Publications by authors named "Takeru Shiroiwa"

46 Publications

Japanese Population Norms of EQ-5D-5L and Health Utilities Index Mark 3: Disutility Catalog by Disease and Symptom in Community Settings.

Value Health 2021 Aug 22;24(8):1193-1202. Epub 2021 Apr 22.

Center for Outcomes Research and Economic Evaluation for Health, National Institute of Public Health, Wako, Saitama, Japan.

Objectives: This study aimed to establish the Japanese population norms of the EQ-5D-5L and Health Utilities Index Mark 3 (HUI3) and estimate the disutility associated with diseases and symptoms.

Methods: We performed a door-to-door survey of the general population by random sampling. The planned sample size was 10 000 residents (age ≥16 years) of 334 districts in Japan. In addition to the EQ-5D-5L and HUI3 questionnaires, questions regarding demographic factors and self-reported main diseases and symptoms were asked. The EQ-5D-5L and HUI3 responses were converted to index values on the basis of Japanese value sets. Summary values by age and sex were calculated to obtain Japanese normative values. A multiple linear model was used to examine relationships between these values and diseases and symptoms.

Results: We collected 10 183 responses from 334 districts. The mean EQ-5D-5L index values were 0.821 (male) and 0.774 (female) in the age group of 80 to 89 years, which were lower compared with 0.978 (male) and 0.967 (female) in the age group of 16 to 19 years. Similar trends were observed for the HUI3 values. Age, sex, household income, and education level had a significant influence on the values of both instruments. When measured with the EQ-5D-5L, Parkinson disease, dementia, and stroke were associated with the largest disutility (>0.2), and the disutility for depression was approximately 0.18. In contrast, the HUI3 disutility values for Parkinson disease and dementia were approximately 0.4.

Conclusions: This study established the Japanese population norms of the EQ-5D-5L and HUI3, which can be used in healthcare decision making and contribute to a more reliable analysis of economic evaluations.
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http://dx.doi.org/10.1016/j.jval.2021.03.010DOI Listing
August 2021

EQ-5D-Y Population Norms for Japanese Children and Adolescents.

Pharmacoeconomics 2021 Jul 22. Epub 2021 Jul 22.

Center for Outcomes Research and Economic Evaluation for Health (C2H), National Institute of Public Health, 2-3-6 Minami, Wako, Saitama, 351-0197, Japan.

Objective: This study was aimed at establishing population norms of EQ-5D-Y in Japan by a nationwide large sample survey.

Methods: We performed a door-to-door survey by visiting the homes of children/adolescents aged 8-15 years selected by random sampling. The planned sample size was 3600 from 100 districts in Japan. Children/adolescents were asked to respond to the EQ-5D-Y instrument, and their parents, to background questions on themselves and their children. Summary statistics by age/sex were calculated to obtain the Japanese population norms. A multiple linear regression model was used to examine the relationships between the EQ-5D-Y index and their parents' demographic factors, the children/adolescents' diseases/symptoms and the family environment.

Results: We collected 3636 responses from 100 districts. The overall EQ-5D-Y index values (all sexes, ages) ranged from 0.90 to 0.95. The percentage of respondents reporting full health ranged from 40 to 60%. In regard to the influence of the children/adolescents' diseases/symptoms on disutility, developmental disability showed the largest disutility values of 0.090. Sleeplessness and body pain were the symptoms that exerted the greatest influence on the EQ-5D-Y index; the effect sizes ranged from - 0.030 to - 0.098 for sleeplessness, and from - 0.023 to - 0.079 for body pain. The EQ-5D-Y index of children/adolescents with parents who reported severe stress was lower by 0.072 (p < 0.001), as compared with that of children/adolescents with parents reporting no stress.

Conclusions: Population norms of EQ-5D-Y were established for the first time. We also clarified the relationship between the EQ-5D-Y index value and the children/adolescents' diseases/symptoms and the family environment.
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http://dx.doi.org/10.1007/s40273-021-01063-0DOI Listing
July 2021

Randomized Controlled Trial of Paper-Based at a Hospital versus Continual Electronic Patient-Reported Outcomes at Home for Metastatic Cancer Patients: Does Electronic Measurement at Home Detect Patients' Health Status in Greater Detail?

Med Decis Making 2021 Apr 24:272989X211010171. Epub 2021 Apr 24.

Department of Biomedical Sciences, College of Life Sciences, Ritsumeikan University, Kusatsu, Shiga, Japan.

Purpose: This study aimed to determine whether continual electronic patient-reported outcome (ePRO) measurements at home can capture the fluctuations in health-related quality of life (HRQOL) scores between visits.

Methods: We performed a randomized controlled trial to compare the scores obtained by standard practice (paper-based measurements in the hospital) to scores by continuous measurement of ePRO at home. Metastatic cancer patients were randomly assigned to either the paper-based ( = 50) or the ePRO group ( = 52). EQ-5D-5L and EORTC QLQ C-30 scores were obtained on 3 different chemotherapy days in the paper-based group. Meanwhile, scores were obtained on the chemotherapy day and on days 3, 7, 10, and 14 in the ePRO group during 2 cycles. The first hypothesis of our study was that both scores at the same time points would be equivalent despite different measurement frequency, place, or mode of measurement. The second hypothesis was that PRO score-adjusted time would be different between the groups. For equivalence, the endpoint was the mean EQ-5D-5L index value on the chemotherapy day before the outpatient treatment. Only if equivalence was shown, quality-adjusted life-days (QALDs) were considered using all the data.

Results: The adjusted mean difference in the EQ-5D-5L index was determined to be -0.013 (95% confidence interval [CI]: -0.049 to 0.022); the 95% CI did not exceed the equivalence margin. Similarly, the mean difference in global health status (2.28 [95% CI: -2.55 to 7.11]) also showed equivalence. However, the QALD by EQ-5D-5L was significantly lower in the ePRO group by 1.36 per 30 d (95% CI: -2.22 to -0.51; = 0.0021).

Conclusions: Continual measurements of the HRQOL at home by ePRO may yield more detailed profiles of the HRQOL.
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http://dx.doi.org/10.1177/0272989X211010171DOI Listing
April 2021

Valuation Survey of EQ-5D-Y Based on the International Common Protocol: Development of a Value Set in Japan.

Med Decis Making 2021 07 23;41(5):597-606. Epub 2021 Mar 23.

EuroQol Research Foundation, Rotterdam, South Holland, The Netherlands.

Background: EQ-5D-Y is a preference-based measure for children and adolescents (aged 8-15 y). This is the first study to develop an EQ-5D-Y value set for converting EQ-5D-Y responses to index values.

