Japan's advanced medicine

Sho, Ri; Narimatsu, Hiroto; Murakami, Masayasu

doi:10.5582/bst.2013.v7.5.245

Cited by 3 publications

(4 citation statements)

References 7 publications

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“…16,43 The other label, CYP2D6 for eliglustat (row 6 of Table S3), was a safety PGBM described in the Contraindications section, and the testing was approved as "advanced medicine". 52 Although the prevalence of coverage (14/14, 100%, rows 3-16 of Table S3) for PGBM testing and CDx approval (13/14, 93%, rows 3-15 of Table S3) was very high in Required, we could not find any definite element coupled with PGx levels in the Japanese labels. The prevalence of testing coverage according to the PGx level for Japanese labels was 1 (100%) of 1 in Recommended (row 17 of Table S3), 2 (6%) of 31 in Actionable (rows 18 and 19 of Table S3) and 2 (33%) of 6 in Informative (rows 49 and 50 of Table S3).…”

Section: Pharmgkb Listing Of Pgx Levels For Japanese Drug Labelsmentioning

confidence: 70%

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Pharmacogenomic biomarkers: Interpretation of information included in United States and Japanese drug labels

Shimazawa

Ikeda

2018

J Clin Pharm Ther

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Section: Pharmgkb Listing Of Pgx Levels For Japanese Drug Labelsmentioning

confidence: 70%

“…16,43 The other label, CYP2D6 for eliglustat (row 6 of Table S3), was a safety PGBM described in the Contraindications section, and the testing was approved as "advanced medicine". 52 …”

Section: Pharmgkb Listing Of Pgx Levels For Japanese Drug Labelsmentioning

confidence: 99%

Pharmacogenomic biomarkers: Interpretation of information included in United States and Japanese drug labels

Shimazawa

Ikeda

2018

J Clin Pharm Ther

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“…Japan also has a unique system called Advanced Medicine (Senshin Iryou) that offers highly technological medical care. Such services are not covered by public health insurance [ 28 ]. Recently, the Japanese government indicated that, if a new medical device can replace an old device, new and old devices can be used in the same population, and there is no need to set the new functional category for a replaceable device.…”

Section: Reimbursement Coverage Decisions and Pricing In Detailmentioning

confidence: 99%

The reimbursement coverage decisions and pricing rules for medical devices in Taiwan

Tsai

Huang

Chang

et al. 2022

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Medical technology is undergoing rapid transformations, and the classifications of medical devices have also expanded greatly; therefore, it is necessary to develop appropriate reimbursement policies and pricing mechanisms in a timely manner. This paper aims to introduce the reimbursement coverage and pricing rules for medical devices in Taiwan. In addition, this paper identifies and evaluates available health technology assessments (HTA) and literature on published websites concerning medical device decision-making processes and pricing systems in South Korea and Japan, which are near Taiwan and have similar reimbursement coverage processes. Reimbursement policy and pricing mechanisms are constantly being revised in Taiwan, Japan, and South Korea. Recently, all three countries attempted to establish new reimbursement coverage decision-making and pricing rules, adopting a differentiated approach based on the level of evidence required for the appropriated reimbursement in terms of a feasible evaluation mechanism for providing patients with more effective medical devices. This article is expected to contribute to providing references to new reimbursement coverage decision-making and pricing rules.

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“…In this article, we provide the detailed design of this investigator-initiated clinical study in adult jawbone defect patients as an exploratory study in Japan (the TEOM study). Incidentally, the main design of this trial is undergoing the process of approval by the Advanced Medical Care B program of the Ministry of Health, Labour and Welfare (MHLW), which is one of the unique systems in Japan and able to evaluate as a novel medical technology whether to be approved by the Central Medical Council on Social Insurance for coverage by public health insurance or not, based on its efficacy and safety [20].…”

Section: Introductionmentioning

confidence: 99%

Design of a Randomized Controlled Clinical Study of tissue-engineered osteogenic materials using bone marrow-derived mesenchymal cells for Maxillomandibular bone defects in Japan: the TEOM study protocol

et al. 2019

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Background Maxillomandibular bone defects arise from maxillofacial injury or tumor/cyst removal. While the standard therapy for bone regeneration is transplantation with autologous bone or artificial bone, these therapies are still unsatisfactory. Autologous bone harvesting is invasive and occasionally absorbed at the implanted site. The artificial bone takes a long time to ossify and it often gets infected. Therefore, we have focused on regenerative therapy consisting of autologous bone marrow-derived mesenchymal cells (BM-MSCs), which decreases the burden on patients. Based on our previous research in patients with maxillomandibular bone defects or alveolar bone atrophy using a mixture of BM-MSCs, platelet-rich plasma (PRP), thrombin, and calcium, we confirmed the efficacy and acceptable safety profile of this treatment. In this investigator-initiated clinical study (the TEOM study), we intended to add β-tricalcium phosphate (β-TCP) owing to large defect with patients. The TEOM study aimed to evaluate the efficacy and safety of bone regeneration using mixtures of BM-MSCs in patients with bone defects resulting from maxillofacial injury, and tumor/cyst removal in the maxillomandibular region. Methods The TEOM study is an open-label, single-center, randomized controlled study involving a total of 83 segments by the Fédération Dentaire Internationale numbering system in maxillomandibular bone defects that comprise over 1/3 of the maxillomandibular area with a remaining bone height of ≤10 mm. The primary endpoint is rate of procedure sites with successful bone regeneration defined as a computed tomography (CT) value of more than 400 and a bone height of more than 10 mm. Our specific hypothesis is that the number of required regions was calculated assuming that the rate of procedure sites with successful bone regeneration is similar and the non-inferiority margin is 15.0%. Discussion The TEOM study is the first randomized controlled study of regenerative treatment using BM-MSCs for large maxillomandibular bone defects. We will evaluate the efficacy and safety in this study to provide an exploratory basis for the necessity of BM-MSCs for these patients. Trial registration This trial was registered at the University Hospital Medical information Network Clinical Trials Registry (UMIN-CTR Unique ID: UMIN000020398; Registration Date: Jan 15, 2016; URL: https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016543 ).

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Japan's advanced medicine

Cited by 3 publications

References 7 publications

Pharmacogenomic biomarkers: Interpretation of information included in United States and Japanese drug labels

Pharmacogenomic biomarkers: Interpretation of information included in United States and Japanese drug labels

The reimbursement coverage decisions and pricing rules for medical devices in Taiwan

Design of a Randomized Controlled Clinical Study of tissue-engineered osteogenic materials using bone marrow-derived mesenchymal cells for Maxillomandibular bone defects in Japan: the TEOM study protocol

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