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1.  Do economic evaluation studies inform effective healthcare resource allocation in Iran? A critical review of the literature 
To aid informed health sector decision-making, data from sufficient high quality economic evaluations must be available to policy makers. To date, no known study has analysed the quantity and quality of available Iranian economic evaluation studies. This study aimed to assess the quantity, quality and targeting of economic evaluation studies conducted in the Iranian context.
The study systematically reviewed full economic evaluation studies (n = 30) published between 1999 and 2012 in international and local journals. The findings of the review indicate that although the literature on economic evaluation in Iran is growing, these evaluations were of poor quality and suffer from several major methodological flaws. Furthermore, the review reveals that economic evaluation studies have not addressed the major health problems in Iran.
While the availability of evidence is no guarantee that it will be used to aid decision-making, the absence of evidence will certainly preclude its use. Considering the deficiencies in the data identified by this review, current economic evaluations cannot be a useful source of information for decision makers in Iran. To improve the quality and overall usefulness of economic evaluations we would recommend; 1) developing clear national guidelines for the conduct of economic evaluations, 2) highlighting priority areas where information from such studies would be most useful and 3) training researchers and policy makers in the calculation and use of economic evaluation data.
doi:10.1186/1478-7547-12-15
PMCID: PMC4105166  PMID: 25050084
Economic evaluation; Pharmacoeconomics; Review; Iran
2.  Incremental cost of increasing access to maternal health care services: perspectives from a demand and supply side intervention in Eastern Uganda 
Introduction
High maternal and infant mortality continue to be major challenges to the attainment of the Millennium Development Goals for many low and middle-income countries. There is now evidence that voucher initiatives can increase access to maternal health services. However, a dearth of knowledge exists on the cost implications of voucher schemes. This paper estimates the incremental costs of a demand and supply side intervention aimed at increasing access to maternal health care services.
Methods
This costing study was part of a quasi-experimental voucher study conducted in two districts in Eastern Uganda to explore the impact of demand and supply - side incentives on increasing access to maternal health services. The provider’s perspective was used and the ingredients approach to costing was employed. Costs were based on market prices as recorded in program records. Total, unit, and incremental costs were calculated.
Results
The estimated total financial cost of the intervention for the one year of implementation was US$525,472 (US$1 = 2200UgShs). The major cost drivers included costs for transport vouchers (35.3%), health system strengthening (29.2%) and vouchers for maternal health services (18.2%). The average cost of transport per woman to and from the health facility was US$4.6. The total incremental costs incurred on deliveries (excluding caesarean section) was US$317,157 and US$107,890 for post natal care (PNC). The incremental costs per additional delivery and PNC attendance were US$23.9 and US$7.6 respectively.
Conclusion
Subsidizing maternal health care costs through demand and supply – side initiatives may not require significant amounts of resources contrary to what would be expected. With Uganda’s Gross Domestic Product (GDP) per capita of US$55` (2012), the incremental cost per additional delivery (US$23.9) represents about 5% of GDP per capita to save a mother and probably her new born. For many low income countries, this may not be affordable, yet reliance on donor funding is often not sustainable. Alternative ways of raising additional resources for health must be explored. These include; encouraging private investments in critical sectors such as rural transport, health service provision; mobilizing households to save financial resources for preparedness, and financial targeting for the most vulnerable.
doi:10.1186/1478-7547-12-14
PMCID: PMC4074383  PMID: 24976793
Vouchers; Maternal health; Costs; Sustainability; Demand-side; Supply-side
3.  Multi-criteria decision analysis of breast cancer control in low- and middle- income countries: development of a rating tool for policy makers 
Background
The objective of this study was to develop a rating tool for policy makers to prioritize breast cancer interventions in low- and middle- income countries (LMICs), based on a simple multi-criteria decision analysis (MCDA) approach. The definition and identification of criteria play a key role in MCDA, and our rating tool could be used as part of a broader priority setting exercise in a local setting. This tool may contribute to a more transparent priority-setting process and fairer decision-making in future breast cancer policy development.
Methods
First, an expert panel (n = 5) discussed key considerations for tool development. A literature review followed to inventory all relevant criteria and construct an initial set of criteria. A Delphi study was then performed and questionnaires used to discuss a final list of criteria with clear definitions and potential scoring scales. For this Delphi study, multiple breast cancer policy and priority-setting experts from different LMICs were selected and invited by the World Health Organization. Fifteen international experts participated in all three Delphi rounds to assess and evaluate each criterion.
Results
This study resulted in a preliminary rating tool for assessing breast cancer interventions in LMICs. The tool consists of 10 carefully crafted criteria (effectiveness, quality of the evidence, magnitude of individual health impact, acceptability, cost-effectiveness, technical complexity, affordability, safety, geographical coverage, and accessibility), with clear definitions and potential scoring scales.
Conclusions
This study describes the development of a rating tool to assess breast cancer interventions in LMICs. Our tool can offer supporting knowledge for the use or development of rating tools as part of a broader (MCDA based) priority setting exercise in local settings. Further steps for improving the tool are proposed and should lead to its useful adoption in LMICs.
doi:10.1186/1478-7547-12-13
PMCID: PMC4031156  PMID: 24855456
Multi-criteria decision analysis; Priority setting; Breast cancer
4.  A pilot study to assess feasibility of value based pricing in Cyprus through pharmacoeconomic modelling and assessment of its operational framework: sorafenib for second line renal cell cancer 
Background
The continuing increase of pharmaceutical expenditure calls for new approaches to pricing and reimbursement of pharmaceuticals. Value based pricing of pharmaceuticals is emerging as a useful tool and possess theoretical attributes to help health system cope with rising pharmaceutical expenditure.
Aim
To assess the feasibility of introducing a value-based pricing scheme of pharmaceuticals in Cyprus and explore the integrative framework.
Methods
A probabilistic Markov chain Monte Carlo model was created to simulate progression of advanced renal cell cancer for comparison of sorafenib to standard best supportive care. Literature review was performed and efficacy data were transferred from a published landmark trial, while official pricelists and clinical guidelines from Cyprus Ministry of Health were utilised for cost calculation. Based on proposed willingness to pay threshold the maximum price of sorafenib for the indication of second line renal cell cancer was assessed.