Methods: We recruited 1047 respondents (aged 20-79 y) from the general population, stratified by gender and age group, in 5 Japanese cities. All data were collected through face-to-face surveys. Respondents were asked to value EQ-5D-Y states for a hypothetical 10-y-old child from a proxy perspective using composite time tradeoff (cTTO) and a discrete choice experiment (DCE). The discrete choice data were analyzed using a mixed logit model. Latent DCE values were then converted to a 0 (death)/1 (full health) scale by mapping them to the cTTO values.

Results: The mean observed cTTO value of the worst health state [33333] was 0.20. Analysis of the DCE data showed that the coefficients of the domains related to mental functions ("Having pain or discomfort" and "Feeling worried, sad, or unhappy") were larger than those for the domains related to physical and social functions. By converting latent DCE values to a utility scale, we constructed a value set for EQ-5D-Y. No inconsistencies were observed. The minimum predicted score was 0.288 [33333], and the second-best score was 0.957 [12111].

Conclusion: A value set for EQ-5D-Y was successfully constructed. This is the first survey of an EQ-5D-Y value set. Interpreting the differences between EQ-5D-Y and EQ-5D-5L value sets is a future task with implications for health care policy.
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http://dx.doi.org/10.1177/0272989X211001859DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8191148PMC
July 2021

Prospective observational study estimating willingness-to-pay for breast cancer treatments through contingent valuation method in Japanese breast cancer patients (JCOG1709A).

Jpn J Clin Oncol 2021 Mar;51(3):498-503

Aichi Cancer Center Hospital, Aichi, Japan.

In April 2016, the Japanese government introduced health technology assessment as a response to rising medical expenses due to 'medical innovation'. This study investigates how Japanese breast cancer patients who received treatment in Japan consider the financial value (willingness-to-pay; WTP) for their life and health by using the contingent valuation method (CVM) prospectively. First, 168 patients (84 primary breast cancer patients and 84 metastatic breast cancer patients) were pre-examined their WTP with dichotomous-choice method survey form. Next, 1,596 patients (798 primary breast cancer patients and 798 metastatic breast cancer patients) will be surveyed to their WTP for hypothetical scenarios in CVM. Based on our results, we will construct an evaluation axis from the patients' viewpoint for the cost-effectiveness of clinical trials to establish standard treatments for breast cancer. We believe this research can contribute to create a meaningful healthcare system for patients, clinicians, industries, and healthcare policymakers.
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http://dx.doi.org/10.1093/jjco/hyaa241DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7937425PMC
March 2021

Incident reports involving hospital administrative staff: analysis of data from the Japan Council for Quality Health care nationwide database.

BMC Health Serv Res 2020 Nov 20;20(1):1054. Epub 2020 Nov 20.

Iwate Medical University, 2-1-1 Idaidori, Yahabacho, Shiwagun, Iwate, 028-3695, Japan.

Background: Task shifting and task sharing in health care are rapidly becoming more common as the shortage of physicians increases. However, research has not yet examined the changing roles of hospital administrative staff. This study clarified: (1) the adverse incidents caused by hospital administrative staff, and the direct and indirect impact of these incidents on patient care; and (2) the incidents that directly involved hospital administrative staff.

Methods: This study used case report data from the Japan Council for Quality Health care collected from April 1, 2010 to March 31, 2019, including a total of 30,823 reports. In April 2020, only the 88 self-reported incidents by hospital administrative staff were downloaded, excluding incidents reported by those in medical and co-medical occupations. Data from three reports implicating pharmacists were rejected and the quantitative and textual data from the remaining 85 case reports were analyzed in terms of whether they impacted patient care directly or indirectly.

Results: Thirty-nine reports (45.9%) involved direct impact on patient care, while 46 (54.1%) involved indirect impact on patient care. Most incidents that directly impacted patient care involved administrative staff writing prescriptions on behalf of a doctor (n = 24, 61.5%); followed by errors related to system administration, information, and documentation (n = 7, 17.9%). Most reported errors that indirectly affected patient care were related to system administration, information, and documentation used by administrative staff (n = 22, 47.8%), or to reception (n = 9, 19.6%). Almost all errors occurred during weekdays. Most frequent incidents involved outpatients (n = 23, 27.1%), or occurred next to examination/operation rooms (n = 12, 14.1%). Further, a total of 14 cases (16.5%) involved patient misidentification.

Conclusions: Incidents involving hospital administrative staff, the most common of which are medication errors from incorrect prescriptions, can lead to severe consequences for patients. Given that administrative staff now form a part of medical treatment teams, improvements in patient care may require further submission and review of incident reports involving administrative staff.
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http://dx.doi.org/10.1186/s12913-020-05903-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7677098PMC
November 2020

Mapping EORTC QLQ-C30 and FACT-G onto EQ-5D-5L index for patients with cancer.

Health Qual Life Outcomes 2020 Nov 3;18(1):354. Epub 2020 Nov 3.

Department of Biomedical Sciences, College of Life Sciences, Ritsumeikan University, Kusatsu, Japan.

Background: To develop direct and indirect (response) mapping algorithms from the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and the Functional Assessment of Cancer Therapy General (FACT-G) onto the EQ-5D-5L index.

Methods: We conducted the QOL-MAC study where EQ-5D-5L, EORTC QLQ-C30, and FACT-G were cross-sectionally evaluated in patients receiving drug treatment for solid tumors in Japan. We developed direct and indirect mapping algorithms using 7 regression methods. Direct mapping was based on the Japanese value set. We evaluated the predictive performances based on root mean squared error (RMSE), mean absolute error, and correlation between the observed and predicted EQ-5D-5L indexes.

Results: Based on data from 903 and 908 patients for EORTC QLQ-C30 and FACT-G, respectively, we recommend two-part beta regression for direct mapping and ordinal logistic regression for indirect mapping for both EORTC QLQ-C30 and FACT-G. Cross-validated RMSE were 0.101 in the two methods for EORTC QLQ-C30, whereas they were 0.121 in two-part beta regression and 0.120 in ordinal logistic regression for FACT-G. The mean EQ-5D-5L index and cumulative distribution function simulated from the recommended mapping algorithms generally matched with the observed ones except for very good health (both source measures) and poor health (only FACT-G).

Conclusions: The developed mapping algorithms can be used to generate the EQ-5D-5L index from EORTC QLQ-C30 or FACT-G in cost-effectiveness analyses, whose predictive performance would be similar to or better than those of previous algorithms.
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http://dx.doi.org/10.1186/s12955-020-01611-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7641825PMC
November 2020

What Is a Valid Mapping Algorithm in Cost-Utility Analyses? A Response From a Missing Data Perspective.

Value Health 2020 09 1;23(9):1218-1224. Epub 2020 Aug 1.

Center for Outcomes Research and Economic Evaluation for Health, National Institute of Public Health, Wako, Japan.

