Analysis of the cost-effectiveness of proton beam therapy for unresectable pancreatic cancer in Japan.

BACKGROUND: Proton beam therapy (PBT) has recently been included in Japan's social health insurance benefits package. This study aimed to determine the cost-effectiveness of PBT for unresectable, locally advanced pancreatic cancer (LAPC) as a replacement for conventional photon radiotherapy (RT). METHODS: We estimated the incremental cost-effectiveness ratio (ICER) of PBT as a replacement for three-dimensional conformal RT (3DCRT), a conventional photon RT, using clinical evidence in the literature and expense complemented by expert opinions. We used a decision tree and an economic and Markov model to illustrate the disease courses followed by LAPC patients. Effectiveness was estimated as quality-adjusted life years (QALY) using utility weights for the health state. Social insurance fees were calculated as the costs. The stability of the ICER against the assumptions made was appraised using sensitivity analyses. RESULTS: The effectiveness of PBT and 3DCRT was 1.67610615 and 0.97181271 QALY, respectively. The ICER was estimated to be ¥5,376,915 (US$46,756) per QALY. According to the suggested threshold for anti-cancer therapy from the Japanese authority of ¥7,500,000 (US$65,217) per QALY gain, such a replacement would be considered cost-effective. The one-way and probabilistic sensitivity analyses demonstrated stability of the base-case ICER. CONCLUSION: PBT, as a replacement for conventional photon radiotherapy, is cost-effective and justifiable as an efficient use of finite healthcare resources. Making it a standard treatment option and available to every patient in Japan is socially acceptable from the perspective of health economics.

Cost-effectiveness of mass screening for dipstick hematuria in Japan.

BACKGROUND: Dipstick urine tests are a simple and inexpensive method for detecting kidney and urological diseases, such as IgA nephropathy and bladder cancer. The nationwide mass screening program, Specific Health Checkup (SHC), started in Japan in 2008 and targeted all adults between 40 and 74 years of age. Dipstick urine tests for proteinuria and glucosuria are mandatory as part of the SHC, but dipstick urine tests for hematuria are not. However, the dipstick hematuria test is often administered simultaneously with these mandatory tests by some health insurers. Hematuria is common in Japanese general screening participants, particularly elderly women, and the necessity of mass screening using the dipstick hematuria test has been discussed. This study aimed to evaluate the cost-effectiveness of mass screening for dipstick hematuria tests in addition to the SHC. METHODS: Using a decision tree and Markov modeling, we conducted a cost-effectiveness analysis from a Japanese societal perspective. RESULTS: Compared with the current SHC, mass screening for dipstick hematuria tests, in addition to the SHC, costs less and gains more, which means cost-saving. Similar findings were observed in the sex-specific analysis. CONCLUSION: Our results suggest that mandating the dipstick hematuria test could be justifiable as an efficient use of finite healthcare resources. The results have implications for mass screening programs not only in Japan but worldwide.

Cost-effectiveness of a New Opportunistic Screening Strategy for Walk-in Fingertip HbA1c Testing at Community Pharmacies in Japan.

OBJECTIVE: A new opportunistic community-based strategy was launched in Japan in April 2014 to detect lifestyle-related diseases, including diabetes, by creating Specimen Measurement Offices (SMOs). SMOs offer walk-in fingertip HbA1c testing. This article aimed to assess the value-for-money of HbA1c testing services at SMOs by conducting a cost-effectiveness analysis. RESEARCH DESIGN AND METHODS: We compared two scenarios: 1) status quo, defined as HbA1c testing that is available only through conventional screening, and 2) HbA1c testing available at SMOs as a complement to the status quo scenario. The model consisted of a screening module with a decision tree and a disease progression module with a Markov model. We calculated incremental cost-effectiveness ratios (i.e., cost per quality-adjusted life-years [QALYs]) over the lifetime analytic horizon as the primary end point of the cost-effectiveness analysis. In this model, we assumed the participant cohort to be people 40-74 years of age who sought walk-in fingertip HbA1c testing at SMOs on the premises of community pharmacies. Costs and outcomes were discounted at a rate of 3%. The cost-effectiveness was analyzed from a societal perspective. RESULTS: The incremental cost per individual for those 40-74 years of age was estimated to be -527 U.S. dollars (USD) (-52,722 Japanese yen [JPY]) for HbA1c testing at SMOs compared with the status quo. Incremental effectiveness was estimated to be 0.0203 QALYs for HbA1c testing at SMOs compared with the status quo. Therefore, this cost-effectiveness analysis showed that compared with the status quo, HbA1c testing at SMOs was more effective and had lower cost for the population studied. CONCLUSIONS: We consider our results to be robust because most simulations were under the threshold of USD 50,000 (JPY 5,000,000) per QALYs gained, by sensitivity analysis. These results will be useful to managers of pharmacies or other health institutions and/or policy makers in local government.