Results
Sorafenib value based price was found to be significantly lower compared to its current reference price.
Conclusion
Feasibility of Value Based Pricing is documented and pharmacoeconomic modelling can lead to robust results. Integration of value and affordability in the price are its main advantages which have to be weighed against lack of documentation for several theoretical parameters that influence outcome. Smaller countries such as Cyprus may experience adversities in establishing and sustaining essential structures for this scheme.
doi:10.1186/1478-7547-12-12
PMCID: PMC4029980  PMID: 24910539
JEL 110; JEL 130; JEL 300; Value based pricing; Pharmacoeconomic modelling; Sorafenib; Markov Model
5.  Cost-effectiveness of community vegetable gardens for people living with HIV in Zimbabwe 
Background
There is little evidence to date of the potential impact of vegetable gardens on people living with HIV (PLHIV), who often suffer from social and economic losses due to the disease. From 2008 through 2011, Action Contre la Faim France (ACF) implemented a project in Chipinge District, eastern Zimbabwe, providing low-input vegetable gardens (LIGs) to households of PLHIV. Program partners included Médecins du Monde, which provided medical support, and Zimbabwe's Agricultural Extension Service, which supported vegetable cultivation. A survey conducted at the end of the program found LIG participants to have higher Food Consumption Scores (FCS) and Household Dietary Diversity Scores (HDDS) relative to comparator households of PLHIV receiving other support programs. This study assessed the incremental cost-effectiveness of LIGs to improve FCS and HDDS of PLHIV compared to other support programs.
Methods
This analysis used an activity-based cost model, and combined ACF accounting data with estimates of partner and beneficiary costs derived using an ingredients approach to build an estimate of total program resource use. A societal perspective was adopted to encompass costs to beneficiary households, including their opportunity costs and an estimate of their income earned from vegetable sales. Qualitative methods were used to assess program benefits to beneficiary households. Effectiveness data was taken from a previously-conducted survey.
Results
Providing LIGs to PLHIV cost an additional 8,299 EUR per household with adequate FCS and 12,456 EUR per household with HDDS in the upper tertile, relative to comparator households of PLHIV receiving other support programs. Beneficiaries cited multiple tangible and intangible benefits from LIGs, and over 80% of gardens observed were still functioning more than one year after the program had finished.
Conclusions
Cost outcomes were 20–30 times Zimbabwe's per capita GDP, and unlikely to be affordable within government services. This analysis concludes that LIGs are not cost-effective or affordable relative to other interventions for improving health and nutrition status of PLHIV. Nonetheless, given the myriad benefits acquired by participant households, such programs hold important potential to improve quality of life and reduce stigma against PLHIV.
doi:10.1186/1478-7547-12-11
PMCID: PMC4022439  PMID: 24834014
Vegetable gardens; Livelihoods; People living with HIV; Food consumption score; Household dietary diversity score; Cost-effectiveness; Societal costs; Mixed methods; Activity-based cost analysis; Zimbabwe
6.  Estimating the cost-effectiveness of nutrition supplementation for malnourished, HIV-infected adults starting antiretroviral therapy in a resource-constrained setting 
Background
Low body mass index (BMI) individuals starting antiretroviral therapy (ART) for HIV infection in sub-Saharan Africa have high rates of death and loss to follow-up in the first 6 months of treatment. Nutritional supplementation may improve health outcomes in this population, but the anticipated benefit of any intervention should be commensurate with the cost given resource limitations and the need to expand access to ART in the region.
Methods
We used Markov models incorporating historical data and program-wide estimates of treatment costs and health benefits from the Zambian national ART program to estimate the improvements in 6-month survival and program retention among malnourished adults necessary for a combined nutrition support and ART treatment program to maintain cost-effectiveness parity with ART treatment alone. Patients were stratified according to World Health Organization criteria for severe (BMI <16.0 kg/m2), moderate (16.00-16.99 kg/m2), and mild (17.00-18.49 kg/m2) malnutrition categories.
Results
19,247 patients contributed data between May 2004 and October 2010. Quarterly survival and retention were lowest in the BMI <16.0 kg/m2 category compared to higher BMI levels, and there was less variation in both measures across BMI strata after 180 days. ART treatment was estimated to cost $556 per year and averted 7.3 disability-adjusted life years. To maintain cost-effectiveness parity with ART alone, a supplement needed to cost $10.99 per quarter and confer a 20% reduction in both 6-month mortality and loss to follow-up among BMI <16.0 kg/m2 patients. Among BMI 17.00-18.49 kg/m2 patients, supplement costs accompanying a 20% reduction in mortality and loss to follow-up could not exceed $5.18 per quarter. In sensitivity analyses, the maximum permitted supplement cost increased if the ART program cost rose, and fell if patients classified as lost to follow-up at 6 months subsequently returned to care.
Conclusions
Low BMI adults starting ART in sub-Saharan Africa are at high risk of early mortality and loss to follow-up. The expense of providing nutrition supplementation would require only modest improvements in survival and program retention to be cost-effective for the most severely malnourished individuals starting ART, but interventions are unlikely to be cost-effective among those in higher BMI strata.
doi:10.1186/1478-7547-12-10
PMCID: PMC4024113  PMID: 24839400
HIV; Antiretroviral therapy; Nutrition; Malnutrition; Zambia; Africa
7.  The impact of incorporating Bayesian network meta-analysis in cost-effectiveness analysis - a case study of pharmacotherapies for moderate to severe COPD 
Objective
To evaluate the impact of using network meta-analysis (NMA) versus pair wise meta-analyses (PMA) for evidence synthesis on key outputs of cost-effectiveness analysis (CEA).
Methods
We conducted Bayesian NMA of randomized clinical trials providing head-to-head and placebo comparisons of the effect of pharmacotherapies on the exacerbation rate in chronic obstructive pulmonary disease (COPD). Separately, the subset of placebo–comparison trials was used in a Bayesian PMA. The pooled rate ratios (RR) were used to populate a decision-analytic model of COPD treatment to predict 10-year outcomes.