Objectives: Although numerous mapping algorithms from a non-preference-based measure to a target health utility measure have been developed and applied in cost-utility analyses (CUAs), conditions for a mapping algorithm to work well in a CUA are still unclear. In this research, we formulate the mapping problem as a missing data problem and clarify these conditions.

Methods: We defined a valid mapping algorithm based on the purpose of mapping (ie, not for prediction but for CUA), and derived a sufficient set of conditions for a valid mapping algorithm. We also conducted a simulation study to investigate properties of a mapping algorithm under situations where the conditions are satisfied and violated.

Results: The derived sufficient conditions indicate that the complete overlap of the source measure with the target health utility measure is important and that a covariate that is omitted from a mapping algorithm but has an effect on the target health utility measure not captured by the source measure may invalidate a mapping algorithm. The conditions cannot be verified from data in a CUA but can be supported using external data. A simulation study showed that when at least 1 of the 3 conditions was violated, a mapping algorithm provided biased health utility estimates in a CUA, and that prediction accuracy did not necessarily reflect performance of a mapping algorithm in a CUA.

Conclusion: The derived conditions provide a fundamental basis for better practices in developing and selecting a mapping algorithm.
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http://dx.doi.org/10.1016/j.jval.2020.03.020DOI Listing
September 2020

Response Shift-Adjusted Treatment Effect on Health-Related Quality of Life in a Randomized Controlled Trial of Taxane Versus S-1 for Metastatic Breast Cancer: Structural Equation Modeling.

Value Health 2020 06 17;23(6):768-774. Epub 2020 May 17.

Division of Breast and Medical Oncology, National Cancer Center Hospital East, Kashiwa, Chiba, Japan.

Objective: We investigated the quantification of the response shift-adjusted treatment effect on quality-of-life (QOL) data in a randomized controlled trial of taxane versus S-1 for patients with metastatic breast cancer (SELECT-BC).

Methods: This study was a secondary data analysis of a previously published trial. The response shift-adjusted treatment effect on health-related QOL (HRQOL) data measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) was estimated using structural equation modeling techniques in addition to quantifying the "true" treatment effect. Measurement invariances in the values of the common factor loadings, intercepts, and residual variances between before treatment and at the 3-, 6-, and 12-month visits were considered the response shift effects.

Results: In the taxane group, we observed positive recalibration effects for role functioning and positive reprioritization and negative recalibration effects for emotional functioning. The observed change of -4.56 for role functioning comprised +2.26 response shifts and -6.82 "true" change. The observed change of +9.41 for emotional functioning comprised +12.43 response shifts and -1.17 "true" change. In the S-1 group, we observed positive reprioritization and negative recalibration effects for emotional functioning and positive reprioritization effects for social functioning. The observed change of +10.54 for emotional functioning comprised +10.07 response shifts and +0.47 "true" change. The observed change of +2.43 for social functioning comprised +3.50 response shifts and -1.07 "true" change.

Conclusion: Detailed analysis of the response shift effects will improve the evaluation reliability of observed HRQOL data during clinical trials.
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http://dx.doi.org/10.1016/j.jval.2020.02.003DOI Listing
June 2020

Cost-effectiveness evaluation for pricing medicines and devices: A new value-based price adjustment system in Japan.

Authors:
Takeru Shiroiwa

Int J Technol Assess Health Care 2020 Jun 18;36(3):270-276. Epub 2020 May 18.

Center for Outcomes Research and Economic Evaluation for Health (C2H), National Institute of Public Health, Wako, Japan.

Objectives: In Japan, a new cost-effectiveness evaluation system for medicine and medical device pricing was employed in April 2019 after a trial implementation. This study describes the discussions held from April 2016 to March 2019 concerning the newly introduced system.

Methods: Using published government documents, discussions with stakeholders, and the minutes of the Chuikyo committee meetings, the following issues are addressed: (i) the results of the trial implementation and (ii) an overview of the newly introduced system.

Results: During the trial implementation, thirteen products were evaluated and their prices adjusted. The process of the new system-which was to be implemented in FY 2019-takes about 15-18 months to complete after listing of the target products by the National Health Insurance. The target products are selected principally based on sales volume, degree of innovation (premium), and disclosure of rationale for price setting. First, a manufacturer submits the cost-effectiveness data, which is then reviewed by the Center for Outcomes Research and Economic Evaluation for Health (C2H) in collaboration with academics. The results of the cost-effectiveness evaluation are not considered during the decision-making process concerning the product's listing. The price adjustment system is similar to value-based pricing (VBP); hence, the new system can be considered as VBP adjustment.

Conclusion: Cost-effectiveness evaluation can help promote both technological innovation and sustainability of the healthcare system. We need to create a greater capacity for enhancing this academic review system.
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http://dx.doi.org/10.1017/S0266462320000264DOI Listing
June 2020

An Observational Study of Team Management Approach for CapeOX Therapy in Patients with Advanced and Recurrent Colorectal Cancer: SMILE Study (The Study of Metastatic colorectal cancer to investigate the Impact of Learning Effect).

J Anus Rectum Colon 2020 28;4(2):79-84. Epub 2020 Apr 28.

Fujita Health University Hospital International Medical center, Toyoake, Japan.

Objectives: In recent years, CapeOX therapy for patients with colorectal cancer is widely used. We previously reported that a multidisciplinary approach decreases the worsening of adverse events and increases patient satisfaction. In this study, we conducted a multicenter, prospective, observational study to evaluate the incidence of adverse events, health-related quality of life (HRQOL) of the patient, and efficacy of a management (intervention) according to the support system (SMILE study).

Methods: As the interventional method, the following more than one method was carried out in each institute, 1: support with telephone, 2: dosing instruction by a pharmacist, 3: skin care instruction by a nurse, and 4: patient instruction by a doctor. The primary endpoint was the incidence of hand-foot syndrome (HFS) of more than grade 2. The secondary endpoint was the HRQOL evaluation and efficacy. The questionnaire (HADS) was administered before the start of the chemotherapy and in 1, 2, 4, 5, and 8 courses to evaluate quality of life (QOL).

Results: From April 2011 to September 2012, 80 patients were enrolled from 14 sites, and all patients were the subjects of analysis. The demographic background was as follows: man/woman: 46/34, age median: 63 (36-75), and management interventional method 1/2/3/4: 36/68/73/78. The overall percentage of HFS that exceeded grade 2 within 6 months was 16.3%. It was 11.1% with the telephone support group and 20.5% without the telephone support group (p = 0.26).

Conclusions: A multi-professional telephone support may reduce the deterioration of HFS. Further study which includes larger cohort is needed in the future.
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http://dx.doi.org/10.23922/jarc.2019-020DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7186009PMC
April 2020

Development of a multiplicative, multi-attribute utility function and eight single-attribute utility functions for the Health Utilities Index Mark 3 in Japan.

J Patient Rep Outcomes 2020 Apr 3;4(1):23. Epub 2020 Apr 3.

