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1.

Background

The cost utility of treatments of age-related macular degeneration (AMD) is commonly assessed using health state transition models defined by levels of visual acuity. However, there is evidence that another measure of visual function, contrast sensitivity, may be better associated with utility than visual acuity. This paper investigates the difference in cost effectiveness resulting from models based on visual acuity and contrast sensitivity using the example of bevacizumab (Avastin) for neovascular AMD. The implications of the choice of outcome on structural uncertainty in the model are investigated.

Method

Health state transition Markov models based on levels of visual acuity and contrast sensitivity are used to represent the costs, health utilities and outcomes of the Avastin for choroidal neovascular age-related macular degeneration (ABC) trial. Health states are associated with costs and utilities based on literature values. Treatment outcomes from the ABC trial are used to predict transitions between states in both models. Total costs and quality-adjusted life-years (QALYs) are calculated for a cohort of patients treated over a defined number of model cycles.

Results

Over a 5-year time horizon, a contrast sensitivity model predicts a statistically significant (p < 0.05) 25 % greater QALY gain than the visual acuity model based on 10,000 Monte Carlo simulations. Bevacizumab is more effective and less costly than the comparator in the contrast sensitivity model and the visual acuity model.

Conclusion

There is considerable structural uncertainty associated with the choice of outcome for modelling the cost effectiveness of AMD treatments. Bevacizumab has a higher incremental QALY gain and more favourable incremental cost-effectiveness ratio when cost effectiveness is assessed using contrast sensitivity outcomes compared with using visual acuity outcomes. Previous cost-effectiveness analyses may have underestimated the cost effectiveness of anti-vascular endothelial growth factor (anti-VEGF) therapy.  相似文献   

2.

Background

This work has investigated under what conditions confidence intervals around the differences in mean costs from a cluster RCT are suitable for estimation using a commonly used cluster-adjusted bootstrap in preference to methods that utilise the Huber-White robust estimator of variance. The bootstrap's main advantage is in dealing with skewed data, which often characterise patient costs. However, it is insufficiently well recognised that one method of adjusting the bootstrap to deal with clustered data is only valid in large samples. In particular, the requirement that the number of clusters randomised should be large would not be satisfied in many cluster RCTs performed to date.

Methods

The performances of confidence intervals for simple differences in mean costs utilising a robust (cluster-adjusted) standard error and from two cluster-adjusted bootstrap procedures were compared in terms of confidence interval coverage in a large number of simulations. Parameters varied included the intracluster correlation coefficient, the sample size and the distributions used to generate the data.

Results

The bootstrap's advantage in dealing with skewed data was found to be outweighed by its poor confidence interval coverage when the number of clusters was at the level frequently found in cluster RCTs in practice. Simulations showed that confidence intervals based on robust methods of standard error estimation achieved coverage rates between 93.5% and 94.8% for a 95% nominal level whereas those for the bootstrap ranged between 86.4% and 93.8%.

Conclusion

In general, 24 clusters per treatment arm is probably the minimum number for which one would even begin to consider the bootstrap in preference to traditional robust methods, for the parameter combinations investigated here. At least this number of clusters and extremely skewed data would be necessary for the bootstrap to be considered in favour of the robust method. There is a need for further investigation of more complex bootstrap procedures if economic data from cluster RCTs are to be analysed appropriately.  相似文献   

3.

Background

The acquisition costs of biologic drugs are often considered to be relatively high compared with those of nonbiologics. However, the total costs of delivering these drugs also depend on the cost of administration. Ignoring drug administration costs may distort resource allocation decisions because these affect cost effectiveness.

Objectives

The objectives of this systematic review were to develop a framework of drug administration costs that considers both the costs of physical administration and the associated proximal costs; and, as a case example, to use this framework to evaluate administration costs for biologics within the UK National Health Service (NHS).

Methods

We reviewed literature that reported estimates of administration costs for biologics within the UK NHS to identify how these costs were quantified and to examine how differences in dosage forms and regimens influenced administration costs. The literature reviewed were identified by searching the Centre for Review and Dissemination Databases (DARE, NHS EED and HTA); EMBASE (The Excerpta Medica Database); MEDLINE (using the OVID interface); Econlit (EBSCO); Tufts Medical Center Cost Effectiveness Analysis (CEA) Registry; and Google Scholar.

