Health Insurance System In Japan Research Articles

Preliminary outcomes of boron neutron capture therapy for head and neck cancers as a treatment covered by public health insurance system in Japan: Real-world experiences over a 2-year period.

Since June 2020, boron neutron capture therapy (BNCT) has been a health care service covered by health insurance in Japan to treat locally advanced or recurrent unresectable head and neck cancers. Therefore, we aimed to assess the clinical outcomes of BNCT as a health insurance treatment and explore its role among the standard treatment modalities for head and neck cancers. We retrospectively analyzed data from patients who were treated using BNCT at Kansai BNCT Medical Center, Osaka Medical and Pharmaceutical University, between June 2020 and May 2022. We assessed objective response rates based on the Response Evaluation Criteria in Solid Tumors version 1.1, and adverse events based on the Common Terminology Criteria for Adverse Events, version 5.0. Additionally, we conducted a survival analysis and explored the factors that contributed to the treatment results. Sixty-nine patients (72 treatments) were included in the study, with a median observation period of 15 months. The objective response rate was 80.5%, and the 1-year locoregional control, progression-free survival, and overall survival rates were 57.1% (95% confidence interval [CI]: 43.9%-68.3%), 42.2% (95% CI: 30.1%-53.8%), and 75.4% (95% CI: 62.5%-84.5%), respectively. Locoregional control was significantly longer in patients with earlier TNM staging and no history of chemotherapy. BNCT may be an effective treatment option for locally advanced or recurrent unresectable head and neck cancers with no other definitive therapies. If definitive surgery or radiation therapy are not feasible, BNCT should be considered at early disease stages.

Prognostic impact of cancer genomic profile testing for advanced or metastatic solid tumors in clinical practice.

Cancer genomic profile (CGP) testing, which is covered by the national health insurance system in Japan, has been introduced as a routine clinical practice. However, the effects of CGP testing on prognoses remain unclear. Drug accessibility rates and prognoses after CGP testing were retrospectively investigated in 713 patients who underwent CGP testing examined by our molecular tumor board between November 2019 and October 2022,. Overall survival (OS) was examined using the log-rank test and the Kaplan-Meier method. The median age of patients (326 males and 387 females) was 58 years (12-85 years). CGP testing revealed one or more gene mutations in 681 cases (95.5%), among which actionable gene mutations were detected in 439 (61.6%). Although treatment options were recommended for 285 cases (40.0%) by the molecular tumor board, only 45 received treatment based on their gene mutations. During the median observation period of 8.6 months, 351 (49.2%) patients died of the exacerbation of existing diseases. No significant differences were observed in OS between patients treated with and without genomically matched therapy (p = 0.285). According to clinical responses to treatment based on gene mutations, median OS was significantly longer in patients who achieved partial response and stable disease (26.5 months; 95% CI 14.4-38.6) than in those with progressive disease and not evaluated (9.8 months; 95% CI 5.8-13.8, p = 0.013). Responses to treatment based on gene mutations may improve prognoses, and it is important to increase the drug accessibility rate after CGP testing.

Review of frequently used Kampo prescriptions: Part 4, Ninjin'yoeito

AbstractBackgroundThe source of ninjin'yoeito (NYT) is considered the ‘Formulary of Bureau of Taiping People's Welfare Pharmacy’, written around 1241–52 AD. NYT is used to treat patients with chronic fatigue, malaise with qi deficiency, and exhaustion of all five parenchymatous viscera with difficulty in recovering.Key FindingsNYT formula consists of 12 crude drugs. NYT extract for medical use is covered by the National Health Insurance system of Japan for convalescence after recovery from diseases, fatigue and malaise, anorexia, perspiration during sleep, cold limbs, and anemia. Studies have shown clinical effects of NYT: treatment of anemia, cancer treatment support, frailty, cognitive dysfunction, apathy, fatigue/malaise, anorexia, and lung diseases. Preclinical studies support clinical studies; activating ghrelin‐neuropeptide Y pathway‐mediated appetite‐enhancing effects, inhibiting muscle volume loss through the Akt/mTOR pathway‐mediated hyperphosphorylation of 4E‐BP1 and FoxO1‐mediated Atrogin‐1, suppressing the hypothalamic–pituitary–adrenal axis by downregulating the sympathetic‐adrenal‐medullary axis and GABA neurons for improving sociability, promoting recovery from skeletal muscle atrophy through the activation of PGC‐1α, hematopoiesis‐promoting effects, and increasing the number of immune cells in immunocompromised models. The incidence of adverse events of NYT was reported as 3.09 or 2.03%. The most significant adverse effects of NYT are gastrointestinal disorders.ConclusionRecently, NYT has been widely used to treat several symptoms and conditions under the National Health Insurance System of Japan. Clinical studies showed the efficacy of NYT to treat anemia, frailty, cognitive dysfunction, anorexia, apathy, and fatigue/malaise, as well as for long‐term cancer treatment support. The pharmacological mechanisms supporting its effects are also being reported.

