Drug pricing for a novel treatment for wet macular degeneration: using incremental cost-effectiveness ratios to ensure societal value. Economic Evaluation of a Problem Solving Intervention to Prevent Recurrent Sickness Absence in Workers with Common Mental Disorders Economic evaluation of an intensive home visiting programme for vulnerable families: a cost-effectiveness analysis of a public health intervention. The Cost-Effectiveness and Cost-Benefit of Screening and Brief Intervention for Unhealthy Alcohol Use in Medical Settings More money, fewer lives: the cost effectiveness of welfare reform in the United States. A pharmacoeconomic comparison of UFT and 5-FU chemotherapy for colorectal cancer in South America. Economic Evaluation of Bone Morphogenetic Protein Versus Autogenous Iliac Crest Bone Graft in Single-Level Anterior Lumbar Fusion: An Evidence-Based Modeling Approach Economic evaluation of a workplace intervention for sick-listed employees with distress Cost-effectiveness of pazopanib: an example of improved transparency and accessibility of industry-sponsored economic evaluations through publication in peer-reviewed journals. Cost-effectiveness and cost-benefit of sumatriptan in patients with migraine. Interventions for enhancing medication compliance/adherence with benefits in treatment outcomes Economic evaluation of oral valdecoxib versus diclofenac in the treatment of patients with rheumatoid arthritis in a randomized clinical trial. Cost analysis and cost-benefit analysis of a medication review with follow-up service in aged polypharmacy patients A computer simulation model of the natural history and economic impact of chronic obstructive pulmonary disease. An economic model of the long-term health care burden of Type II diabetes Economic evaluation of three two-drug chemotherapy regimens in advanced non-small-cell lung cancer Immunotherapy with autologous tumor cell-BCG vaccine in patients with colon cancer: a prospective study of medical and economic benefits. Economic impact of providing workplace influenza vaccination. A model and case study application at a Brazilian pharma-chemical company. Surveillance for isocyanate asthma: a model based cost effectiveness analysis Not Only Clinical Efficacy in Psychological Treatments: Clinical Psychology Must Promote Cost-Benefit, Cost-Effectiveness, and Cost-Utility Analysis A cost utility analysis of treatment options for gallstone disease: methodological issues and results. Something old, something new, something borrowed, something blue: a framework for the marriage of health econometrics and cost-effectiveness analysis. Economic evaluation of occupational therapy in Parkinson's disease: A randomized controlled trial.
OBJECTIVE Health economic models can assist policy-makers in determining the value of novel treatments from the viewpoint of society . In this context , value is defined as the benefit of treatment , given its cost . A new treatment for wet age-related macular degeneration ( AMD ) , juxtascleral administration of anecortave acetate , 15 mg for depot suspension ( Retaane ) , is now in a late-phase clinical trial . In a theoretical analysis , we sought to determine the cost at which this treatment might offer economic value to society , using incremental cost-effectiveness ratios ( ICERs ) . METHODS A series of 1-year cost-utility models was created for the investigational treatment and st and ard treatment ( photodynamic therapy [ PDT ] with verteporfin [ Visudyne ] ) . Value to society was defined in terms of theoretical associated ICERs ( in US dollars ) : $ 100,000 per quality -adjusted life-year ( QALY ) , $ 50,000/QALY , $ 20,000/QALY and $ 0/QALY , the point of economic indifference . Models were created from the societal perspective and included a patient-derived utility assessment involving regression equations to estimate time trade-off preferences , event probabilities derived from a r and omized clinical trial comparing the safety and efficacy of anecortave administration and PDT with verteporfin , decision analysis and relevant costing information . RESULTS An ICER of $ 100,000/QALY would be associated with an anecortave cost of $ 3022/vial , an ICER of $ 50,000/QALY with an anecortave cost of $ 2986/vial and an ICER of $ 20,000/QALY with an anecortave cost of $ 2964/vial . The point of economic indifference between anecortave administration and st and ard therapy would occur with an anecortave cost of $ 2950/vial . INTERPRETATION In theory , an anecortave cost of $ 2986/vial is associated with an ICER of $ 50,000/QALY , the threshold used by many health technology assessment and reimbursement agencies Objectives Workers with common mental disorders ( CMDs ) frequently experience recurrent sickness absence  but scientifically evaluated interventions to prevent recurrences are lacking . The objectives of this study are to evaluate the cost-effectiveness and cost-benefit of a problem solving intervention aim ed at preventing recurrent sickness absence in workers with CMDs compared to care as usual  . Methods An economic evaluation was conducted alongside a cluster-r and omised controlled trial with 12 months follow-up . Treatment providers were r and omised to either a 2-day training in the SHARP-at work intervention , i.e. a problem solving intervention , or care as usual . Effect outcomes were the incidence of recurrent sickness absence and time to recurrent sickness absence . Self-reported health care utilisation was measured by question naires . A cost-effectiveness analysis ( CEA ) from the societal perspective and a cost-benefit analysis ( CBA ) from the employer ’s perspective were conducted . Results The CEA showed that the SHARP-at  work intervention was more effective but also more expensive than care as usual . The CBA revealed that employer ’s occupational health care costs were significantly higher in the intervention group compared to care as usual . Overall , the SHARP-at work intervention showed no economic benefit compared to care as usual . Conclusions As implementation of the SHARP-at work intervention might require additional investments , health care policy makers need to decide if these investments are worthwhile considering the results that can be accomplished in reducing recurrent sickness absence BACKGROUND Recent review s have shown that home visiting programmes that address parenting have the potential to improve long term health and social outcomes for children . However there are few studies exploring the cost-effectiveness of such interventions . The objective of this study was to evaluate the cost-effectiveness of an intensive home visiting programme directed at vulnerable families during the antenatal and postnatal periods . METHODS The design was an economic evaluation alongside a multicentre r and omized controlled trial , in which 131 eligible women were r and omly allocated to receive 18 months of intensive home visiting ( n=67 ) or st and ard services ( n=64 ) . Due to the public health nature of the intervention a cost-effectiveness analysis was undertaken from a societal perspective . RESULTS The mean ' societal costs ' in the control and intervention arms were 3874 pounds and 7120 pounds , respectively , a difference of 3246 pounds ( p<0.000 ) . The mean ' health service only ' costs were 3324 pounds and 5685 pounds respectively , a difference of 2361 pounds ( p<0.000 ) . As well as significant improvements in maternal sensitivity and infant cooperativeness there was also a non-significant increase in the likelihood of the intervention group infants being removed from the home due to abuse and neglect . These incremental benefits were delivered at an incremental societal cost of 3246 pounds per woman . CONCLUSIONS The results of