Results

We identified 4,344 potentially relevant studies, of which 43 studies were selected for this systematic review. We extracted estimates of the administration costs of biologics from these studies. We found evidence of variation in the way that administration costs were measured, and that this affected the magnitude of costs reported, which could then influence cost effectiveness.

Conclusions

Our findings suggested that manufacturers of biologic medicines should pay attention to formulation issues and their impact on administration costs, because these affect the total costs of healthcare delivery and cost effectiveness.  相似文献   

4.

Background

Pharmacists successfully manage patients with anemia and chronic kidney disease (CKD), but the cost effectiveness of these programs is unknown.

Objective

To compare the cost effectiveness of pharmacist-managed erythropoiesis-stimulating agent (ESA) clinics with that of usual care in patients with non-dialysis-dependent (NDD)-CKD.

Methods

A Markov model was used to estimate the incremental cost effectiveness of pharmacist-managed ESA clinics compared with usual care in outpatient veterans receiving ESAs for NDD-CKD in 2009. The analysis was conducted from a US Veterans Health Administration perspective with a 5-year time horizon, and the year of valuation for cost results was 2012. The effect of parameter uncertainty was explored in one-way and probabilistic sensitivity analyses.

Results

In the deterministic base case analysis, costs and effectiveness per patient over 5 years were US$13,412 and 2.096 quality-adjusted life-years (QALYs) in the pharmacist-managed ESA clinics and US$16,173 and 2.093 QALYs in usual care; ESA clinics dominated usual care. In one-way sensitivity analyses, ESA clinics no longer dominated if their patients’ probability of being in the target hemoglobin range fell to 52 % (base case 71 %) or if the mean cost/patient/month of epoetin or darbepoetin in ESA clinics increased to approximately US$382 (base case US$226) or US$477 (base case US$268), respectively. When all parameters were varied simultaneously in a probabilistic sensitivity analysis, ESA clinics were favored ≥80 % of the time at willingness-to-pay thresholds of US$0–$100,000 per QALY gained.

Conclusions

Pharmacist-managed ESA clinics were less costly and more effective than usual care in patients receiving ESAs for anemia and NDD-CKD. Results were robust to variation and support the use of pharmacist-managed ESA clinics.  相似文献   

5.

Background

Drug-eluting stents have been shown to reduce the rate of repeat revascularization after percutaneous coronary intervention for acute myocardial infarction (AMI) as compared with bare metal stents (BMS). A few studies have reported the cost effectiveness of sirolimus-eluting stents (SES) in several countries, but none in the particular setting of AMI in France.

Objectives

To assess the cost effectiveness of SES compared with BMS in a pre-specified subgroup of French patients with AMI in the randomized, multicentre TYPHOON trial.

Methods

A prospective economic evaluation was conducted for the 337 patients in the TYPHOON trial who were enrolled in the French centres. In the TYPHOON trial, patients with AMI with ST-segment elevation less than 12 hours after the onset of chest pain were randomized to undergo percutaneous coronary intervention with either SES or BMS. Data on clinical outcomes and resource use were collected prospectively over a 1-year follow-up period (from October 2003 to October 2005). Unit costs were applied to the resource utilization data. The main outcome measure was the incremental cost-effectiveness ratio (ICER) for additional cost per target-vessel revascularization (TVR) avoided. The perspective of the study was the French healthcare system and costs were expressed in 2007 values.

Results

SES significantly reduced the rate of TVR (6.6% vs 22.2% with BMS, p < 0.0001). There was no difference in the rate of death, recurrent myocardial infarction or stent thrombosis after 1 year of follow-up between the SES and BMS groups. Mean index admission costs, including the angioplasty procedure, were increased by €1282 per patient in the SES group, mostly driven by the price of the SES. Mean follow-up costs were €140 per patient lower in the SES group. Mean aggregate 1-year costs showed a €1142 per-patient increase in the SES group compared with the BMS group. The ICER was €7321 per TVR avoided.

Conclusion

In this pre-specified subgroup analysis of the TYPHOON trial, the use of SES in patients with AMI with ST-segment elevation less than 12 hours after the onset of chest pain reduced the rate of TVR compared with BMS. However, SES had a debatable ICER for the payer if it was based only on the specific benefit of TVR avoided.  相似文献   

6.

