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1.
2.

Objectives

To assess the cost-effectiveness of gemcitabine (G), G + 5-fluorouracil, G + capecitabine, G + cisplatin, G + oxaliplatin, G + erlotinib, G + nab-paclitaxel (GnP), and FOLFIRINOX in the treatment of advanced pancreatic cancer from a Canadian public health payer’s perspective, using data from a recently published Bayesian network meta-analysis.

Methods

Analysis was conducted through a three-state Markov model and used data on the progression of disease with treatment from the gemcitabine arms of randomized controlled trials combined with estimates from the network meta-analysis for the newer regimens. Estimates of health care costs were obtained from local providers, and utilities were derived from the literature. The model estimates the effect of treatment regimens on costs and quality-adjusted life-years (QALYs) discounted at 5% per annum.

Results

At a willingness-to-pay (WTP) threshold of greater than $30,666 per QALY, FOLFIRINOX would be the most optimal regimen. For a WTP threshold of $50,000 per QALY, the probability that FOLFIRINOX would be optimal was 57.8%. There was no price reduction for nab-paclitaxel when GnP was optimal.

Conclusions

From a Canadian public health payer’s perspective at the present time and drug prices, FOLFIRINOX is the optimal regimen on the basis of the cost-effectiveness criterion. GnP is not cost-effective regardless of the WTP threshold.  相似文献   

3.

Background

Recent evidence signals the need for effective forms of home support to people with dementia and their carers. The cost-effectiveness evidence of different approaches to support is scant.

Objectives

To appraise economic evidence on the cost-effectiveness of home support interventions for dementia to inform future evaluation.

Methods

A systematic literature review of full and partial economic evaluations was performed using the British National Health Service Economic Evaluation Database supplemented by additional references. Study characteristics and findings, including incremental cost-effectiveness ratios, when available, were summarized narratively. Study quality was appraised using the National Health Service Economic Evaluation Database critical appraisal criteria and independent ratings, agreed by two reviewers. Studies were located on a permutation matrix describing their mix of incremental costs/effects to aid decision making.

Results

Of the 151 articles retrieved, 14 studies met the inclusion criteria: 8 concerning support to people with dementia and 6 to carers. Five studies were incremental cost-utility analyses, seven were cost-effectiveness analyses, and two were cost consequences analyses. Five studies expressed incremental cost-effectiveness ratios as cost per quality-adjusted life-year (£6,696–£207,942 per quality-adjusted life-year). In four studies, interventions were dominant over usual care. Two interventions were more costly but more beneficial and were favorable against current acceptability thresholds.

Conclusions

Occupational therapy, home-based exercise, and a carers’ coping intervention emerged as cost-effective approaches for which there was better evidence. These interventions used environmental modifications, behavior management, physical activity, and emotional support as active components. More robust evidence is needed to judge the value of these and other interventions across the dementia care pathway.  相似文献   

4.

Background

In September 2014, the PARADIGM-HF trial showed the heart failure drug combination sacubitril/valsartan to be superior to enalapril for patients with a reduced ejection fraction.

Objectives

To determine the incremental cost-effectiveness of sacubitril/valsartan compared with enalapril in the Netherlands using the clinical data from the PARADIGM-HF trial.

Methods

To compare sacubitril/valsartan and enalapril in a cost-effectiveness study, a Markov model was developed using the effectiveness data from the PARADIGM-HF trial. A health care payer’s perspective was applied in the economic evaluation. The developed model was used to evaluate the cost-effectiveness for sacubitril/valsartan at different per diem prices.

Results

The base-case analysis showed that sacubitril/valsartan can be cost-effective at maximum daily costs of €5.50 and €14.14 considering willingness-to-pay thresholds of €20,000 and €50,000 per quality-adjusted life-year (QALY), respectively. Sensitivity analysis demonstrated the robustness of the model, identifying only the price of sacubitril/valsartan and the mortality within the sacubitril/valsartan group as significant drivers of the cost-effectiveness ratio. Sacubitril/valsartan was cost-effective at a willingness-to-pay threshold of €20,000 per QALY (€50,000 per QALY) in more than 80% of the replications with certainty at the price point of €3 (€10).

Conclusions

Sacubitril/valsartan can be considered a cost-effective treatment at a daily price of €5.25. Unless priced lower than enalapril (<€0.045 per day), sacubitril/valsartan is very unlikely to be cost-saving/dominant.  相似文献   

5.