Center for Outcomes Research and Economic Evaluation for Health (C2H), National Institute of Public Health, Wako, Saitama, Japan.

Background: The Health Utilities Index Mark 3 (HUI3) is a generic multi-attribute, preference-based system for assessing health-related quality of life. It is widely used overseas as an outcome measure and for estimating quality-adjusted life years. We aimed to estimate a multi-attribute and eight single-attribute utility functions for the HUI3 system based on community preferences in Japan. We conducted two preference surveys in this study. The first survey was designed to estimate a model of utility function and collect preference scores, and the second survey was designed to evaluate predictive validity of the utility function and provide independent scores. Values obtained from the feeling thermometer and standard gamble scores obtained from using a chance board were included in the preference scale. We recruited 1043 respondents (age: 20-79 years) from five cities in Japan through the general population classified by sex and age groups. Respondents were further randomly divided into a modeling group (n = 774) and a direct group (n = 263).

Results: We acquired the estimation for eight single-attribute and a global multi-attribute utility function. The minimum expected multi-attribute utility score was - 0.002. The intraclass correlation coefficient between the directly measured utility score and the score generated by multi-attribute function in terms of 53 health conditions was 0.742.

Conclusions: The HUI3 scoring function developed in Japan has a strong theoretical and empirical basis. It will be useful in future to predict the directly measured score of health technology assessments in Japan.
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http://dx.doi.org/10.1186/s41687-020-00188-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7125285PMC
April 2020

Formal Implementation of Cost-Effectiveness Evaluations in Japan: A Unique Health Technology Assessment System.

Value Health 2020 01 16;23(1):43-51. Epub 2019 Dec 16.

Center for Outcomes Research and Economic Evaluation for Health, National Institute of Public Health, Saitama, Japan.

In April 2019, Japan formally introduced health technology assessment (HTA) and, more specifically, a cost-effectiveness analysis, to inform healthcare decision making, mainly when it comes to the pricing of new technologies. This article provides an overview of this new policy, which was implemented formally after a pilot program. In the fiscal year (FY) 2012, discussions on cost-effectiveness assessments were initiated in Japan. After 7 years of deliberations, a cost-effectiveness assessment was implemented formally in April 2019. In Japan, the cost-effectiveness analysis has been used to inform price adjustments of healthcare technologies, although it has not yet been used for decision making on insurance coverage. Selection criteria were established because not all drugs and medical devices could be evaluated owing to a shortage of experts. Exclusion criteria have also been applied to prevent access restriction. The scope of the evaluation's price adjustment target is limited to part of the product price. If the cost per quality-adjusted life-year (QALY) threshold falls below ¥5 million per QALY, the price adjustment rate changes stepwise according to the cost per QALY. In addition to price reduction, a price-raising scheme has also been implemented for scenarios where products are evaluated to be highly cost-effective and innovative. This article describes the first formally implemented HTA system in Japan. Although it is too early to make any conclusions about its effect, the Japan-specific context makes this system unique. To fully understand the opportunities and challenges of the new system, it is vital that Japan accumulates experience with this system and develops human resources in health economic evaluation.
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http://dx.doi.org/10.1016/j.jval.2019.10.005DOI Listing
January 2020

Development of Japanese utility weights for the Adult Social Care Outcomes Toolkit (ASCOT) SCT4.

Qual Life Res 2020 Jan 4;29(1):253-263. Epub 2019 Sep 4.

Personal Social Services Research Unit (PSSRU), London School of Economics and Political Science (LSE), Houghton Street, London, WC2A 2AE, UK.

Purpose: In developed countries, progressive rapid aging is increasing the need for social care. This study aimed to determine Japanese utility weights for the Adult Social Care Outcomes Toolkit (ASCOT) four-level self-completion questionnaire (SCT4).

Methods: We recruited 1050 Japanese respondents from the general population, stratified by sex and age, from five major cities. In the best-worst scaling (BWS) phase, respondents ranked various social care-related quality of life (SCRQoL) states as "best," "worst," "second-best," or "second-worst," as per the ASCOT. Then, respondents were asked to evaluate eight different SCRQOL states by composite time-trade off (cTTO). A mixed logit model was used to analyze BWS data. The association between cTTO and latent BWS scores was used to estimate a scoring formula that would convert BWS scores to SC-QALY (social care quality-adjusted life year) scores.

Results: Japanese BWS weightings for ASCOT-SCT4 were successfully estimated and found generally consistent with the UK utility weights. However, coefficients on level 3 of "Control over daily life" and "Occupation" domains differed markedly between Japan and the UK. The worst Japanese SCRQoL state was lower than that for the UK, as Japanese cTTO results showed more negative valuations. In general, Japanese SC-QALY score (for more than 90% of health states) was lower than that for the UK.

Conclusions: We successfully obtained Japanese utility weights for ASCOT SCT4. This will contribute to the measurement and understanding of social care outcomes.
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http://dx.doi.org/10.1007/s11136-019-02287-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6962125PMC
January 2020

Japanese translation and cross-cultural validation of the Adult Social Care Outcomes Toolkit (ASCOT) in Japanese social service users.

Health Qual Life Outcomes 2019 Apr 11;17(1):59. Epub 2019 Apr 11.

Personal Social Services Research Unit (PSSRU), London School of Economics and Political Science, Houghton St, London, WC2A 2AE, UK.

Background: The aim of this study was to develop and perform cross-cultural validation of a Japanese version of the Adult Social Care Outcomes Toolkit (ASCOT) four-level Self-Completion questionnaire (SCT4) instrument to measure Social-Care Related Quality of Life. It was important to develop a Japanese version of the ASCOT-SCT4 and validate it in the Japanese context, given the interest in measuring outcomes of social care services in Japan.

Methods: The original version of ASCOT-SCT4 was translated into Japanese following good practice guidelines. Additionally, comments and feedback were obtained from an independent committee engaged in managing and providing social care services to refine the flow of sentences of the newly developed translated version. The resulting version was tested for cross-cultural validation among community-dwelling adults who use social care services to confirm the factorial structure and the scale system of the Japanese version, using Structural Equation Modeling and Item Response Theory.

Results: Vigorous discussion was needed to translate the original version into Japanese especially for the items control over daily life and dignity. These two items were linguistically difficult to express in everyday language so potential participants could easily understand the intended concepts. In the cross-cultural validation, we obtained values for model fit within the acceptable range: between 0.706 and 0.550 for factor loadings, 0.923 for the Comparative Fit Index, 0.910 for the Tucker-Lewis Index, and 0.083 for the Root Mean Square Error of Approximation. This confirmed the factorial structure of the Japanese version. The IRT analysis, however, revealed that the scale system needed refinement to facilitate appropriate differentiation between each response option.