Background

Vasectomy is generally considered a safe and effective method of permanent contraception. The historical effectiveness of vasectomy has been questioned by recent research results indicating that the most commonly used method of vasectomy – simple ligation and excision (L and E) – appears to have a relatively high failure rate, with reported pregnancy rates as high as 4%. Updated methods such as fascial interposition (FI) and thermal cautery can lower the rate of failure but may require additional financial investments and may not be appropriate for low-resource clinics. In order to better compare the cost-effectiveness of these different vasectomy methods, we modelled the costs of different vasectomy methods using cost data collected in India, Kenya, and Mexico and effectiveness data from the latest published research.

Methods

The costs associated with providing vasectomies were determined in each country through interviews with clinic staff. Costs collected were economic, direct, programme costs of fixed vasectomy services but did not include large capital expenses or general recurrent costs for the health care facility. Estimates of the time required to provide service were gained through interviews and training costs were based on the total costs of vasectomy training programmes in each country. Effectiveness data were obtained from recent published studies and comparative cost-effectiveness was determined using cost per couple years of protection (CYP).

Results

In each country, the labour to provide the vasectomy and follow-up services accounts for the greatest portion of the overall cost. Because each country almost exclusively used one vasectomy method at all of the clinics included in the study, we modelled costs based on the additional material, labour, and training costs required in each country. Using a model of a robust vasectomy program, more effective methods such as FI and thermal cautery reduce the cost per CYP of a vasectomy by $0.08 – $0.55.

Conclusion

Based on the results presented, more effective methods of vasectomy – including FI, thermal cautery, and thermal cautery combined with FI – are more cost-effective than L and E alone. Analysis shows that for a programme in which a minimum of 20 clients undergo vasectomies per month, the cost per CYP is reduced in all three countries by updated vasectomy methods.  相似文献   

7.

Background

Golimumab is a novel TNF-α inhibitor licensed to treat patients with active PsA. Although its clinical efficacy has been proven in clinical trials, its cost effectiveness is yet to be established.

Objectives

To estimate the cost effectiveness of golimumab among patients with active PsA from the UK NHS perspective.

Methods

A decision analytic model was used to simulate progression of a hypothetical cohort of active PsA patients on golimumab and other TNF-α inhibitors as well as palliative care. The clinical evidence was derived from clinical trials of TNF-α inhibitors and compared using mixed treatment models. The primary outcome measure was quality-adjusted life years (QALYs) estimated based on change in Health Assessment Questionnaire (HAQ) and Psoriasis Area Severity Index (PASI) from baseline. The annual acquisition cost of golimumab was assumed to be identical to annual cost of other subcutaneous TNF-α inhibitors. The resource use costs and outcomes were discounted at 3.5% over a period of 40?years. The uncertainty surrounding important variables was further explored using probabilistic sensitivity analyses (PSA).

Results

TNF-α inhibitors were significantly superior to palliative care but comparable to each other on Psoriatic Arthritis Response Criteria (PsARC), HAQ and PASI response. The incremental cost effectiveness ratio (ICERs) for golimumab compared to palliative care was £16,811 for PsA patients and £16,245 for a subgroup of PsA patients with significant psoriasis. At an acceptability threshold of £30,000 per QALY, the probability of golimumab being cost effective is 89%.

Conclusion

Once monthly, golimumab is a cost-effective treatment alternative for patients with active PsA. With its patient-focussed attributes, golimumab is likely to offer additional choice in PsA treatment.  相似文献   

8.

Objectives

A high prevalence of Coeliac Disease (CD) is found among patients with a clinical diagnosis of irritable bowel syndrome (IBS) compared to the general population. Symptoms of CD are quite similar to IBS, but its treatment is different. The aim of this study was to evaluate the cost-effectiveness of screening for CD in patients with diarrhoea/mixed type IBS (IBS-D/mix) in terms of cost per quality adjusted life year (QALY) in the Netherlands.

Methods

A decision model was constructed to evaluate the costs and health benefits of serological testing followed by confirmatory endoscopy with biopsy. Probabilistic sensitivity analysis (PSA) was performed to examine the effect of parameter uncertainty. Finally, the budget impact of implementing the screening process was also computed for implementation over a 10-year time horizon.