Background

In 2014, Austrian health authorities implemented an organized breast cancer screening program. Until then, there has been a long-standing tradition of opportunistic screening.

Objectives

To evaluate the cost-effectiveness of organized screening compared with opportunistic screening, as well as to identify factors influencing the clinical and economic outcomes.

Methods

We developed and validated an individual-level state-transition model and assessed the health outcomes and costs of organized and opportunistic screening for 40-year-old asymptomatic women. The base-case analysis compared a scenario involving organized biennial screening with a scenario reflecting opportunistic screening practice for an average-risk woman aged 45 to 69 years. We applied an annual discount rate of 3% and estimated the incremental cost-effectiveness ratio in terms of the cost (2012 euros) per life-year gained (LYG) from a health care perspective. Deterministic and probabilistic sensitivity analyses were performed to assess uncertainty.

Results

Compared with opportunistic screening, an organized program yielded on average additional 0.0118 undiscounted life-years (i.e., 4.3 days) and cost savings of €41 per woman. In the base-case analysis, the incremental cost-effectiveness ratio of organized screening was approximately €20,000 per LYG compared with no screening. Assuming a willingness-to-pay threshold of €50,000 per LYG, there was a 70% probability that organized screening would be considered cost-effective. The attendance rate, but not the test accuracy of mammography, was an influential factor for the cost-effectiveness.

Conclusions

The decision to adopt organized screening is likely an efficient use of limited health care resources in Austria.  相似文献   

6.

Background

Conditional reimbursement of new health technologies is increasingly considered as a useful policy instrument. It allows gathering more robust evidence regarding effectiveness and cost-effectiveness of new technologies without delaying market access. Nevertheless, the literature suggests that ending reimbursement and provision of a technology when it proves not to be effective or cost-effective in practice may be difficult.

Objectives

To investigate how policymakers and the general public in the Netherlands value removing a previously reimbursed treatment from the basic benefits package relative to not including a new treatment.

Methods

To investigate this issue, we used discrete-choice experiments. Mixed multinomial logit models were used to analyze the data. Compensating variation values and changes in probability of acceptance were calculated for withdrawal of reimbursement.

Results

The results show that, ceteris paribus, both the general public (n = 1169) and policymakers (n = 90) prefer a treatment that is presently reimbursed over one that is presently not yet reimbursed.

Conclusions

Apparently, ending reimbursement is more difficult than not starting reimbursement in the first place, both for policymakers and for the public. Loss aversion is one of the possible explanations for this result. Policymakers in health care need to be aware of this effect before engaging in conditional reimbursement schemes.  相似文献   

7.

Background

Economic evaluations often measure an intervention effect with mean overall survival (OS). Emerging types of cancer treatments offer the possibility of being “cured” in that patients can become long-term survivors whose risk of death is the same as that of a disease-free person. Describing cured and noncured patients with one shared mean value may provide a biased assessment of a therapy with a cured proportion.

Objective

The purpose of this article is to explain how to incorporate the heterogeneity from cured patients into health economic evaluation.

Methods

We analyzed clinical trial data from patients with advanced melanoma treated with ipilimumab (Ipi; n = 137) versus glycoprotein 100 (gp100; n = 136) with statistical methodology for mixture cure models. Both cured and noncured patients were subject to background mortality not related to cancer.

Results

When ignoring cured proportions, we found that patients treated with Ipi had an estimated mean OS that was 8 months longer than that of patients treated with gp100. Cure model analysis showed that the cured proportion drove this difference, with 21% cured on Ipi versus 6% cured on gp100. The mean OS among the noncured cohort patients was 10 and 9 months with Ipi and gp100, respectively. The mean OS among cured patients was 26 years on both arms. When ignoring cured proportions, we found that the incremental cost-effectiveness ratio (ICER) when comparing Ipi with gp100 was $324,000/quality-adjusted life-year (QALY) (95% confidence interval $254,000–$600,000). With a mixture cure model, the ICER when comparing Ipi with gp100 was $113,000/QALY (95% confidence interval $101,000–$154,000).

Conclusions

This analysis supports using cure modeling in health economic evaluation in advanced melanoma. When a proportion of patients may be long-term survivors, using cure models may reduce bias in OS estimates and provide more accurate estimates of health economic measures, including QALYs and ICERs.  相似文献   

8.

