Advanced Medical Care System
Japan's Advanced Medical Care System is one type of "Evaluation-Based Medical Care" (Hyoka Ryoyo) conducted to evaluate future inclusion in public health insurance. It is broadly divided into "Advanced Medical Care A" (formerly Class II Advanced Medical Care) and "Advanced Medical Care B" (formerly Class III Advanced Medical Care) based on the novelty of the technology and the degree of evaluation required.
Advanced Medical Care A: Targets technologies whose effectiveness and safety have been established to a certain extent, without involving the use of unapproved pharmaceuticals or medical devices. This includes cases such as applying existing technology to new surgical procedures.
Advanced Medical Care B: Targets extremely novel medical technologies that involve the use of unapproved pharmaceuticals or medical devices, or even without them, are judged to require particularly focused observation and evaluation regarding their implementation, implementation environment, technological effects, etc., in consideration of the technology's safety and effectiveness.
Reference Materials
Overview from the Patient's Perspective
Purpose and Merits: This is a system that allows patients to receive advanced, high-level medical technologies—which are being considered for future public health insurance coverage—in combination with treatments already covered by insurance. This enables access to the latest treatments that are not yet widely available.
Cost Burden: The technical fees for advanced medical care are entirely borne by the patient (out-of-pocket). However, parts common to standard treatment, such as consultations, examinations, medications, and hospitalization fees, are covered by public health insurance. Some local governments may have subsidy programs for the out-of-pocket portion of advanced medical care.
Procedure: Before receiving treatment, patients must receive a full explanation of the treatment content and costs from the medical institution, understand it, and sign a consent form.
Overview from the Medical Technology Provider’s Perspective
Purpose and Positioning: This is an important step aimed at achieving future insurance reimbursement (coverage by public health insurance) for newly developed medical technologies (including unapproved pharmaceuticals and medical devices). Through this system, data is collected to evaluate the technology's effectiveness and safety in actual clinical settings.
Merits: At the pre-insurance-coverage stage, the technology can be clinically introduced at limited medical institutions, building a track record in society. The data obtained here becomes important evidence for future insurance reimbursement applications.
Procedures and Requirements: To be approved as advanced medical care, an application must be submitted to the Ministry of Health, Labour and Welfare, and it must undergo a rigorous review by an expert panel. The review evaluates not only "technical validity," such as the technology's effectiveness and safety, but also "social validity," including ethics and diffusibility. Particularly for "Advanced Medical Care B," which targets highly novel technologies, focused observation and evaluation are required.
Consultation Desks
The responsible departments at the MHLW are the Medical Care Division, Health Insurance Bureau, and the Advanced Medical Care Section, Research and Development Policy Division, Health Policy Bureau, Ministry of Health, Labour and Welfare.
@K.Kamitani
Advanced Medical Care A: Targets technologies whose effectiveness and safety have been established to a certain extent, without involving the use of unapproved pharmaceuticals or medical devices. This includes cases such as applying existing technology to new surgical procedures.
Advanced Medical Care B: Targets extremely novel medical technologies that involve the use of unapproved pharmaceuticals or medical devices, or even without them, are judged to require particularly focused observation and evaluation regarding their implementation, implementation environment, technological effects, etc., in consideration of the technology's safety and effectiveness.
Reference Materials
- Overview of Advanced Medical Care | Ministry of Health, Labour and Welfare https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/iryouhoken/sensiniryo/index.html
- Regarding the Advanced Medical Care Evaluation System (Draft) https://www.mhlw.go.jp/shingi/2008/03/dl/s0312-12f.pdf
- Advanced Medical Care Program for the Rapid Introduction of Healthcare Technologies to the National Health Insurance System in Japan - PMC （english)
Overview from the Patient's Perspective
Purpose and Merits: This is a system that allows patients to receive advanced, high-level medical technologies—which are being considered for future public health insurance coverage—in combination with treatments already covered by insurance. This enables access to the latest treatments that are not yet widely available.
Cost Burden: The technical fees for advanced medical care are entirely borne by the patient (out-of-pocket). However, parts common to standard treatment, such as consultations, examinations, medications, and hospitalization fees, are covered by public health insurance. Some local governments may have subsidy programs for the out-of-pocket portion of advanced medical care.
Procedure: Before receiving treatment, patients must receive a full explanation of the treatment content and costs from the medical institution, understand it, and sign a consent form.
Overview from the Medical Technology Provider’s Perspective
Purpose and Positioning: This is an important step aimed at achieving future insurance reimbursement (coverage by public health insurance) for newly developed medical technologies (including unapproved pharmaceuticals and medical devices). Through this system, data is collected to evaluate the technology's effectiveness and safety in actual clinical settings.
Merits: At the pre-insurance-coverage stage, the technology can be clinically introduced at limited medical institutions, building a track record in society. The data obtained here becomes important evidence for future insurance reimbursement applications.
Procedures and Requirements: To be approved as advanced medical care, an application must be submitted to the Ministry of Health, Labour and Welfare, and it must undergo a rigorous review by an expert panel. The review evaluates not only "technical validity," such as the technology's effectiveness and safety, but also "social validity," including ethics and diffusibility. Particularly for "Advanced Medical Care B," which targets highly novel technologies, focused observation and evaluation are required.
Consultation Desks
The responsible departments at the MHLW are the Medical Care Division, Health Insurance Bureau, and the Advanced Medical Care Section, Research and Development Policy Division, Health Policy Bureau, Ministry of Health, Labour and Welfare.
- Prior Consultation Application Form for Advanced Medical Care https://www.mhlw.go.jp/seisakunitsuite/bunya/kenkou_iryou/iryou/koudoiryou-hyouka/dl/moushikomi.pdf
- soudan.pdf https://www.mhlw.go.jp/seisakunitsuite/bunya/kenkou_iryou/iryouhoken/sensiniryo/minaoshi/dl/soudanB.pdf
- Many of these medical institutions are also Core Clinical Research Hospitals.
@K.Kamitani