Current Medical Technology Reimbursement System in Japan

ObjectivesThe process for reimbursement of medical technologies in Japan is complex, and to date, it has not been well described overall. This article aims to provide an overview of the reimbursement system for medical technologies in Japan, including the reimbursement application process and the payment decision making. MethodsConduct review for relevant health policy and regulation and gather opinion from the key stakeholders. ResultsThe Japanese functional category listing system for the reimbursement of medical technologies is a unique fee-for-service payment system, and the timing for the listing is dependent on the application category. A key positive aspect of the current system is the level of transparency and the predictable pathway for reimbursement of new medical technologies. Conversely, the current reimbursement process may not capture the true extent of the innovation of new technologies, especially when creating a new functional category and/or a new medical procedure coding. ConclusionsThere are potential areas where changes could improve access, efficiencies, and value, such as the price revision system based on the market survey, the foreign average price assessment, and the health technology assessment system. These additions and modifications in policy and regulation of reimbursement will help facilitate the effective and efficient access to new innovative medical technologies within the context of a sustainable and affordable National Health Insurance system in Japan.

MO15-5 A proposal of efficient operation of expert panel for genomic medicine by pre-review meeting (pre-EP)

Under the National Health Insurance system in Japan, the cancer genome core hospitals must hold expert panels (EP) which consist of multidisciplinary specialists to evaluate the indication of treatments and possibilities of secondary findings (SFs). After August 2021, serum-based cancer comprehensive genomic profiling test was also reimbursed by National Health Insurance system. This situation will increase the number of cases which must be evaluated by EP. However, some cases have obvious druggable genomic alterations or some cases have neither recommended treatment nor SFs.

O12-4 Clinical significance of comprehensive genomic profiling in pediatric cancer patients

Since June 2019, gene alterations in patients (pts) with advanced solid cancers are screened on comprehensive genomic profiling (CGP) tests, which is covered by the national health insurance system in Japan. Although most of the molecular-targeted drugs corresponding to the actionable genes alterations in solid cancers are off-labeled in pediatric pts, their therapeutic efficacy may be superior to conventional anticancer drugs.

P68-4 Feasibility study of a new tissue-based comprehensive genome profiling test

Two tissue-based comprehensive genome profiling (CGP) tests (FoundationOne® CDx and OncoGuideTM NCC Oncopanel System) have been introduced into daily clinical practice since June 2019. Currently the CGP test for patients with advanced solid tumor which gets refractory to standard therapies or for which no standard therapy exists are covered by national health insurance system of Japan. Since both CGP tests require at least 20% of tumor cell contents in the specimen, patients whose tissue sample does not meet this criteria cannot undergo tissue-based CGP test.

12-month effect of middle ear pressure therapy with the EFET01 device for intractable definite Meniere’s disease and delayed endolymphatic hydrops after certification by the public health insurance system in Japan

Background Middle ear pressure therapy (MEPT) is effective for intractable vertigo in patients with definite Meniere’s disease (MD) and treatment-refractory delayed endolymphatic hydrops (DEH). Four-month MEPT with the EFET01®, an MEPT device developed in Japan and covered by national health insurance since September 2018, has shown efficacy. However, efficacy and safety after 12 months of treatment, which is appropriate for determining the therapeutic effect of MEPT devices, is unclear. Objectives Examine the therapeutic effect of 12-month MEPT using the ETET01®. Material and Methods Patients underwent MEPT using the EFET01® from September 2018 to July 2021. Thirty-three patients followed for >12 months were enrolled in this retrospective study. Clinical data were evaluated in the first and second 6-month treatment periods. Data from the second 6-month period were compared with data from an MEPT study using a different device. Results MEPT with the EFET01® significantly improved vertigo in the first period, with further improvement in the second period. The efficacy and safety were comparable to MEPT with other devices. Conclusions MEPT with the EFET01® is effective for intractable vertigo in patients with definite MD and DEH, and 12-month follow-up is recommended. Significance The efficacy of 12-month MEPT with the EFET01® was demonstrated.

