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

AbstractBackgroundThe 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.ObjectivesTo present the Japanese DCE value set of the EQ-5D-5L and compare three methods for converting latent DCE values.MethodsThe 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.ResultsThe 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.ConclusionsJapanese 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

Effectiveness of Messenger RNA Coronavirus Disease 2019 Vaccines Against Symptomatic Severe Acute Respiratory Syndrome Coronavirus 2 Infections During the Delta Variant Epidemic in Japan: Vaccine Effectiveness Real-time Surveillance for SARS-CoV-2 (VERSUS)

Background. Although high vaccine effectiveness of messenger RNA (mRNA) coronavirus disease 2019 (COVID-19) vaccines has been reported in studies in several countries, data are limited from Asian countries, especially against the Delta (B.1.617.2) variant.Methods. We conducted a multicenter test-negative case-control study in patients aged ≥16 years visiting hospitals or clinics with signs or symptoms consistent with COVID-19 from 1 July to 30 September 2021, when the Delta variant was dominant (≥90% of SARS-CoV-2 infections) nationwide in Japan. Vaccine effectiveness of BNT162b2 or mRNA-1273 against symptomatic SARS-CoV-2 infections was evaluated. Waning immunity among patients aged 16–64 years was also assessed.Results. We enrolled 1936 patients, including 396 test-positive cases and 1540 test-negative controls for SARS-CoV-2. The median age was 49 years, 53.4% were male, and 34.0% had underlying medical conditions. Full vaccination (receiving 2 doses ≥14 days before symptom onset) was received by 6.6% of cases and 38.8% of controls. Vaccine effectiveness of full vaccination against symptomatic SARS-CoV-2 infections was 88.7% (95% confidence interval [CI], 78.8%–93.9%) among patients aged 16–64 years and 90.3% (95% CI, 73.6%–96.4%) among patients aged ≥65 years. Among patients aged 16–64 years, vaccine effectiveness was 91.8% (95% CI, 80.3%–96.6%) within 1–3 months after full vaccination, and 86.4% (95% CI, 56.9%–95.7%) within 4–6 months.Conclusions. mRNA COVID-19 vaccines had high effectiveness against symptomatic SARS-CoV-2 infections in Japan during July–September 2021, when the Delta variant was dominant nationwide

Effectiveness of mRNA COVID-19 vaccines against symptomatic SARS-CoV-2 infections during the SARS-CoV-2 Omicron BA.1 and BA.2 epidemic in Japan: vaccine effectiveness real-time surveillance for SARS-CoV-2 (VERSUS)

Background: Evaluating COVID-19 vaccine effectiveness (VE) domestically is crucial for assessing and determining national vaccination policy. This study aimed to evaluate VE of mRNA COVID-19 vaccines in Japan. Methods: We conducted a multicenter test-negative case-control study. The study comprised indivi-duals aged ≥16 visiting medical facilities with COVID-19-related signs or symptoms from 1 January to 26 June 2022, when Omicron BA.1 and BA.2 were dominant nationwide. We evaluated VE of primary and booster vaccination against symptomatic SARS-CoV-2 infections and relative VE of booster compared with primary.Results: We enrolled 7,931 episodes, including 3,055 test positive. The median age was 39, 48.0% were male, and 20.5% had underlying medical conditions. In individuals aged 16 to 64, VE of primary vaccination within 90 days was 35.6% (95% CI, 19.0–48.8%). After booster, VE increased to 68.7% (60.6–75.1%). In individuals aged ≥65, VE of primary and booster was 31.2% (−44.0–67.1%) and 76.5% (46.7–89.7%), respectively. Relative VE of booster compared with primary vaccination was 52.9% (41.0– 62.5%) in individuals aged 16 to 64 and 65.9% (35.7–81.9%) in individuals aged ≥65.Conclusions: During BA.1 and BA.2 epidemic in Japan, mRNA COVID-19 primary vaccination provided modest protection. Booster vaccination was necessary to protect against symptomatic infections

A health economic evaluation of aspirin in the primary prevention of cardiovascular disease in Japan

