Modelling Spillover Effects on Informal Carers: The Carer QALY Trap.

The provision of informal (unpaid) care can impose significant 'spillover effects' on carers, and accounting for these effects is consistent with the efficiency and equity objectives of health technology assessment (HTA). Inclusion of these effects in health economic models, particularly carer health-related quality of life (QOL), can have a substantial impact on net quality-adjusted life year (QALY) gains and the relative cost effectiveness of new technologies. Typically, consideration of spillover effects improves the value of a technology, but in some circumstances, consideration of spillover effects can lead to situations whereby life-extending treatments for patients may be considered cost ineffective due to their impact on carer QOL. In this piece we revisit the classic 'QALY trap' and introduce an analogous 'carer QALY trap' which may have practical implications for economic evaluations where the inclusion of carer QOL reduces incremental QALY gains. Such results may align with a strict QALY-maximisation rule, however we consider the extent to which this principle may be at odds with the preferences of carers themselves (and possibly society more broadly), potentially leading decision makers into the carer QALY trap as a result. We subsequently reflect on potential solutions, highlighting the important (albeit limited) role that deliberation has to play in HTA.

Unmet Parenthood Goals, Health-Related Quality of Life and Apparent Irrationality: Understanding the Value of Treatments for Infertility.

An increasing number of prospective parents are experiencing infertility along with associated negative impacts on mental health and life satisfaction that can extend across a network of individuals and family members. Assistive reproductive technologies (ART) can help prospective parents achieve their parenthood goals but, like any health technology, they must demonstrate acceptable 'value for money' to qualify for public funding. We argue that current approaches to understanding the value of ART, including quality-adjusted life-year (QALY) gains based on changes in health-related quality of life (HRQOL) and, more often, cost per live birth, are too narrow to capture the full impact of unmet parenthood goals and ART. We see a fundamental disconnect between measures of HRQOL and broader measures of wellbeing associated with met and unmet parenthood goals. We also suggest that simple concepts such as 'patient' and 'carer' are of limited applicability in the context of ART, where 'spillovers' extend across a wide network of individuals, and the person receiving treatment is often not the infertile individual. Consideration of individual and societal wellbeing beyond HRQOL is necessary to understand the full range of negative impacts associated with unmet parenthood goals and the corresponding positive impacts of successful ART. We suggest moving towards a wellbeing perspective on value to achieve a fuller understanding of value and promote cross-sector allocative efficiency.

Considering Severity in Health Technology Assessment: Can We Do Better?

There is strong evidence that individuals and the public assign relatively greater value to health gains from relatively more severe health states. This preference is increasingly reflected in health technology assessment, with some consideration of severity incorporated by health technology assessment bodies in, among others, The Netherlands, England and Wales, Norway, Sweden, and the United States. If a societal "severity premium" is to be considered fairly and consistently, we argue that a more explicit and quantitative approach is needed. We highlight drawbacks of categorical approaches, especially discontinuities between severity categories that arguably violate concepts of vertical equity, and argue that a more continuous approach to understanding severity is needed. We also note challenges to more explicit approaches, including implications of a lower threshold for less severe conditions and the relative complexity of calculating a continuous severity adjustment.

The Relative Importance of Clinical, Economic, Patient Values and Feasibility Criteria in Cancer Drug Reimbursement in Canada: A Revealed Preferences Analysis of Recommendations of the Pan-Canadian Oncology Drug Review 2011-2017.

BACKGROUND: Most Canadian provinces and territories rely on the pan-Canadian Oncology Drug Review (pCODR) to provide recommendations regarding public reimbursement of cancer drugs. The pCODR review process considers four dimensions of value-clinical benefit, economic evaluation, patient-based values and adoption feasibility-but they do not define weights for individual decision criteria or an acceptable threshold for any of the criteria. Given this implicit review process, it is of interest to understand which factors appear to carry the most weight in pCODR recommendations using a revealed preferences approach. METHODS: Using publicly available decision summaries (n = 91) describing submissions and resulting recommendations 2011-2017, we extracted ten attributes that characterized each submission. Using logistic regression, we identified statistically significant attributes and estimated their relative impact in final recommendations. RESULTS: Clinical aspects appear to carry the greatest weight in the decision to reject or not reject, along with aspects of patient value (treatments with no alternatives were less likely to be rejected). Cost effectiveness does not appear to play a role in the initial decision to reject or not reject but is critical in full versus conditional approvals. There is evidence of a maximum acceptable threshold of around $Can140,000 per quality-adjusted life-year (QALY) gained. CONCLUSION: A set of factors driving pCODR recommendations is identifiable, supporting the consistency of the review process. However, the implicit nature of the review process and the difficulty of extracting and interpreting some of the attribute levels used in the analysis suggests that the process may still lack full transparency.