Efficiency of a novel middle ear pressure device for intractable definite Meniere’s disease and delayed endolymphatic hydrops after certification by the public health insurance system in Japan

Background Middle ear pressure therapy (MEPT) is effective in treating intractable vertigo in patients with definite Meniere’s disease (MD) and delayed endolymphatic hydrops (DEH) refractory to conservative treatment. A novel middle ear pressure device, the EFET01®, which requires no transtympanic ventilation tubes, was developed in Japan, approved by the Japanese Ministry of Health, Labour and Welfare, and has been used under Japanese national health insurance since September 2018. Objectives To examine short-term therapeutic effect of MEPT using the ETET01® compared with previous clinical trial results. Methods Patients selected according to Japan Society for Equilibrium Research (JSER) guidelines underwent MEPT using the EFET01 from September 2018 to July 2021, and 44 patients were enrolled in this retrospective study. Clinical data analysed at 4 months after the start of MEPT were compared with those of the previous clinical trial for the EFET01. Results MEPT using the EFET01 showed the same therapeutic efficacy as that of the previous clinical trial, i.e. improvement in the intensity and frequency of vertigo with no effect on hearing, even under JSER guidelines for proper use of MEPT. Conclusion MEPT using the EFET01 provided an effective treatment option for intractable vertigo in patients with definite MD and DEH.

Precision management of gene-based tests not covered by the National Health Insurance system in Japan: a questionnaire-based study.

Precision management of gene-based tests not covered by the National Health Insurance system in Japan: a questionnaire-based study.

Advances in understanding of phosphate homeostasis and related disorders.

Inorganic phosphate (Pi) in the mammalian body is balanced by its influx and efflux through the intestines, kidneys, bones, and soft tissues, at which several sodium/Pi co-transporters mediate its active transport. Pi homeostasis is achieved through the complex counter-regulatory feedback balance between fibroblast growth factor 23 (FGF23), 1,25-dihydroxyvitamin D (1,25(OH)2D), and parathyroid hormone. FGF23, which is mainly produced by osteocytes in bone, plays a central role in Pi homeostasis and exerts its effects by binding to the FGF receptor (FGFR) and αKlotho in distant target organs. In the kidneys, the main target, FGF23 promotes the excretion of Pi and suppresses the production of 1,25(OH)2D. Deficient and excess FGF23 result in hyperphosphatemia and hypophosphatemia, respectively. FGF23-related hypophosphatemic rickets/osteomalacia include tumor-induced osteomalacia and various genetic diseases, such as X-linked hypophosphatemic rickets. Coverage by the national health insurance system in Japan for the measurement of FGF23 and the approval of burosumab, an FGF23-neutralizing antibody, have had a significant impact on the diagnosis and treatment of FGF23-related hypophosphatemic rickets/osteomalacia. Some of the molecules responsible for genetic hypophosphatemic rickets/osteomalacia are highly expressed in osteocytes and function as local regulators of FGF23 production. A number of systemic factors also regulate FGF23 levels. Although the mechanisms responsible for Pi sensing in mammals have not yet been elucidated in detail, recent studies have suggested the involvement of FGFR1. The further clarification of the mechanisms by which osteocytes detect Pi levels and regulate FGF23 production will lead to the development of better strategies to treat hyperphosphatemic and hypophosphatemic conditions.

The Development of a Nationwide, Multicenter Electronic Database for Spinal Instrumentation Surgery in Japan: Japanese Spinal Instrumentation Society Database (JSIS-DB).

(1) Background: Despite the number of complicated and expensive spine surgery procedures maintained by the national health insurance system in Japan, until now there has been no large-scale multicenter clinical database for this field to understand and improve healthcare expenditure and treatment outcomes. The purpose of this report is to announce the establishment and methodology of a nationwide registry system for spinal instrumentation surgeries by the Japanese Spinal Instrumentation Society (JSIS), and to report the progress over the first 1.5 years of this database’s operation. (2) Methods: The JSIS recently produced an online database with an electronic server. The collected information included patient background, surgery information, and early complications of primary and revision cases. Analysis included data from February 2018, when registration began, to August 2019. (3) Results: As of August 2019, 73 facilities have completed the required paperwork to start, and 55 facilities have registered cases. Of the total 5456 registered cases, 4852 were valid and 2511 were completed. (4) Conclusions: JSIS-DB, the nationwide web-based registry system for spinal instrumentation surgery in Japan, was launched for the purpose of research, healthcare policy regulation, and improved patient care, and its methodology and progress in the first 1.5 years are reported in this study.

Cost-Effectiveness Analysis of Perioperative Oral Management after Cancer Surgery and an Examination of the Reduction in Medical Costs Thereafter: A Multicenter Study.

