Japanese Healthcare Research Articles

Survey on Specialty Preference and Work-Life Balance among Residents of Japanese Red Cross Hospitals.

Introduction: The paucity and maldistribution of physicians among various specialties are key issues facing the Japanese health care system. Studies have shown that young physicians place more emphasis on work-life balance while selecting their specialty and that they prefer controllable lifestyle (CL) specialties over noncontrollable lifestyle (NCL) specialties. As this may be a cause of maldistribution, we investigated the relationship between views on work-life balance and specialty selection among young physicians in Japan.Methods: An online questionnaire was sent to 1451 residents (postgraduate years 1-5) at 60 Japanese Red Cross hospitals across Japan. Results: In all, 226 physicians responded (response rate: 15%), with 21% in CL and 74% in NCL specialties. When compared with NCL specialties, CL specialties had less overtime (43% vs. 16%, p = 0.001), considered life to be more important than work (26% vs. 15%, p = 0.018), and were more likely to give precedence to work-life balance over medical interest while choosing their specialty (49% vs. 30%, p < 0.001). Furthermore, physicians were more likely to change their choice of specialty, contrary to their professional interest, because of social reasons (49% vs. 26%, p = 0.007). Conclusions: Our study suggests that young physicians in CL specialties have better working hours and place more emphasis on work-life balance while choosing their specialty compared with those in NCL specialties. The increase in the number of physicians in CL specialties is likely attributable to the growing preference for an optimal work-life balance among young physicians; this seems to have increased the maldistribution of physicians among various specialties. Institutional mechanisms to support the lifestyle of physicians (especially in NCL specialties) are required to provide a balanced medical service in Japan.

Challenges for the Japanese healthcare system in the future: From cases of medical facilities in other countries

Challenges for the Japanese healthcare system in the future: From cases of medical facilities in other countries

S5-KL-1 CANCER GENOMIC MEDICINE: FROM BENCH TO CLINIC

Over the last two decades, genomic technology such as microarray and next generation sequencing (NGS) enabled comprehensive analysis of cancer genome. International cancer genome consortium, established in 2007, completed the analysis of 25,000 cases and has brought discovery of novel cancer driver genes and improved our understanding cancer biology. For example, discovery of IDH1/2 mutation in various cancers created a new concept, 2-hydroxyglutarate as Oncometabolite. The mutational signature patterns allow us to predict how the individual cancer was developed. Anti-cancer drugs, such as alkylating agents, occasionally modify the bases and introduce mutations through mispairing in replication.Currently we are aware that cancer is a genetic disease, where accumulation of genetic and epigenetic alterations in the genome leads to cellular transformation, and that mutation in each patient is unique. To realize the personalized oncology, clinical sequencing test was developed. This year a couple of NGS-based cancer panel tests have been approved for reimbursement by nation-wide healthcare system in Japan.In this seminar I will discuss the future improvement in genomic oncology.

Fall-related mortality trends in older Japanese adults aged ≥65 years: a nationwide observational study

ObjectivesFall-related mortality among older adults is a major public health issue, especially for ageing societies. This study aimed to investigate current trends in fall-related mortality in Japan using nationwide population-based...

Japan's health care system faces a perfect storm

Although Japan has implemented a universal health care system that is universal in terms of free access to health care services, it is managed by fragmented and financially insecure insurance societies that have cumulative deficits even with government subsidies. In terms of insurance premiums, the system is regressive to low-income and unstable workers, and the social benefit scheme only captures 1.6% of this population. The Japanese government is continuously instituting new health care policies to reduce growing health care expenditures. Recent health care reforms may improve economic efficiency, but the changes remain limited to controlling access to health services and pricing measures.

A retrospective observational study of antimicrobial treatment for non-tuberculous mycobacteria disease using a nationwide claims database in Japan