Adjuvant Statin Therapy for Esophageal Adenocarcinoma: A Cost-Utility Analysis.

BACKGROUND: Emerging preclinical evidence indicates statins, medications commonly used in the prevention of cardiovascular disease (CVD), inhibit proliferation, promote apoptosis and limit invasiveness of esophageal adenocarcinoma (EAC). Population-based observational data demonstrate statin treatment after diagnosis of EAC is associated with significant reductions in all-cause and cancer-specific mortality. A feasibility study of adjuvant statin therapy following potentially curative resection for EAC has been completed, with planned progression to a full phase III, randomized controlled trial. OBJECTIVE: The aim was to estimate the cost-utility of statin therapy following surgical resection for EAC from a UK National Health Service (NHS) perspective. METHODS: A Markov model was developed to estimate the costs and outcomes [quality-adjusted life years (QALYs)] for hypothetical cohorts of patients with EAC exposed or not exposed to statins following potentially curative surgical resection. Model parameters were based on estimates from published observational and trial data. Costs, utilities and transition probabilities were modeled to reflect clinical practice from a payer's perspective. Probabilistic and one-way sensitivity analyses were performed to account for uncertainty in key parameters. RESULTS: Overall, a cost saving of £6781 per patient was realized with statin treatment compared to no statins. In probabilistic sensitivity analysis, 99% of all iterations were cost saving and 99% of all iterations were less than £20,000 per QALY gained. These results were robust to changes in the price and effectiveness of statins. CONCLUSIONS: The cohort exposed to statins had lower costs and better QALY outcomes than the no statin cohort. Assuming a causal improvement in disease outcomes following resection for EAC, statin therapy is very likely to be a cost-saving treatment.

On Effective Graphic Communication of Health Inequality: Considerations for Health Policy Researchers.

Policy Points: Effective graphs can be a powerful tool in communicating health inequality. The choice of graphs is often based on preferences and familiarity rather than science. According to the literature on graph perception, effective graphs allow human brains to decode visual cues easily. Dot charts are easier to decode than bar charts, and thus they are more effective. Dot charts are a flexible and versatile way to display information about health inequality. Consistent with the health risk communication literature, the captions accompanying health inequality graphs should provide a numerical, explicitly calculated description of health inequality, expressed in absolute and relative terms, from carefully thought-out perspectives. CONTEXT: Graphs are an essential tool for communicating health inequality, a key health policy concern. The choice of graphs is often driven by personal preferences and familiarity. Our article is aimed at health policy researchers developing health inequality graphs for policy and scientific audiences and seeks to (1) raise awareness of the effective use of graphs in communicating health inequality; (2) advocate for a particular type of graph (ie, dot charts) to depict health inequality; and (3) suggest key considerations for the captions accompanying health inequality graphs. METHODS: Using composite review methods, we selected the prevailing recommendations for improving graphs in scientific reporting. To find the origins of these recommendations, we reviewed the literature on graph perception and then applied what we learned to the context of health inequality. In addition, drawing from the numeracy literature in health risk communication, we examined numeric and verbal formats to explain health inequality graphs. FINDINGS: Many disciplines offer commonsense recommendations for visually presenting quantitative data. The literature on graph perception, which defines effective graphs as those allowing the easy decoding of visual cues in human brains, shows that with their more accurate and easier-to-decode visual cues, dot charts are more effective than bar charts. Dot charts can flexibly present a large amount of information in limited space. They also can easily accommodate typical health inequality information to describe a health variable (eg, life expectancy) by an inequality domain (eg, income) with domain groups (eg, poor and rich) in a population (eg, Canada) over time periods (eg, 2010 and 2017). The numeracy literature suggests that a health inequality graph's caption should provide a numerical, explicitly calculated description of health inequality expressed in absolute and relative terms, from carefully thought-out perspectives. CONCLUSIONS: Given the ubiquity of graphs, the health inequality field should learn from the vibrant multidisciplinary literature how to construct effective graphic communications, especially by considering to use dot charts.