Conclusions: This study provided preliminary evidence that the Japanese version of ASCOT-SCT4 is valid. As a result, the Japanese version was finalized and approved by the instrument developer.
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http://dx.doi.org/10.1186/s12955-019-1128-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6458614PMC
April 2019

Exploring the Application of Cost-Effectiveness Evaluation in the Japanese National Health Insurance System.

Int J Technol Assess Health Care 2019 21;35(6):452-460. Epub 2019 Mar 21.

National Institute of Public Health, Saitama, Japan.

Objectives: Advances in health care due to the development and introduction of new drugs and medical devices have brought considerable benefits to people and patients in terms of upgraded quality of life and extended years of survival. However, some are concerned that the very advancement of health care would increase further the inflation of national healthcare costs. In response to these concerns, Japan's Central Social Insurance Medical Council ("Chuikyo") began in 2012 to examine how cost-effectiveness evaluation might be applied to the national health insurance system, and has been working toward establishing a system for its usage.

Methods: Cost-effectiveness evaluation was adopted on a trial basis in fiscal year (FY) 2016, targeting seven drugs and six medical devices. Analyses and re-analyses were performed by manufacturers and a public expert organization, respectively. Based on these analyses, a cost-effectiveness evaluation expert organization conducted an overall assessment ("appraisal"). Results of the evaluation were used to adjust the prices of the target items.

Results: Following the trial adoption of cost-effectiveness evaluation, price adjustments were performed for three items in April 2018. Meanwhile, a decision was also made to examine seven items for which technical requirements were identified due to differences in the understanding of analysis methods between involved parties.

Conclusions: The Chuikyo will examine how to meet the newly identified technical requirements and discuss specific details with regard to establishing a system that incorporates cost-effectiveness evaluation. The Chuikyo plans to reach a conclusion by the end of FY 2018.
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http://dx.doi.org/10.1017/S0266462319000060DOI Listing
August 2020

To what extent does the EQ-5D-3L correlate with the FACT-H&N of patients with oral cancer during the perioperative period?

Int J Clin Oncol 2019 Apr 3;24(4):350-358. Epub 2018 Nov 3.

Department of Health and Welfare Services, National Institute of Public Health, 2-3-6 Minami, Wako, Saitama, 351-0197, Japan.

Background: The EuroQol 5-dimension scale (EQ-5D) is one of the most frequently used preference-based quality of life (QOL) measures for health technology assessment. The 3-level version of the EQ-5D comprises a descriptive system (the EQ-5D-3L) and a visual analog scale (EQ-VAS). It remains unclear whether this five-item scale correlates with the QOL of patients with oral cancer during the perioperative period. We sought to clarify this point in the present study.

Methods: Participants were 84 patients with oral malignancies who underwent radical treatment and completed the EQ-5D-3L and Functional Assessment of Cancer Therapy-Head and Neck (FACT-H&N) at regular intervals over 3 months after treatment. We analyzed the correlations between the EQ-5D-3L, EQ-VAS, and FACT-H&N, and conducted multiple regression analyses to examine how the FACT-H&N subscales relate to the EQ-5D-3L and EQ-VAS. We also investigated whether the EQ-5D-3L shows ceiling effects.

Results: The EQ-5D-3L and EQ-VAS were strongly correlated with the FACT-H&N (r = 0.621 and 0.638, respectively; P < 0.01). Furthermore, the EQ-5D-3L was significantly related with all FACT-H&N subscales except for social/family well-being. Particularly, the physical well-being subscale had the strongest relationship with the EQ-5D-3L. The FACT H&N and EQ-5D-3L showed similar changes over time. The EQ-5D-3L did not have a ceiling effect statistically.

Conclusions: Our results indicate that actual physical performance might be most important for cost-utility analysis, whereas the assessment of familial feelings or friendship seems less important. However, the EQ-5D-3L appears to generally correlate with the FACT-H&N of patients with oral cancer during the perioperative period. Therefore, it is reasonable to assess the cost performance of oral cancer treatment using the EQ-5D-3L in Japan.
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http://dx.doi.org/10.1007/s10147-018-1364-6DOI Listing
April 2019

Healthcare costs for the elderly in Japan: Analysis of medical care and long-term care claim records.

PLoS One 2018 14;13(5):e0190392. Epub 2018 May 14.

Department of Medical Informatics and Management, University Hospital, University of Occupational and Environmental Health, Kitakyushu, Fukuoka, Japan.

Background: The population is aging rapidly in many developed countries. Such countries need to respond to the growing demand and expanding costs of healthcare (HC) for the elderly. Therefore, it is important to investigate the factors correlating such HC costs. In Japan, HC is composed of two sections, namely medical care (MC) and long-term care (LTC). While many studies have examined MC and LTC costs on their own, few studies have conducted comprehensive investigations of HC costs. The aim of this study is to examine the risk factors that influence HC costs for the elderly who enroll in the LTC insurance system in Japan.

Methods: The inclusion criteria in the present study are as follows: being 65 years of age, or older; certified eligibility for, and use of services offered by the LTC insurance system at home or in an institutional setting in December 2009; and being covered by the National Health Insurance (NHI) system. MC and LTC insurance data were obtained from claim records for the elderly in July and December of 2007, 2008, and 2009 (i.e., a total of six survey points). Panel data, per subject, were constructed using MC and LTC claim records. The sample included 810 subjects and 4029 observations.

Results: We estimated a regression equation with a censored dependent variable using a Tobit model. Significant associations between MC or LTC costs and interaction terms (household composition × seasonal effects) were investigated. MC costs significantly decreased and LTC costs significantly increased among subjects living alone during winter. Income level was also a positive determinant of MC costs, while eligibility level was a positive determinant of LTC costs.

Conclusions: We recommend that the health policy for the elderly focus more on seasonal effects, household composition, and income level, as well as on eligibility level.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0190392PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5951584PMC
July 2018

Cost-Minimization Analysis of Deep-Brain Stimulation Using National Database of Japanese Health Insurance Claims.

Neuromodulation 2018 Aug 26;21(6):548-552. Epub 2018 Apr 26.

Department of Health and Welfare Service, National Institution of Public Health, Wako, Saitama, Japan.

Objectives: A new rechargeable dual-channel deep brain stimulation (DBS) system has been introduced for the treatment of Parkinson's disease and other movement disorders. However, the clinical value of the device, which has a high cost, remains unclear.

Materials And Methods: We conducted a cost-minimization analysis using a national database of health insurance claims in Japan. DBS-related costs were compared between rechargeable and non-rechargeable devices and estimated across a 20-year period.

Results: Although the price of rechargeable DBS was higher than that of non-rechargeable DBS, we observed total cost-savings of 8.4 million yen across 20 years by considering costs related to implantation surgery, frequency of replacement, and risk of complications.

