 CMS가 승인한 가이드라인(Compendia)에 권고된 경우에만 보험 적용이 가능하다. 또한 CAR-T 치료제를 투약하기 위한 환자의 입원에 대해서도 일부 지원이 가능하다....

'프리미엄 뉴스서비스 BioS+'는 독자들에게 가치(value)있는 기사를 제공합니다.
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