Japanese Medical Insurance System Research Articles

Japan's healthcare delivery system: From its historical evolution to the challenges of a super-aged society

Although Japan's healthcare delivery system is highly regarded internationally, the COVID-19 pandemic has exposed its structural problems. Behind these issues lies a history of medical care provisions supported mainly by an unrestricted, "free labeling" system, and independently financed private hospitals. In addition, patients have a high degree of freedom of choice under the Japanese medical insurance system, making it difficult to provide comprehensive and continuous health management from initial diagnosis and treatment (primary care), specialized treatment, to supporting a return to home, providing nursing care and lifestyle support. As Japan becomes a "super-aged" society with individuals over 65 making up over 30% of the population, the nature of medical care will have to undergo major changes. Medical care's basic function must still be the treatment and cure of patients, but the system will also have to provide support. That means conceiving of care in a way that treats a person's life with dignity and does not sacrifice life for treatment. The implementation of a family doctor function and the clarification of the functions and roles of small and medium-sized community-based hospitals that support this function, as well as the establishment of a community comprehensive care network with multidisciplinary cooperation that goes beyond medical care, should also be set forth in future regional medical care plans.

Immunosuppressive Agent Options for Primary Nephrotic Syndrome: A Review of Network Meta-Analyses and Cost-Effectiveness Analysis.

Therapeutic options with immunosuppressive agents for glomerular diseases have widened with refinements to the Kidney Disease Improving Global Outcomes (KDIGO) guidelines from 2012 to 2021. However, international guidelines do not necessarily match the reality in each country. Expensive therapies such as rituximab and calcineurin inhibitors are sometimes inaccessible to patients with refractory nephrotic syndrome due to cost or regulations. Under the Japanese medical insurance system, rituximab is accessible but still limited to steroid-dependent patients who developed idiopathic nephrotic syndrome in childhood. Based on international KDIGO guidelines and other national guidelines, possible applications of immunosuppressive agents for nephrotic syndrome are comprehensively examined in this review. While rituximab has become the mainstay of immunosuppressive therapy for nephrotic syndrome, clinical trials have indicated that options such as cyclophosphamide, calcineurin inhibitors, and mycophenolate mofetil would be preferable. Given the rising number of patients with nephrotic syndrome worldwide, KDIGO guidelines mention the need for further consideration of cost-effectiveness. If the new option of rituximab is to be the first choice in combination with steroids for nephrotic syndrome, its cost-effectiveness should also be verified. Among the few studies examining the cost-effectiveness of treatments for nephrotic syndrome, administration of rituximab to young adults has been shown to be cost-beneficial, at least in Japan. However, further large-scale studies involving multiple facilities are needed to verify such findings. Network meta-analyses have concluded that the efficacy of rituximab remains controversial and confirmation through high-quality studies of large cohorts is needed. To this end, the mechanisms of action underlying immunosuppressive agents, both old and new, need to be understood and experience must be accumulated to evaluate possible effects and side effects.

An algorithm for PCT-guided antimicrobial therapy: a consensus statement by Japanese experts.

In Japan, a national antimicrobial resistance (AMR) action plan was adopted in 2016, advocating a 20% reduction in antibiotic consumption by 2020. However, there is still room for improvement to accomplish this goal. Many randomized controlled trials have reported that procalcitonin (PCT)-guided antimicrobial therapy could help to reduce antibiotic consumption without negative health effects, specifically in acute respiratory infections. In September 2018, some experts in Europe and the USA proposed algorithms for PCT-guided antimicrobial therapy in mild to moderate infection cases outside the ICU and severe cases in the ICU (the international experts consensus). Thereafter, a group of Japanese experts, including specialists in intensive care medicine, emergency medicine, respiratory medicine and infectious diseases, created a modified version of a PCT-guided algorithm (Japanese experts consensus). This modified algorithm was adapted to better fit Japanese medical circumstances, since PCT-guided therapy is not widely used in daily clinical practice in Japan. The Japanese algorithm has three specific characteristics. First, the target patients are limited to only hospitalized ICU or non-ICU patients. Second, pneumonia due to Pseudomonas aeruginosa, Staphylococcus aureus and Legionella species are excluded. Finally, a different timing of PCT follow-up measurement was proposed to meet restrictions of the Japanese medical insurance system. The adapted algorithms has high potential to further improve the safe reduction in antibiotic consumption in Japan, while reducing the spread of AMR pathogens.