Results

Screening resulted in an increase of about 0.07 quality life years (QALYs) per patient over a lifetime horizon. The incremental cost effectiveness ratio was about 6,200 €/QALY compared to no screening. The PSA showed that the uncertainty in cost effectiveness results is not considerable. The value of information analysis confirmed the robustness of the results. Screening all current patients with diarrhea/mixed type IBS would require a total budget of about 25 million Euros over a 10 year time period.

Conclusion

Screening patients with IBS-D or IBS-mix for CD is almost certainly cost-effective. The screening program would improve the quality of life of those patients with IBS symptoms who actually have CD at a relatively low cost.  相似文献   

9.

Background

Prostate cancer remains a prevalent diagnosis with a spectrum of treatment choices that offer similar oncologic outcomes but differing side effect profiles and associated costs. As the technology for prostate radiation therapy has advanced, its associated costs have escalated, thus making cost-effectiveness analyses critical to assess the value of competing treatment options, including watchful waiting, surgery, brachytherapy, intensity-modulated radiation therapy (IMRT), 3D-conformal radiation therapy (3D-CRT), proton beam therapy (PBT), and stereotactic body radiation therapy (SBRT).

Objective

The aim of this systematic review was to identify articles that performed a cost-effectiveness analysis on different radiation treatment options for localized prostate cancer, summarize their findings, and highlight the main drivers of cost effectiveness.

Methods

A literature search was performed on two databases, PubMed and the Cost-Effectiveness Analysis Registry (https://research.tufts-nemc.org/cear4), using search terms that included ‘prostate’, ‘cost effectiveness prostate radiation’ and ‘cost analysis comparative effectiveness prostate radiation’. Studies were included in this review if the cost data were from 2002 or later, and outcomes reported both cost and effectiveness, preferably including a cost–utility analysis with the outcome of an incremental cost-effectiveness ratio with quality-adjusted life-year (QALY) as the effectiveness measure.

Results

There were 14 articles between 2003 and 2013 that discussed cost effectiveness of prostate radiotherapy in men over the age of 65. All but four of the papers were from the US; the others were from Canada and the UK. The majority of the papers used Markov decision analysis and estimated cost from a payer’s perspective, usually from Medicare reimbursement data. Assumptions for the model and utilities to calculate QALYs were estimated using published literature at the time of the analysis. Each analysis had a sensitivity analysis to compensate for the uncertainty of the model inputs. The main drivers of cost effectiveness were the cost of the radiation treatment and the differential QALYs accrued because of different treatment-related morbidities. Brachytherapy was consistently found to be more cost effective when compared with surgery and other radiation treatment options. IMRT was cost effective when compared with 3D-CRT. PBT was not found to be cost effective in any of the analyses, mostly due to the high costs of PBT. SBRT was the newest technology that was analyzed, and it was also found to be cost effective compared with IMRT and PBT.

Conclusions

Cost-effectiveness research of prostate radiation treatments allows patients, providers, and payers to better understand the true value of each treatment choice. Due to the variation in each of these analyses (e.g., costing, and disease and complication assumptions, etc.), it is difficult to generalize the results. One must be careful in drawing conclusions from these studies and extrapolating to individual patients, particularly with the clear utility dependence seen in the majority of these studies.  相似文献   

10.

Background

Inappropriate use of antidepressants (AD), defined as either continuation in the absence of a proper indication or continuation despite the lack of therapeutic efficacy, applies to approximately half of all long term AD users.

Methods/design

We have designed a cluster randomized controlled clinical trial to assess the (cost-) effectiveness of an antidepressant cessation advice in the absence of a proper indication for maintenance treatment with antidepressants in primary care. We will select all patients using antidepressants for over 9 months from 45 general practices. Patients will be diagnosed using the Composite International Diagnostic Interview (CIDI) version 3.0, extended with questions about the psychiatric history and previous treatment strategies. General practices will be randomized to either the intervention or the control group. In case of overtreatment, defined as the absence of a proper indication according to current guidelines, a cessation advice is given to the general practitioner. In the control groups no specific information is given. The primary outcome measure will be the proportion of patients that successfully discontinue their antidepressants at one-year follow-up. Secondary outcomes are dimensional measures of psychopathology and costs.

Discussion

This study protocol provides a detailed overview of the design of the trial. Study results will be of importance for refining current guidelines. If the intervention is effective it can be used in managed care programs.