The Macrolides (MLs), clarithromycin and azithromycin, are key drugs for non-tuberculous mycobacteria (NTM) diseases treatment. A three antibiotics regimen including MLs, rifampicin (RFP) and ethambutol (EB) has been recommended for the treatment of NTM diseases in ATS/IDSA guideline. However, anti-biotics are not necessarily prescribed in compliance with the guideline. Inappropriate regimens are risk of introducing MLs resistance. Therefore, we planned this study to evaluate the current Japanese NTM diseases treatment conditions. We used the national database (NDB) from 2011 to 2014.A total of 183 patients were entered into the study. The patients number increased at an accelerating rate in patients aged ≥55 years. Patients aged ≥55 years made up 91.3% of the total NTM diseases. Male and female patients were 61 and 122, respectively, a female/male ratio of 2.00. Clarithromycin, RFP, EB and fluoroquinolones were frequently prescribed, with the numbers of prescriptions being 125, 66, 57 and 45, respectively. The regimen of MLs, RFP and EB recommend by ATS/IDSA guideline 2007 was only followed by 25.1% of the patients. MLs monotherapy was as high as 30.6% of NTM diseases and would be a risk factor leading to an increase of MLs resistance and poor treatment outcome. Without effective NTM disease therapy, the increase of MLs-resistant NTM diseases would be a burden for Japanese health care facilities.

Guiding patients to appropriate care: developing Japanese outpatient triage nurse competencies.

ABSTRACTJapanese patients often seek hospital services without a primary provider’s referral. A triage nurse who is the initial point of contact for a patient is challenged with the task of expertly evaluating the urgency of the condition and selecting the appropriate specialty service for every patient’s needs. A triage nurse must also recognize any conditions requiring emergency medical services instead of a specialty outpatient service. A modified Delphi method was used to establish expert consensus regarding triage nursing competencies for secondary and higher-level health care facilities in Japan.The initial Delphi round was completed using a questionnaire of 80 competencies that were evaluated by 85 Japanese nurse experts with in-depth knowledge of triage and/or the current Japanese hospital system. Four additional competency items were added based on the experts’ suggestions for a total of 84 items. The experts rated these items on a 7-point Likert scale based on importance. Minimal attrition rate yielded consistent and rich results.The results were analyzed to identify items rated as very important by the majority. Twenty-two items were included in the final list of competencies. The authors then refined the language and reorganized the items into four proposed domains. The proposed domains and the refined list of competencies provide a foundation for the development of training programs for outpatient triage nurses in the current Japanese health care system.

Trends in Medical Costs for Adolescent Idiopathic Scoliosis Surgery in Japan.

Study Design:A retrospective review of clinical data and costs was performed for surgeries for adolescent idiopathic scoliosis (AIS) conducted from 2008 to 2017.Objective:Cost containment and healthcare value have become focal points in Japanese health care policy. The purpose of the study was to investigate trends over time in medical costs for surgery for AIS.Methods:A total of 83 patients underwent surgery for AIS from 2008 to 2017 at our hospital. Clinical data and length of stay were collected, and medical costs for surgery, local bone grafting, fees per day, and surgical instruments were evaluated.Results:There were slight year-by-year decreases in fees per day and decreases in costs of surgical instruments. The average length of stay was 16.4 days and gradually decreased over time. In contrast, scoliosis surgery costs increased about 1.6 times in 10 years from $9515 to $15 130.Conclusion:The trends for decreases in fees per day and prices for surgical instruments reflect recent government medical cost control policies. The cost for scoliosis surgery is also defined by the government, and the increase over 10 years may reflect the perspective of valuing effective and advanced surgeries. This study of cost trends of operative spinal intervention provides an assessment of surgical benefit and is likely to influence health care costs.

2641. The Characteristics of Influenza-Like Illness (ILI) Management in Japan

BackgroundInfluenza-like illness (ILI) is a common disease that imposes a severe disease burden at the population level. ILI management is important in view of population health, and Japan’s management is distinct from that in other countries, especially regarding diagnosis and treatment of seasonal influenza. This study’s main objective was to quantitatively assess ILI management in Japanese healthcare settings.MethodsIn February 2019, we conducted an online survey of 600 participants in 200 households concerning ILI and its management in Japan. Respondents reported ILI episodes they and/or their family members experienced during January 2019. The 12-Item Short-Form Health Survey, Version 2 (SF-12v2) was included in the questionnaire to estimate quality of life (QOL) lost through ILI, and quality-adjusted life years (QALYs) lost in that way. We analyzed participants’ healthcare-seeking behavior to clarify the characteristics of Japanese ambulatory care for ILI.ResultsOf the participants, 261 of 600 (43.5%) reported at least one episode of ILI during January 2019. Of these, 194 (75.5%) visited healthcare facilities and 167 (86.1%) visited facilities within 2 days of symptom onset. A rapid influenza diagnostic test (RIDT) was given to 169 of 191 (88.5%) and 101 patients received a diagnosis of influenza, rather than ILI. Antivirals were used to treat 92.2% of the influenza cases. The median values of QOL and QALYs lost during a symptomatic period of ILI were 0.67 (interquartile range: 0.60–0.79) and 0.0055 (interquartile range: 0.0040–0.0072), respectively.ConclusionIn Japan, most ILI patients visit healthcare facilities in the early phase of symptoms, and most physicians examine them using the RIDT. Most laboratory-diagnosed influenza cases are treated using antivirals. Future work should examine the relation between this early diagnosis and treatment practice, and the duration and severity of ILI symptoms. Disclosures All authors: No reported disclosures.