Botulinum Toxin Therapy for Spasmodic Dysphonia in Japan: The History and an Update.

Spasmodic dysphonia (SD) is a rare neurological disorder that impairs phonatory function by triggering involuntary and intermittent contractions of the intrinsic laryngeal muscles. SD is classified into three types: adductor SD (AdSD), abductor SD (AbSD), and mixed SD. Of these, AdSD accounts for 90–95% of disease; younger females are predominantly affected. Botulinum toxin injection into the laryngeal muscles is safe, minimally invasive, and very effective. Here, we review the history of clinical research for SD conducted in Japan. The first use of botulinum toxin injection therapy to treat SD in Japan was by Kobayashi et al. in 1989. The group developed an objective mora (syllable) method to evaluate SD severity. Recently, we conducted a placebo-controlled, randomized, double-blinded clinical trial of botulinum toxin therapy for AdSD and an open-label trial for AbSD to obtain the approval of such therapy by the Japanese medical insurance system. The mora method revealed significant voice improvement and the evidence was of high quality. Additionally, a clinical trial of type 2 thyroplasty using titanium bridges confirmed the efficacy and safety of such therapy. These studies broadened the SD treatment options and have significantly benefited patients.

Development and application of Japanese kampo medicine granules

This article explores the development process of Japanese kampo medicine granules, which may be related to the popularization of convenience coffee in Japan in the 1940s. The development achievements were made mainly by two people: Itakura Takeshi and Watanabe Takeshi.Itakura Takeshi made the granule in 1944, and Watanabe Takeshi published an article about granule in 1947. In 1950, the granules were applied to clinic by Hosoya Shirou. In 1957, Kotaro pharmaceutical Co. Ltd was the first to sell granules in the market. Ten years later, in 1967, five classes and six kinds of drugs entered the Japanese medical insurance system, which has epoch-making significance in the history of the development of kampo medicine. Later, the guidelines of application and management for granules-The Handbook of Kampo Medicine Prescriptions for General Use-were formulated by experts convened by the Ministry of Health and Welfare of Japan, it had a great influence on clinical application. At the same time, Japan Pharmaceutical Manufacturers Association played a good coordinating role in the process of drug production and marketing.

Comparative Cost-utility Analysis Between Aprepitant- and Fosaprepitant-containing Regimens To Prevent Chemotherapy-induced Nausea and Vomiting in Patients Receiving Highly Emetogenic Chemotherapy in Japan

PurposeClinical trials have shown that the addition of aprepitant (APR) or a phosphorylated prodrug of aprepitant, fosaprepitant (FosAPR) as prophylactic antiemetic therapy consisting of a 5-hydrotryptamine-3 receptor antagonist and dexamethasone is effective in patients receiving highly emetogenic chemotherapy. These combination therapies have been commonly used in Japan. In the present study, we performed a cost-utility analysis of APR and FosAPR in the context of the Japanese medical insurance system, and economic efficiency was compared. MethodsData from randomized controlled trials that examined the efficacy of APR and FosAPR in the Japanese population were used. A decision tree was constructed to estimate the effectiveness of chemotherapy for 5 days from the day of the treatment and the cost associated with outpatient chemotherapy from the perspective of a payer. Health outcome was expressed in quality-adjusted life-years (QALYs), and costs were estimated based on medical fees and drug prices from 2018. An incremental cost-effectiveness ratio (ICER) was calculated for each regimen containing either APR or FosAPR. The robustness of the model was assessed using 1-way and probabilistic sensitivity analysis. FindingsThe base-case analysis estimated that the addition of APR or FosAPR would have incremental effects of 0.00166 and 0.00143 QALY and incremental costs of 8305 and 11,348 JPY (74 and 101 USD [1 USD = 112.17 JPY]), resulting in ICERs of 4,992,172 and 7,955,560 JPY/QALY (44,505 and 70,924 USD/QALY), respectively. Sensitivity analysis revealed that the probability of a complete response for delayed chemotherapy-induced nausea and vomiting had the most influence on the ICERs. Reductions in the drug costs of APR and FosAPR also had an effect on the ICERs. According to the probabilistic sensitivity analysis, APR and FosAPR were dominant in terms of cost-effectiveness in 48.7% and 8.55% of cases, respectively. ImplicationsThe ICER of outpatient prophylactic antiemetic therapy in patients receiving highly emetogenic chemotherapy was calculated in the context of the Japanese medical insurance system. Assuming the willingness-to-pay of 5,000,000 JPY/QALY based on the calculated ICER, our findings suggest that although the addition of APR is cost-effective, FosAPR is not cost-effective.