Trial registration

NTR2032  相似文献   

11.

Background

Premenstrual syndrome (PMS) is reported to affect between 13% and 31% of women. Between 3% and 8% of women are reported to meet criteria for the more severe form of PMS, premenstrual dysphoric disorder (PMDD). Although PMDD has received increased attention in recent years, the cost effectiveness of treatments for PMDD remains unknown.

Objective

To evaluate the cost effectiveness of the four medications with a US FDA-approved indication for PMDD: fluoxetine, sertraline, paroxetine and drospirenone plus ethinyl estradiol (DRSP/EE).

Methods

A decision-analytic model was used to evaluate both direct costs (medication and physician visits) and clinical outcomes (treatment success, failure and discontinuation). Medication costs were based on average wholesale prices of branded products; physician visit costs were obtained from a claims database study of PMDD patients and the Agency for Healthcare Research and Quality. Clinical outcome probabilities were derived from published clinical trials in PMDD. The incremental cost-effectiveness ratio (ICER) was calculated using the difference in costs and percentage of successfully treated patients at 6 months. Deterministic and probabilistic sensitivity analyses were used to assess the impact of uncertainty in parameter estimates. Threshold values where a change in the cost-effective strategy occurred were identified using a net benefit framework.

Results

Starting therapy with DRSP/EE dominated both sertraline and paroxetine, but not fluoxetine. The estimated ICER of initiating treatment with fluoxetine relative to DRSP/EE was $US4385 per treatment success (year 2007 values). Cost-effectiveness acceptability curves revealed that for ceiling ratios ≥$US3450 per treatment success, fluoxetine had the highest probability (≥0.37) of being the most cost-effective treatment, relative to the other options. The cost-effectiveness acceptability frontier further indicated that DRSP/EE remained the option with the highest expected net monetary benefit for ceiling values ≤$US3900 per treatment success.

Conclusion

These analyses suggest that initiating therapy with DRSP/EE may be a cost-effective option in the treatment of PMDD.  相似文献   

12.

Purpose

To determine the cost effectiveness of lenalidomide plus dexamethasone (LEN/DEX) versus DEX alone in managing multiple myeloma (MM) patients who have failed one prior therapy.

Materials and Methods

An individual simulation model was designed to capture the costs and outcomes of LEN/DEX versus DEX therapy in relapsed refractory MM patients. MM009/010 efficacy data were adjusted for treatment cross-over and extrapolated to patient lifetime. Resource use for MM disease progression and adverse events were obtained from expert physicians and costed from the perspective of the National Health Service (England and UK) and included a patient access scheme for LEN. Utility values were obtained from published literature.

Results

The simulation model estimated an incremental improvement in time to progression of 9.5 months, an additional 3.2 life-years, and 2.2 quality adjusted life years (QALY) for LEN/DEX compared to DEX alone. Including the costs of therapy with the patient access scheme, adverse events, and disease follow-up, the incremental cost effectiveness ratio was £30,153/QALY for LEN/DEX compared to DEX alone in MM patients who have failed one prior therapy.

Conclusion

LEN/DEX is a cost effective oncology therapy from the perspective of the NHS for MM patients with one prior treatment.  相似文献   

13.

Background

A considerable proportion of patients with asthma remain uncontrolled or symptomatic despite treatment with a high dose of inhaled glucocorticosteroids (ICSs) and long-acting β2-agonists (LABAs). Tiotropium Respimat® added to usual care improves lung function, asthma control, and the frequency of non-severe and severe exacerbations, in a population of adult asthma patients who are uncontrolled despite treatment with ICS/LABA.

Objective

This study estimated the cost effectiveness of tiotropium therapy as add-on to usual care in asthma patients that are uncontrolled despite treatment with ICS/LABA combination from the perspective of the UK National Health Service (NHS).

Methods

A Markov model was developed which considers levels of asthma control and exacerbations. The model analysed cost and quality-adjusted life-years (QALYs); sensitivity and scenario analyses were also conducted to test the robustness of the base case outcomes. All costs are given at 2012 prices.

Results

The model found that in this category of asthma with unmet need, add-on tiotropium therapy generated an incremental 0.24 QALYs and £5,238 costs over a lifetime horizon, resulting in an incremental cost-effectiveness ratio of £21,906 per QALY gained. Sensitivity analysis suggested that findings were most dependent on the costs of managing uncontrolled asthma and the cost of treatment with tiotropium.