the study provide evidence to suggest that , within the context of regular home visits , specially trained home visitors can increase maternal sensitivity and infant cooperativeness and are better able to identify infants in need of removal from the home for child protection . The extent to which these benefits are ' worth ' the societal cost of 3246 pounds per woman however is a matter of judgment SUMMARY Economic evaluation can be a valuable tool for assessing the efficiency and value of health care programs . To examine the literature on the economic evaluation of  alcohol screening and brief intervention in medical setting s , relevant studies were identified in the MEDLINE data base ( 1966 through November 2006 ) and by h and - search ing the references of identified articles and relevant journals . The 15 identified studies used a range of economic evaluation methods , including cost analysis , cost-benefit , cost-effectiveness , and cost-utility . Nearly all of the studies supported the use of alcohol screening and brief intervention . The studies that prospect ively collected cost and effect data and /or conformed closely to method ological guidelines demonstrated a strong economic benefit of alcohol screening and brief intervention when compared to usual care . Overall , the review ed studies support alcohol SBI in medical setting s as a wise use of health care re sources and illustrate the usefulness of economic evaluation for assessing alcohol prevention and treatment programs OBJECTIVES We evaluated the economic benefits of  Temporary Assistance to Needy Families ( TANF )  relative to the previous program , Aid to Families with Dependent Children ( AFDC ) . METHODS We used pooled mortality hazard ratios from 2 r and omized controlled trials-Connecticut Jobs First and the Florida Transition Program , which had follow-up from the early and mid-1990s through December 2011- and previous estimates of health and economic benefits of TANF and AFDC .  We entered them into a Markov model to evaluate TANF 's economic benefits relative to AFDC and weigh them against the potential health threats of TANF . RESULTS Over the working life of the average cash assistance recipient , AFDC would cost approximately $ 28000 more than TANF from the societal perspective . However , it would also bring 0.44 additional years of life . The incremental cost effectiveness of AFDC would be approximately $ 64000 per life-year saved relative to TANF . CONCLUSIONS AFDC may provide more value as a health investment than TANF . Additional attention given to the neediest US families denied cash assistance could improve the value of TANF The escalating role played by managed care organizations in the health-care system is reflected in the increased dem and for cost-effectiveness analyses ( CEAs ) to assess the balance between economic impact and clinical efficacy . For example , the high incidence and costs associated with colorectal cancer in Latin America calls for a comprehensive economic evaluation to ensure appropriate allocation of limited health-care funds . In addition , the current call for a " societal " perspective of such analyses indicates the need for increased consideration of the concerns of both patient and health-care provider . The introduction of oral tegafur and uracil ( UFT ) provided the opportunity to evaluate the pharmacoeconomic advantage of the new agent compared with the st and ard fluorouracil ( 5-FU ) . Results of this study indicated an economic advantage for oral UFT vs a 5-FU-based regimen in the treatment of colorectal cancer in Brazil and Argentina . It was further noted that the mild toxicity profile of UFT reduced both the number of clinic visits and the need for venipuncture procedures . Noting that oral UFT may have a positive impact on quality of life in addition to its estimated economic benefit , it was concluded that prospect i ve economic research and quality -of-life evaluations are needed to fully assess the pharmacoeconomic impact of oral UFT Study Design . Economic evaluation provides a framework to explicitly measure and compare the value of alternative medical interventions in terms of their clinical , health-related quality -of-life , and economic outcomes . Comput-erized economic models can help inform the design of future prospect i ve studies by identifying the cost-drivers , the most uncertain parameter estimates , and the parameters with the greatest impact on the results and inferences . Objective . An economic analysis of bone morphogenetic protein versus autogenous iliac crest bone graft for single-level anterior lumbar fusion poses several method ologic challenges . This article describes how such an economic evaluation may be framed and design ed , while enumerating challenges , offering some solutions , and suggesting an agenda for future research . Summary of Background Data . An evidence -based modeling approach can incorporate epidemiologic , clinical , and economic data from several sources including r and omized clinical trials , peer- review ed literature , and expert opinion . Sensitivity analyses can be conducted by varying key parameter estimates within a reasonable range to assess the impact on the results and inferences . Results . Preliminary results suggest that from a payer perspective , the upfront price of bone morphogenetic protein is likely to be entirely offset by reductions in the use of other medical re sources . That is , bone morphogenetic protein appears to be cost neutral . The cost offsets were attributable largely to prevention of pain and complications associated with autogenous iliac crest bone graft , as well as reduction of the costs associated with fusion failures . Conclusions . Future research should focus on quantifying the health-related quality -of-life impact of bone morphogenetic protein relative to autogenous iliac crest bone graft , as well as the impact on lost productivity Objectives To evaluate the cost effectiveness , cost utility and cost benefit of a workplace intervention compared with usual care for sick-listed employees with distress . Methods An economic evaluation was conducted alongside a r and omised controlled trial . Employees with distress and who were sick-listed for 2–8 weeks were r and omised to a workplace intervention ( n=73 ) or to usual care ( n=72 ) . The workplace intervention is a stepwise process involving the sick-listed employee and their supervisor , aim ed at formulating a consensus-based plan for return to work ( RTW ) . The effect outcomes were lasting RTW and quality -adjusted life years ( QALYs ) . Healthcare utilisation was measured over 12 months . Cost effectiveness analyses ( CEA ) and cost utility analyses ( CUA ) were conducted from the societal perspective and cost benefit analyses ( CBA ) from the employer perspective . Bootstrapping techniques were used to estimate cost and effect differences , related CIs , and cost effectiveness and cost utility ratios . Cost effectiveness planes were presented and subgroup analyses were performed . Results CEA and CUA revealed no statistically significant differences in lasting RTW , QALYs or costs . The CBA indicated a statistically significant higher cost of occupational health services in the workplace intervention group . The workplace intervention was not cost effective according to the CEA , CUA and CBA . Conclusions Widespread implementation of the workplace intervention for sick-listed employees with distress is not recommended because there was no economic benefit compared with usual care . Future trials should confirm if the workplace intervention is cost effective for the subgroup employees who intended to return to work despite symptoms . This trial has been registered at the Dutch National