In April 2012, perioperative oral management (POM) was approved for inclusion in the national health insurance system of Japan to prevent the occurrence of pneumonia, a major complication in cancer patients. The subsequent decrease in the incidence of postoperative pneumonia indicated the prophylactic effect of POM. The constant increase in health expenditure necessitates a cost-effectiveness analysis. In addition, the effect of reducing healthcare costs owing to health technologies must be evaluated. In the present multi-institutional study, the cost-effectiveness analysis of POM was conducted by comparing the incidence of postoperative pneumonia and the healthcare costs between patients who received surgery for malignant tumors before (n = 11,886) and after (n = 13,668) the introduction of POM. Additionally, the effect of reducing healthcare costs was evaluated. Reductions in the number of patients who developed pneumonia, duration of hospitalization, and number of deaths were observed after the introduction of POM. The incremental cost-effectiveness ratio was 111,927 yen, hence the prevention of postoperative pneumonia needs 111,927 yen per patient in healthcare costs. Consequently, a maximum reduction of 250,368,129 yen in healthcare costs was observed between the incremental costs for pneumonia treatment and the cost of POM. These findings indicate that improvements in cost-effectiveness can be expected in the future through the development of procedure and system for POM.

Appropriate use of cancer comprehensive genome profiling assay using circulating tumor DNA.

Comprehensive genomic profiling (CGP) is being increasingly used for the routine clinical management of solid cancers. In July 2018, the use of tumor tissue‐based CGP assays became available for all solid cancers under the universal health insurance system in Japan. Several restrictions presently exist, such as patient eligibility and limitations on the opportunities to perform such assays. The clinical implementation of CGP based on plasma circulating tumor DNA (ctDNA) is also expected to raise issues regarding the selection and use of tissue DNA and ctDNA CGP. A Joint Task Force for the Promotion of Cancer Genome Medicine comprised of three Japanese cancer‐related societies has formulated a policy proposal for the appropriate use of plasma CGP (in Japanese), available at https://www.jca.gr.jp/researcher/topics/2021/files/20210120.pdf, http://www.jsco.or.jp/jpn/user_data/upload/File/20210120.pdf, and https://www.jsmo.or.jp/file/dl/newsj/2765.pdf. Based on these recommendations, the working group has summarized the respective advantages and cautions regarding the use of tissue DNA CGP and ctDNA CGP with reference to the advice of a multidisciplinary expert panel, the preferred use of plasma specimens over tissue, and multiple ctDNA testing. These recommendations have been prepared to maximize the benefits of performing CGP assays and might be applicable in other countries and regions.

「患者自己負担の在り方をめぐる諸問題」特集 第二部 医療保険制度の一部負担の歴史に関する座談会録

「患者自己負担の在り方をめぐる諸問題」特集 第二部 医療保険制度の一部負担の歴史に関する座談会録

The initial assessment of expert panel performance in core hospitals for cancer genomic medicine in Japan

BackgroundSince June 2019, cancer genomic profiling (CGP) tests have been reimbursed by the National Health Insurance system in Japan, with restrictions for government-designated hospitals with a molecular tumor board composed of multidisciplinary specialists, known as an expert panel (EP). The standardization of EPs is a critical challenge for implementing precision oncology in the clinical setting.MethodsData on consecutive cases who underwent the CGP tests at 11 core hospitals between June 2019 and January 2020 were collected. We evaluated the proportions of cases that received genomically matched treatments, including investigational new drugs (INDs) based on CGP results, and/or for which genetic counseling was recommended. Two simulated cases were annotated by each EP. The annotated reports were then centrally assessed.ResultsEach EP mainly discussed the applicability to genomically matched treatments and the necessity of performing genetic counseling. A pre-review of the report by key members in each EP reportedly made the EP conference more interactive and efficient, and thereby saved time. A total of 747 cases underwent CGP tests, 28 cases (3.7%) received genomically matched treatment, and 17 cases (2.3%) were referred for genetic counseling. Annotated reports for the simulated cases varied across the EPs, particularly the number of recommended IND trials, which seemed to be associated with the actual number of participants in IND trials.ConclusionsThis investigation provides reference data for the application of precision oncology in a clinical setting. Further investigations on the standardization of clinical annotations are warranted.

Usefulness of Castor Oil and Elobixibat and Lactulose and ascorbic Aid for Bowel Preparation for Colon Capsule Endoscopy-Initial examination

Colon capsule endoscopy was approved for reimbursement under the national health insurance system of Japan in 2014. However, the capsule excretion rate after recommended bowel preparation reportedly ranges from 70% to 90%, and administration of boosters is also necessary. The caster oil-based booster had an emission rate of 97%, but required a total water content of 3L. Considering whether it is possible to popularize colon capsule endoscopy by reducing the amount of water, including dialysis patients with water restrictions, we will consider whether the capsule discharge rate can be improved by combining new laxatives.