Conclusions: In this study, real-world evidence indicated that rechargeable dual-channel DBS is a reasonable choice for saving total medical costs. Price revisions should consider cost-effectiveness findings for medical devices.
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http://dx.doi.org/10.1111/ner.12782DOI Listing
August 2018

Cost-effectiveness analysis of the introduction of S-1 therapy for first-line metastatic breast cancer treatment in Japan: results from the randomized phase III SELECT BC trial.

BMC Cancer 2017 Nov 17;17(1):773. Epub 2017 Nov 17.

Division of Breast and Medical Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan.

Background: This study evaluated the cost-effectiveness of replacing standard intravenous therapy (taxane) with oral S-1 therapy for first-line metastatic breast cancer treatment.

Methods: This cost-effectiveness analysis was based on data from a randomized phase III trial (SELECT BC). As cost-effectiveness was a secondary endpoint of the SELECT BC trial, some of the randomized patients participated in an EQ-5D survey (N = 391) and health economic survey (N = 146). The EQ-5D responses, claims, and prescription data were collected for as long as possible until death. The expected quality-adjusted life years (QALY) obtained from each treatment were calculated using patient-level EQ-5D data, and the expected cost was calculated using patient-level claim data. The analysis was performed from the perspective of public healthcare payers.

Results: The estimated EQ-5D least-square means and 95% CI up to 48 months were 0.764 (95% CI, 0.741-0.782) and 0.742 (95% CI, 0.720-0.764) in the S-1 and taxane arms, respectively. The expected QALY was 2.11 for the S-1 arm and 2.04 for the taxane arm, with expected costs of JPY 5.13 million (USD 46,600) and JPY 5.56 million (USD 50,500), respectively. These results show that S-1 is cost-saving. According to probabilistic sensitivity analysis, S-1 was dominant with a probability of 63%. When the willingness to pay (WTP) value was JPY 5 million (USD 45,500) per QALY, the probability of being cost-effective was 92%.

Conclusions: Our results show that the introduction of oral S-1 therapy for metastatic breast cancer is highly likely to be cost-effective.

Trial Registration: UMIN CTR C000000416 . Registered on May 10, 2006.
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http://dx.doi.org/10.1186/s12885-017-3774-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5693567PMC
November 2017

Patient-Reported Outcome Results from the Open-Label Randomized Phase III SELECT BC Trial Evaluating First-Line S-1 Therapy for Metastatic Breast Cancer.

Oncology 2018 17;94(2):107-115. Epub 2017 Nov 17.

Biostatistics Division, Clinical Research Support Center, The University of Tokyo Hospital, Tokyo, Japan.

Objective: To evaluate the effects of S-1, an orally administered 5-FU agent, versus taxane on patient-reported outcomes (PROs) in the SELECT BC trial.

Methods: Patients with HER2-negative and endocrine treatment-resistant breast cancer with metastasis or recurrence after surgery were randomly assigned to receive first-line taxane or S-1. PROs (secondary endpoint) were assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and Patient Neurotoxicity Questionnaire (PNQ) at baseline and at 3, 6, and 12 months. We conducted a responder analysis for the QLQ-C30 and PNQ and created cumulative distribution function (CDF) plots as a sensitivity analysis.

Results: The questionnaire response rates were over 80% from 386 patients, who completed at least one baseline questionnaire. S-1 was significantly superior to taxane with respect to 6 scales (physical functioning [p = 0.03], role functioning [p = 0.04], social functioning [p < 0.01], financial difficulties [p = 0.01], global health status [p = 0.02], and constipation [p < 0.01]) and sensory neuropathy (p = 0.01). The CDF plots partially supported the conclusions and their robustness.

Conclusion: First-line S-1 therapy has clinical benefits with respect to many aspects of health-related quality of life for metastatic breast cancer patients.
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http://dx.doi.org/10.1159/000484142DOI Listing
March 2018

Impact of Adverse Events on Health Utility and Health-Related Quality of Life in Patients Receiving First-Line Chemotherapy for Metastatic Breast Cancer: Results from the SELECT BC Study.

Pharmacoeconomics 2018 02;36(2):215-223

Department of Breast and Medical Oncology, National Cancer Center Hospital East, Kashiwa, Japan.

Objective: The aim of this study was to investigate the impact of adverse events (AEs) on health utility and health-related quality of life (HRQOL) in patients with metastatic breast cancer undergoing first-line chemotherapy.

Methods: We analyzed the data from the SELECT BC study, a multicenter, open-label, randomized, phase III study conducted in Japan, which compared first-line S-1 with taxane therapies. Heath utility and HRQOL were assessed using the EQ-5D-3L and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) at baseline and 3, 6, and 12 months after treatment initiation. Health utility was calculated based on societal preferences, and AEs were reported at each cycle of the study treatment. Linear marginal mean models were used to quantify the impact of the last AEs (with 10 or more incidences) observed before HRQOL assessment on health utility and HRQOL.

Results: Analysis included 380 patients and 12 (of 15) AEs. Grade 1 nausea and oral mucositis, grade 1 and 2 edema, and grade 2 fatigue, motor and sensory neuropathy, and myalgia were significantly associated with disutility, measured using the EQ-5D-3L. Grade 1 oral mucositis, grade 1 and 2 fatigue, and grade 2 sensory neuropathy were significantly associated with impaired global health status in the EORTC QLQ-C30. AEs associated with decrements in the five functioning scales included fatigue, oral mucositis, nausea, edema, motor and sensory neuropathy, and myalgia.

Conclusions: We reported disutilities caused by AEs in patients with metastatic breast cancer under chemotherapy. These findings can be applied to future model-based cost-effectiveness analyses.

Trial Registration Number: C000000416.
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http://dx.doi.org/10.1007/s40273-017-0580-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5805818PMC
February 2018

New decision-making processes for the pricing of health technologies in Japan: The FY 2016/2017 pilot phase for the introduction of economic evaluations.

Health Policy 2017 Aug 23;121(8):836-841. Epub 2017 Jun 23.

Department of Healthcare Economics and Health policy, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo 1130033, Japan.

Economic evaluation is used for decision-making processes in healthcare technologies in many developed countries. In Japan, no health economic data have been requested for drugs, medical devices, and interventions till date. However, economic evaluation is gradually gaining importance, and a trial implementation of the cost-effectiveness evaluation of drugs and medical devices has begun. Discussions on economic evaluation began in May 2012 within a newly established sub-committee of the Chuikyo, referred to as the "Special Committee on Cost Effectiveness." After four years of discussions, this committee determined that during the trial implementation, the results of the cost-effectiveness evaluation would be used for the re-pricing of drugs and medical devices at the end of fiscal year (FY) 2017. Chuikyo selected 13 products (7 drugs and 6 medical devices) as targets for this evaluation. These products will be evaluated until the end of FY 2017 based on the following process: manufacturers will submit the data of economic evaluation; the National Institute of Public Health will coordinate the review process; academic groups will perform the actual review of the submitted data, and the expert committee will appraise these data. This represents the first step to introducing cost-effectiveness analysis in the Japanese healthcare system. We believe that these efforts will contribute to the efficiency and sustainability of the Japanese healthcare system.
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http://dx.doi.org/10.1016/j.healthpol.2017.06.001DOI Listing
August 2017

Development of an Official Guideline for the Economic Evaluation of Drugs/Medical Devices in Japan.