Is febrile neutropenia prophylaxis with granulocyte-colony stimulating factors economically justified for adjuvant TC chemotherapy in breast cancer?

PURPOSE: Febrile neutropenia (FN) during adjuvant chemotherapy is associated with morbidity, mortality risk, and substantial cost, and subsequent chemotherapy dose reductions may result in poorer outcomes. Patients at high risk of, or who develop FN, often receive prophylaxis with granulocyte colony-stimulating factors (G-CSF). We investigated whether different prophylaxis strategies with G-CSF offered favorable value-for-money. METHODS: We developed a decision model to estimate the short- and long-term costs and outcomes of a hypothetical cohort of women with breast cancer receiving adjuvant taxotere + cyclophosphamide (TC) chemotherapy. The short-term phase estimated upfront costs and FN risks with adjuvant TC chemotherapy without G-CSF prophylaxis (i.e., chemotherapy dose reductions) as well as with secondary and primary G-CSF prophylaxis strategies. The long-term phase estimated the expected costs and quality-adjusted life years (QALYs) for patients who completed adjuvant TC chemotherapy with or without one or more episodes of FN. RESULTS: Secondary G-CSF was associated with lower costs and greater QALY gains than a no G-CSF strategy. Primary G-CSF appears likely to be cost-effective relative to secondary G-CSF at FN rates greater than 28%, assuming some loss of chemotherapy efficacy at lower dose intensities. The cost-effectiveness of primary vs. secondary G-CSF was sensitive to FN risk and mortality, and loss of chemotherapy efficacy following FN. CONCLUSIONS: Secondary G-CSF is more effective and less costly than a no G-CSF strategy. Primary G-CSF may be justified at higher willingness-to-pay thresholds and/or higher FN risks, but this threshold FN risk appears to be higher than the 20% rate recommended by current clinical guidelines.

Constant-sum paired comparisons for eliciting stated preferences: a tutorial.

There is growing recognition of the importance of formally including public preferences and values in societal decision-making processes. Constant-sum paired comparison (CSPC), sometimes known as a 'budget pie' task, is a stated preference method than can be used to elicit and measure these preferences and values. It requires respondents to allocate resources between two alternatives, and the relative allocation of this resource is assumed to reflect the importance or priority that respondents attach to the attribute levels in each alternative. CSPC is useful in addressing questions over preferences for the distribution of resources, and allows for an explicit linkage of budget constraints, opportunity costs, outcomes and group characteristics. A key property of CSPC is the ability to allocate some resources to the less preferred alternative, forcing respondents to reflect on the relative value of both alternatives, and possibly giving it an advantage in contexts such as healthcare where respondents may find it ethically difficult or objectionable to make all-or-nothing allocations. This tutorial will outline the theory underlying CSPC, and will work through a detailed example of administering and interpreting a CSPC elicitation, including defining attributes and levels, constructing experimental design, task presentation, and analysis and interpretation.

Societal preferences for distributive justice in the allocation of health care resources: a latent class discrete choice experiment.