Background

The German Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen) adapted the efficiency frontier (EF) approach to conform to statutory provisions on cost-effectiveness analysis of health technologies. EF serves as a framework for evaluating cost-effectiveness and indirectly for pricing and reimbursement decisions.

Objectives

To calculate an EF on the basis of single multidimensional benefit by taking patient preferences and uncertainty into account; to evaluate whether EF is useful to inform decision makers about cost-effectiveness of new therapies; and to find whether a treatment is efficient at given prices demonstrated through a case study on chronic hepatitis C.

Methods

A single multidimensional benefit was calculated by linear additive aggregation of multiple patient-relevant end points. End points were identified and weighted by patients in a previous discrete-choice experiment (DCE). Aggregation of overall benefit was ascertained using preferences and clinical data. Monte-Carlo simulation was applied. Uncertainty was addressed by price acceptability curve (PAC) and net monetary benefit (NMB).

Results

The case study illustrates that progress in benefit and efficiency of hepatitis C virus treatments could be depicted very well with the EF. On the basis of cost, effect, and preference data, the latest generations of interferon-free treatments are shown to yield a positive NMB and be efficient at current prices.

Conclusions

EF was implemented taking uncertainty into account. For the first time, a DCE was used with the EF. The study shows how DCEs in combination with EF, PAC, and NMB can contribute important information in the course of reimbursement and pricing decisions.  相似文献   

9.

Background

Concerns about pathology testing such as the value provided by new tests and the potential for inappropriate utilization have led to a greater need to assess costs and benefits. Economic evaluations are a formal method of analyzing costs and benefits, yet for pathology tests, questions remain about the scope and quality of the economic evidence.

Objective

To describe the extent and quality of published evidence provided by economic evaluations of pathology tests from 2010 to 2015.

Methods

Economic evaluations relating to pathology tests from 2010 to 2015 were reviewed. Eight databases were searched for published studies, and details recorded for the country, clinical focus, type of testing, and consideration of sensitivity, specificity, and false test results. The reporting quality of studies was assessed using the Consolidated Health Economic Evaluation Reporting Standards checklist and cost-effectiveness ratios were analyzed for publication bias.

Results

We found 356 economic evaluations of pathology tests, most of which regarded developed countries. The most common economic evaluations were cost-utility analyses and the most common clinical focus was infectious diseases. More than half of the studies considered sensitivity and specificity, but few studies considered the impact of false test results. The average Consolidated Health Economic Evaluation Reporting Standards checklist score was 17 out of 24. Cost-utility ratios were commonly less than $10,000/quality-adjusted life-year or more than $200,000/quality-adjusted life-year.

Conclusions

The number of economic evaluations of pathology tests has increased in recent years, but the rate of increase has plateaued. Furthermore, the quality of studies in the past 5 years was highly variable, and there is some question of publication bias in reporting cost-effectiveness ratios.  相似文献   

10.

Objectives

To evaluate the cost-effectiveness of an automated medication system (AMS) implemented in a Danish hospital setting.

Methods

An economic evaluation was performed alongside a controlled before-and-after effectiveness study with one control ward and one intervention ward. The primary outcome measure was the number of errors in the medication administration process observed prospectively before and after implementation. To determine the difference in proportion of errors after implementation of the AMS, logistic regression was applied with the presence of error(s) as the dependent variable. Time, group, and interaction between time and group were the independent variables. The cost analysis used the hospital perspective with a short-term incremental costing approach. The total 6-month costs with and without the AMS were calculated as well as the incremental costs. The number of avoided administration errors was related to the incremental costs to obtain the cost-effectiveness ratio expressed as the cost per avoided administration error.

Results

The AMS resulted in a statistically significant reduction in the proportion of errors in the intervention ward compared with the control ward. The cost analysis showed that the AMS increased the ward’s 6-month cost by €16,843. The cost-effectiveness ratio was estimated at €2.01 per avoided administration error, €2.91 per avoided procedural error, and €19.38 per avoided clinical error.

Conclusions

The AMS was effective in reducing errors in the medication administration process at a higher overall cost. The cost-effectiveness analysis showed that the AMS was associated with affordable cost-effectiveness rates.  相似文献   

11.