Modern pension and health insurance systems in Japan

The article substantiates the relevance of issues related to the functioning of social protection systems for the population of developed countries. The review and analysis of the modern pension system in Japan is made. The mechanism of recognition of Japanese citizens and foreign citizens residing in it as insured persons of a certain category and the mechanism of functioning of individual subsystems of the pension insurance system (in particular, basic pension, employee pension insurance, optional (additional) pension insurance system) are considered. The data on the absolute amounts and rates of insurance premiums, the formulas by which the monthly pension is calculated, and the conditions that must be met by insured persons to acquire the right to a pension (for old age, for disability, for the loss of a breadwinner) are given. The conditions for receiving and the amount of benefits for dependents and child benefits are indicated. The review and analysis of the modern health insurance system in Japan is made. The mechanism of functioning of individual subsystems of the pension insurance system (in particular, insurance at the place of work, insurance at the municipal level, insurance for persons aged 75 and over) is considered. The data on the absolute amounts and rates of insurance premiums, on the specifics of fi nancing the activities of public and private organizations, which, on the basis of the principles of non-commercial activity, provide medical services to the population of Japan are presented. The conditions for receiving and the amount of benefits for the birth of a child, for a funeral, for temporary disability are indicated. Attention is drawn to the distinctive features of the pension and health insurance systems in Japan. It is proposed to use the Japanese experience to reform the national systems of social protection of the population.

Cost-effectiveness analysis for preventing hepatitis B virus reactivation-related death in Japan

Abstract Background There is no worldwide standard recommendation for preventing hepatitis B virus (HBV) reactivation for patients with resolved infection treated with an anti-CD20 antibody for B-cell non-Hodgkin lymphoma. This study aims to compare the cost-effectiveness between two commonly used strategies to prevent HBV reactivation-related death. Methods The two strategies compared were prophylactic antiviral therapy (Pro NAT) and HBV DNA monitoring followed by on-demand antiviral therapy (HBV DNA monitoring) using entecavir (Entecavir, a generic drug for Baraclude). Effectiveness was defined as the prevention of death due to HBV reactivation and costs were calculated under the health insurance system of Japan as of April 2018 using Markov model. A cost-minimization analysis, one of the cost-effectiveness analyses, was applied, since the effectiveness was the same between the two strategies according to a meta-analysis. To consider the effect of uncertainty for each parameter, probabilistic sensitivity analysis (PSA) was performed. In the scenario analysis, costs were calculated using lamivudine (Zefix) or tenofovir alafenamide (Vemlidy) instead of entecavir. All analyses were done using TreeAge Pro 2019 (TreeAge Software, Inc., MA, USA). Results Estimated costs per patient during the 30 months after initiation of chemotherapy for lymphoma were 1,513 USD with Pro NAT and 1,265 USD with HBV DNA monitoring. A PSA revealed that HBV DNA monitoring was more consistently cost-effective compared with Pro NAT when some parameters were set randomly according to probability distributions. In our scenario analysis, costs of Pro NAT and HBV DNA monitoring were calculated as 2,762 and 1,401 USD using lamivudine, 4,857 and 1,629 USD using tenofovir alafenamide. Conclusions Our cost-effectiveness analysis shows that an HBV DNA monitoring strategy using entecavir should be recommended for preventing HBV reactivation-related death in Japan. Key messages Cost-effectiveness analysis demonstrated that HBV DNA monitoring was more cost-effective compared to Pro NAT; this result was consistent with PSA. HBV DNA monitoring strategy should be recommended to prevent HBV reactivation-related death for the patients with resolved HBV infection in Japan.

A report on the clinical use of bonding systems for coronal restorations produced from CAD/CAM resin blocks.

Computer-aided design and manufacturing (CAD/CAM) resin-produced restorations were approved by a health insurance system in Japan from the year 2014. In this study, we investigated the use of CAD/CAM resin blocks in Japan since 2014, and the clinical use of adhesive systems for CAD/CAM resin-produced restorations in dentistry. Our findings indicated a rise in the clinical application of these products; however, some studies have reported instances of debonding and fracture of the restorations. CAD/CAM resin blocks were implemented in the health insurance system in Japan as an alternative for alloys due to the continuous rise in the prices of gold and palladium. Thus, in order to reduce the number of failures in CAD/CAM resin-produced restorations due to debonding and fracture, the integration of these restorations with the tooth structures is of utmost importance.