Trial Register IS RCT N92307123 We congratulate Amdahl et al.1 on publishing their paper about the cost-effectiveness of pazopanib compared with sunitinib in metastatic renal cell carcinoma ( mrcc ) in Canada . The article reports an analysis similar to the one su bmi tted to the pan-Canadian Oncology Drug Review to support the funding request for pazopanib in mrcc , up date d with final overall survival ( os ) data from the pivotal trial2 . Economic evaluations in oncology are increasingly important to guide both policy and practice . We commend the efforts of these authors to put their su bmi tted analyses into the public domain for transparency and to support and inform future research . The base-case analysis ( using the list prices of pazopanib and sunitinib ) by Amdahl et al.1 found that , compared with sunitinib , which is the st and ard of care for first-line therapy in mrcc , first-line pazopanib is likely cost-saving . The base case analysis also suggested that pazopanib might be slightly more effective than sunitinib numerically , with an incremental gain of 0.057 life-years and 0.059 quality -adjusted life-years . Before concluding that pazopanib is dominant ( that is , it provides more benefit for a lower cost ) with respect to sunitinib , it is important to review the clinical data comparing pazopanib and sunitinib in mrcc to assess the comparative efficacy and preference-based measures of health-related quality of life ( hrqol ) associated with those agents — that is , their health utilities — to examine the face validity of the economic model in its base case . The efficacy differences between the pazopanib and sunitinib in the comparz study 3 were not statistically significant , median progression-free survival for pazopanib and sunitinib being 8.4 months [ 95 % confidence interval ( ci ) : 8.3 to 10.9 months ] and 9.5 months ( 95 % ci : 8.3 to 11.1 months ) respectively , with a hazard ratio of 1.05 ( 95 % ci : 0.90 to 1.22 ) . The study met its primary endpoint of non-inferiority in progression-free survival . No os difference was observed in the comparz study , in which median os was 28.4 months for pazopanib ( 95 % ci : 26.2 to 35.6 months ) and 29.3 months for sunitinib ( 95 % ci : 25.3 to 32.5 months ) , with a hazard ratio of 0.91 ( 95 % ci : 0.76 to 1.08 ) . At the up date d analysis , os was similar in the two groups ( hazard ratio for pazopanib vs. sunitinib : 0.92 ; 95 % ci : 0.79 to 1.06 ; p = 0.24)2 . With similar survival results for pazopanib and sunitinib based on the comparz study , one might ask , “ How did the model project an incremental gain of 0.057 life-years in favour of pazopanib ? ” The model actually projected a shorter life expectancy while patients were taking pazopanib than while their counterparts were taking sunitinib ( 0.013 life-years lost in the progression-free state ) . However , the model also projected that , after patients progressed and stopped taking pazopanib , their life expectancy was longer than it was for patients who received sunitinib ( 0.070 life-years gained in the post-progression state ) . Together , the loss and the gain result ed in a net gain in life expectancy for pazopanib , implying that the survival benefit of pazopanib acted only after progression , when patients were no longer taking pazopanib . There is no biologic basis for that phenomenon , and it likely simply reflects small numerical differences between the pazopanib and sunitinib progression-free survival and os curves , without accounting for uncertainty . Interestingly , the model also predicted that pazopanib would be more effective in at least 80 % ( or possibly all ) of the simulations despite the nonsignificant result . Although the comparz study 3 collected some hrqol measures , it did not collect preference-based measures of hrqol to allow for the calculation of quality -adjusted life-years for the purpose of economic evaluation . The pisces study 4—a r and omized , double-blind trial with a crossover design ( that is , pazopanib→sunitinib vs. sunitinib→pazopanib)—had , as its primary endpoint , an examination of patient preference for either pazopanib or sunitinib , which suggested that patients preferred pazopanib over sunitinib . However , the study had a few limitations 5 , including a relatively high proportion of the r and omly assigned patients ( 33 % ) not being evaluable for the primary endpoint , and the analysis of the pazopanib preference being based on a “ modified ” intention-to-treat population . The EQ-5D ( EuroQoL Group , Rotterdam , Netherl and s ) was also collected as the preference-based measure of hrqol in the pisces study 4 , but the EQ-5D results would have been subject to similar limitations . The data from the pisces study were used in the su bmi ssion to the pan-Canadian Oncology Drug Review . In the up date d analysis 1 , the authors conducted a regression based on patients in a trial comparing pazopanib with placebo6  , assuming that the effect of adverse events ( aes ) were driving the differences in hrqol , regardless of actual treatment received . For the analysis , the aes were grouped by severity and whether the aes were more commonly occurring in the sunitinib or the pazopanib group of the comparz trial . Using that approach , the regression model found that the health utility decrement was larger for the group of aes more commonly occurring in patients who used sunitinib than for the remaining aes more frequently occurring in patients who used pazopanib in the comparz trial . The results of the regression model were combined with the incidence and duration of aes in each treatment arm to derive the mean utility values used in the model , producing mean utility values of 0.7089 ( st and ard error : 0.0193 ) for pazopanib and 0.6832 ( st and ard error : 0.0236 ) for sunitinib , an incremental difference of 0.0257 in the progression-free period1 . Given that the comparz trial demonstrated similar efficacy and a more favourable toxicity profile for pazopanib , it is not unreasonable that the point estimate of the utility score could slightly favour the pazopanib group . However , these mean utility values were not directly derived and might be neither statistically nor clinical ly different , especially because the difference was smaller than the reported estimates of minimal important differences for health utilities ( which are in the range of 0.05–0.08 for the EQ-5D)7,8 . Thus , it is somewhat difficult to conclude from those data that pazopanib is associated with better utility than sunitinib . It might be reasonable to conservatively expect that the utilities of pazopanib and sunitinib are fairly similar given the size of the st and ard errors of the two utilities , subject to a reasonable amount of uncertainty9,10 . Given that clinical trials did not demonstrate a statistically significant survival benefit or EQ-5D health utility benefit for pazopanib over sunitinib , we feel that an appropriate interpretation could be that the study findings suggest similar efficacy and health utility for the two drugs . Reasonably , the pan-Canadian Oncology Drug Review ’s Expert Review Committee also concluded that it is reasonable to assume similar efficacy and to focus on the cost comparison between pazopanib and sunitinib in this setting 11 . We appreciate that the sensitivity analyses by Amdahl et al.1 address all the considerations discussed here , including the importance of the relative price of the two drugs . The authors demonstrate as part of their additional analyses that — assuming similar efficacy , health utility , and daily price of the two therapies — only minor cost differences remain . Thus , interpreting the analyses in light of the evidence , it appears that these two