Background

The obesity epidemic is linked to substantial health care resource use, reduction in workforce and home productivity, and poor health-related quality of life (HRQOL). Changes in body mass index (BMI) are associated with improvements in HRQOL; the nature of this relationship, however, has not been reliably described.

Objectives

To determine the independent association between changes in BMI and change in utility-based HRQOL.

Methods

Data were prospectively collected on 500 severely obese adult patients enrolled in a single-center obesity management clinic. Univariable and multivariable linear regressions were performed, adjusting for the effect of the intervention itself, obesity-related comorbidities, BMI at enrollment, age, and sex.

Results

A 1-unit reduction in BMI was associated with a 0.0075 (95% confidence interval 0.0041–0.0109) increase in the EuroQol five-dimensional questionnaire score. This relationship was unaltered in various analyses, and is likely applicable to any health-care–induced changes in BMI.

Conclusions

The quantification of this association advances the understanding of the clinical benefits of interventions that affect BMI, and can inform more robust cost-utility analyses.  相似文献   

12.

Background

The 2009 A/H1N1 influenza pandemic generated additional data and triggered new studies that opened debate over the optimal strategy for handling a pandemic. The lessons-learned documents from the World Health Organization show the need for a cost estimation of the pandemic response during the risk-assessment phase. Several years after the crisis, what conclusions can we draw from this field of research?

Objective

The main objective of this article was to provide an analysis of the studies that present cost-effectiveness or cost-benefit analyses for A/H1N1 pandemic interventions since 2009 and to identify which measures seem most cost-effective.

Methods

We reviewed 18 academic articles that provide cost-effectiveness or cost-benefit analyses for A/H1N1 pandemic interventions since 2009. Our review converts the studies’ results into a cost-utility measure (cost per disability-adjusted life-year or quality-adjusted life-year) and presents the contexts of severity and fatality.

Results

The existing studies suggest that hospital quarantine, vaccination, and usage of the antiviral stockpile are highly cost-effective, even for mild pandemics. However, school closures, antiviral treatments, and social distancing may not qualify as efficient measures, for a virus like 2009’s H1N1 and a willingness-to-pay threshold of $45,000 per disability-adjusted life-year. Such interventions may become cost-effective for severe crises.

Conclusions

This study helps to shed light on the cost-utility of various interventions, and may support decision making, among other criteria, for future pandemics. Nonetheless, one should consider these results carefully, considering these may not apply to a specific crisis or country, and a dedicated cost-effectiveness assessment should be conducted at the time.  相似文献   

13.

Background

For women who have had a previous low transverse cesarean delivery, the decision to undergo a trial of labor after cesarean (TOLAC) or an elective repeat cesarean delivery (ERCD) has important clinical and economic ramifications.

Objectives

To evaluate the cost-effectiveness of the alternative choices of a TOLAC and an ERCD for women with low-risk, singleton gestation pregnancies.

Methods

We searched EMBASE, MEDLINE, CINAHL, Cochrane Library, EconLit, and the Cost-Effectiveness Analysis Registry with no language, publication, or date restrictions up until October 2015. Studies were included if they were primary research, compared a TOLAC with an ERCD, and provided information on the relative cost of the alternatives. Abstracts and partial economic evaluations were excluded.

Results

Of 310 studies initially reviewed, 7 studies were included in the systematic review. In the base-case analyses, 4 studies concluded that TOLAC was dominant over ERCD, 1 study found ERCD to be dominant, and 2 studies found that although TOLAC was more costly, it offered more benefits and was thus cost-effective from a population perspective when considering societal willingness to pay for better outcomes. In sensitivity analyses, cost-effectiveness was found to be dependent on a high likelihood of TOLAC success, low risk of uterine rupture, and low relative cost of TOLAC compared with ERCD.

Conclusions

For women who are likely to have a successful vaginal delivery, routine ERCD may result in excess morbidity and cost from a population perspective.  相似文献   

14.

Background

Mortality from intra-abdominal candidiasis in intensive care units (ICUs) is high. It takes many days for peritoneal-fluid fungal culture to become positive, and the recommended empirical antifungal therapy involves excessive costs. Polymerase chain reaction (PCR) should produce results more rapidly than fungal culture.

Objectives

To perform a cost-effectiveness analysis of the combination of several diagnostic and therapeutic strategies to manage Candida peritonitis in non-neutropenic adult patients in ICUs.

