よむ、つかう、まなぶ。
別紙３○先進医療Ｂの総括報告書に関する評価について（告示番号旧12/ UMIN000019694）（告示番号旧51/ UMIN000042408） (19 ページ)
出典
| 公開元URL | https://www.mhlw.go.jp/stf/shingi2/0000205617_00056.html |
| 出典情報 | 先進医療会議（第120回 4／6）《厚生労働省》 |
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また、CMS のホームページには、以下のように記載され、治療タイミングに関し
ては限定しておりません。
https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?NCDId=372
Indications and Limitations of Coverage
B.
Nationally Covered Indications
1.
Somatic (Acquired) Cancer
Effective for services performed on or after March 16, 2018, the Centers
for Medicare & Medicaid Services (CMS) has determined that Next
Generation Sequencing (NGS) as a diagnostic laboratory test is reasonable
and necessary and covered nationally, when performed in a Clinical
Laboratory Improvement Amendments (CLIA)-certified laboratory, when
ordered by a treating physician, and when all of the following
requirements are met:
a. Patient has:
either recurrent, relapsed, refractory, metastatic, or advanced stage
III or IV cancer; and not been previously tested with the same test
using NGS for the same cancer genetic content, and decided to seek
further cancer treatment (e.g., therapeutic chemotherapy).
b. The diagnostic laboratory test using NGS must have:
Food & Drug Administration (FDA) approval or clearance as a companion
in vitro diagnostic; and, an FDA-approved or -cleared indication for use
in that patient’s cancer; and, results provided to the treating physician
for management of the patient using a report template to specify
treatment options.
最新の ESMO ガイドライン（文献１）では、胆道癌に対しては一次治療開始前
に NGS 検査を実施することが推奨されており （下図, 赤枠）、Molecular
profiling should be carried out before/during first-line therapy. Gene
panel should include FGFR2, IDH1, HER2/neu and BRAF to test for hotspot
mutations, but may also include genes such as NTRK and c-MET. The rapidly
5/6
19
ては限定しておりません。
https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?NCDId=372
Indications and Limitations of Coverage
B.
Nationally Covered Indications
1.
Somatic (Acquired) Cancer
Effective for services performed on or after March 16, 2018, the Centers
for Medicare & Medicaid Services (CMS) has determined that Next
Generation Sequencing (NGS) as a diagnostic laboratory test is reasonable
and necessary and covered nationally, when performed in a Clinical
Laboratory Improvement Amendments (CLIA)-certified laboratory, when
ordered by a treating physician, and when all of the following
requirements are met:
a. Patient has:
either recurrent, relapsed, refractory, metastatic, or advanced stage
III or IV cancer; and not been previously tested with the same test
using NGS for the same cancer genetic content, and decided to seek
further cancer treatment (e.g., therapeutic chemotherapy).
b. The diagnostic laboratory test using NGS must have:
Food & Drug Administration (FDA) approval or clearance as a companion
in vitro diagnostic; and, an FDA-approved or -cleared indication for use
in that patient’s cancer; and, results provided to the treating physician
for management of the patient using a report template to specify
treatment options.
最新の ESMO ガイドライン（文献１）では、胆道癌に対しては一次治療開始前
に NGS 検査を実施することが推奨されており （下図, 赤枠）、Molecular
profiling should be carried out before/during first-line therapy. Gene
panel should include FGFR2, IDH1, HER2/neu and BRAF to test for hotspot
mutations, but may also include genes such as NTRK and c-MET. The rapidly
5/6
19