Humanistic and economic burden among caregivers of patients with cancer in Japan

Aims: As the number of cancer patients increases in Japan, and people are living longer with cancer, the need for caregivers of cancer patients is expected to increase substantially. This study intended to reveal the humanistic and economic burden among caregivers of cancer patients, and to compare it with the burden among caregivers of patients with other conditions (other caregivers) and non-caregivers.Materials and methods: This cross-sectional analysis used data from the Japan National Health and Wellness Survey 2017. Outcome measures included the Short Form 12-item Health Survey for health-related quality of life (HRQoL), EuroQol 5-dimension scale (EQ-5D) for health states utilities, Work Productivity and Activity Impairment questionnaire for the impact of health on productivity and activity, and indirect costs. Multivariate analysis was used to compare across groups, with adjustment for potential confounding effects.Results: A total of 251 caregivers of cancer patients, 1,543 other caregivers, and 27,300 non-caregivers were identified. Caregivers of cancer patients (average 48.0 years old) tended to be younger than non-caregivers (51.5) and other caregivers (54.4) and had the highest education level (57.8% completed university education). Fewer non-caregivers had stress-related comorbidities than caregivers. Non-caregivers had significantly higher EQ-5D index scores than caregivers (average 0.81 vs. 0.73 vs. 0.74). Caregivers of cancer patients had significantly lower mental component summary scores than non-caregivers (40.18 vs. 46.70), and the difference indicated a clinically meaningful decrease in HRQoL. Caregivers of cancer patients had significantly higher presenteeism (37.31% vs. 20.43%), total work productivity impairment (38.85% vs. 21.98%), and activity impairment (40.94% vs. 25.78%) than non-caregivers. Additionally, caregivers of cancer patients had significantly higher total indirect costs (36.34% vs. 20.03% of average annual income).Conclusions: These results have implications for future healthcare planning, suggesting the importance of healthcare systems in Japan to consider the substantial burden borne by caregivers of cancer patients.

Carbon footprint of Japanese health care services from 2011 to 2015

The carbon footprint of Japanese health care services, i.e. the domestic greenhouse gas (GHG) emissions caused by health care expenditures, including the associated fixed capital, were calculated using input-output analysis. In 2011 the total carbon footprint of these services was 62.5 × 106 metric tons of CO2 equivalent (MtCO2e), which is 4.6% of total domestic GHG emissions. Medical services involving hospitalization accounted for the greatest share, at 15.7 MtCO2e. The second highest category, Medical services without hospitalization, accounted for only slightly less: 14.2 MtCO2e. However, the difference in emissions per patient between these two categories was considerable. On average, emissions per patient for Medical services (hospitalization) were 12 tCO2e/patient, whereas for Medical services (non-hospitalization) they were only 2.1 tCO2e/patient, or 5.4 times less. In terms of type of medical condition, the greatest annual emissions were associated with cardiovascular disease (6.2 MtCO2e) and neoplasm (4.0 MtCO2e). In terms of age, emissions attributed to patients aged 65 and over accounted for more than half of total health care emissions. By 2015, the total carbon footprint had increased to 72.0 MtCO2e, a rise of over 15% in four years. Although medical care and pharmaceuticals are the main factors responsible for this increase, emissions associated with nursing services have also risen, suggesting that demographic aging may be having a significant impact on GHG emissions. As a countermeasure, the potential annual GHG mitigation achievable through avoidance of unused prescribed medicines resulting in waste was estimated at 1.24 MtCO2e, comparable with the total carbon footprint of home medicines. To safeguard planetary health, in addition to implementing technological improvements to the supply chains of health care services, it will be necessary to provide citizens further options for achieving health promotion and GHG mitigation simultaneously.