Methods

We constructed a decision tree model to evaluate the cost effectiveness. Cost and effectiveness were taken into account in a 1-year time horizon and from the French National Health Insurance perspective. Six strategies were compared: fluconazole or echinocandin as an empirical therapy, plus diagnosis by fungal culture or detection by PCR of all Candida species, or use of PCR to detect most fluconazole-resistant Candida species (i.e., Candida krusei and Candida glabrata).

Results

The use of fluconazole empirical treatment and PCR to detect all Candida species is more cost effective than using fluconazole empirical treatment without PCR (incremental cost-effectiveness ratio of €40,055/quality-adjusted life-year). Empirical treatment with echinocandin plus PCR to detect C. krusei and C. glabrata is the most effective strategy, but has an incremental cost-effectiveness ratio of €93,776/quality-adjusted life-year. If the cost of echinocandin decreases, then strategies involving PCR plus empirical echinocandin become more cost-effective.

Conclusions

Detection by PCR of all Candida species and of most fluconazole-resistant Candida species could improve the cost-effectiveness of fluconazole and echinocandin given to non-neutropenic patients with suspected peritoneal candidiasis in ICUs.  相似文献   

15.

Background

Several organizations have developed frameworks to systematically assess the value of new drugs. These organizations include the American Society of Clinical Oncology (ASCO), the European Society for Medical Oncology (ESMO), the Institute for Clinical and Economic Review (ICER), and the National Comprehensive Cancer Network (NCCN).

Objectives

To understand the extent to which these four tools can facilitate value-based treatment decisions in oncology.

Methods

In this pilot study, eight panelists conducted value assessments of five advanced lung cancer drugs using the ASCO, ESMO, and ICER frameworks. The panelists received instructions and published clinical data required to complete the assessments. Published NCCN framework scores were abstracted. The Kendall's W coefficient was used to measure convergent validity among the four frameworks. Intraclass correlation coefficients were used to measure inter-rater reliability among the ASCO, ESMO, and ICER frameworks. Sensitivity analyses were conducted.

Results

Drugs were ranked similarly by the four frameworks, with Kendall's W of 0.703 (P = 0.006) across all the four frameworks. Pairwise, Kendall's W was the highest for ESMO-ICER (W = 0.974; P = 0.007) and ASCO-NCCN (W = 0.944; P = 0.022) and the lowest for ICER-NCCN (W = 0.647; P = 0.315) and ESMO-NCCN (W = 0.611; P = 0.360). Intraclass correlation coefficients (confidence interval [CI]) for the ASCO, ESMO, and ICER frameworks were 0.786 (95% CI 0.517–0.970), 0.804 (95% CI 0.545–0.973), and 0.281 (95% CI 0.055–0.799), respectively. When scores were rescaled to 0 to 100, the ICER framework provided the narrowest band of scores.

Conclusions

The ASCO, ESMO, ICER, and NCCN frameworks demonstrated convergent validity, despite differences in conceptual approaches used. The ASCO inter-rater reliability was high, although potentially at the cost of user burden. The ICER inter-rater reliability was poor, possibly because of its failure to distinguish differential value among the sample of drugs tested. Refinements of all frameworks should continue on the basis of further testing and stakeholder feedback.  相似文献   

16.

Background

A broad literature on health state utility values exists, but compared with chronic health states (HSs), issues surrounding the valuation of temporary health states (THSs) have been poorly explored.

Objectives

To assess the methods used by previous studies to value HSs that are considered temporary so as to determine the strengths and limitations associated with various approaches and to inform future study designs.

Methods

A systematic review was undertaken to explore the methods used, assess how the valuation was conducted for diseases that might lead to HSs deemed as temporary, and identify the challenges encountered in the valuation of THSs.

Results

Of the 36 relevant studies, 22 were explicit that the HS being valued was temporary. Most of the studies used more than one technique (often incorporating both conventional and adapted approaches). In using adapted techniques, the primary challenge was identifying an appropriate intermediate “anchor” HS and the possibility of negative utilities.

Conclusions

There is no agreement on the most methodologically robust approach to THS valuation. Valuation is complex and important issues relating to the validity, practicality, and reliability of the techniques used were not adequately covered by most of the studies identified.  相似文献   

17.

Background

The national newborn bloodspot screening programs (NBSPs) are continually expanding to screen for more conditions.

Objectives

To quantify parents’ preferences for information and the way in which this is provided in example NBSPs.