options for first-line therapy in mrcc might be largely similar and , taking into account the relative prices of the two drugs , the hope would be that , after confidential negotiations , they will also be similar in cost . In that case , having both drugs available would give patients the option to choose based on individual preference and side effect profile , especially in the case of intolerance to one of the drugs , and would ensure that health care re sources are being efficiently used . The generalizability of the study findings remains to be seen in practice . Verification from experience is needed to know whether the comparative outcomes as laid out will be realized . In Canada , jurisdictions have an important opportunity and challenge to evaluate the real-world effectiveness and cost-effectiveness of therapies in clinical practice after drugs are funded . Moreover , post-market research can provide valuable insights into practice patterns when two alternatives are funded and can possibly inform continued uncertainties such as sequencing and long-term adverse effects . We applaud the approach of the authors to share their analyses with the broader clinical and research communities , and we encourage more authors of economic evaluations created and su bmi tted to review bodies ( for example , the Canadian Agency for Drugs and Technologies in Health , the pan-Canadian Oncology Drug Review ) to follow suit . We expect that this activity will build on the principle of transparency being increasingly championed by the review organizations and will improve the rigour of the economic evidence used to inform policy . Finally , we call on the community to continue to pursue both academic merit and clinical and policy relevance by supporting the availability of peer- review ed publications of economic evaluations to inform the reimbursement review process . Ideally , it would be helpful if economic evaluations were to be published before decision-making so as to engage more stakeholders in the discussion 12 . In doing so , the clinical and economic evidence bases supporting the health technology assessment processes in Canada might be brought into better alignment , improving the robustness of decision-making and ultimately helping health care systems in Canada to provide effective and appropriate care to patients OBJECTIVE To investigate the cost-effectiveness and cost-benefit of initiating sumatriptan therapy in patients with acute migraine who were previously taking nontriptan drugs . PATIENTS AND METHODS This is an economic analysis of a prospect i ve , pretest-posttest , observational 6-month outcomes study of 178 patients with a physician diagnosis of migraine who received their first prescription for sumatriptan between October 1994 and August 1996 and were members of a mixed-model managed care organization in western Pennsylvania . Migraine-related re source use data were obtained from the managed care organization 's medical and pharmacy cl aims data bases . The primary outcome measure for this economic analysis was the total disability time that patients experienced because of migraine . Patients reported time missed from work and usual nonwork activities because of migraine on self-administered question naires at baseline and at 3 and 6 months after initiation of sumatriptan . RESULTS Initiation of sumatriptan result ed in a decrease of 662 migraine-disability-days for work and 1236 migraine-disability-days for nonwork activities during the 6 months of the study ( decrease from 27.8 to 17.2 days per person ) , totaling 1898 migraine-disability-days averted with sumatriptan therapy .  Migraine-related medical costs were lower after sumatriptan was initiated ( $ 18,351 vs $ 26,192 ) , whereas migraine-related pharmacy costs were lower with prior nontriptan drug therapy ( $ 22,209 vs $ 74,861 ) . The overall net cost savings after sumatriptan was initiated in these patients was $ 222,332 ( $ 1249 per patient ) with a benefit-to-cost ratio of $ 5.67 gained for each health care dollar spent from a societal perspective . The incremental cost-effectiveness ratio was $ 25 for each additional migraine-disability-day averted by using sumatriptan vs nontriptan drug therapy . Sensitivity analysis showed that changes in medical costs had little effect on the ratios and that sumatriptan remained cost-beneficial across a wide range of patient wages . CONCLUSION This study showed that initiation of sumatriptan in patients previously receiving nontriptan therapy was cost-effective and had an economic benefit for patients , employers , and society . Sumatriptan also helped patients and physicians achieve goals recommended by the US Headache Consortium by reducing patients ' disability and thus improving their ability to function at work and nonwork activities Scientific background Poor compliance or adherence in  drug therapy  can cause increased morbidity , mortality and enormous costs in the healthcare system ( in Germany annually approximately 10 billion euros ) . Different methods are used for enhancing the compliance or adherence . Research questions The evaluation addresses the questions about existence , efficacy , cost-benefit relation as well as ethical-social and juridical implication s of strategies for enhancing compliance or adherence in drug therapy with concomitant improvements in treatment outcomes . Methods A systematic literature search was conducted in the medical , also health economic relevant , literature data bases in January 2007 , beginning from 2002 . Systematic review s on the basis of ( r and omised controlled trials ( RCT ) concerning interventions to enhance compliance or adherence with regard to treatment outcomes as well as systematic review s of health economic analyses were included in the evaluation . Additionally , it was also search ed for publications which primarily considered ethical-social and juridical aspects of these interventions for the German context . Results One systematic review with data for 57 RCT was included in the medical evaluation and one systematic review with data for six studies into the health economic evaluation . No publication primary concerning ethical-social or juridical implication s could be identified . A significant positive effect on the treatment outcome was reported for 22 evaluated interventions . For many interventions the results can be classified as reliable : counseling with providing an information leaflet and compliance diary chart followed by phone consultation for helicobacter pylori positive patients , repeated counseling for patients with acute asthma symptoms , telephone calls to establish the level of compliance and to make recommendations based on that for the therapy of cardiovascular diseases , calls of an automated telephone system with phone counseling in problem cases for diabetics , different family based interventions including repeated family counseling , education and " culturally modified family therapy " in patients with schizophrenia , repeated " compliance therapy " sessions for patients with acute psychosis . For other interventions the results should be viewed with more concern ( because of the poor method ical quality of the underlying studies ) . The effect size of the interventions can not be estimated from the available data . From the available data , no reliable results can be provided concerning the cost-benefit relation of these strategies . Discussion Many of the reported studies had a poor reporting and method ological quality . The reliability of the conclusions of the studies is restricted because of method ical shortcomings . Efficacy and cost estimates determined in the health economic studies are not transferable to the current situation in Germany . It has been discussed recently that the compliance or adherence enhancing interventions can restrict the autonomy and the privacy of the patients . Conclusions In drug therapy some compliance or adherence enhancing interventions with concomitant positive effect on the treatment outcome may be used . The cost-benefit relation of these interventions is to be estimated . Using these interventions the patient ’s autonomy and privacy are to be restricted as few as possible In contrast to economic models that provide probabilistic estimates of economic impact , data extracted from clinical trials may be used to evaluate and compare actual re source utilization and costs . Health-care re source utilization and the costs of these re sources were compared from the perspective of the UK National Health Service using data obtained in a 6-month clinical trial of oral valdecoxib 20 mg once daily and diclofenac 75 mg twice daily for the symptomatic treatment of rheumatoid arthritis . However , calculated health-care costs were exclusive of drug acquisition costs because the price of valdecoxib was not available at the time of analysis . While the efficacy of the two treatments was similar , use of valdecoxib was associated with a reduction in total health-care costs amounting to approximately 200 British pounds per patient . This lower cost was associated with reduced use of health-care re sources for gastrointestinal serious adverse events ( gastrointestinal SAEs ) . In particular , the incidence of hospitalization and number of hospital days for gastrointestinal SAEs was lower in the valdecoxib group . Analysis of cost per gastrointestinal SAE favoured valdecoxib ( cost savings of 742 British pounds ) , suggesting that even when these events did occur they were less severe . When costs of gastrointestinal SAEs were averaged over the entire population , valdecoxib was suggested to have lower total costs per patient compared with diclofenac ( cost savings of 115 British pounds per patient ) , mainly result ing from significant savings in hospitalization costs ( 76.49 British pounds per patient ) . These data are consistent with economic models and suggest that the favourable gastrointestinal profile of valdecoxib observed in clinical trials will be of economic benefit Background Drug related problems have a significant clinical and economic burden on patients and the healthcare system . Medication review with follow-up ( MRF ) is a professional pharmacy service aim ed at improving patient ’s health outcomes through an optimization of the medication . Objective To ascertain the economic impact of the MRF service provided in community pharmacies to aged polypharmacy patients comparing MRF with usual care , by undertaking a cost analysis and a cost-benefit analysis . Methods The economic evaluation was based on a cluster r and omized controlled trial . Patients in the intervention group ( IG ) received the MRF service and the comparison group ( CG ) received usual care . The analysis was conducted from the national health system ( NHS ) perspective over 6 months . Direct medical costs were included and expressed in euros at 2014 prices . Health benefits were estimated by assigning a monetary value to the quality -adjusted life years . One-way deterministic sensitivity analysis was undertaken in order to analyse the uncertainty . Results The analysis included 1403 patients ( IG : n = 688 vs CG : n = 715 ) . The cost analysis showed that the MRF saved 97 € per patient in 6 months . Extrapolating data to 1 year and assuming a fee for service of 22 € per patient-month , the estimated savings were 273 € per patient-year . The cost-benefit ratio revealed that for every 1 € invested in MRF , a benefit of 3.3 € to 6.2 € was obtained . Conclusion The MRF provided health benefits to patients and substantial cost savings to the NHS . Investment in this service would represent an efficient use of healthcare re sources OBJECTIVE Chronic obstructive pulmonary disease ( COPD ) is a major health problem with high societal costs . The Global Initiative for Chronic Lung Disease ( GOLD ) has identified a need for health economics data for COPD . For chronic diseases , such as COPD , where the natural history of disease is lifetime , a modeling approach for economic evaluation may be more realistic than prospect i ve , piggy-backed clinical trials or specific COPD cohort studies . Simulation models can be used to extrapolate clinical data beyond the limited time frame of clinical trials , to analyze subgroups of patients or to explore uncertainty regarding the results by using sensitivity analysis techniques . Our purpose has been to develop a flexible computer simulation model for COPD that will represent disease progression and GOLD recommendations , useful for economic evaluations of new medicines to meet the needs of various payer requirements for reimbursement and re source allocation . METHODS This article describes a two-dimensional Markov model , which uses data from multiple sources about disease progression , exacerbation frequency and duration , mortality , costs , burden of illness , and the relationships between those variables . The model is evaluated using stochastic uncertainty analysis , it allows comparison of treatments affecting different disease mechanisms , and it uses primary data vali date d against published sources . RESULTS We have evaluated two hypothetical interventions treating different features of the disease ( lung function decline and acute exacerbations ) . These analyses show that reducing lung function decline must be a long-term strategy compared to reducing the number of exacerbations . It was necessary to have a long term like 30 years , with 10,000 patients and 20 % increase in price , or 20 years with equal prices to show cost-effectiveness with statistical significance for a treatment that reduces lung function decline . CONCLUSIONS Our study shows the value of modeling as a tool for evaluating different scenarios and for combining several sources of data , to provide estimates that would otherwise be unavailable . Clinical trials of this size and duration would be unrealistic Abstract . Aims /hypothesis : To develop a long-term economic model of health care for Type II diabetes initially for the United Kingdom ; characterize experiences of diabetes-related morbidities and the use of health care re sources among a typical Type II diabetes cohort ; to estimate lifetime differences in expected health outcomes and costs attributable to Type II diabetes ; and to facilitate evaluation of policies or interventions in treating Type II diabetes from the funder 's perspective . Methods : A compact spreadsheet structure of interconnected Markov chain modules was developed to facilitate rapid estimation of costs and outcomes for whole population s. Recent clinical findings from the United Kingdom Prospect i ve Diabetes Study and other sources were incorporated and a detailed costing module developed from United Kingdom observational data . Results : The model allows the assessment of costs and long-term complications experienced by people suffering from Type II diabetes , including direct health care costs associated with the main diabetic complications and second-order effects on other health services required by such patients . Initial results suggest that the lifetime cost of health care for patients from the diagnosis of diabetes is more than double that for an equivalent non-diabetic population . Conclusion /interpretation : The model is intended for use by health care policy makers and payers to assess the long-term budgetary impact of trends in a variety of demographic and epidemiological factors on future services , and is also useful to physicians