Results
Efficacy estimates from the NMA and PMA were similar, but the NMA provided estimates with higher precision. This resulted in similar incremental cost-effectiveness ratios (ICER). Probabilities of being cost-effective at willingness-to-pay thresholds (WTPs) between $25,000 and $100,000 per quality adjusted life year (QALY) varied considerably between the PMA- and NMA-based approaches. The largest difference in the probabilities of being cost-effective was observed at a WTP of approximately $40,000/QALY. At this threshold, with the PMA-based analysis, ICS, LAMA and placebo had a 43%, 30, and 18% probability of being the most cost-effective. By contrast, with the NMA based approach, ICS, LAMA, and placebo had a 56%, 19%, and 21% probability of being cost-effective. For larger WTP thresholds the probability of LAMA being the most cost-effective became higher than that of ICS. Under the PMA-based analyses the cross-over occurred at a WTP threshold between $60,000/QALY-$65,000/QALY, whereas under the NMA-based approach, the cross-over occurred between $85,000/QALY-$90,000/QALY.
Conclusion
Use of NMAs in CEAs is feasible and, as our case study showed, can decrease uncertainty around key cost-effectiveness measures compared with the use of PMAs. The approval process of health technologies in many jurisdictions requires estimates of comparative efficacy and cost-effectiveness. NMAs play an increasingly important role in providing estimates of comparative efficacy. Their use in the CEAs therefore results in methodological consistency and reduced uncertainty.
doi:10.1186/1478-7547-12-8
PMCID: PMC4007707  PMID: 24625208
Meta-analysis; Multiple treatment comparison; Bayesian analysis; Cost-effectiveness
8.  Economic evaluation of policy initiatives in the organisation and delivery of healthcare: a case study of gastroenterology endoscopy services 
Background
Complex clinical interventions are increasingly subject to evaluation by randomised trial linked to economic evaluation. However evaluations of policy initiatives tend to eschew experimental designs in favour of interpretative perspectives which rarely allow the economic evaluation methods used in clinical trials. As evidence of the cost effectiveness of such initiatives is critical in informing policy, it is important to explore whether conventional economic evaluation methods apply to experimental evaluations of policy initiatives.
Methods
We used mixed methods based on a quasi-experimental design to evaluate a policy initiative whose aim was to expedite the modernisation of gastroenterology endoscopy services in England. We compared 10 sites which had received funding and support to modernise their endoscopy services with 10 controls. We collected data from five waves of patients undergoing endoscopy. The economic component of the study compared sites by levels of investment in modernisation and patients’ use of health service resources, time off work and health related quality of life.
Results
We found no statistically significant difference between intervention and control sites in investment in modernisation or any patient outcome including health.
Conclusions
This study highlights difficulties in applying the rigour of a randomised trial and associated technique of economic evaluation to a policy initiative. It nevertheless demonstrates the feasibility of using this approach although further work is needed to demonstrate its generalisability in other applications. The present application shows that the small incentives offered to intervention sites did not enhance modernisation of gastroenterology endoscopy services or improve patient outcomes.
doi:10.1186/1478-7547-12-7
PMCID: PMC3945072  PMID: 24597703
Cost effectiveness; Evaluation; Health policy; Modernisation; Endoscopy; Cost
9.  Cost-effectiveness of eye care services in Zambia 
Objective
To estimate the cost-effectiveness of cataract surgery and refractive error/presbyopia correction in Zambia.
Methods
Primary data on costs and health related quality of life were collected in a prospective cohort study of 170 cataract and 113 refractive error/presbyopia patients recruited from three health facilities. Six months later, follow-up data were available from 77 and 41 patients who had received cataract surgery and spectacles, respectively. Costs were determined from patient interviews and micro-costing at the three health facilities. Utility values were gathered by administering the EQ-5D quality of life instrument immediately before and six months after cataract surgery or acquiring spectacles. A probabilistic state-transition model was used to generate cost-effectiveness estimates with uncertainty ranges.
Results
Utility values significantly improved across the patient sample after cataract surgery and acquiring spectacles. Incremental costs per Quality Adjusted Life Years gained were US$ 259 for cataract surgery and US$ 375 for refractive error correction. The probabilities of the incremental cost-effectiveness ratios being below the Zambian gross national income per capita were 95% for both cataract surgery and refractive error correction.
Conclusion
In spite of proven cost-effectiveness, severe health system constraints are likely to hamper scaling up of the interventions.
doi:10.1186/1478-7547-12-6
PMCID: PMC3944959  PMID: 24568593
Costs; Cataract; Refractive error; Presbyopia; Quality of life
10.  Economic evaluation of rivaroxaban in stroke prevention for patients with atrial fibrillation in Greece 
Background
To undertake an economic evaluation of rivaroxaban relative to the standard of care for stroke prevention in patients with non-valvular atrial fibrillation (AF) in Greece.
Methods
An existing Markov model designed to reflect the natural progression of AF patients through different health states, in the course of three month cycles, was adapted to the Greek setting. The analysis was undertaken from a payer perspective. Baseline event rates and efficacy data were obtained from the ROCKET-AF trial for rivaroxaban and vitamin-K-antagonists (VKAs). Utility values for events were based on literature. A treatment-related disutility of 0.05 was applied to the VKA arm. Costs assigned to each health state reflect the year 2013. An incremental cost effectiveness ratio (ICER) was calculated where the outcome was quality-adjusted-life year (QALY) and life-years gained. Probabilistic analysis was undertaken to deal with uncertainty. The horizon of analysis was over patient life time and both cost and outcomes were discounted at 3.5%.
Results
Based on safety-on-treatment data, rivaroxaban was associated with a 0.22 increment in QALYs compared to VKA. The average total lifetime cost of rivaroxaban-treated patients was €239 lower compared to VKA. Rivaroxaban was associated with additional drug acquisition cost (€4,033) and reduced monitoring cost (-€3,929). Therefore, rivaroxaban was a dominant alternative over VKA. Probabilistic analysis revealed that there is a 100% probability of rivaroxaban being cost-effective versus VKA at a willingness to pay threshold of €30,000/QALY gained.