Conclusion

In this modelled analysis of two clinical trials, tiotropium was found to be cost effective when added to usual care in patients who remain uncontrolled despite treatment with high-dose ICS/LABA. Further research should investigate the long-term treatment effectiveness of tiotropium.  相似文献   

14.

Background

Bloodstream infections (BSI) occur in up to 350 000 inpatient admissions each year in the US, with BSI rates among patients receiving parenteral nutrition (PN) varying from 1.3% to 39%. BSI-attributable costs were estimated to approximate $US12000 per episode in 2000. While previous studies have compared the cost of different PN preparation methods, this analysis evaluates both the direct costs of PN and the treatment costs for BSI associated with different PN delivery methods to determine whether compounded or manufactured pre-mixed PN has lower overall costs.

Objective

The purpose of this study was to compare costs in the US associated with compounded PN versus pre-mixed multi-chamber bag (MCB) PN based on underlying infection risk.

Methods

Using claims information from the Premier Perspective? database, multivariate logistic regression was used to estimate the risk of infection. A total of 44 358 hospitalized patients aged ≥18 years who received PN between 1 January 2005 and 31 December 2007 were included in the analyses. A total of 3256 patients received MCB PN and 41 102 received compounded PN. The PN-associated costs and length of stay were analysed using multivariate ordinary least squares regression models constructed to measure the impact of infectious events on total hospital costs after controlling for baseline and clinical patient characteristics.

Results

There were 7.3 additional hospital days attributable to BSI. After adjustment for baseline variables, the probability of developing a BSI was 30% higher in patients receiving compounded PN than in those receiving MCB PN (16.1% vs 11.3%; odds ratio= 1.56; 95% CI 1.37, 1.79; p<0.0001), demonstrating 2172 potentially avoidable infections. The observed daily mean PN acquisition cost for patients receiving MCB PN was $US164 (including all additives and fees) compared with $US239 for patients receiving compounded PN (all differences p < 0.001). With a mean cost attributable to BSI of $US16 141, the total per-patient savings (including avoided BSI and PN costs) was $US1545.

Conclusion

In this analysis of real-world PN use, MCB PN is associated with lower costs than compounded PN with regards to both PN acquisition and potential avoidance of BSI. Our base case indicates that $US1545 per PN patient may be saved; even if as few as 50% of PN patients are candidates for standardized pre-mix formulations, a potential savings of $US773 per patient may be realized.  相似文献   

15.

Background

Patients with resistant hypertension are at a high risk for developing serious cardiovascular events and renal complications. Catheter-based renal denervation (RDN) is a procedure with the potential to normalize systolic blood pressure (SBP).

Objective

The overall objective of the study was to estimate the cost effectiveness of RDN in the UK for patients with diagnosed resistant hypertension, expressed as a standard cost per quality-adjusted life-year (QALY) ratio.

Methods

A patient lifetime, economic, Markov heath-state model was developed, linking expected changes in SBP to reductions in risks for cardiovascular events and renal complications, using the Framingham, PROCAM, and other published risk equations. The model was developed from the perspective of the healthcare payer in the UK using relevant cost data from 2012. Clinical effectiveness for RDN (a mean reduction of 32 mmHg in SBP) was taken from the phase III Symplicity HTN-2 trial, in patients with a mean baseline SBP of 178 mmHg. HTN-2 was the largest, multicenter randomized controlled trial on the effectiveness of RDN therapy at the time of the model development. A systematic review identified UK-specific sources for utility, mortality, and cost parameter values, and included recently published UK guidelines for the clinical management of hypertension.

Results

RDN therapy resulted in an increase in health benefit over a patient’s lifetime compared with anti-hypertensive pharmacological treatment alone (12.77 vs. 12.16 QALYs; discounted). Additional lifetime costs per patient were modeled at £2,961; equivalent to an incremental cost per additional QALY of £4,805. This result was robust to full probabilistic sensitivity and scenario analyses.

Conclusion

RDN is an effective clinical procedure that offers patients a meaningful and cost-effective alternative for achieving SBP control, where traditional combination, anti-hypertensive pharmacologic strategies have been proven to be ineffective.  相似文献   

16.