Economic theory suggests that resources should be allocated in a way that produces the greatest outputs, on the grounds that maximizing output allows for a redistribution that could benefit everyone. In health care, this is known as QALY (quality-adjusted life-year) maximization. This justification for QALY maximization may not hold, though, as it is difficult to reallocate health. Therefore, the allocation of health care should be seen as a matter of distributive justice as well as efficiency. A discrete choice experiment was undertaken to test consistency with the principles of QALY maximization and to quantify the willingness to trade life-year gains for distributive justice. An empirical ethics process was used to identify attributes that appeared relevant and ethically justified: patient age, severity (decomposed into initial quality and life expectancy), final health state, duration of benefit, and distributional concerns. Only 3% of respondents maximized QALYs with every choice, but scenarios with larger aggregate QALY gains were chosen more often and a majority of respondents maximized QALYs in a majority of their choices. However, respondents also appeared willing to prioritize smaller gains to preferred groups over larger gains to less preferred groups. Marginal analyses found a statistically significant preference for younger patients and a wider distribution of gains, as well as an aversion to patients with the shortest life expectancy or a poor final health state. These results support the existence of an equity-efficiency tradeoff and suggest that well-being could be enhanced by giving priority to programs that best satisfy societal preferences. Societal preferences could be incorporated through the use of explicit equity weights, although more research is required before such weights can be used in priority setting.

Choosing vs. allocating: discrete choice experiments and constant-sum paired comparisons for the elicitation of societal preferences.

BACKGROUND: There is growing evidence of a reluctance to allocate health care solely on the basis of maximizing quality-adjusted life years (QALYs). Stated preference methods can be used to elicit preferences for efficiency vs. equity in the allocation of health-care resources. OBJECTIVE: To compare discrete choice experiment (DCE) and constant-sum paired comparison (CSPC) methods for eliciting societal preferences. METHODS: Over a series of choice pairs, DCE respondents allocated a fixed budget to one preferred group and CSPC respondents allocated budget percentages between the groups. Questionnaires were compared in terms of completion rates, preference consistency, dominant preferences and derived attribute importance. RESULTS: There was no significant difference in the proportions that rated the questionnaires somewhat or extremely difficult, but a significantly greater proportion completed the DCE compared to the CSPC. Preference consistency was also higher in the DCE. The incidence of dominant preferences, including for aggregate QALYs, was low and not significantly different between questionnaires. Similarly, no CSCP respondents equalized budgets or outcomes in every task. Final health state was the most important attribute in both questionnaires, but the rankings diverged for the other attributes. Notably, the total patients' treated attribute was important in the CSPC but insignificant in the DCE, perhaps reflecting a 'prominence effect'. CONCLUSIONS: Despite lower completion rates and preference consistency, CSPC may offer advantages over DCE in eliciting preferences over the distribution of resources and/or outcomes as well as attribute levels, avoiding extreme 'all-or-nothing' distributions and possibly aligning respondent attention more closely with a societal perspective.

Clinical benefits and economic impact of post-surgical care provided by pharmacists in a Canadian hospital.

OBJECTIVE: Clinical pharmacists improve the quality of patient care by reducing adverse drug events (ADEs), length of stay and mortality. This impact is currently not well described in surgery. The objective was to evaluate clinical and economic outcomes after clinical pharmacist services were added to two general surgical wards in an adult hospital. METHODS: This was a prospective, observational study. All clinical interventions to resolve drug therapy problems were documented and assessed for severity, value and the probability of preventing an ADE. Cost avoidance was calculated using two methods: by avoiding additional days in hospital (CA$3593/ADE) or additional hospital costs ($7215/ADE). Two clinical pharmacy specialists and the surgical care pharmacist independently categorized the interventions; disagreements were resolved by consensus. KEY FINDINGS: The pharmacists made 1097 interventions in 6 months with a 98% acceptance rate by surgical staff. Half of the interventions were rated significant for severity (561, 51.1%) and value (559, 51.0%). One-quarter of the interventions had a 40% or greater probability of preventing an ADE (270, 24.6%). Cost avoidance was estimated to be $0.68-1.36 million or $617-1239 per intervention. Pharmacists avoided an additional 867 days in the hospital for surgical patients. CONCLUSION: The pharmacist's role in the management of the drug therapy needs of the post-surgical patient has the potential to improve clinical and patient outcomes and avoid healthcare costs. The inclusion of clinical pharmacists in surgical wards may result in $7 in savings for every $1 invested.

Is the 21-gene recurrence score a cost-effective assay in endocrine-sensitive node-negative breast cancer?