Conclusion
Rivaroxaban may represent for payers a dominant option for the prevention of thromboembolic events in moderate to high risk AF patients in Greece.
doi:10.1186/1478-7547-12-5
PMCID: PMC3942277  PMID: 24512351
Cost-effectiveness; Vitamin-K-antagonists; Cost-utility
11.  Cost-effectiveness of a universal strategy of brief dietary intervention for primary prevention in primary care: population-based cohort study and Markov model 
Background
A healthy diet is associated with reduced risk of diabetes, cardiovascular disease and cancer. The study aimed to evaluate the cost-effectiveness of a universal strategy to promote healthy diet through brief intervention in primary care.
Methods
The research was informed by a systematic review of randomised trials which found that brief interventions in primary care may be associated with a 0.5 portion per day increase in fruit and vegetable consumption. A Markov model that included five long-term conditions (diabetes, coronary heart disease, stroke, colorectal cancer and depression) was developed. Empirical data from a large cohort of United Kingdom-based participants sampled from the Clinical Practice Research Datalink populated the model. Simulations compared an intervention promoting healthy diet over 5 years in healthy adults, and standard care in which there was no intervention. The annual cost of intervention, in the base case, was one family practice consultation per participant year. Health service costs were included and the model adopted a lifetime perspective. The primary outcome was net health benefit in quality adjusted life years (QALYs).
Results
A cohort of 262,704 healthy participants entered the model. Intervention was associated with an increase in life years lived free from physical disease of 41.9 (95% confidence interval -17.4 to 101.0) per 1,000 participants entering the model (probability of increase 88.0%). New incidences of disease states were reduced by 28.4 (18.7 to 75.8) per 1,000, probability reduced 84.6%. Discounted incremental QALYs were 4.3 (-8.8 to 18.0) per 1,000, while incremental costs were £139,755 (£60,466 to 220,059) per 1,000. Net health benefits at £30,000 per QALY were -0.32 (-13.8 to 13.5) QALYs per 1,000 participants (probability cost-effective 47.9%). When the intervention was restricted to adults aged 50 to 74 years, net health benefits were 2.94 (-21.3 to 26.4) QALYs per 1000, probability increased 59.0%.
Conclusions
A universal strategy to promote healthy diet through brief intervention in primary care is unlikely to be cost-effective, even when delivered at low unit cost. A targeted strategy aimed at older individuals at higher risk of disease might be more cost-effective. More effective dietary change interventions are needed.
doi:10.1186/1478-7547-12-4
PMCID: PMC4015683  PMID: 24485221
Dietary intervention; Primary care; Markov model; Cost effectiveness; Outcomes; Diabetes; Coronary heart disease; Stroke; Colorectal cancer; Depression
12.  Budget constraint and vaccine dosing: a mathematical modelling exercise 
Background
Increasing the number of vaccine doses may potentially improve overall efficacy. Decision-makers need information about choosing the most efficient dose schedule to maximise the total health gain of a population when operating under a constrained budget. The objective of this study is to identify the most efficient vaccine dosing schedule within a fixed vaccination budget from a healthcare payer perspective.
Methods
An optimisation model is developed in which maximizing the disease reduction is the functional objective and the constraint is the vaccination budget. The model allows variation in vaccination dosing numbers, in cost difference per dose, in vaccine coverage rate, and in vaccine efficacy. We apply the model using the monovalent rotavirus vaccine as an example.
Results
With a fixed budget, a 2-dose schedule for vaccination against rotavirus infection with the monovalent vaccine results in a larger reduction in disease episodes than a 3-dose scheme with the same vaccine under most circumstances. A 3-dose schedule would only be better under certain conditions: a cost reduction of >26% per dose, combined with vaccine efficacy improvement of ≥5% and a target coverage rate of 75%. Substantial interaction is observed between cost reduction per dose, vaccine coverage rate, and increased vaccine efficacy. Sensitivity analysis shows that the conditions required for a 3-dose strategy to be better than a 2-dose strategy may seldom occur when the budget is fixed. The model does not consider vaccine herd effect, precise timing for additional doses, or the effect of natural immunity development.
Conclusions
Under budget constraint, optimisation modelling is a helpful tool for a decision-maker selecting the most efficient vaccination dosing schedule. The low dosing scheme could be the optimal option to consider under the many scenarios tested. The model can be applied under many different circumstances of changing dosing schemes with single or multiple vaccines.
doi:10.1186/1478-7547-12-3
PMCID: PMC3904011  PMID: 24450591
Rotavirus; Vaccination; Economic evaluation; Budget optimisation modelling
13.  Lifetime QALY prioritarianism in priority setting: quantification of the inherent trade-off 
Background
Multiple principles are relevant in priority setting, two of which are often considered particularly important. According to the greater benefit principle, resources should be directed toward the intervention with the greater health benefit. This principle is intimately linked to the goal of health maximization and standard cost-effectiveness analysis (CEA). According to the worse off principle, resources should be directed toward the intervention benefiting those initially worse off. This principle is often linked to an idea of equity. Together, the two principles accord with prioritarianism; a view which can motivate non-standard CEA. Crucial for the actual application of prioritarianism is the trade-off between the two principles, and this trade-off has received scant attention when the worse off are specified in terms of lifetime health. This paper sheds light on that specific trade-off and on the public support for prioritarianism by providing fresh empirical evidence and by clarifying the close links between the findings and normative theory.
Methods
A new, self-administered, computer-based questionnaire was used, to which 96 students in Norway responded. How respondents wanted to balance quality-adjusted life years (QALYs) gained against benefiting those with few lifetime QALYs was quantified for a range of different cases.
Results
Respondents supported both principles and were willing to make trade-offs in a particular way. In the baseline case, the median response valued a QALY 3.3 and 2.5 times more when benefiting someone with lifetime QALYs of 10 and 25 rather than 70. Average responses harbored fundamental disagreements and varied modestly across distributional settings.