when considering the impact of new treatment strategies or programmes to modify risk factors for diabetic complications . [ Diabetologia ( 2001 ) 44 : 2140–2155 Abstract Background : During the 1990s , a number of new cytotoxic agents with clinical ly relevant activity in non-small-cell lung cancer ( NSCLC ) , and with a more favourable therapeutic index than drugs already in use , became available . Given the high prices of these new drugs and the large number of patients affected , it is important to compare the relative benefits and costs of these treatments with the existing regimens before treatment policy decisions are changed . Purpose : An economic evaluation of three different regimens of chemotherapy in patients with advanced NSCLC was performed from the perspective of the Dutch health insurance system using tariffs valid for 2002 . The economic evaluation was integrated into a phase III clinical trial in which the reference regimen cisplatinpaclitaxel was compared with two experimental regimens : cisplatin-gemcitabine and gemcitabine-paclitaxel . Material s and methods : Unit costs were applied to re source use data collected prospect ively on case report forms during the trial . The average total ( uncensored ) cost per patient was determined for each of the treatment groups . The principal outcome measure for the economic evaluation was the estimated mean survival time per treatment group . This outcome was then incorporated into incremental cost-effectiveness ratios based on costs corrected for censoring . The impact of uncertainty was assessed by bootstrap techniques , and the analysis and interpretation of the data focused on the bivariate density of differences in outcomes and costs in the incremental cost-effectiveness plane . The final results were summarised by the derivation of cost-effectiveness acceptability curves . Results : The estimated mean survival time was equivalent in the two cisplatinbased regimens with largely overlapping confidence intervals . There was a 99 % probability that cisplatin-gemcitabine is the least costly regimen of the two and a 72 % probability that this regimen reduces costs while at the same time improving survival . Compared with cisplatin-paclitaxel , the gemcitabine-paclitaxel regimen engendered a borderline significant reduction in mean survival time combined with an almost 90 % probability of an increase in costs . Conclusion : The two cisplatin-based regimens are equivalent in terms of survival , but cisplatin-gemcitabine may reduce costs by approximately € 2000 per patient compared with cisplatin-paclitaxel . Gemcitabine-paclitaxel is a dominated option with higher costs and a reduction in mean survival time compared with cisplatinpaclitaxel We have completed a multicenter , r and omized controlled phase III clinical trial in Stages II and III colon cancer patients with active specific immunotherapy ( ASI ) using autologous tumor cells with an immunomodulating adjuvant bacillus Callmette-Guerin ( BCG ) vaccine ( OncoVAX ) in an adjuvant setting . In this study , patients were r and omized to receive either OncoVAX therapy or no therapy after surgical resection of the primary tumor and stratified by stage of disease . Since the biologic essence of the effective tumor immunotherapy is the presence in the vaccine of a minimum number of viable , metabolically active , autologous tumor cells , the processing of the vaccine product , occurred within 48 h after surgery . Analysis of prognostic benefit in the pivotal phase III trial , with a 5.8 year median follow-up , showed that a beneficial effect of OncoVAX is statistically significant for all endpoints including recurrence-free interval , overall survival , and recurrence-free survival in Stage II colon cancer patients . Surgery alone cures approximately 65 % of Stage II ( Dukes B2 , B3 ) colon cancer patients . In the remaining patients , OncoVAX in an adjuvant setting , significantly prolongs recurrence-free interval ( 57.1 % relative risk reduction ) and significantly improves 5-year overall survival and recurrence-free survival . No statistically significant prognostic benefits were achieved in Stage III ( Duke 's C1-C3 ) patients . A health economics assessment was performed on these results in Stage II colon cancer patients using disease-free survival and overall survival ( for the entire intent-to-treat population ) . Cost-effectiveness , cost-utility and sensitivity analysis were applied with , cost of life years , recurrence-free life years and quality adjusted life years ( QALYs ) as the primary endpoints to this analysis . The perspective of the economic analysis was the current direct medical cost established by the health care providers . The introduction of new technologies often leads to additional costs . This report verified that the use of OncoVAX for patients with Stage II colon cancer not only has significant prognostic benefit and positive clinical outcomes , but also showed that OncoVAX therapy yields impressive health economics benefits OBJECTIVE To develop and apply a model to assess the economic value of a  workplace influenza programme  from the perspective of the employer . DESIGN The model calculated the avoided costs of influenza , including treatment costs , lost productivity , lost worker added value and the cost of replacing workers . Subtracted from this benefit were the costs associated with a  vaccination programme , including administrative costs , the time to give the vaccine , and lost productivity due to adverse reactions . The framework of the model can be applied to any company to estimate the cost-benefit of an influenza immunisation programme . SETTING The model developed was applied to 4030 workers in the core divisions of a Brazilian pharma-chemical company . RESULTS The model determined a net benefit of $ US121,441 [ 129,335 Brazilian reals ( $ Brz ) ] , or $ US35.45 ( $ Brz37.75 ) per vaccinated employee ( 1997 values ) . The cost-benefit ratio was 1:2.47 . The calculations were subjected to a battery of 1-way and 2-way sensitivity analyses that determined that net benefit would be retained as long as the vaccine cost remained below $ US45.40 ( $ Brz48.40 ) or the vaccine was at least 32.5 % effective . Other alterations would retain a net benefit as well , including several combinations of incidence rate and vaccine effectiveness . CONCLUSIONS The analysis suggests that providing an influenza vaccination programme can incur a substantial net benefit for an employer , although the size of the benefit will depend upon who normally absorbs the costs of treating influenza and compensating workers for lost work time due to illness , as well as the type of company in which the immunisation programme is applied Aims : Because logistical and financial obstacles impede using large prospect i ve cohort studies , surveillance decisions in occupational setting s must often be made without evidence of relative benefits and costs . Using the example of isocyanate induced asthma , the most commonly reported immune mediated occupational asthma , the authors developed a model based approach to evaluate the costs and benefits of surveillance from both an employer and a societal perspective . Methods : The authors used a mathematical simulation model of isocyanate asthma to compare annual surveillance to passive case finding . Outcome measures included symptom free days ( SFD ) , quality adjusted life years ( QALY ) , direct costs , productivity losses , and incremental cost effectiveness ratio ( CER ) , measured from the employer and the societal perspectives . Input data were obtained from a variety of published sources . Results : For 100 000 exposed workers , surveillance result ed in 683 fewer cases of disability