Background

Several treatment options are available for patients with type 2 diabetes mellitus who are making the transition from oral antidiabetes drugs (OADs) to insulin. Two options currently recommended by the Canadian Diabetes Association for initiating insulin therapy in patients with type 2 diabetes who are no longer responsive to OADs alone are insulin glargine plus OADs, and premixed insulin therapy only. Because of differences in efficacy, adverse events (such as hypoglycaemia) and acquisition costs, these two treatment options may lead to different long-term clinical and economic outcomes.

Objective

To determine the cost effectiveness of insulin glargine plus OADs compared with premixed insulin without OADs in insulin-naive patients with type 2 diabetes in Canada.

Methods

Using treatment effects taken from a published clinical trial, the validated IMS-CORE Diabetes Model was used to simulate the long-term cost effectiveness of insulin glargine with OADs, versus premixed insulin. Input treatment effects for the two therapeutic approaches were based on changes in glycosylated haemoglobin A1c (HbA1c) at clinical trial endpoint, and hypoglycaemia rates. The analysis was conducted from the perspective of the Canadian Provincial payer. Direct treatment and complication costs were obtained from published sources (primarily from Ontario) and reported in $Can, year 2008 values. All base-case costs and outcomes were discounted at 5% per year. Sensitivity analyses were conducted around key parameters and assumptions used in the study. Outcomes included direct medical costs associated with both treatment and diabetes-related complications. Cost-effectiveness outcomes included total average lifetime (35 years) costs, life expectancy (LE), QALYs and incremental cost-effectiveness ratios (ICERs).

Results

Base-case analyses showed that, compared with premixed insulin only, insulin glargine in combination with OADs was associated with a 0.051-year increase in LE and a 0.043 increase in QALYs. Insulin glargine plus OADs showed a very slight increase in total direct costs ($Can343 ± 2572), resulting in ICERs of $Can6750 per life-year gained (LYG) and $Can7923 per QALY gained. However, considerable uncertainty around the ICERs was demonstrated by insulin glargine having a 50% probability of being cost effective at a willingness-to-pay threshold of $Can10 000 per QALY, and a 54% probability at a $Can20 000 threshold. Base-case results were most sensitive to assumed disutilities for hypoglycaemic events, to the assumed effect of insulin glargine plus OADs on HbA1c, and to its assumed acquisition costs.

Conclusions

These findings should be interpreted within the context of a large degree of uncertainty and of several study limitations that include a single clinical trial as the source for primary treatment assumptions and a single province as the source for most cost inputs. Under current study assumptions and limitations, insulin glargine plus OADs was projected to be a cost-effective option, compared with premixed insulin only, for the treatment of insulin-naive patients with type 2 diabetes unresponsive to OADs. Additional work is needed to examine the generalizability of the findings to individual jurisdictions of the Canadian healthcare system.  相似文献   

17.

Background

Patients with gallbladder and common bile duct stones are generally treated by pre-operative endoscopic sphincterotomy (ES) followed by laparoscopic cholecystectomy (POES). Recently, a meta-analysis has shown that intra-operative ES during laparoscopic cholecystectomy (IOES) results in fewer complications than POES, with similar efficacy. The cost effectiveness of IOES versus POES is unknown.

Objective

The objective of this study was to compare the cost effectiveness of IOES versus POES from the UK NHS perspective.

Methods

A decision-tree model estimating and comparing costs to the UK NHS and QALYs gained following a policy of either IOES or POES was developed with a time horizon of 3 years. Uncertainty was investigated with probabilistic sensitivity analysis, and the expected value of perfect information (EVPI) and partial information (EVPPI) were also calculated.

Results

IOES was less costly than POES (approximately ???623 per patient [year 2008 values]) and resulted in similar quality of life (+0.008 QALYs per patient) as POES. Given a willingness-to-pay threshold of ??20 000 per QALY gained, there was a 92.9% probability that IOES is cost effective compared with POES. Full implementation of IOES could save the NHS ??2.8 million per annum. At a willingness to pay of ??20 000 per QALY gained, the 10-year population EVPI was estimated at ??0.6 million.

Conclusions

IOES appears to be cost effective compared with POES.  相似文献   

18.