Stopping the HPV vaccine crisis in Japan: Quantifying the benefits and risks of HPV vaccination in quality-adjusted life-years for appropriate decision-making

BackgroundThe human papilloma virus (HPV) vaccination coverage rate in Japan has dropped dramatically from more than 70% to less than 1% since 2013. With conflicting information and a lack of quantification of the benefits and risks of the HPV vaccine, parents have been hindered in making their decision. We quantified the benefits and risks of the HPV vaccine in terms of quality-adjusted life-years (QALYs), to help their informed decision. MethodA literature search was performed to determine the incidence and burden of each outcome in a decision tree model. The benefits and the risks of the HPV vaccination were determined in QALY change with a sensitivity analysis. ResultThe benefits of the HPV vaccine in terms of QALYs gained were 703.72, 14.45, and 30.83/100,000 persons for cervical cancer, cervical intraepithelial neoplasm 3 (CIN 3), and genital warts, respectively. The QALY loss due to acute adverse reactions, chronic adverse reactions without assistance needs, and chronic adverse reactions with assistance needs were 0.07, 5.83, and 5.82/100,000 persons, respectively. The risk/benefit ratio in QALY change in the base case was 0.0156. In all scenarios, the benefit of the HPV vaccine was significantly greater than the risk. ConclusionThe benefits are much greater than the risks, even if it is assumed that all reported adverse events were due to the vaccination. The Japanese government and health care providers should immediately recommend the HPV vaccine to all adolescent girls irrespective of any causal links between the vaccine and reported adverse events.

Cost-Effectiveness Analysis of Vedolizumab Compared with Other Biologics in Anti-TNF-Naïve Patients with Moderate-to-Severe Ulcerative Colitis in Japan

BackgroundVedolizumab (VDZ) was approved by the Japanese Ministry of Health, Labor and Welfare in 2018 for the treatment of patients with moderate-to-severe active ulcerative colitis (UC). The comparative cost-effectiveness of VDZ compared with other biologics is unknown in Japan. This information could be useful for decision makers at the time of repricing biologics for the treatment of patients with moderate-to-severe UC.ObjectiveThe aim was to assess the cost-effectiveness of VDZ versus other branded biologics for the treatment of patients with moderate-to-severe UC who were anti-tumor necrosis factor (TNF)-naïve, from the Japanese public healthcare payer perspective.MethodsA hybrid decision tree/Markov model was developed to predict the number of patients who achieved response and remission at the end of the induction phase and sustained it during the maintenance phase, translating this into quality-adjusted life-years (QALYs) and costs. Treatment-related adverse events, discontinuation and surgery, and their impact on QALYs and costs were also modeled. A systematic literature review and network meta-analysis were conducted to estimate the comparative efficacy of each treatment versus placebo. Rates of adverse events, surgery, surgery complications, and utilities were from the literature. Costs (2018 Japanese yen) were obtained from the Japanese National Health Insurance drug price list and medical fee table and local claims databases. Clinical and economic outcomes were projected over a lifetime and discounted at 2% annually.ResultsOver a lifetime, VDZ yielded greater QALYs and cost savings compared with golimumab and was cost-effective compared with adalimumab and infliximab (incremental cost-effectiveness ratios ¥4,821,940 and ¥4,687,692, respectively). Deterministic and probabilistic analyses supported the robustness of the findings in the base-case analysis, indicating that VDZ was either dominant or cost-effective in most scenarios and replications. The main limitations of this analysis include excluding tofacitinib and infliximab biosimilar as comparators, health-state utility estimates were obtained from population studies in the United Kingdom, and the impact of subsequent (i.e., second-line) biologic treatment was not evaluated.ConclusionOur analysis suggests that VDZ is dominant or cost-effective compared with other branded biologics for the treatment of anti-TNF-naïve patients with moderate-to-severe UC in Japan.Electronic supplementary materialThe online version of this article (10.1007/s40273-019-00841-1) contains supplementary material, which is available to authorized users.