Agranulocytosis due to an α-glucosidase inhibitor, voglibose

Dear Sir, Voglibose, an α-glucosidase inhibitor, lowers the daily glycemic excursions and inhibits overwork of the pancreatic β-cells [1]. Recently, voglibose has been reported to reduce the development of type 2 diabetes in individuals with impaired glucose tolerance (IGT) [2], and now, the use of voglibose for high-risk IGT individuals with dyslipidemia and/or hypertension has been approved by Japanese medical insurance system [2]. Here, we report a case with IGT who showed agranulocytosis due to voglibose. A 55-year-old woman was diagnosed as having hypertension, systemic sclerosis, and pulmonary fibrosis in December 2013, and she has been treated with prednisolone and amlodipine on December 5. Beraprost sodium, pirfenidone, and lansoprazole were started to treat her Raynaud’s phenomenon and pulmonary fibrosis and to prevent peptic ulcer on January 23 and February 15 and 27, 2014, respectively. Pirfenidone was stopped due to liver dysfunction on March 27. Liver dysfunction was ameliorated on April 3; serum aspartate aminotransferase (normal, 13–33 U/l) decreased from 140 U/l (March 27) to 49 U/l (April 3), and serum alanine aminotransferase (normal, 6–27 U/l) decreased from 327 U/l (March 27) to 172 U/l (April 3). She also showed dyslipidemia and IGT; serum levels of low-density lipoprotein cholesterol (184 mg/dl) and triglyceride (210 mg/dl) were elevated, and 2-h post-load plasma glucose concentration (199 mg/ dl) was high. We started to use voglibose (0.6 mg/day) on March 27, and the count of leukocytes and neutrophils were 9,000 and 7,506/μl, respectively, and serum C-reactive protein (CRP) level was 0.07 mg/dl (normal, <0.3 mg/dl). On April 3 (1 week after the cessation of pirfenidone), the count of leukocytes and neutrophils were 8,400 and 6,577/μl, respectively, and serum CRP level was 0.04 mg/dl (normal, <0.3 mg/dl). On April 15, she showed fever and the count of leukocytes significantly decreased to 1,300/μl and neutrophils completely disappeared, and serum CRP level increased to 11.36 mg/dl and we stopped voglibose. On the day following the stopping of voglibose, she was admitted to our hospital and the count of leukocytes and neutrophils increased to 1,500 and 37.5/μl, respectively. After the admission, we administered antibiotics and recombinant granulocyte colony-stimulating factor to her. On April 24, the count of leukocytes (6,900/μl) and neutrophils (3,968/μl) increased to normal range and serum CRP level decreased to 0.31 mg/dl, and she was discharged. After her discharge, the development of agranulocytosis has not ever been observed. We observed liver dysfunction due to pirfenidone, however, which was promptly ameliorated by the cessation of pirfenidone. Furthermore, on the day of the cessation and also at 1 week after the cessation of pirfenidone, agranulocytosis and also elevation of CRP R. Yoshikawa :H. Yanai (*) Department of Internal Medicine, National Center for Global Health and Medicine Kohnodai Hospital, 1-7-1 Kohnodai, Ichikawa, Chiba 272-8516, Japan e-mail: dyanai@hosk.ncgm.go.jp

Alcohol consumption, hospitalization and medical expenditure: a large epidemiological study on the medical insurance system in Japan.