over 10 years . Surveillance conferred benefits at an incremental cost of $ 24,000/QALY ( employer perspective ; $ 13.33/SFD ) and was cost saving from the societal perspective . Results were sensitive to assumptions about sensitisation rate , removal rates , and time to diagnosis , but not to assumptions about therapy costs and disability rates . Conclusions : Baseline results placed the CER for surveillance for isocyanate asthma within the acceptable range . Costs from the societal and employer perspective differed substantially with a more attractive CER from the societal perspective , suggesting opportunities for employer/societal cost sharing . The analysis demonstrates the value of a model based approach to evaluate the cost effectiveness of surveillance programmes for isocyanate asthma , and to inform shared decision making among clinicians , patients , employers , and society . Such a modeling approach may be applicable to surveillance programmes for other work related conditions Treating mental disorders is a critical issue for modern societies due to high costs for the different national healthcare systems . Evidence -based psychological therapies and structured psychotherapies have been recommended for common mental health problems , but real provision of them has not yet achieved significant spread and impact ( Mukuria et al. , 2013 ) . To improve access to psychological therapies may provide cost-effective solutions , since their positive long-term impact on health has been largely demonstrated ( Castelnuovo , 2010a , b ; Campbell et al. , 2013 ; Dezetter et al. , 2013 ; Mukuria et al. , 2013 ; Emmelkamp et al. , 2014 ) . However , in many developed countries , such as France or Italy , psychotherapies are not enough covered and promoted by the national healthcare systems and health insurance companies ( Dezetter et al. , 2013 ) . Differently , in the UK , to tackle the huge problem of mental illness , a comprehensive programme of psychological therapy has been launched and watched worldwide . An estimation of its long-term clinical and economic benefits , has , in fact , led to ascertain that “ psychological therapy costs nothing ” ( Layard and Clark , 2014 ; Clark and Layard , 2015 ) . In order to mimic the positive experience developed in the UK , other countries have now to demonstrate not only the fundamental role and scientific validity of psychological treatments in both clinical and health setting s , but also their significant cost-efficacy . As noted by Emmelkamp et al. ( 2014 ) , “ There is little doubt from a scientific perspective that  psychotherapy  according to this definition is effective , highly beneficial and cost-effective for a wide range of mental disorders and health conditions , such as anxiety , stress and trauma-related disorders , depressive and somatoform and pain disorders , personality disorder , substance use disorders and behavioral addictions , eating disorders and a number of childhood disorders . For all these disorders , various variants of CBT have been established in clinical r and omized trials ” ( pp . 66 , 67 ) , but research in psychotherapy lacks of cost-benefit analysis of interventions : “ even if a psychological treatment could show strong efficacy and /or effectiveness , due to high costs it might never be assimilated in real clinical practice ” ( p. 67 , Emmelkamp et al. , 2014 ) . Unfortunately , most clinical psychologists and psychotherapists are not willing to measure the impact of their clinical practice , even if Beutler ( 2009 ) underlined that the gap existing between science and practice could be more imputed to scientists ' attitude than to practitioners ' intransigence : “ scientists were intentionally obscuring many important results because of an unwarranted devotion to a limited number of scientific methods . In fact , I came to believe that they may be using methods and defining psychotherapy and research informed practice in ways that hindered clinicians from being optimally effective ” ( p. 301 , Beutler , 2009 ) . Considering that psychological therapies should be studied not only in the narrow frame of Empirically Supported Treatments ( ESTs ) approach , but also using different and integrated research and statistical methods ( Beutler , 2009 ) , their cost-effectiveness demonstration remains an unaddressed issue in the psychotherapy field . Indeed , as argued by Lilienfeld et al. ( 2013 ) with references to how to promote new evidence -based psychological treatments , “ organizational support is often tied to the perceived financial viability of a new treatment ( Nelson et al. , 2006 ) . Consequently , in order to obtain financial support for learning new approaches and techniques within a clinical context , professionals must first estimate and prove the economic gain of training courses to funding organizations . Treatments that have not demonstrated ( or treatments whose cost-effectiveness have not been explored ) are therefore less viable options for organizations to support ” ( p. 895 , Lilienfeld et al. , 2013 ) . More clinical studies aim ed at providing cost-offset estimations also measuring additional intangible benefits and showing that psychological treatments could be effective , at both clinical and economic levels , are thus necessary ( Wunsch et al. , 2014 ) . It is important not to confuse a necessary  cost-effective  approaches in psychotherapy with dangerous cheap performances provided by the mental health practitioners : “ while cost-effective treatments can yield savings in healthcare costs , disability cl aims , and other societal costs , cost-effective by no means translates to cheap but instead describes treatments that are clinical ly effective and provided at a cost that is considered reasonable given the benefit they provide , even if the treatments increase direct expenses ” ( p. 423 , Lazar , 2014 ) . In clinical psychology , st and ardized , and internationally recognized psychotherapeutic outcome measures have therefore been developed in order to demonstrate patient improvements ( Tarescavage and Ben-Porath , 2014 ) , and an ample set of measurements that are useful to evaluate patients outcomes is currently available considering different criteria ( administration time and cost , psychometrics and sensitivity to change , etc . ) . Among these , the Behavior and Symptom Identification Scale-24 ( BASIS-24 ) ; the Clinical Outcomes in Routine Evaluation Outcome Measure ( CORE-OM ) ; the Depression Anxiety Stress Scales ( DASS ) ; the Health Survey Short Form-36 ( SF-36 ) ; the Outcome Question naire-45 ( OQ-45 ) ; the Patient Reported Outcome Measurement Information System ( PROMIS ) ; the Symptom Checklist-90-Revised ( SCL-90-R ) ; and the Brief Symptom Inventory ( BSI ) ( Tarescavage and Ben-Porath , 2014 ) are just a few . However , no agreement has been yet reached over what constitutes relevant ad universal measurements in psychopathology , as requested by the International Consortium for Health Outcomes Measurement ( ICHOM ) ( Porter et al. , 2016 ) . Also , clinical psychologists and research ers should strive to develop st and ardized sets of measures able to estimate savings costs of psychological treatments . In this regard , commonly used analytic approaches to obtain economic evaluations of health care services are : ( 1 ) cost-benefit analysis ( focusing on the socially desirable outcome achieved by a particular treatment ) , ( 2 ) cost-effectiveness analysis ( taking into account the relationship between monetary costs and measures of treatment outcome , evaluating a possible symptoms reduction or a growing work productivity ) , ( 3 )  cost-utility analysis  ( with similar features of the cost-effectiveness analysis but using a valuing