Development of a Fried Frailty Phenotype Questionnaire for Use in Screening Community-Dwelling Older Adults

ObjectivesThe aim of this study was to develop a Fried Frailty Phenotype Questionnaire (FFPQ) and a Japanese FRAIL (fatigue, resistance, ambulation, illnesses, and loss of weight) scale (FRAIL-J) and to evaluate the reliability and validity of both questionnaires in Japanese community-dwelling older adults. DesignCross-sectional analysis of Itoshima Frail Study (IFS). SettingThe IFS is an ongoing community-based prospective study in Itoshima (Japan). ParticipantsA total of 858 older adults age 65-75 years. MethodsThe FRAIL-J comprises 5 existing items comparable to those in original FRAIL scale but with broader utilization in the Japanese healthcare system. In FFPQ, resistance, ambulation, and loss of weight were the same as those in FRAIL-J. Fatigue was the same with exhaustion in FFP and inactivity was assessed using a yes or no question. Data including demographics, and physical and cognitive functions, and objective physical activity was collected and analyzed in relation to both questionnaires. ResultsThe FFPQ and FRAIL-J showed low internal consistency (Kuder-Richardson formula 20 coefficients = 0.32 and 0.29) and good test-retest reliability (intraclass correlation coefficients = 0.79 and 0.72). The correlations ranged from −0.22 to 0.49 when correlating each item with cross-sectional outcomes. Using FFP as a criterion, the ares under the curve for FRAIL-J and FFPQ were 0.86 and 0.88, respectively. The optimal cut-off for FRAIL-J was 2, with a higher Youden index (66.7% vs 20.3% for 3) and a high negative predictive value (99.5%) but low positive predictive value (13.1%). As for FFPQ, either 2 or 3 was evaluated as cut-off because the Youden index (62.2% vs 58.5%) and negative predictive value (99.7% vs 99.2%) were similar although the positive predictive value was low (9.7% vs 33.3%). Using a 2-point cut-off, both questionnaires had slight agreement with FFP. The highest agreement (kappa = 0.42) was found between FFP and FFPQ using a 3-point cut-off. Conclusions/ImplicationsThe FFPQ and FRAIL-J can be used for frailty screening in Japanese community-dwelling older adults.

Analysis of the emotional experiences of Japanese Alcoholics Anonymous members striving for sobriety

BackgroundJapan’s tolerance of alcohol consumption and intoxication pose extreme difficulties for community-dwelling alcoholics who wish to abstain from alcohol and maintain sobriety. Emotional problems triggered in daily life can easily lead to relapse, especially after abstinence. Alcoholics Anonymous places great emphasis on dealing with attendees’ emotional experiences. However, the specific nature of this support is not well understood. Therefore, this study aimed to elucidate the emotional experiences of AA members who strive for sobriety while attending AA and to identify suggestions for new methods of support.MethodsThe present study employed an interview method. Data were analyzed using the KJ Method, which was developed by Japanese cultural anthropologist Jiro Kawakita. Study participants were 36 men chosen from AA groups in the Kanto and Kyushu regions of Japan.ResultsLong-term abstinence was achieved through the following process: 1) gaining objectivity, 2) striving to maintain an attitude of acceptance, and 3) remaining devoted to discipline for one’s goals, thereby 4) recovering one’s contradictory self. This was an unending process that unfolded as the individual tasks affected each other. To facilitate this process, AA members dealt with risk cues that destabilized post-cessation emotional balance while making daily efforts to regulate their own emotions.ConclusionsTo maintain sobriety, AA members strove to regulate their emotions. By doing so, they experienced personal growth and attained a life in which they did not require alcohol (i.e., sobriety). The present study indicated that Japanese nursing and health care workers should be willing to learn from AA members, such as by understanding the 12-step culture. The data also suggest the need to create environments conducive to AA activities, from which many alcoholics derive emotional support.

Associations of social relationships with curative and preventive dental care use among young and middle‐aged adults: Evidence from a population‐based study in Japan

Social relationships are important for diffusion of information and behaviours. Access to preventive dental care is more difficult than access to curative dental care under the Japanese universal healthcare system. Our objective was to examine whether social relationships were differentially associated with curative and preventive dental care use in Japan. A questionnaire survey was conducted between 2010 and 2011 among residents aged 25-50years in Japanese metropolitan areas. Valid responses were obtained from 1919 men and 2207 women. Social relationships included social networks (membership of organizations and number of close ties) and social support (informational support and instrumental support). Poisson regression analyses with robust variance estimators were conducted to examine associations between each social relationship variable and curative dental care use or preventive dental care use, adjusted for covariates. While 38.4% of men and 42.0% of women used curative dental care, 22.9% of men and 32.5% of women used preventive dental care in the past year. No measures of social relationships were associated with curative dental care use among men and women, except the number of close ties among men. By contrast, all measures of social relationships were associated with preventive dental care use among men; the multivariate-adjusted prevalence ratios (95% confidence intervals) of the highest compared with the lowest level of social relationships were 1.58 (1.18-2.13) for membership of organizations, 1.58 (1.24-2.00) for the number of close ties, 1.41 (1.10-1.82) for informational support and 1.30 (1.01-1.68) for instrumental support. Among women, no measures of social relationships were associated with preventive dental care use. Social relationships were associated with preventive dental care use among men but not among women, while these were not associated with curative dental care use.