Background

Antiplatelet therapy plays a central role in the prevention of atherothrombotic events. Both acetylsalicylic acid (aspirin) and Clopidogrel have been shown to reduce the risk of recurrent cardiovascular events in various subgroups of patients with vascular disease.

Objective

To estimate the cost effectiveness of clopidogrel versus aspirin in Sweden for the prevention of atherothrombotic events based on CAPRIE trial data. The focus of this study is on two high-risk subpopulations: (i) patients with pre-existing symptomatic atherosclerotic disease; and (ii) patients with polyvascular disease.

Methods

A Markov model combining clinical, epidemiological and cost data was used to assess the economic value of clopidogrel compared with aspirin during a patient’s lifetime. A societal perspective was used, with costs stated in Swedish kronor (SEK), year 2007 values. For the first 2 years, the clinical input for the model was based on the relevant subpopulations in the CAPRIE trial. Thereafter, transition probabilities were extrapolated, taking account of increased risks related to age and to a history of events. Cost effectiveness of 2 years of therapy is presented as cost per life-year gained (LYG) and as cost per QALY. Univariate and multivariate sensitivity analyses were performed to investigate robustness of results.

Results

For patients resembling the total CAPRIE population, who were treated with clopidogrel, the expected cost per LYG was SEK217 806 and the cost per QALY was estimated at SEK169 154. For the high-risk CAPRIE subpopulations, costs per QALY were lowest for patients with pre-existing symptomatic atherosclerotic disease (SEK38 153). Using a ‘willingness-to-pay’ perspective indicated that treatment with Clopidogrel instead of aspirin in high-risk patients is associated with a high probability for cost effectiveness; 81% using a threshold of SEK100 000 per QALY and 98% using a threshold of SEK500 000 per QALY. Overall, the results appeared to be robust over the sensitivity analyses performed.

Conclusion

When considering the cost-effectiveness categorization as proposed by the Swedish National Board of Health and Welfare, clopidogrel appears to be associated with costs per QALY that range from intermediate in the total CAPRIE population to low in high-risk atherosclerotic patients.  相似文献   

19.

Objective

The objective of this study was to conduct an economic evaluation to identify any differences in the expected costs and outcomes between patients treated with pulmonary artery catheters (PACs) and those without, in order to better inform healthcare decision makers.

Method

The evaluation was carried out alongside a clinical trial investigating the use of PACs in intensive care units (ICUs) in the UK. It was conducted from the perspective of the UK NHS, in which PACs are an established intervention. Treating patients without using a PAC was characterised as the new intervention. The primary outcome measure was QALYs. The secondary outcome measure was hospital mortality. NHS costs per patient were calculated for the financial year 2002/03. The bootstrap method was used to characterise the uncertainty of the results and to construct cost-effectiveness acceptability curves.

Results

The cost per QALY and per life gained from the withdrawal of PACs were £2892 and £21 164, respectively.

Conclusion

The results of this study indicate that withdrawal of PACs from routine clinical use in ICUs within the NHS would be considered cost effective in the current decision-making climate.  相似文献   

20.

Background

The aging of the population is likely to increase the number of osteoporosis-related fractures, such as hip fractures, and hence the economic burden for society. Therefore, strategies to identify women at increased risk are of major interest.

Objective

The aim of this study was to determine the cost effectiveness of preventive services for osteoporosis, comparing secondary plus tertiary prevention (SP/TP) versus tertiary prevention (TP) alone in post-menopausal women in Germany.

Methods

A cost-utility analysis and a budget-impact analysis were performed from the perspective of the German statutory health insurance (SHI). A Markov model simulated costs and benefits discounted at 3% over a lifetime horizon.

Results

Cost effectiveness of TP compared with no screening was ?69, ?77 and ?85 per QALY for women aged 60, 70 and 80 years, respectively (year 2010 values). In women aged 50 years, TP dominated no prevention. Cost effectiveness of SP/TP compared with TP was ?543, ?9 791, ?670 and ?368 for women aged 50, 60, 70 and 80 years, respectively. SP/TP resulted in additional costs of ?09 million or 0.10% of the SHI’s annual budget (TP alone = ? million).

Conclusion

Compared with TP, a strategy based on SP/TP appears to be more expensive but more effective in each age group. Given that cost effectiveness seems acceptable, allocation of resources to SP/TP to decrease post-menopausal osteoporotic fracture risk may be justified.  相似文献   

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