Conclusion
In the specific context of lifetime health, the findings underscore the insufficiency of pure QALY maximization and explicate how people make trade-offs in a way that can help operationalize lifetime prioritarianism and non-standard CEA. Seen through the lens of normative theory, the findings highlight key challenges for prioritarianism applied to priority setting.
doi:10.1186/1478-7547-12-2
PMCID: PMC3896665  PMID: 24418267
Priority setting; Prioritarianism; Cost-effectiveness; Equity weights; Quality-adjusted life years; Political philosophy; Empirical ethics
14.  Cost-effectiveness of changes in alcohol taxation in Denmark: a modelling study 
Introduction
Excessive alcohol consumption is a public health problem in many countries including Denmark, where 6% of the burden of disease is due to alcohol consumption, according to the new estimates from the Global Burden of Disease 2010 study. Pricing policies, including tax increases, have been shown to effectively decrease the level of alcohol consumption.
Methods
We analysed the cost-effectiveness of three different scenarios of changed taxation of alcoholic beverages in Denmark (20% and 100% increase and 10% decrease). The lifetime health effects are estimated as the difference in disability-adjusted life years between a Danish population that continues to drink alcohol at current rates and an identical population that changes their alcohol consumption due to changes in taxation. Calculation of cost offsets related to treatment of alcohol-related diseases and injuries, was based on health care system costs from Danish national registers. Cost-effectiveness was evaluated by calculating cost-effectiveness ratios (CERs) compared to current practice.
Results
The two scenarios of 20% and 100% increased taxation could avert 20,000 DALY and 95,500 DALY respectively, and yield cost savings of -€119 million and -€575 million, over the life time of the Danish population. Both scenarios are thus cost saving. The tax decrease scenario would lead to 10,100 added DALY and an added cost of €60 million. For all three interventions the health effects build up and reach their maximum around 15–20 years after implementation of the tax change.
Conclusion
Our results show that decreased taxation will lead to an increased burden of disease and related increases in health care costs, whereas both a doubling of the current level of alcohol taxation and a scenario where taxation is only increased by 20% can be cost-saving ways to reduce alcohol related morbidity and mortality. Our results support the growing evidence that population strategies are cost-effective and should be considered for policy making and prevention of alcohol abuse.
doi:10.1186/1478-7547-12-1
PMCID: PMC3914680  PMID: 24405884
Cost-effectiveness; Taxation; Alcohol; Public health; Health effects; Health care costs; Simulation modelling
15.  Surrogate outcomes: experiences at the Common Drug Review 
Background
Surrogate outcomes are a significant challenge in drug evaluation for health technology assessment (HTA) agencies. The research objectives were to: identify factors associated with surrogate use and acceptability in Canada’s Common Drug Review (CDR) recommendations, and compare the CDR with other HTA or regulatory agencies regarding surrogate concerns.
Methods
Final recommendations were identified from CDR inception (September 2003) to December 31, 2010. Recommendations were classified by type of outcome (surrogate, final, other) and acceptability of surrogates (determined by the presence/absence of statements of concern regarding surrogates). Descriptive and statistical analyses examined factors related to surrogate use and acceptability. For thirteen surrogate-based submissions, recommendations from international HTA and regulatory agencies were reviewed for statements about surrogate acceptability.
Results
Of 156 final recommendations, 68 (44%) involved surrogates. The overall ‘do not list’ (DNL) rate was 48%; the DNL rate for surrogates was 41% (p = 0.175). The DNL rate was 64% for non-accepted surrogates (n = 28) versus 25% for accepted surrogates (odds ratio 5.4, p = 0.002). Clinical uncertainty, use of economic evidence over price alone, and a premium price were significantly associated with non-accepted surrogates. Surrogates were used most commonly for HIV, diabetes, rare diseases, cardiovascular disease and cancer. For the subset of drugs studied, other HTA agencies did not express concerns for most recommendations, while regulatory agencies frequently stated surrogate acceptance.
Conclusions
The majority of surrogates were accepted at the CDR. Non-accepted surrogates were significantly associated with clinical uncertainty and a DNL recommendation. There was inconsistency of surrogate acceptability across several international agencies. Stakeholders should consider collaboratively establishing guidelines on the use, validation, and acceptability of surrogates.
doi:10.1186/1478-7547-11-31
PMCID: PMC3866929  PMID: 24341379
Reimbursement; Decision-making; Surrogate outcomes; Health technology assessment
16.  Marginal costing methods highlight the contributing cost of comorbid conditions in Medicare patients: a quasi-experimental case–control study of ischemic stroke costs 
Background
Cost of illness studies are needed to provide estimates for input into cost-effectiveness studies and as information drivers to resource allocation. However, these studies often do not differentiate costs associated with the disease of interest and costs of co-morbidities. The goal of this study was to identify the 1-year cost of ischemic stroke compared to the annual cost of care for a comparable non-stroke group of South Carolina (SC) Medicare beneficiaries resulting in a marginal cost estimate.
Methods
SC data for 2004 and 2005 were used to estimate the mean 12 month cost of stroke for 2,976 Medicare beneficiaries hospitalized for Ischemic Stroke in 2004. Using nearest neighbor propensity score matching, a control group of non-stroke beneficiaries were matched on age, gender, race, risk factors, and Charlson comorbidity index and their costs were calculated. Marginal cost attributable to ischemic stroke was calculated as the difference between these two adjusted cost estimates.
Results
The total cost estimated for SC stroke patients for 1 year (2004) was $81.3 million. The cost for the matched comparison group without stroke was $54.4 million. Thus, the 2004 marginal costs to Medicare due to Ischemic stroke in SC are estimated to be $26.9 million.
Conclusions
Accurate estimates of cost of care for conditions, such as stroke, that are common in older patients with a high rate of comorbid conditions require the use of a marginal costing approach. Over estimation of cost of care for stroke may lead to prediction of larger savings than realizable from important stroke treatment and prevention programs, which may damage the credibility of program advocates, and jeopardize long term funding support. Additionally, correct cost estimates are needed as inputs for valid cost-effectiveness studies. Thus, it is important to use marginal costing for stroke, especially with the increasing public focus on evidence-based economic decision making to be expected with healthcare reform.
doi:10.1186/1478-7547-11-29
PMCID: PMC3842820  PMID: 24238629
Marginal cost; Attributable cost; Methods; Rehabilitation; Ischemic stroke
17.  Cost of behavior change communication channels of Manoshi -a maternal, neonatal and child health (MNCH) program in urban slums of Dhaka, Bangladesh 
Background
The cost of behavior change communication (BCC) interventions has not been rigorously studied in Bangladesh. This study was conducted to assess the implementation costs of a BCC intervention in a maternal, neonatal and child health program (Manoshi) run by BRAC, which has been operating in the urban slums of Dhaka since 2007. The study estimates the costs of BCC tools per exposure among the different types of BCC channels: face-to-face, group counseling, and mass media.