Super-aged society: Constructing an integrated information platform of self-recording lifelogs and medical records to support health care in Japan.

As the super-aged society, Japan is facing challenges in health care system. As one of measures to cope with challenges, the Ministry of Health, Labor, and Welfare started to construct an open medical information platform, named PeOPLe, in 2016 for personalized medical care, improvement of medical services, and the redistribution of medical resources. The Ministry plans to build the platform infrastructure by 2020 and put the platform into full-scale operation by 2025. PeOPLe collects only medical records, but it should collect lifelogs as well in order to better improve the health, especially for elderly. A lifelog is a record of a person's activity and it has potential to predict the probability a person will suffer a lifestyle-related disease as a result of the person's lifestyle. This prediction could help to maintain the health of the elderly. In addition, constructing a self-recording platform integrated with the medical platform is the best way to collect lifelogs since collecting a large amount of lifelogs for a long time from various people at public or medical agencies is difficult. A self-recording platform is a place where people can post and manage their lifelogs. In return for posting lifelogs, people will receive personalized health advice, which will attract more people.

Research evidence is essential for the development of family medicine as a discipline in the Japanese healthcare system

Japan is facing an extraordinary rapid ageing rate: approximately 40% of people will be ≥65 years of age in 2060.1 The Japanese Ministry of Health, Labour and Welfare (MHLW) have highlighted the importance of primary care physicians for coping with the ageing population and reducing healthcare expenditure.2 However, a range of stakeholders such as MHLW and the Japan Medical Association (JMA) have been debating the necessity of family medicine as a medical discipline in the Japanese healthcare system. We examined the necessity of family medicine based on the existing discussion in the Japanese healthcare system and propose future research in this area. The main characteristics of the healthcare system in Japan are universal health insurance and a free-access system, whereby patients are free to choose any healthcare facility, regardless of their insurance status or severity of illness.3 All residents of Japan including foreign nationals with a residence card are required by law to be enrolled in a health insurance programme.4 The free-access system allows patients to visit a hospital directly without referral from a family physician.3 Although the Japanese healthcare system has achieved better healthcare outcomes, such as long …

Short-Term Cost-Effectiveness of Switching to Insulin Degludec in Japanese Patients with Type 2 Diabetes Receiving Basal-Bolus Therapy.

IntroductionWith one of the fastest aging populations in the world, demographic changes in Japan are a major public health concern due to the substantial burden that aging-associated diseases, such as type 2 diabetes (T2D), place on public healthcare systems. The aim of this analysis was to evaluate the short-term cost-effectiveness of switching Japanese patients with T2D receiving basal–bolus insulin therapy from their previous basal insulin to insulin degludec (degludec) under conditions of routine clinical practice.MethodsA previously published, open-source model developed in Microsoft Excel was used to evaluate the cost-effectiveness of switching basal–bolus insulin therapy from patients' previous basal insulin to degludec versus continuing the previous basal insulin therapeutic regimen in terms of costs (2018 Japanese Yen [JPY]) and quality-adjusted life years (QALYs), from a Japanese public healthcare payer perspective. The model captured hypoglycemia rates and insulin dosing over a 1-year time horizon, and was informed by Japanese real-world evidence from the T2D cohort (N = 135) of the Kumamoto Insulin Degludec Observational study.ResultsTreatment with degludec was associated with improved effectiveness (+ 0.0354 QALYs), driven by lower daytime non-severe hypoglycemia rates with degludec, at slightly higher annual treatment costs (JPY 9510) versus continuing the previous basal insulin. Switching basal insulin to degludec was found to be a cost-effective intervention with an incremental cost-effectiveness ratio (JPY 268,811 per QALY gained) substantially below the willingness-to-pay threshold of 5 million JPY per QALY used in the Japanese Health Technology Assessment framework. Sensitivity analyses confirmed the robustness of this finding and indicated that the daytime non-severe hypoglycemia benefit with degludec was a key driver of outcomes in the base case.ConclusionBased on Japanese real-world evidence, our analysis suggests that switching Japanese patients with T2D receiving a basal–bolus regimen from their previous basal insulin to degludec would be highly cost-effective. These data may help decision-makers in Japan allocate healthcare resources efficiently.Trial RegistrationThe KIDUNA study is registered with the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR): UMIN000021569.FundingNovo Nordisk Pharma Ltd. Japan.Electronic Supplementary MaterialThe online version of this article (10.1007/s13300-019-0635-1) contains supplementary material, which is available to authorized users.