metric for measuring the treatment impact st and ardized in terms of quality -adjusted life years — QALY ) . Considering not only the clinical efficacy of ESTs , but also the number of years of life in which an individual would be expected to be completely free of symptoms or disability is a key point to persuade policy makers and administrators that allocation of re sources to psychological interventions would lead to both clinical and economic advantages ( Hunsley , 2002 ) . Taking into account that the future of the health care systems will be the promising stepped care approach for both chronic care pathologies ( Davison , 2000 ; Richards et al. , 2003 , 2012 ; Hermens et al. , 2014 ; Castelnuovo et al. , 2015a , b ; Delgadillo et al. , 2015 ) and mental disorders ( Richards , 2012 ; Watzke et al. , 2014 ; Gidding et al. , 2015 ; Gureje et al. , 2015 ; Haug et al. , 2015 ; Manber et al. , 2015 ; Oladeji et al. , 2015 ; Palmer et al. , 2015 ; Paris , 2015 ; Salloum et al. , 2015 ; Edelman et al. , 2016 ) , clinical psychologists will play a key role in delivering positive outcomes by continuously revising and progressively intensifying the therapeutic process through the reduction of costs . Despite evidence of the efficacy and effectiveness of the stepped care approach in the clinical field has not been yet reached , positive results have been obtained for preventive treatments aim ed at reducing subthreshold depression , which used Internet for individuals who were not able to take part in group interventions ( Munoz et al. , 1995 ; Willemse et al. , 2004 ; Van't Veer-Tazelaar et al. , 2009 ; Cuijpers et al. , 2010 ) . Instead , another recent study ( Van Beljouw et al. , 2015 ) evaluating an outreaching stepped care program on depressive symptoms in older adults failed to demonstrate the utility of the model , while revealing a single ( and not stepped ) treatment chosen by the participants being sufficient to achieve positive clinical outcomes . Still , further evidence of the cost-benefit , cost-effectiveness , and cost-utility of both single and stepped care approaches in clinical psychology are needed . Useful indications suggesting how to legitimize clinical psychology in health care system are provided in Table ​Table11 . Table 1 Steps to legitimize clinical psychology in health care system . Future research in psychology and psychotherapy should , therefore , focus more on cost-effective solutions for the treatment of mental disorders , also considering opportunities provided by new technologies ( Castelnuovo et al. , 2003 , 2014 ; Cartreine et al. , 2010 ; Castelnuovo and Simpson , 2011 ; And rews and Williams , 2014 ) The techniques of cost utility analysis ( CUA ) were used to evaluate the treatment of gallstone disease by open and laparoscopic cholecystectomy and by extracorporeal shockwave lithotripsy ( ESWL ) .  The application of the techniques in this context raised three method ological questions which are not satisfactorily resolved in the literature . The first is whether an ex ante or ex post perspective is best adopted for the measurement of quality of life ( QoL ) . The second is the method for converting a short term deterioration in QoL followed by full health into QALYs and the reliability of the methods available . The third is the issue of indirect costs which , in the context of a temporary disease state , can not be easily avoided . The economic evaluation found laparoscopic cholecystectomy to be generally superior than the competitor technologies ( entailing lower costs and better outcomes ) . However , the results were sensitive to assumptions about the perspective for measuring benefits and the inclusion of indirect costs Economic evaluation is often seen as a branch of health economics divorced from mainstream econometric techniques . Instead , it is perceived as relying on statistical methods for clinical trials . Furthermore , the statistic of interest in cost-effectiveness analysis , the incremental cost-effectiveness ratio is not amenable to regression-based methods , hence the traditional reliance on comparing aggregate measures across the arms of a clinical trial . In this paper , we explore the potential for health economists undertaking cost-effectiveness analysis to exploit the plethora of established econometric techniques through the use of the net-benefit framework - a recently suggested reformulation of the cost-effectiveness problem that avoids the reliance on cost-effectiveness ratios and their associated statistical problems . This allows the formulation of the cost-effectiveness problem within a st and ard regression type framework . We provide an example with empirical data to illustrate how a regression type framework can enhance the net-benefit method . We go on to suggest that practical advantages of the net-benefit regression approach include being able to use established econometric techniques , adjust for imperfect r and omisation , and identify important subgroups in order to estimate the marginal cost-effectiveness of an intervention BACKGROUND A large r and omized clinical trial ( the Occupational Therapy in Parkinson 's Disease [ OTiP ] study ) recently demonstrated that home-based occupational therapy improves perceived performance in daily activities of people with Parkinson 's disease ( PD ) . The aim of the current study was to evaluate the cost-effectiveness of this intervention . METHODS We performed an economic evaluation over a 6-month period for both arms of the OTiP study . Participants were 191 community-dwelling PD patients and 180 primary caregivers . The intervention group ( n = 124 patients ) received 10 weeks of home-based occupational therapy ; the control group ( n = 67 patients ) received usual care ( no occupational therapy ) .  Costs were assessed from a societal perspective including healthcare use , absence from work , informal care , and intervention costs . Health utilities were evaluated using EuroQol-5d . We estimated cost differences and cost utility using linear mixed models and presented the net monetary benefit at different values for willingness to pay per quality -adjusted life-year gained . RESULTS In our primary analysis , we excluded informal care hours because of substantial missing data for this item . The estimated mean total costs for the intervention group compared with controls were € 125 lower for patients , € 29 lower for caregivers , and € 122 higher for patient-caregiver pairs ( differences not significant ) . At a value of € 40,000 per quality -adjusted life-year gained ( reported threshold for PD ) , the net monetary benefit of the intervention per patient was € 305 ( P = 0.74 ) , per caregiver € 866 ( P = 0.01 ) and per patient-caregiver pair € 845 ( P = 0.24 ) . CONCLUSION In conclusion , occupational therapy did not significantly impact on total costs compared with usual care . Positive cost-effectiveness of the intervention was only significant for caregivers
Overall , the cohort Markov models remain the most popular approach , followed by decision trees , Individual based model and System dynamics model ( SD ) .
Conclusions This review paper informs policy makers about the availability of modelling techniques that can be used to enhance the quality of economic evaluations for drug and alcohol treatment interventions
Background The overarching goal of health policies is to maximize health and societal benefits .
Economic evaluations can play a vital role in assessing whether or not such benefits occur .
This paper review s the application of modelling techniques in economic evaluations of drug and alcohol interventions with regard to ( i ) modelling paradigms themselves ; ( ii ) perspectives of costs and benefits and ( iii ) time frame .