Methods
The study was conducted from November 2010 to April 2011 in the Dhaka urban slum area. A micro-costing approach was applied using primary and secondary data sources to estimate the cost of BCC tools. Primary data were collected through interviews with service-providers and managers from the Manoshi program, observations of group counseling, and mass media events.
Results
Per exposure, the cost of face-to-face counseling was found to be 3.08 BDT during pregnancy detection, 3.11 BDT during pregnancy confirmation, 12.42 BDT during antenatal care, 18.96 BDT during delivery care and 22.65 BDT during post-natal care. The cost per exposure of group counseling was 22.71 BDT (95% CI 21.30-24.87) for Expected Date of Delivery (EDD) meetings, 14.25 BDT (95% CI 12.37-16.12) for Women Support Group meetings, 17.83 BDT (95% CI 14.90-20.77) for MNCH committee meetings and 6.62 BDT (95% CI 5.99-7.26) for spouse forum meetings. We found the cost per exposure for mass media interventions was 9.54 BDT (95% CI 7.30-12.53) for folk songs, 26.39 BDT (95% CI 23.26-32.56) for street dramas, 0.39 BDT for TV-broadcasting and 7.87 BDT for billboards. Considering all components reaching the target audience under each broader type of channel, the total cost per exposure was found to be 60.22 BDT (0.82 USD) for face-to-face counseling, 61.40 BDT (0.82 USD) for group counseling and 44.19 BDT (0.61 USD) for mass media.
Conclusions
The total cost for group counseling was the highest per exposure, followed by face-to-face counseling and mass media. The cost per exposure varied substantially across BCC channels due to differences in cost drivers such as personnel, materials and refreshments. The cost per exposure can be valuable for planning and resource allocation related to the implementation of BCC interventions in low resource settings.
doi:10.1186/1478-7547-11-28
PMCID: PMC3831249  PMID: 24228844
Cost; BCC; MNCH-intervention; Micro-costing; Urban-Slum; Dhaka-Bangladesh
18.  Balancing efficiency, equity and feasibility of HIV treatment in South Africa – development of programmatic guidance 
South Africa, the country with the largest HIV epidemic worldwide, has been scaling up treatment since 2003 and is rapidly expanding its eligibility criteria. The HIV treatment programme has achieved significant results, and had 1.8 million people on treatment per 2011. Despite these achievements, it is now facing major concerns regarding (i) efficiency: alternative treatment policies may save more lives for the same budget; (ii) equity: there are large inequalities in who receives treatment; (iii) feasibility: still only 52% of the eligible population receives treatment.
Hence, decisions on the design of the present HIV treatment programme in South Africa can be considered suboptimal. We argue there are two fundamental reasons to this. First, while there is a rapidly growing evidence-base to guide priority setting decisions on HIV treatment, its included studies typically consider only one criterion at a time and thus fail to capture the broad range of values that stakeholders have. Second, priority setting on HIV treatment is a highly political process but it seems no adequate participatory processes are in place to incorporate stakeholders’ views and evidences of all sorts.
We propose an alternative approach that provides a better evidence base and outlines a fair policy process to improve priority setting in HIV treatment. The approach integrates two increasingly important frameworks on health care priority setting: accountability for reasonableness (A4R) to foster procedural fairness, and multi-criteria decision analysis (MCDA) to construct an evidence-base on the feasibility, efficiency, and equity of programme options including trade-offs. The approach provides programmatic guidance on the choice of treatment strategies at various decisions levels based on a sound conceptual framework, and holds large potential to improve HIV priority setting in South Africa.
doi:10.1186/1478-7547-11-26
PMCID: PMC3851565  PMID: 24107435
Antiretroviral therapy; Technology assessment; Program evaluation; Cost-effectiveness; Ethics
19.  Cost-effectiveness analysis of treatment with peginterferon-alfa-2a versus peginterferon-alfa-2b for patients with chronic hepatitis C under the public payer perspective in Brazil 
Background
Chronic hepatitis C affects approximately 170 million people worldwide, and thus being one of the main causes of chronic liver disease. About 20% of patients with chronic hepatitis C will develop cirrhosis over 20 years, and present an increased risk of developing hepatic complications. Sustained virological response (SVR) is associated with a better prognosis compared to untreated patients and treatment failures.
The objective of this analysis was to compare treatment costs and outcomes of pegylated interferon-alfa-2a versus pegylated interferon-alfa-2b, both associated with ribavirin, in the therapeutic scheme of 24 weeks and 48 week for hepatitis C genotypes 2/3 and genotype 1, respectively, under the Brazilian Public Health System (SUS) scenario.
Methods
To project disease progression, a Markov model was built based on clinical stages of chronic disease. A Delphi panel was conducted to evaluate medical resources related to each stage, followed by costing of related materials, services, procedures and pharmaceutical products. The evaluation was made from a public payer perspective. The source used for costing was government reimbursement procedures list (SAI/SIH–SUS). Drug acquisition costs were obtained from the Brazilian Official Gazette and “Banco de Preços em Saúde” (government official source). It was assumed a mean patient weight of 70 kg. Costs were reported in 2011 Brazilian Reais (US$1 ≈ $Brz1.80). A systematic review followed by a meta-analysis of the 7 identified randomized controlled trials (RCTs) which compared pegylated interferons, was conducted for obtaining relative efficacy of both drugs: for genotype 2/3, mean rate of SVR was 79.2% for peginterferon-alfa-2a and 73.8% for peginterferon-alfa-2b. For genotype 1, SVR mean rate was 42.09% versus 33.44% (peginterferon-alfa-2a and peginterferon-alfa-2b respectively). Time horizon considered was lifetime. Discount rate for costs and outcomes was 5%, according to Brazilian guidelines for Health Technology Assessment (HTA).