The 21-gene recurrence score (RS) is a gene expression profile assay currently endorsed for use in patients with endocrine-sensitive node-negative breast cancers. The RS has been shown to augment current 'prognostic' and 'predictive' assessments of relapse risk and chemotherapy benefits, respectively, and lead to significant change in oncologists' recommendations for adjuvant chemotherapy, with an overall reduction in chemotherapy utilization. The RS (Oncotype DX) is marketed by Genomic Health Inc. (CA, USA) and currently retails for approximately US$4290 per patient. Like all novel tests/therapies, however, these upfront costs should be examined in the context of all its clinical benefits through cost-effectiveness or cost-utility evaluations. This review highlights the clinical evidence supporting RS testing for patients with endocrine-sensitive node-negative breast cancers, and examines all published economic evaluations that examined its 'value for money' in this setting.

Intermittent LHRH therapy in the management of castrate-resistant prostate cancer (CRPCa): results of a multi-institutional randomized prospective clinical trial.

BACKGROUND: Patients who develop castration-resistant prostate cancer (CRPCa) typically continue on androgen deprivation therapy (ADT). Whether these patients need to remain on ADT has not been well studied. We conducted a multicenter randomized trial to compare an intermittent versus continuous approach to ADT in CRPCa patients. Overall survival, health-related quality of life (QOL), and cost were the main endpoints. METHODS: CRPCa patients were randomized 2:1 to intermittent or continuous luteinizing hormone-releasing hormone agonists (LHRHa). Patients were followed with clinical assessments, laboratory investigations, and QOL questionnaires (EORTC QLQ-C30 or PROSQOLI) every 2 months. If the serum testosterone rose above castrate levels (1.75 nmol/L), LHRHa were reinitiated. The study was designed to close if >50% of patients needed to restart ADT in the intermittent arm. RESULTS: Thirty-one patients were followed with a median follow-up of 26.8 months-18 in the intermittent arm and 13 in the continuous. Twelve of 18 patients on the intermittent arm were reinitiated on LHRHa at a median time of 17.9 months. There was no difference in overall or cancer-specific survival between the 2 arms. There was no statistically significant difference in QOL between the 2 arms at 0 and 12 months. The total mean costs at 24 months were significantly lower in the intermittent arm ($3135 vs. $8253 Canadian dollars, P=0.0167) compared with the continuous. The main limitation of this study is the small sample size. CONCLUSIONS: We have observed that intermittent ADT in patients with CRPCa, using a testosterone of >1.75 ngmol/L as a trigger to reinitiate LHRHa, results in a substantial cost savings with no negative impact on oncologic and QOL outcomes.

Cost-utility of the 21-gene recurrence score assay in node-negative and node-positive breast cancer.

The 21-gene recurrence score (Oncotype DX: RS) appears to augment clinico-pathologic prognostication and is predictive of adjuvant chemotherapy benefit in node-negative (N-) and node-positive (N+), endocrine-sensitive breast cancer. RS is a costly assay that is associated with good 'value for money' in N- disease, while economic evaluations in N+ disease based on most recent data have not been conducted. We examined the cost-utility (CU) of a RS-guided adjuvant strategy, compared to current practice without RS in N- and N+, endocrine-sensitive, breast cancer from a Canadian health care system perspective. A generic state-transition model was developed to compute cumulative costs and quality-adjusted life years (QALYs) over a 25-year horizon. Patient outcomes with and without chemotherapy in RS-untested cohorts and in those with low, intermediate and high RS were examined based on the reported prognostic and predictive impact of RS in N- and N+ disease. Chemotherapy utilization (current vs. RS-guided), unit costs and utilities were derived from a Nova Scotia Canadian population-based cohort, local unit costs and the literature. Costs and outcomes were discounted at 3% annually, and costs were reported in 2011 Canadian dollars ($). Probabilistic and one-way sensitivity analyses were conducted for key model parameters. Compared to a non-RS-guided strategy, RS-guided adjuvant therapy was associated with $2,585 and $864 incremental costs, 0.27 and 0.06 QALY gains, and resultant CUs of $9,591 and $14,844 per QALY gained for N- and N+ disease, respectively. CU estimates were robust to key model parameters, and were most sensitive to chemo utilization proportions. RS-guided adjuvant therapy appears to be a cost-effective strategy in both N- and N+, endocrine-sensitive breast cancer with resultant CU ratios well below commonly quoted thresholds.