Cost-effectiveness of obstructive sleep apnea screening for patients with diabetes or chronic kidney disease.

PURPOSE: Obstructive sleep apnea (OSA) is a common disorder with a high prevalence among patients with cardiovascular disease (CVD), diabetes, and chronic kidney disease (CKD). Routine evaluation of OSA for patients with CVD including hypertension has been performed according to the clinical guidelines for both OSA and CVD. However, most patients with diabetes and CKD who could benefit from treatment remain undiagnosed because routine screening of OSA is not recognized as part of standard practice. This study aims to evaluate the cost-effectiveness of OSA screening for patients with diabetes and CKD. METHODS: Cost-effectiveness analysis by a decision tree and Markov modeling from the societal perspective in Japan was carried out to provide evidence based on the economic evaluation of current clinical practice concerning diabetes and CKD. RESULTS: Incremental cost-effectiveness ratios of OSA screening compared with do-nothing were calculated as ¥3,516,976 to 4,514,813/quality-adjusted life year (QALY) (US$35,170 to 45,148/QALY) for diabetes patients and ¥3,666,946 to 4,006,866/QALY (US$36,669 to 40,069/QALY) for CKD patients. CONCLUSIONS: Taking the threshold to judge cost-effectiveness according to a suggested value of social willingness to pay for one QALY gain in Japan as ¥5 million/QALY (US$50,000QALY), OSA screening is cost-effective. Our results suggest that active case screening and treatment of OSA for untreated middle-aged male patients with diabetes or CKD could be justifiable as an efficient use of finite health-care resources in the world with high prevalence of these diseases.

Budget impact analysis of chronic kidney disease mass screening test in Japan.

BACKGROUND: Our recently published cost-effectiveness study on chronic kidney disease mass screening test in Japan evaluated the use of dipstick test, serum creatinine (Cr) assay or both in specific health checkup (SHC). Mandating the use of serum Cr assay additionally, or the continuation of current policy mandating dipstick test only was found cost-effective. This study aims to examine the affordability of previously suggested reforms. METHODS: Budget impact analysis was conducted assuming the economic model would be good for 15 years and applying a population projection. Costs expended by social insurers without discounting were counted as budgets. RESULTS: Annual budget impacts of mass screening compared with do-nothing scenario were calculated as ¥79-¥-1,067 million for dipstick test only, ¥2,505-¥9,235 million for serum Cr assay only and ¥2,517-¥9,251 million for the use of both during a 15-year period. Annual budget impacts associated with the reforms were calculated as ¥975-¥4,129 million for mandating serum Cr assay in addition to the currently used mandatory dipstick test, and ¥963-¥4,113 million for mandating serum Cr assay only and abandoning dipstick test. CONCLUSIONS: Estimated values associated with the reform from ¥963-¥4,129 million per year over 15 years are considerable amounts of money under limited resources. The most impressive finding of this study is the decreasing additional expenditures in dipstick test only scenario. This suggests that current policy which mandates dipstick test only would contain medical care expenditure.

Economic evaluation of the 70-gene prognosis-signature (MammaPrint®) in hormone receptor-positive, lymph node-negative, human epidermal growth factor receptor type 2-negative early stage breast cancer in Japan.