Value Health 2017 03 21;20(3):372-378. Epub 2016 Oct 21.

Department of Medical Statistics, Kobe Pharmaceutical University, Kobe, Hyogo, Japan.

Objectives: In Japan, cost-effectiveness evaluation was implemented on a trial basis from fiscal year 2016. The results will be applied to the future repricing of drugs and medical devices. On the basis of a request from the Central Social Insurance Medical Council (Chuikyo), our research team drafted the official methodological guideline for trial implementation. Here, we report the process of developing and the contents of the official guideline for cost-effectiveness evaluation.

Methods: The guideline reflects discussions at the Chuikyo subcommittee (e.g., the role of quality-adjusted life-year) and incorporates our academic perspective. Team members generated research questions for each section of the guideline and discussions on these questions were carried out. A draft guideline was prepared and submitted to the Ministry of Health, Labour and Welfare (MHLW), and then to the subcommittee. The draft guideline was revised on the basis of the discussions at the subcommitte, if appropriate.

Results: Although the "public health care payer's perspective" is standard in this guideline, other perspectives can be applied as necessary depending on the objective of analysis. On the basis of the discussions at the subcommittee, quality-adjusted life-year will be used as the basic outcome. A discount rate of 2% per annum for costs and outcomes is recommended. The final guideline was officially approved by the Chuikyo general assembly in February 2016.

Conclusions: This is the first officially approved guideline for the economic evaluation of drugs and medical devices in Japan. The guideline is expected to improve the quality and comparability of submitted cost-effectiveness data for decision making.
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http://dx.doi.org/10.1016/j.jval.2016.08.726DOI Listing
March 2017

Comparison of Value Set Based on DCE and/or TTO Data: Scoring for EQ-5D-5L Health States in Japan.

Value Health 2016 Jul-Aug;19(5):648-54. Epub 2016 Apr 26.

Department of Biomedical Sciences, College of Life Sciences, Ritsumeikan University, Kusatsu, Japan.

Background: The valuation study of the five-level version of the EuroQol five-dimensional questionnaire (EQ-5D-5L) involved composite time trade-off (cTTO) and a discrete choice experiment (DCE). The DCE scores must be anchored to the quality-of-life scale from 0 (death) to 1 (full health). Nevertheless, the characteristics of the statistical methods used for converting the EQ-5D-5L DCE results by using TTO information are not yet clearly known.

Objectives: To present the Japanese DCE value set of the EQ-5D-5L and compare three methods for converting latent DCE values.

Methods: The survey sampled the general population at five locations in Japan. 1098 respondents were stratified by age and sex. To obtain and compare the value sets of the EQ-5D-5L, the cTTO and DCE data were analyzed by a linear mixed model and conditional logit, respectively. The DCE scores were converted to the quality-of-life scale by anchoring to the worst state using cTTO, mapping DCE onto cTTO, and a hybrid model.

Results: The data from 1026 respondents were analyzed. All the coefficients in the cTTO and DCE value sets were consistent throughout all the analyses. Compared with the cTTO algorithm, the mapping and hybrid methods yielded very similar scoring coefficients. The hybrid model results, however, produced a lower root mean square error and fewer health states with errors exceeding 0.05 than did the other models. The DCE anchored to the worst state overestimated the cTTO scores of almost all the health states.

Conclusions: Japanese value sets based on DCE were demonstrated. On comparing the observed cTTO scores, we found that the hybrid model was slightly superior to the simpler methods, including the TTO model.
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http://dx.doi.org/10.1016/j.jval.2016.03.1834DOI Listing
May 2017

The Effects of Diagnostic Definitions in Claims Data on Healthcare Cost Estimates: Evidence from a Large-Scale Panel Data Analysis of Diabetes Care in Japan.

Pharmacoeconomics 2016 10;34(10):1005-14

Department of Health and Welfare Services, National Institute of Public Health, 2-3-6, Minami, Wako, Saitama, 351-0197, Japan.

Background: Inaccurate estimates of diabetes-related healthcare costs can undermine the efficiency of resource allocation for diabetes care. The quantification of these costs using claims data may be affected by the method for defining diagnoses.

Objectives: The aims were to use panel data analysis to estimate diabetes-related healthcare costs and to comparatively evaluate the effects of diagnostic definitions on cost estimates.

Research Design: Monthly panel data analysis of Japanese claims data.

Subjects: The study included a maximum of 141,673 patients with type 2 diabetes who received treatment between 2005 and 2013.

Measures: Additional healthcare costs associated with diabetes and diabetes-related complications were estimated for various diagnostic definition methods using fixed-effects panel data regression models.

Results: The average follow-up period per patient ranged from 49.4 to 52.3 months. The number of patients identified as having type 2 diabetes varied widely among the diagnostic definition methods, ranging from 14,743 patients to 141,673 patients. The fixed-effects models showed that the additional costs per patient per month associated with diabetes ranged from US$180 [95 % confidence interval (CI) 178-181] to US$223 (95 % CI 221-224). When the diagnostic definition excluded rule-out diagnoses, the diabetes-related complications associated with higher additional healthcare costs were ischemic heart disease with surgery (US$13,595; 95 % CI 13,568-13,622), neuropathy/extremity disease with surgery (US$4594; 95 % CI 3979-5208), and diabetic nephropathy with dialysis (US$3689; 95 % CI 3667-3711).

Conclusions: Diabetes-related healthcare costs are sensitive to diagnostic definition methods. Determining appropriate diagnostic definitions can further advance healthcare cost research for diabetes and its applications in healthcare policies.
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http://dx.doi.org/10.1007/s40273-016-0402-3DOI Listing
October 2016

Societal Preferences for Interventions with the Same Efficiency: Assessment and Application to Decision Making.

Appl Health Econ Health Policy 2016 Jun;14(3):375-85

Department of Health and Welfare Service, National Institute of Public Health, 2-3-6 Minami, Wako, Saitama, 351-0197, Japan.

Background And Objectives: Although quality-adjusted life-years (QALYs) may not completely reflect the value of a healthcare technology, it remains unclear how to adjust the cost per QALY threshold. First, the present study compares two survey methods of measuring people's preferences for a specific healthcare technology when each choice has the same efficiency. The second objective was to consider how this information regarding preferences could be used in decision making.