An incremental economic evaluation of targeted and universal influenza vaccination in pregnant women.

OBJECTIVE: Pregnancy is associated with increased influenza hospitalizations and physician visits (events) in healthy women and those with co-morbidities. Annual influenza immunization is recommended for all pregnant women. Although vaccination is expected to reduce influenza-related events, the economic implications are unclear. We developed an economic model to estimate the cost-effectiveness (CE) of different vaccination strategies in Nova Scotia. METHODS: A decision tree characterized the one-year costs and consequences of targeted (pregnant women with co-morbidities only) and universal (all pregnant women) vaccination strategies relative to a no-vaccination strategy. Baseline event probabilities, vaccine effectiveness, costs and quality-of-life weights were derived from individual-level Nova Scotia administrative databases, health system sources and published reports. Sensitivity analyses tested the impact of varying key parameters, including vaccine effectiveness and mode of delivery. RESULTS: Targeted vaccination was cost-saving relative to no vaccination when delivered by public health clinics (PHC) or routine family practitioner (FP) visit. Cost per quality-adjusted life year gained by universal vaccination relative to targeted strategy was < $40,000 when delivered by PHC or routine FP visit. Net cost of universal vaccination by PHC or a routine FP visit was < $10 per pregnant woman. CONCLUSION: Universal vaccination of pregnant women appears cost-effective when delivered by PHC or as part of a routine FP prenatal visit. Targeted vaccination of pregnant women with co-morbidities can be cost-saving, but the possibility of higher vaccine uptake with a universal compared to a targeted strategy must be considered in addition to costs in program planning.

Simultaneous liver kidney transplantation: a medical decision analysis.

BACKGROUND: The use of simultaneous liver kidney transplantation has increased dramatically. When the liver and kidney are available from the same deceased donor, what is the best decision? There are two allocation options. In the combined allocation, both organs are allocated to a liver failure (end-stage liver disease [ESLD]) patient on dialysis leaving an end-stage renal disease (ESRD) patient on dialysis. In split allocation, the liver is allocated to the liver failure patient on dialysis and the kidney to the patient with ESRD. METHODS: A computerized medical decision analysis was performed using published US survival data. The two options were compared by examining differences in projected quality-adjusted life years (QALYs). RESULTS: Combined allocation was the best strategy (+0.806 QALYs) if liver transplant recipients on dialysis have proportionately worse survival compared with kidney failure alone patients on dialysis. However, because some patients with hepatorenal syndrome recover kidney function post-liver transplant alone (LTA), a second analysis incorporated the possibilities of being dialysis free. If the chance of recovery of renal function is 50% rather than 0%, the decision reversed. Here, the split allocation provided 1.02 more total QALYs than the combined allocation. CONCLUSIONS: This study demonstrates that simultaneous liver kidney transplantation is an excellent strategy in most patients with both ESLD and ESRD. However, allocating a kidney to a patient with ESLD, who has the potential to be dialysis free without a kidney transplant, does not maximize overall outcomes when all patients are considered.

The cost-utility of sequential adjuvant trastuzumab in women with Her2/Neu-positive breast cancer: an analysis based on updated results from the HERA Trial.