Results
Analysis showed that peginterferon-alfa-2a is a dominant therapy compared to peginterferon-alfa-2b for genotype 1 ($Brz 4,345 savings and 0.10 LY/0.25 QALY gains) as well for genotype 2/3 ($Brz 8,001 savings and 0.16 LY/0.39 QALY gains). Projections indicated that for each 1000 patients treated with peginterferon-alfa-2a instead of peginterferon-alfa-2b, the amount of resources saved would be of $Brz 4.3 million for genotypes 2/3 and up to $Brz 8 million for genotype 1.
Conclusion
These findings suggest that treatment with peginterferon-alfa-2a is more effective and less costly when compared to peginterferon-alfa-2b under SUS perspective in Brazil.
doi:10.1186/1478-7547-11-25
PMCID: PMC3851805  PMID: 24103591
Chronic hepatitis C; Peginterferon-alfa-2a; Peginterferon-alfa-2b; Cost-effectiveness; Brazil; SUS
20.  The cost-effectiveness of growth hormone replacement therapy (Genotropin®) in hypopituitary adults in Sweden 
Background
To evaluate the cost-effectiveness of growth hormone (GH) treatment (Genotropin®) compared with no GH treatment in adults with GH deficiency in a Swedish societal setting.
Methods
A Markov-type cost-utility simulation model was constructed and used to simulate, for men and women, morbidity and mortality for GH-treated and -untreated individuals over a 20-year period. The calculations were performed using current available prices concerning morbidity-related healthcare costs and costs for Genotropin®. All costs and treatment effects were discounted at 3%. Costs were expressed in Euro (1€ = 9.03 SEK). GH-treated Swedish patients (n = 434) were identified from the KIMS database (Pfizer International Metabolic Database) and untreated patients (n = 2135) from the Swedish Cancer Registry and the Hospital Discharge Registry.
Results
The results are reported as incremental cost per quality-adjusted life year (QALY) gained, including both direct and indirect costs for GH-treated versus untreated patients. The weighted sum of all subgroup incremental cost per QALY was €15,975 and €20,241 for men and women, respectively. Including indirect cost resulted in lower cost per QALY gained: €11,173 and €10,753 for men and women, respectively. Key drivers of the results were improvement in quality of life, increased survival, and intervention cost.
Conclusions
The incremental cost per QALY gained is moderate when compared with informal thresholds applied in Sweden. The simulations suggest that GH-treatment is cost-effective for both men and women at the €55,371 (SEK 500,000 – the informal Swedish cost-effectiveness threshold) per QALY threshold.
doi:10.1186/1478-7547-11-24
PMCID: PMC3850881  PMID: 24079522
Cost effectiveness; Adults; Growth hormone; QALY
21.  Drug versus vaccine investment: a modelled comparison of economic incentives 
Background
Investment by manufacturers in research and development of vaccines is relatively low compared with that of pharmaceuticals. If current evaluation technologies favour drugs over vaccines, then the vaccines market becomes relatively less attractive to manufacturers.
Methods
We developed a mathematical model simulating the decision-making process of regulators and payers, in order to understand manufacturers’ economic incentives to invest in vaccines rather than curative treatments. We analysed the objectives and strategies of manufacturers and payers when considering investment in technologies to combat a disease that affects children, and the interactions between them.
Results
The model confirmed that, for rare diseases, the economically justifiable prices of vaccines could be substantially lower than drug prices, and that, for diseases spread across multiple cohorts, the revenues derived from vaccinating one cohort per year (routine vaccination) could be substantially lower than those generated by treating sick individuals.
Conclusions
Manufacturers may see higher incentives to invest in curative treatments rather than in routine vaccines. To encourage investment in vaccines, health authorities could potentially revise their incentive schemes by: (1) committing to vaccinate all susceptible cohorts in the first year (catch-up campaign); (2) choosing a long-term horizon for health technology evaluation; (3) committing higher budgets for vaccines than for treatments; and (4) taking into account all intangible values derived from vaccines.
doi:10.1186/1478-7547-11-23
PMCID: PMC3846654  PMID: 24011090
Incentives; Vaccines; Drugs; Research and development; Investment; Net present value
22.  WTP for a QALY and health states: More money for severer health states? 
Background
In economic evaluation, cost per quality-adjusted life year (QALY) is generally used as an indicator for cost-effectiveness. Although JPY 5 million to 6 million (USD 60, 000 to 75,000) per QALY is frequently referred to as a threshold in Japan, do all QALYs have the same monetary value?
Methods
To examine the relationship between severity of health status and monetary value of a QALY, we obtained willingness to pay (WTP) values for one additional QALY in eight patterns of health states. We randomly sampled approximately 2,400 respondents from an online panel. To avoid misunderstanding, we randomly allocated respondents to one of 16 questionnaires, with 250 responses expected for each pattern. After respondents were asked whether they wanted to purchase the treatment, double-bounded dichotomous choice method was used to obtain WTP values.
Results
The results clearly show that the WTP per QALY is higher for worse health states than for better health states. The slope was about JPY −1 million per 0.1 utility score increase. The mean and median WTP values per QALY for 16 health states were JPY 5 million, consistent with our previous survey. For respondents who wanted to purchase the treatment, WTP values were significantly correlated with household income.
Conclusion
This survey shows that QALY based on the EQ-5D does not necessarily have the same monetary value. The WTP per QALY should range from JPY 2 million (USD 20,000) to JPY 8 million (USD 80,000), corresponding to the severity of health states.
doi:10.1186/1478-7547-11-22
PMCID: PMC3766196  PMID: 24128004
Quality-adjusted life years; Willingness-to-pay; Threshold; Cost-effectiveness analysis
23.  A cost-effectiveness analysis of a 10-valent pneumococcal conjugate vaccine in children in six Latin American countries 
Background
A recently developed 10-valent pneumococcal non-typeable H influenzae protein D-conjugate vaccine (PHiD-CV) is expected to afford protection against more than two thirds of isolates causing IPD in children in Latin America, and also against acute otitis media caused by both Spn and NTHi. The objective of this study is to assess the cost-effectiveness of PHiD-CV in comparison to non-vaccination in children under 10 years of age in Argentina, Brazil, Chile, Colombia, Mexico and Peru.