The 70-gene prognosis-signature is validated as a good predictor of recurrence for hormone receptor-positive (ER+), lymph node-negative (LN-), human epidermal growth factor receptor type 2-negative (HER2-) early stage breast cancer (ESBC) in Japanese patient population. Its high cost and potential in avoiding unnecessary adjuvant chemotherapy arouse interest in its economic impact. This study evaluates the cost-effectiveness of including the assay into Japan's social health insurance benefit package. An economic decision tree and Markov model under Japan's health system from the societal perspective is constructed with clinical evidence from the pool analysis of validation studies. One-way sensitivity analyses are also performed. Incremental cost-effectiveness ratio is estimated as ¥3,873,922/quality adjusted life year (QALY) (US$43,044/QALY), which is not more than the suggested social willingness-to-pay for one QALY gain from an innovative medical intervention in Japan, ¥5,000,000/QALY (US$55,556/QALY). However, sensitivity analyses show the instability of this estimation. The introduction of the assay into Japanese practice of ER+, LN-, HER2- ESBC treatment by including it to Japan's social health insurance benefit package has a reasonable chance to be judged as cost-effective and may be justified as an efficient deployment of finite health care resources.

Cost-effectiveness of chronic kidney disease mass screening test in Japan.

BACKGROUND: Chronic kidney disease (CKD) is a significant public health problem. Strategy for its early detection is still controversial. This study aims to assess the cost-effectiveness of population strategy, i.e. mass screening, and Japan's health checkup reform. METHODS: Cost-effectiveness analysis was carried out to compare test modalities in the context of reforming Japan's mandatory annual health checkup for adults. A decision tree and Markov model with societal perspective were constructed to compare dipstick test to check proteinuria only, serum creatinine (Cr) assay only, or both. RESULTS: Incremental cost-effectiveness ratios (ICERs) of mass screening compared with do-nothing were calculated as ¥1,139,399/QALY (US $12,660/QALY) for dipstick test only, ¥8,122,492/QALY (US $90,250/QALY) for serum Cr assay only and ¥8,235,431/QALY (US $91,505/QALY) for both. ICERs associated with the reform were calculated as ¥9,325,663/QALY (US $103,618/QALY) for mandating serum Cr assay in addition to the currently used mandatory dipstick test, and ¥9,001,414/QALY (US $100,016/QALY) for mandating serum Cr assay and applying dipstick test at discretion. CONCLUSIONS: Taking a threshold to judge cost-effectiveness according to World Health Organization's recommendation, i.e. three times gross domestic product per capita of ¥11.5 million/QALY (US $128 thousand/QALY), a policy that mandates serum Cr assay is cost-effective. The choice of continuing the current policy which mandates dipstick test only is also cost-effective. Our results suggest that a population strategy for CKD detection such as mass screening using dipstick test and/or serum Cr assay can be justified as an efficient use of health care resources in a population with high prevalence of the disease such as in Japan and Asian countries.

Economic evaluation of the 21-gene signature (Oncotype DX) in lymph node-negative/positive, hormone receptor-positive early-stage breast cancer based on Japanese validation study (JBCRG-TR03).

The 21-gene signature is validated as a good predictor of recurrence for lymph node-negative/positive, hormone receptor-positive, early-stage breast cancer in Japanese patient population. This study evaluates the cost-effectiveness of two scenarios designed to include the assay into Japan's social health insurance benefit package: one for LN-, ER+, ESBC and another for LN-/+, ER+, ESBC. An economic decision tree and Markov model under Japan's health system from the societal perspective is constructed with new evidence from the Japanese validation study. Incremental cost-effectiveness ratios are estimated as ¥384,828 (US$3,848) per QALY for the indication for LN- scenario and ¥568,533 (US$5,685) per QALY for the indication for LN-/+ scenario. Both are not more than the suggested social willingness-to-pay for one QALY gain from an innovative medical intervention in Japan, ¥5,000,000/QALY (US$50,000/QALY). Sensitivity analyses show that this result is plausibly robust, since ICERs do not exceed the threshold by various changes of assumptions made and values employed. In conclusion, the inclusion of the assay in Japan's social health insurance benefit package for not only LN- diseases but also LN+ diseases is cost-effective. Such a decision can be justifiable as an efficient use of finite resources for health care.

Economic evaluation of intensive chemotherapy with prophylactic granulocyte colony-stimulating factor for patients with high-risk early breast cancer in Japan.

