Table 1.

Advanced Medical Care Program‐type B technologies ultimately covered by the National Health Insurance^a

Name of technology	Category	n d	Path to NHI coverage	Special track
Designated for NHI overage via AMC Conference recommendation
Da Vinci robotic‐assisted surgery for partial nephrectomy	Device	100	AMCP‐type B validation
Da Vinci robotic‐assisted surgery for prostatectomy	Device	176	AMCP‐type B validation
Da Vinci robotic‐assisted surgery for gastrectomy	Device	300	AMCP‐type B validation
Endoscopic neck lumpectomy for benign tumor	Technology	‐	AMCP‐type A validation after AMCP‐type Be
Endoscopic neck lumpectomy for malignancy	Technology	‐	AMCP‐type A validation after AMCP‐type Be
Laparoscopic hepatectomy	Technology	‐	AMCP‐type A validation after AMCP‐type Be
Radio wave hepatectomyb	Technology	80	AMCP‐type B validation
Genetic diagnosis of malignant lymphoma in the sentinel lymph node	Technology (diagnostic)	95	AMCP‐type B validation
Designated for NHI coverage via conventional pharmaceutical approval
Cochlear implant	Device	24	Reference for conventional approval	Needed device
Leptin for lipodystrophy	Drug	12	Reference for conventional approval	Orphan
Fetal ventriculoperitoneal shunt	Device	20	Clinical evaluation of medical device for conventional approval	Orphan
Sentinel lymph node identification for malignant lymphoma	Drug	6	Equivalent to application based on public knowledge	Unmet need (public domain)
Sentinel lymph node identification for breast cancer	Drug	516	Equivalent to application based on public knowledge	Unmet need (public domain)
Da Vinci transoral robotic surgery for laryngopharyngeal cancerc	Device	16	Reference for conventional approval	Needed device
Angiogenesis by HGF gene therapy	Regenerative medicine	6	Reference for conditional time‐limited approval	Time‐limited conditional

AMC Conference, Advanced Medical Care Conference; AMCP, Advanced Medical Care Program; HGF, hepatocyte growth factor; NHI, National Health Insurance.

^aAll clinical trials in this table are done with single arm design.

^bRadio wave technology was approved in 2005, and the technology for hepatectomy was introduced into NHI coverage with AMCP‐type B data.

^cDa Vinci transoral robotic surgery is approved for laryngopharyngeal cancer but is not yet covered by the NHI.

^dSample size for a clinical trial under the AMCP‐type B.

^eAMPC type A do not require a form of clinical trial, but a practice with registries, sample sizes for clinical trials were not found in the public documents from Ministry of Health, Labour, and Welfare.