PF431 CLINICAL CHARACTERISTICS, TREATMENT PATTERNS, AND THROMBOEMBOLIC RISK OF PATIENTS WITH COLD AGGLUTININ DISEASE (CAD) IN JAPAN

Background:CAD is a rare form of autoimmune hemolytic anemia with a prevalence in Northern Europe of 16 cases per 1 million inhabitants (Berentsen S. Semin Hematol 2018). Ig M autoantibodies bind to red blood cells and trigger hemolysis via activation of the classical complement pathway. Although clinical and epidemiological studies are limited, recent evidence indicates that CAD patients in Europe and North America have an increased risk of thromboembolic events (TE) (Bylsma LC, et al. EHA 2018; Broome C, et al. Blood 2017). The 1‐year case‐fatality of TE has been reported as 23% (Tagalakis V, et al. Am J Med 2013). There are no studies evaluating the clinical course and risk of TE in CAD patients in Japan or other Asian populations.Aims:To describe clinical characteristics, treatment patterns, and risk of TE in CAD patients in Japan.Methods:Patients were retrospectively identified from 2008 to 2017 using a hospital‐based administrative claims database (Medical Data Vision), representing approximately 300 hospitals and 20 million patients in Japan. CAD cohort inclusion required age ≥18 years and CAD diagnosis (Japanese Disease Code 2830009) entry on ≥3 separate occasions within the study period. The first CAD diagnostic code entry was used as the index date. Patients in the comparison cohort had no history of CAD and were matched 10:1 to patients in the CAD group by age, sex, year and season of diagnosis, follow‐up time, and comorbidities using the Charlson Comorbidity Index. Conditional logistic regression was used to adjust for these variables when comparing cohorts.Results:344 CAD patients were identified with a slight female preponderance (53.2%), mean age of 66.8 years and 18.9‐month mean duration of follow‐up. The most frequently used treatment was steroids (34.2%). Other treatments included cytotoxic chemotherapy (6.9%), rituximab (5.9%), and immunosuppressants (5.9%). A total of 3440 patients with matching characteristics were included in the control group to compare the risk of TE among cohorts. Overall, CAD patients had an increased rate of TE versus patients without CAD (34.8% vs 17.9%, respectively; P &lt; 0.0001) (Figure). The rate of arterial and venous TE was also higher in CAD versus non‐CAD cohorts (25.0% vs 4.6% and 8.4% vs 4.0%, respectively; P &lt; 0.0001 for both analyses). Most cases of arterial TE in CAD patients corresponded to myocardial infarctions (87.2%). There was no difference in cerebral TE among the CAD and non‐CAD groups (10.4% vs 11.9%, respectively). The overall odds ratio (OR [95% confidence interval]) for development of TE in the CAD cohort versus non‐CAD cohort was 2.81 (2.18–3.61). Corresponding ORs for arterial and venous TE were 8.59 (6.16–11.98) and 2.37 (1.56–3.62), respectively.Summary/Conclusion:This study is the first to evaluate the clinical characteristics, treatment practices, and TE risk of CAD patients in Japan. Our results indicate that the CAD treatment approach used in Japan (ie, predominantly with steroids) differs from that reported for other countries. However, in accordance with recent reports from non‐Asian populations, this study demonstrates an increased risk of TE in the Japanese population. Interestingly, the rate of arterial TE was higher in Japan, which was mostly attributed to the high prevalence of myocardial infarctions in our CAD cohort. Japanese healthcare providers should be aware of these risks to properly monitor their CAD patients. Prospective studies are needed to further evaluate these findings.image