OBJECTIVE: This study assessed the cost-effectiveness and budget impact of third-generation chemotherapy regimens with prophylactic granulocyte colony-stimulating factor (G-CSF) relative to second-generation regimens without prophylactic G-CSF for patients with high-risk early breast cancer in Japan. METHODS: We conducted a cost-effectiveness analysis with Markov modeling and calculated incremental cost-effectiveness ratios (ICERs) for the comparison between second-generation regimens without prophylactic G-CSF and third-generation regimens with prophylactic G-CSF. The comparisons consisted of fluorouracil, doxorubicin, and cyclophosphamide, a second-generation regimen, versus docetaxel, doxorubicin, and cyclophosphamide (TAC) with G-CSF, a third-generation regimen; and doxorubicin, cyclophosphamide, and paclitaxel (AC-T) q3wk, a second-generation regimen, versus dose-dense (DD) AC-T q2wk with G-CSF, a third-generation regimen. Patients were stratified by the age at which chemotherapy was started into cohorts aged 35, 45, and 55 years. Outcomes were estimated in terms of life-years (LYs) and quality-adjusted LYs (QALYs). ICER calculations were done from a societal perspective. We also estimated the budget impact, which included the additional public medical expenditures that would cover all subsequent changes after the additional cost of choosing third-generation regimens if G-CSF were approved for use in third-generation regimens for breast cancer. Costs were calculated using prescription drug prices as of 2006. RESULTS: Estimated ICER values for TAC with prophylactic G-CSF were yen956,471/LY and yen919,443/ QALY for age 35 years, yen1,125,540/LY and yen1,078,967/QALY for age 45 years, and yen1,302,746/LY and yen1,224,896/QALY for age 55 years. Values for DD AC-T q2wk with prophylactic G-CSF were yen291,931/LY and yen311,232/QALY for age 35 years, yen357,354/LY and yen380,148/QALY for age 45 years, and yen377,011/LY and yen399,761/QALY for age 55 years. TAC or DD AC-T q2wk with prophylactic G-CSF would yield cost savings compared with the respective second-generation regimens if the per-dose cost of G-CSF decreased from yen31,355 to yen15,700 (TAC) or to yen24,300 (DD AC-T). The estimated budget impact is yen9.5 to yen11.0 billion per year for the next 5 years. CONCLUSION: According to a Markov model for patients with high-risk early breast cancer in Japan, third-generation regimens with prophylactic G-CSF will yield improved outcomes at a greater cost, but estimated ICER values are still less than the suggested cost-effectiveness threshold value of yen6 million (US $60,000, assuming US $1 = yen100) for a gain of 1 QALY.

Budget impact analysis of chemoprevention of breast cancer with tamoxifen and raloxifene among high-risk women in Japan.

'Cost saving' was suggested in our recent economic evaluation of chemoprevention of breast cancer targeting women at high risk in Japan. However, this budget impact analysis reveals that the introduction of chemoprevention appears to be not budget saving for approximately 20 years, whereas the level of budget impact seems affordable.

Economic evaluation of 21-gene reverse transcriptase-polymerase chain reaction assay in lymph-node-negative, estrogen-receptor-positive, early-stage breast cancer in Japan.

The 21-gene reverse transcriptase-polymerase chain reaction assay with a patented algorithm is validated as a good predictor of prognosis and potential benefit from adjuvant chemotherapy for lymph-node-negative, estrogen-receptor-positive, early-stage breast cancer, while its high cost raises concern about how to finance it. Cost-effectiveness analysis comparing prevalent National Comprehensive Cancer Network (NCCN) guideline/St Gallen recommendation-guided treatment with the assay-guided treatment is carried out with budget impact estimation in the context of Japan's health care system. Incremental cost-effectiveness ratios are estimated as 2,997,495 yen/QALY (26,065 US$/QALY) in the comparison between NCCN guided-treatment vs. the assay-guided treatment, and as 1,239,055 yen/QALY (10,774 US$/QALY) in the comparison between St Gallen guided-treatment vs. the assay-guided treatment. Budget impact is estimated as yen2,638 million (US$23 million) to yen3,225 million (US$28 million) per year. The routine use of the assay is indicated as cost-effective. And the budget impact could be judged as within fundable level.