Objective: Low-dose aspirin is standard care in patients with a history of cardiovascular disease (CVD). But, the use of low-dose aspirin in primary prevention has not yet been fully established in Japan although meta-analyses and US/European guidelines support its use in persons at increased CVD risk. This study assessed the health economic consequences of the use of low-dose aspirin in the primary prevention of CVD in Japan. Patients and Methods: Based on results reported in two recent meta-analyses of Hayden (2002) and Eidelman (2003), a Markov model was constructed to predict the cost-effectiveness of low-dose aspirin in the primary prevention of CVD. The model consists of 5 health states: 1) no history of CVD, 2) history of stroke, 3) history of myocardial infarction, 4) history of CVD, and 5) death, with a 10-year time horizon and 1-year cycles. Direct costs from the insurers' perspective were used, while health outcome was expressed in Life-Years Gained (LYG). 'Discounting Rate' with 3% was applied on effectiveness and costs. Results: For patients with a 1-year risk of coronary heart disease (CHD) of 1.5% (10-year risk of +/- 15%), the model demonstrated 'dominance' of the 'aspirin' arm versus 'no aspirin' arm; the 10-year costs were Japanese Yen (JPY) 634,000 (Euro 4,857) and JPY 518,000 (Euro 3,968) in the 'no aspirin' arm and 'aspirin' arm, respectively, while LYG was 8.33 and 8.36, respectively. Low-dose aspirin treatment saved on average JPY 116,000 (Euro 889) [95% confidence interval (CI) JPY 57,077-175,151] per patient. Dominance was demonstrated (non-significant) in the first year of treatment and, low-dose aspirin was dominant to 'no aspirin' arm from an annual risk of 0.20%. Other results of sensitivity analysis on gastrointestinal (GI) bleeding rate, stroke rate, cost of each event and discounting showed the robustness of the results. Conclusions: Administering low-dose aspirin to patients with a 1-year risk of CHD of 1.5% and more is significantly costsaving from the insurers' perspective in Japan

Cost-Utility Analysis of Varenicline, an Oral Smoking-Cessation Drug, in Japan

Objectives: To conduct a cost-utility analysis of two 12-week smoking-cessation interventions in Japan: smoking-cessation counselling by a physician compared with use of varenicline, an oral smoking-cessation drug, in addition to counselling. Abstract: Methods: A Markov model was constructed to analyse lifetime medical costs and QALYs from the perspective of the healthcare payer. The cycle length was 5 years. Both costs and QALYs were discounted at 3% annually. The cohort of smokers was classified by sex and age, and we assumed that smokers started smoking at the age of 20 years and received smoking-cessation therapy at the ages of 30, 40, 50, 60 or 70 years (five separate models were run). The healthcare costs and QALYs were calculated throughout the term until the age of 90 years. In the base-case analysis, success rates of varenicline plus counselling and counselling alone were assumed to be 37.9% and 25.5%, respectively, in male smokers, and 22.2% and 16.1%, respectively, in female smokers, based on a randomized controlled trial conducted in Japan. Both univariate and probabilistic sensitivity analyses were conducted. Abstract: Results: Prescribed varenicline was shown to be more effective and less costly than smoking-cessation counselling alone. Varenicline would save direct medical costs of Japanese Yen (¥)43 846 ($US381; $US1 - ¥115; Oct 2007) and generate an increase of 0.094 QALYs in male smokers. In females the incremental cost-effectiveness ratio was ¥346 143 per QALY gained. Varenicline is estimated to save ¥23.7 billion ($US206 million) of the medical costs for tobacco-associated diseases for the whole population. Overall savings are ¥9.5 billion. Sensitivity analyses suggested the robustness of the results. Abstract: Conclusion: As with any data of this nature, there is some uncertainty in the results and further research is warranted. However, based on the results of this pharmacoeconomic evaluation, varenicline, the first non-nicotine, oral treatment developed for smoking cessation, appears to be cost effective and may contribute to future medical cost savings in Japan.

Cost-minimisation model of magnetic resonance-guided focussed ultrasound therapy compared to unilateral deep brain stimulation for essential tremor treatment in Japan.

ObjectiveTo investigate the cost differences between magnetic resonance-guided focussed ultrasound (MRgFUS) and unilateral deep brain stimulation (DBS) for the treatment of medication-refractory essential tremor (ET) in Japan using a cost-minimisation model.MethodsA cost-minimisation model estimated total costs for MRgFUS and unilateral DBS by summing the pre-procedure, procedure, and post-procedure costs over a 12-month time horizon, using data from published sources and expert clinical opinion. The model base case considered medical costs from fee-for-service tariffs. Scenario analyses investigated the use of Diagnosis Procedure Combination tariffs, a diagnosis-related group-based fixed-payment system, and the addition of healthcare professional labour costs healthcare professionals using tariffs from the Japanese Health Insurance Federation for Surgery. One-way sensitivity analyses altered costs associated with tremor recurrence after MRgFUS, the extraction rate following unilateral DBS, the length of hospitalisation for unilateral DBS and the procedure duration for MRgFUS. The impact of uncertainty in model parameters on the model results was further explored using probabilistic sensitivity analysis.ResultsCompared to unilateral DBS, MRgFUS was cost saving in the base case and Diagnosis Procedure Combination cost scenario, with total savings of JPY400,380 and JPY414,691, respectively. The majority of savings were accrued at the procedural stage. Including labour costs further increased the cost differences between MRgFUS and unilateral DBS. Cost savings were maintained in each sensitivity analysis and the probabilistic sensitivity analysis, demonstrating that the model results are highly robust.ConclusionsIn the Japanese healthcare setting, MRgFUS could be a cost saving option versus unilateral DBS for treating medication-refractory ET. The model results may even be conservative, as the cost of multiple follow-ups for unilateral DBS and treatment costs for adverse events associated with each procedure were not included. This model is also consistent with the results of other economic analyses of MRgFUS versus DBS in various settings worldwide