Methods: We conducted single-attribute (budget allocation) and multi-attribute (discrete-choice) experiments to survey public medical care preferences. Approximately 1000 respondents were sampled for each experiment. Six questions were prepared to address the attributes included in the study: (a) age; (b) objective of care; (c) disease severity; (d) prior medical care; (e) cause of disease; and (f) disease frequency. For the discrete-choice experiment (a) age, (b) objective of care, (c) disease severity, and (d) prior medical care were orthogonally combined. All assumed medical care had the same costs and incremental cost-effectiveness ratio (ICER; cost per life-year or QALY). We also calculated the preference-adjusted threshold (PAT) to reflect people's preferences in a threshold range.

Results: The results of both experiments revealed similar preferences: intervention for younger patients was strongly preferred, followed by interventions for treatment and severe disease states being preferred, despite the same cost per life-year or QALY. The single-attribute experiment revealed that many people prefer an option in which resources are equally allocated between two interventions. Marginal PATs were calculated for age, objective of care, disease severity, and prior medical care.

Conclusion: The single- and multi-attribute experiments revealed similar preferences. PAT can reflect people's preferences within the decision-maker's threshold range in a numerical manner.
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http://dx.doi.org/10.1007/s40258-016-0236-3DOI Listing
June 2016

Japanese population norms for preference-based measures: EQ-5D-3L, EQ-5D-5L, and SF-6D.

Qual Life Res 2016 Mar 25;25(3):707-19. Epub 2015 Aug 25.

Department of Biomedical Sciences, College of Life Sciences, Ritsumeikan University, Kyoto, Japan.

Purpose: The purpose of this study was to measure the population norms for the Japanese versions of preference-based measures (EQ-5D-3L, EQ-5D-5L, and SF-6D). We also considered the relations between QOL score in the general population and socio-demographic factors.

Methods: A total of 1143 adult respondents (aged ≥ 20 years) were randomly sampled from across Japan using data from the Basic Resident Register. The health status of each respondent was measured using the EQ-5D-3L, EQ-5D-5L, and SF-6D, and responses regarding socio-demographic data as well as subjective diseases and symptoms were obtained. The responses were converted to a QOL score using Japanese value sets.

Results: The percentages of respondents with full health scores were 68 % (EQ-5D-3L), 55 % (EQ-5D-5L), and 4 % (SF-6D). The QOL score measured using the SF-6D was significantly lower than those measured using either EQ-5D score. The QOL score was significantly lower among respondents over the age of 60 years, those who had a lower income, and those who had a shorter period of education. Intraclass correlation coefficient showed a poor agreement between the EQ-5D and SF-6D scores. The differences in QOL scores between respondents with and those without any disease were 0.064 for the EQ-5D-3L, 0.061 for the EQ-5D-5L, and 0.073 for the SF-6D; these differences are regarded as between-group minimal important differences in the general population.

Conclusion: The Japanese population norms of three preference-based QOL measures were examined for the first time. Such information is useful for economic evaluations and research examining QOL score.
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http://dx.doi.org/10.1007/s11136-015-1108-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4759213PMC
March 2016

Cost-effectiveness analysis of EGFR mutation testing and gefitinib as first-line therapy for non-small cell lung cancer.

Lung Cancer 2015 Oct 26;90(1):71-7. Epub 2015 Jul 26.

Department of Drug Development and Regulatory Science, Faculty of Pharmacy, Keio University, Tokyo, Japan. Electronic address:

Objectives: The combination use of gefitinib and epidermal growth factor receptor (EGFR) testing is a standard first-line therapy for patients with non-small cell lung cancer (NSCLC). Here, we examined the cost-effectiveness of this approach in Japan.

Materials And Methods: Our analysis compared the 'EGFR testing strategy', in which EGFR mutation testing was performed before treatment and patients with EGFR mutations received gefitinib while those without mutations received standard chemotherapy, to the 'no-testing strategy,' in which genetic testing was not conducted and all patients were treated with standard chemotherapy. A three-state Markov model was constructed to predict expected costs and outcomes for each strategy. We included only direct medical costs from the healthcare payer's perspective. Outcomes in the model were based on those reported in the Iressa Pan-Asia Study (IPASS). The incremental cost-effectiveness ratio (ICER) was calculated using quality-adjusted life-years (QALYs) gained. Sensitivity and scenario analyses were conducted.

Results: The incremental cost and effectiveness per patient of the 'EGFR testing strategy' compared to the 'no-testing strategy' was estimated to be approximately JP¥122,000 (US$1180; US$1=JP¥104 as of February 2014) and 0.036 QALYs. The ICER was then calculated to be around JP¥3.38 million (US$32,500) per QALY gained. These results suggest that the 'EGFR testing strategy' is cost-effective compared with the 'no-testing strategy' when JP¥5.0 million to 6.0 million per QALY gained is considered an acceptable threshold. These results were supported by the sensitivity and scenario analyses.

Conclusion: The combination use of gefitinib and EGFR testing can be considered a cost-effective first-line therapy compared to chemotherapy such as carboplatin-paclitaxel for the treatment for NSCLC in Japan.
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http://dx.doi.org/10.1016/j.lungcan.2015.07.006DOI Listing
October 2015

WTP for a QALY and health states: More money for severer health states?

Cost Eff Resour Alloc 2013 1;11:22. Epub 2013 Sep 1.

Department of Pharmaceutical Sciences, School of Pharmacy, International University of Health and Welfare, 2600-1 Kitakanemaru, Otawara, Tochigi 3248501, Japan.

Background: In economic evaluation, cost per quality-adjusted life year (QALY) is generally used as an indicator for cost-effectiveness. Although JPY 5 million to 6 million (USD 60, 000 to 75,000) per QALY is frequently referred to as a threshold in Japan, do all QALYs have the same monetary value?

Methods: To examine the relationship between severity of health status and monetary value of a QALY, we obtained willingness to pay (WTP) values for one additional QALY in eight patterns of health states. We randomly sampled approximately 2,400 respondents from an online panel. To avoid misunderstanding, we randomly allocated respondents to one of 16 questionnaires, with 250 responses expected for each pattern. After respondents were asked whether they wanted to purchase the treatment, double-bounded dichotomous choice method was used to obtain WTP values.

Results: The results clearly show that the WTP per QALY is higher for worse health states than for better health states. The slope was about JPY -1 million per 0.1 utility score increase. The mean and median WTP values per QALY for 16 health states were JPY 5 million, consistent with our previous survey. For respondents who wanted to purchase the treatment, WTP values were significantly correlated with household income.

Conclusion: This survey shows that QALY based on the EQ-5D does not necessarily have the same monetary value. The WTP per QALY should range from JPY 2 million (USD 20,000) to JPY 8 million (USD 80,000), corresponding to the severity of health states.
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http://dx.doi.org/10.1186/1478-7547-11-22DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3766196PMC
May 2014
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