Methods
We used a static, deterministic, compartmental simulation model. The dosing regimen considered included three vaccine doses (at 2 months, 4 months and 6 months) and a booster dose (at 13 months) (3 + 1 schedule). Model outcomes included number of cases prevented, deaths averted, quality-adjusted life-years (QALYs) gained and costs. Discount for costs and benefits of long term sequelae was done at 3.5%, and currency reported in 2008-2009 U$S varying between countries.
Results
The largest effect in case prevention was observed in pneumococcal meningitis (from 27% in Peru to 47% in Colombia), neurologic sequelae after meningitis (from 38% in Peru to 65% in Brazil) and bacteremia (from 42% in Argentina to 49% in Colombia). The proportion of predicted deaths averted annually ranged from 18% in Peru to 33% in Brazil. Overall, the health benefits achieved with PHiD-CV vaccination resulted in a lower QALY loss (from 15% lower in Peru to 26% in Brazil). At a cost of USD 20 per vaccine dose, vaccination was cost-effective in all countries, from being cost saving in Chile to a maximum Incremental Cost-effectiveness Ratio of 7,088 US$ Dollars per QALY gained. Results were robust in the sensitivity analysis, and scenarios with indirect costs affected results more than those with herd immunity.
Conclusions
The incorporation of the 10-valent pneumococcal conjugate vaccine into routine infant immunization programs in Latin American countries could be a cost-effective strategy to improve infant population health in the region.
doi:10.1186/1478-7547-11-21
PMCID: PMC3766226  PMID: 24004943
24.  Heterogeneity in cost-effectiveness of lifestyle counseling for metabolic syndrome risk groups -primary care patients in Sweden 
Background
Clinical trials have indicated that lifestyle interventions for patients with lifestyle-related cardiovascular and diabetes risk factors (the metabolic syndrome) are cost-effective. However, patient characteristics in primary care practice vary considerably, i.e. they exhibit heterogeneity in risk factors. The cost-effectiveness of lifestyle interventions is likely to differ over heterogeneous patient groups.
Methods
Patients (62 men, 80 women) in the Kalmar Metabolic Syndrome Program (KMSP) in primary care (Kalmar regional healthcare area, Sweden) were divided into three groups reflecting different profiles of metabolic risk factors (low, middle and high risk) and gender. A Markov model was used to predict future cardiovascular disease and diabetes, including complications (until age 85 years or death), with health effects measured as QALYs and costs from a societal perspective in Euro (EUR) 2012, discounted 3%. Simulations with risk factor levels at start and at 12 months follow-up were performed for each group, with an assumed 4-year sustainability of intervention effects.
Results
The program was estimated cost-saving for middle and high risk men, while the incremental cost vs. do-nothing varied between EUR 3,500 – 18,000 per QALY for other groups. There is heterogeneity in the cost-effectiveness over the risk groups but this does not affect the overall conclusion on the cost-effectiveness of the KMSP. Even the highest ICER (for high risk women) is considered moderately cost-effective in Sweden. The base case result was not sensitive to alternative data and methodology but considerably affected by sustainability assumptions. Alternative risk stratifications did not change the overall conclusion that KMSP is cost-effective. However, simple grouping with average risk factor levels over gender groups overestimate the cost-effectiveness.
Conclusions
Lifestyle counseling to prevent metabolic diseases is cost-effective in Swedish standard primary care settings. The use of risk stratification in the cost-effectiveness analysis established that the program was cost-effective for all patient groups, even for those with very high levels of lifestyle-related risk factors for the metabolic syndrome diseases. Heterogeneity in the cost-effectiveness of lifestyle interventions in primary care patients is expected, and should be considered in health policy decisions.
doi:10.1186/1478-7547-11-19
PMCID: PMC3765778  PMID: 23984906
Cost-effectiveness; Markov model; Metabolic syndrome; Lifestyle counseling; Primary care
25.  Costs of providing food assistance to HIV/AIDS patients in Sofala province, Mozambique: a retrospective analysis 
Background
As care and antiretroviral treatment (ART) for people living with HIV/AIDS become widely available, the number of people accessing these resources also increases. Despite this exceptional progress, the estimated coverage in low- and middle-income countries is still less than half of all people who need treatment. In addition, treatment discontinuation and non-adherence are still concerns for ART programs. Governments and partner institutions have sought to implement a variety of interventions addressing the main reasons behind the low coverage of, discontinuation of, and non-adherence to ART. Food assistance is one of those interventions; increasing evidence suggests that this type of intervention has the potential to improve ART outcomes. However, to our knowledge, no study has estimated its costs in detail. The objective of this study was to assess the costs of a program providing food assistance to HIV/AIDS patients in Sofala province, Mozambique, in 2009.
Methods
We performed a retrospective analysis of the costs of providing food assistance, based on financial and economic costs. We used the ingredients approach to estimate costs, which involved multiplying the total estimated quantities of goods and services actually employed in providing the intervention by their respective unit prices.
Results
In 2009, the cost of providing food assistance to HIV/AIDS patients was $2.27 million, with capital and recurrent costs accounting for 1% and 99% of total costs, respectively. Food made up the largest component, at 49% of total costs. At 24%, transport operating costs were the second largest item. The cost per patient served was $288 over 3 months.
Conclusion
The food distribution program carries significant costs. To assess whether it provides value for money, the present study results should be interpreted in conjunction with the program’s impact, and in comparison with other programs that aim to improve adherence to ART. Our costing analysis revealed important management information, indicating that the program incurred relatively large overhead costs. This result raises questions regarding the efficiency of implementing this food distribution program.
doi:10.1186/1478-7547-11-20
PMCID: PMC3765825  PMID: 24103560
ART; HIV/AIDS; Food assistance; Costs

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