This study investigated the relationship between alcohol drinking habits and the onset of high medical expenditure in a Japanese male population. The cohort comprised 94,307 male beneficiaries 40-69 years of age of the Japanese medical insurance system, who had daily alcohol drinking habits. The likelihood of incurring high medical expenditure, defined as the ≥90th percentile of the medical expenditure distribution in the study population 1 year after baseline, as well as the likelihood of undergoing hospitalization that year were compared among the participants grouped according to their alcohol consumption amount (<2, 2-3.9, 4-5.9, ≥6 drinks/day). Participants who ranked in the top 10% medical expenditure group within the 1 year after baseline each incurred at least 2152 euros/year. The top 10% medical expenditure group accounted for 61.1% of the total medical expenditure in the study population. The odds ratios (95% confidence intervals) for ranking in the top 10% group during the 1-year period, compared with the <2 drinks (23 g of alcohol)/day group, were 1.08 (1.02-1.15) for 2-3.9 drinks/day, 1.11 (1.05-1.19) for 4-5.9 drinks/day, and 1.31 (1.18-1.45) for ≥6 drinks/day after adjustment for age, body mass index, and smoking and exercise habits. The adjusted odds ratios for undergoing hospitalization were 1.11 (1.04-1.19), 1.14 (1.06-1.24) and 1.39 (1.24-1.56), respectively. The likelihood of incurring high medical expenditure and undergoing hospitalization increased with daily alcohol consumption amount.

Results of New Policies for Inpatient Rehabilitation Coverage in Japan

Background. A new interdisciplinary postacute rehabilitation unit, the Kaifukuki (convalescent) rehabilitation ward (KRW), has been incorporated into the Japanese medical insurance system since 2000. More than 57 000 beds (45 beds per 100 000 population) are currently available nationwide. The maximal coverage for therapy sessions increased from 2 to 3 hours per day, 7 days a week, in 2006. Objective. To investigate how changes in policy affected rehabilitation outcomes of KRWs in a retrospective cohort study of 87 917 patients over 10 years. Results. The mean (standard deviation) age of the patients was 73.0 (13.8) years, and 55.4% were women. Diagnoses included stroke (47.9%); orthopedic diseases, including hip fracture (35.2%); and traumatic brain and spinal cord injury (5.4 %). Onset–admission interval (OAI) was 31.5 (18.6) days, length of stay was 75.9 (46.1) days, and 69.1% were discharged home. Daily therapy time was 79.4 (34.5) minutes. Admission/discharge scores of the Barthel Index and the Functional Independence Measure were 49.3 (31.0)/70.4 (31.9) and 75.3 (31.2)/91.7 (31.8), respectively. Year-by-year comparison revealed that older age, greater initial disability, and shorter OAI were coupled with a higher dose of rehabilitative interventions and a higher rate of home discharge. Longitudinal data from a cohort of hospitals implied a small but significant dose-dependent effect of hours of therapy on rehabilitation outcome after stroke. Conclusions. Although the organization of KRWs is in flux as the system of hospitals grows, results over the past 8 years suggest that changes in national insurance policies are affecting the quantity and organization of rehabilitation interventions and improvement in patient outcomes.

Incidence and Risk of Postherpetic Neuralgia after Varicella Zoster Virus Infection in Hematopoietic Cell Transplantation Recipients: Hokkaido Hematology Study Group

To assess the incidence of and risk factors associated with postherpetic neuralgia (PHN) after hematopoietic cell transplantation (HCT) varicella zoster virus (VZV) infection, we conducted a retrospective chart review of 418 consecutive patients who underwent HCT between April 2005 and March 2007. The male/female ratio was 221/197, median age at HCT was 47 years (range: 0-69 years), and autologous/allogeneic/syngeneic HCT ratio was 154/263/1. Seventy-eight patients developed VZV infection after HCT. Sixty-two patients had localized zoster, 11 patients had disseminated zoster (rash like chicken pox), and 4 patients had visceral zoster. All cases were treated with acyclovir (ACV) or valacyclovir (VACV), and there was no VZV infection-related death. Twenty-seven (35%) of the 78 patients with VZV infection suffered PHN after resolution of VZV infection. Multivariate analysis showed that advanced age is the only risk factor in autologous HCT (P = .0075; odds ratio [OR] = 1.14; 95% confidence interval [CI], 0.97-1.33). On the other hand, advanced age (P = .0097; OR = 1.06; 95% CI, 1.01-1.12), male gender (P = .0055; OR = 12.7; 95% CI, 1.61-100.1), and graft-versus-host disease (GVHD) prophylaxis with a tacrolimus-based regimen (P = .0092; OR = 9.56; 95% CI, 1.44-63.3) were associated with increased risk of PHN in allogeneic HCT. This study for the first time clarified the risk of PHN in HCT recipients.