Methods

A hybrid choice experiment, combining a conjoint analysis and a discrete choice experiment, was designed. A sample of current and future parents between the ages of 18 and 45 years was identified via an Internet panel. Respondents completed one of two survey versions (9 conditions and 20 conditions) comprising a validated measure of attitudes toward involvement in decision making, 6 CA questions (11 information attributes), 10 DCE questions (4 attributes: 3 process and the ability to make an informed decision), and demographic questions.

Results

Of the 702 respondents who completed the survey, 58% were women, 48% were between 25 and 34 years old, and 48% were current parents. All types of information were identified to statistically significantly improve parents’ ability to make a decision. Participants preferred taking an “active” role in decision making. Respondents to the 9-condition survey preferred information before 20 weeks (willingness to pay [WTP] £11.88; CI £5.56 to £19.53) and the 20-condition group after 20 weeks (WTP £15.91; CI £10.64 to £21.63). All respondents disliked receiving information 3 days after birth, with the 20-condition group also being averse to receiving it on day 5 (WTP ?£11.20; CI ?£18.40 to 5.72). Respondents in both groups preferred to receive their information in an individual discussion.

Conclusions

This study suggests that parents’ preferences for receiving NBS information differ from how this information is given in current UK practice.  相似文献   

18.

Background

Partially implantable active middle ear implants (aMEIs) offer a solution for individuals who have mild to severe sensorineural hearing loss and an outer ear medical condition that precludes the use of hearing aids. When otherwise left untreated, individuals report a lower quality of life, which may further decrease with increasing disability. In the lack of cost-effectiveness studies and long-term data, there is a need for decision modeling.

Objective

To explore individual-level variance in resource utilization patterns following aMEI implantation.

Methods

A Markov model was developed and analyzed as microsimulation to estimate the incremental cost utility ratio (ICUR) of partially implantable aMEIs compared with no (surgical) intervention in individuals with sensorineural hearing loss and an outer ear medical condition in Australia. Cost data were derived mostly from the Medicare Benefit Schedule and effectiveness data from published literature. A third-party payer perspective was adopted, and a 5% discount rate was applied over a 10-year time horizon.

Results

Compared with baseline strategy, aMEIs yielded an incremental cost of Australian dollars (AUD) 13,339.18, incremental quality-adjusted life-year (QALY) of 1.35, and an ICUR of AUD 9,913.72/QALY. Of the respective number of simulated patients who visited each health state, 75.73% never had a minor adverse event, 99.82% did not experience device failure, and 97.75% did not cease to use their aMEIs. Probabilistic sensitivity analyses showed the ICUR to differ by only 0.95%.

Conclusions

In the Australian setting, partially implantable aMEIs offer a safe and cost-effective solution compared with no intervention and are also well accepted by users.  相似文献   

19.

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.  相似文献   

20.

Objectives

To describe the adaptation of a global health economic model to determine whether treatment with the angiotensin receptor neprilysin inhibitor LCZ696 is cost effective compared with the angiotensin-converting enzyme inhibitor enalapril in adult patients with chronic heart failure with reduced left ventricular ejection fraction in the Netherlands; and to explore the effect of performing the cost-effectiveness analyses according to the new pharmacoeconomic Dutch guidelines (updated during the submission process of LCZ696), which require a value-of-information analysis and the inclusion of indirect medical costs of life-years gained.

Methods

We adapted a UK model to reflect the societal perspective in the Netherlands by including travel expenses, productivity loss, informal care costs, and indirect medical costs during the life-years gained and performed a preliminary value-of-information analysis.

Results

The incremental cost-effectiveness ratio obtained was €17,600 per quality-adjusted life-year (QALY) gained. This was robust to changes in most structural assumptions and across different subgroups of patients. Probability sensitivity analysis results showed that the probability that LCZ696 is cost-effective at a €50,000 per QALY threshold is 99.8%, with a population expected value of perfect information of €297,128. On including indirect medical costs of life-years gained, the incremental cost-effectiveness ratio was €26,491 per QALY gained, and LCZ696 was 99.46% cost effective at €50,000 per QALY, with a population expected value of perfect information of €2,849,647.

Conclusions

LCZ696 is cost effective compared with enalapril under the former and current Dutch guidelines. However, the (monetary) consequences of making a wrong decision were considerably different in both scenarios.  相似文献   

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