BACKGROUND: The efficacy of sequential adjuvant trastuzumab (aTZ) after chemotherapy in women with early-stage human epidermal growth factor-2 (HER2/neu)-positive breast cancer reported by the updated Herceptin Adjuvant (HERA) trial appears less favorable than originally reported. Based on these updated results, we estimated the cost-utility (CU) of sequential aTZ relative to chemotherapy alone in terms of incremental cost per quality-adjusted life-year (QALY) gained. METHODS: A Markov model estimated incremental costs and outcomes of 12 months of aTZ after adjuvant chemotherapy in women with HER2/neu-positive breast cancer over a 25-year horizon. The model incorporated four broad health states (disease-free, local recurrence [LCR], distant recurrence [DCR], death), stratified with or without symptomatic cardiotoxicity. Baseline event rates and 3-year relative risk (RR = 0.75) were derived from the HERA trial. As the duration of the benefit remains uncertain, the analysis considered 5-year and 3-year duration of benefit in two scenarios. Costs and utility weights were from the literature. The analysis took a direct payer perspective, with costs reported in 2007 Canadian dollars. Costs and QALYs were discounted by 3% annually. RESULTS: The mean CU of sequential aTZ at a 25-year horizon was $72,292 per QALY gained in the 5-year scenario and $127,862 per QALY gained in the 3-year scenario. Results were particularly sensitive to the magnitude and duration of carryover benefit. CONCLUSIONS: The CU of sequential aTZ is primarily dependent on the magnitude and duration of benefit. Further clinical research is required to establish the optimum sequence and duration of aTZ therapy and clarify the magnitude and duration of treatment benefit.

Gout in the elderly--a population health study.

OBJECTIVE: To determine the incidence, healthcare utilization, and costs in older adults with gout. METHODS: A 5-year retrospective case-control study of patients with incident gout and matched controls was performed. Study variables were derived from health administrative data and included patient demographics, International Classification of Diseases diagnostic codes, and healthcare cost information. RESULTS: There were 4,071 cases and 16,281 controls, providing a 5-year incidence of gout of 4.4%. The mean (+/-SD) age (77+/-7.3 and 76+/-7.1 yrs) and the male:female ratio (1.0:1.04) were similar in both groups. Gout was diagnosed by family physicians (77%), nonrheumatology subspecialists (18%), general internists (4%), and rheumatologists (0.02%). Hospitalizations were significantly higher in cases (p<0.001) in the year of diagnosis. Patients with gout had an average of 28.1 physician visits per year compared to 20.6 for controls (p<0.0001). Drug utilization for the treatment (nonsteroidal antiinflammatory drugs, colchicine, corticosteroids) and prevention (allopurinol, probenecid, sulfinpyrazone) of gout was significantly higher (p<0.0001). The average healthcare cost differential was +$134 (Cdn) per month (p<0.001) and +$8,020 per case over 5 years. These costs were due to hospital utilization (64.4%), medications (23.1%), and physician visits (12.5%). CONCLUSION: Gout is associated with a high disease burden in older men and women. The cost is primarily attributable to hospitalization, probably due to the comorbidities associated with gout. As the majority of cases are managed by nonrheumatologists, it is important that guidelines for the diagnosis and treatment of gout are disseminated to and met by all physician groups.

Adjuvant chemotherapy for breast cancer: a cost-utility analysis of FEC-D vs. FEC 100.

BACKGROUND: Adjuvant 5-flurouracil, epirubicin and cyclophosphamide-docetaxel (FEC-D) has been shown to improve disease-free and overall survival (DFS and OS), compared to FEC 100, for node-positive breast cancer. An economic evaluation was undertaken to examine the cost-utility (CU) of FEC-D relative to FEC 100 given possible differences in cost between the two regimens. METHODS: A Markov model was developed to calculate the cumulative costs and quality-adjusted life years (QALY) gained over a 10-year horizon for a hypothetical cohort of 1,000 women with node-positive breast cancer treated with FEC 100 or FEC-D. Event rates, costs, and utilities were derived from the literature. Efficacy outcomes were based primarily on the hazard ratio of DFS for all patients, but separate analyses were also conducted according to age and menopausal status as per the PACS 01 subgroup analysis results. The model took a third-party direct payer perspective and reports results in 2006 Canadian dollars ($). Both costs and benefits were discounted at 3%. RESULTS: FEC-D is associated with 0.156 QALY gain and a $2,280 incremental cost compared to FEC 100, with a CU of $14,612/QALY gained. Results were robust to model assumptions and input parameters in a sensitivity analysis but were marginal in pre-menopausal and younger women. CONCLUSIONS: Adjuvant FEC-D is a cost-effective alternative to FEC 100, with a cost-effectiveness ratio well below commonly employed thresholds. The CU according to age and menopausal status should be considered in view of the potential differences in efficacy in these subgroups, if any.