JPN Guidelines for the management of acute pancreatitis: cutting-edge information

The JPN Guidelines for the Management of Acute Pancreatitis are organized under the subject headings: epidemiology, diagnosis, management strategy, severity assessment and transfer criteria, management of gallstone pancreatitis, nonsurgical management, and surgical management. The Guidelines contain cutting-edge information on each of these subjects, as well as a section on the Japanese medical insurance system which provides information that should prove useful to physicians in other countries. The quality of the evidence was evaluated by the evidence-based classification method used at the Cochrane Library. The levels of recommendation of the individual management methods contained in the Guidelines were determined on the basis of the evaluation of evidence by the consensus of the members of the Working Group (see below). The Japanese Society for Abdominal Emergency Medicine, the Japan Pancreas Society, and the Research Group for Intractable Diseases and Refractory Pancreatic Diseases (which is sponsored by the Japanese Ministry of Health, Labour, and Welfare) were commissioned to produce the JPN Guidelines for the Management of Acute Pancreatitis. A Working Group of 20 physicians specializing in pancreatic diseases and emergency medicine investigated and analyzed 14821 cases retrieved by means of a Medline (1960–2004) search and discussed the available literature on acute pancreatitis (limited to human pancreatitis). The Working Group held many general discussions in order to reach a consensus on the content of the Guidelines. After producing a draft, the Publishing Committee of the JPN Guidelines for the Management of Acute Pancreatitis posted it on a website and asked for comments and criticisms. Subsequently, a final version of the Guidelines was published in Japanese in 2003. The Publishing Committee is now making the Guidelines available to a much wider readership by bringing out an English version.

4.わが国の医療保険制度及び臨床研究の現状と将来展望(PS 5 医療問題 : 新しい研修・研究・医療システム)

4.わが国の医療保険制度及び臨床研究の現状と将来展望(PS 5 医療問題 : 新しい研修・研究・医療システム)

3.米国とわが国の保険制度の比較(PS 5 医療問題 : 新しい研修・研究・医療システム)

3.米国とわが国の保険制度の比較(PS 5 医療問題 : 新しい研修・研究・医療システム)

A study of quality assessment in clinical microbiology performance of independent laboratories in Tokyo: 18-year participation in the Tokyo Metropolitan Government External Quality Assessment Program

We evaluated the performance of independent microbiology laboratories in Tokyo over an 18-year period of participation in the external quality assessment (EQA) program, and we estimated the impact of the EQA program. The study design was a longitudinal retrospective analysis of performance, including isolation, identification, and antimicrobial susceptibility testing of bacteria from simulated patients' samples, in "open" surveys compared with "blind" surveys. Independent microbiology laboratories, licensed by the Tokyo Metropolitan Government, have been subject to mandatory evaluation by the EQA program since 1982. Survey reports, correspondence, annual guidance meetings, and inspections are used as quality improvement strategies. The performance for identification in "blind" surveys was significantly worse than that in "open" surveys (P < 0.001). Poorly performing laboratories had common features, including inadequate supervision by physicians and lack of familiarity with the impact of variations on the use of the standards. However, there were improvements in the performance of identification of some pathogens. The performance of susceptibility testing has not yet reached the relatively high level seen for identification. Some of the smaller laboratories have been gradually acquired by commercial chains operating outside Tokyo. The EQA program has established a role both in regard to laboratory improvement and as an educational tool. However, the program lags behind these of other developed countries in regard to the practical sciences. The main problems in regard to laboratory improvements are a shortage of human resources in clinical microbiology, lack of standardization of laboratory methods, and the pressures of financial constraints in the Japanese medical insurance system.

医療保険制度の動向と医療費の適正化について

医療保険制度の動向と医療費の適正化について