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Respiratory syncytial virus (RSV) is a major cause of acute respiratory infection (ARI), with high morbidity and mortality worldwide. RSV costing and burden estimates can highlight the potential benefits of future vaccination programs and are essential for economic evaluations.We aimed to determine RSV healthcare costs across age groups and the overall disease burden of medically attended RSV in Canada.We conducted a retrospective case-control study to estimate the attributable healthcare costs per RSV case in Alberta. We used two case definitions to capture diversity in case severity: laboratory-confirmed RSV and ARI attributable to RSV. Matching occurred on five criteria: (1) age, (2) urban/rural status, (3) sex, (4) prematurity and (5) Charlson Comorbidity Index score. We calculated the age-specific burden of medically attended RSV in Canada from 2010 to 2019 by multiplying the weekly age-specific incidence of medically attended ARI with the RSV positivity rate.Costs per laboratory-confirmed RSV case were (in Canadian dollars [CAD], year 2020 values) $CAD12,713 and 40,028 in the first 30 and 365 days following diagnosis, respectively, whereas a case of ARI potentially attributable to RSV cost $CAD316 and 915, in 30 and 365 days, respectively. Older (aged ≥ 65 years) and younger (aged 90 days) age groups had the highest case costs. The average medically attended RSV incidence rate across nine seasons was 1743 cases per 100,000 people per year.RSV is a common and expensive infection at the extremes of life, and the development of immunization programs targeting older and younger ages may be important for the reduction of RSV burden and cost. more...

Background Decisions based on cost-effectiveness analyses (CEAs) using equal discount rates for health and cost outcomes are consistent with using a constant cost-effectiveness threshold over time. We sought to analyze trends in author-reported cost per quality-adjusted life-year (QALY) thresholds from CEAs published for the US setting over 24 y to retrospectively assess whether the recommended equal discount rates for costs and health were consistent with trends in the CEA literature. Methods We used the Tufts CEA Registry to assess whether author-reported cost-effectiveness thresholds changed in CEAs published for the US setting between 1995 and 2018 and back-calculated the implied discount rate for health based on these trends for inflation-adjusted cost-effectiveness thresholds and an annual discount rate for costs of 3%. Results We found 1995 CEAs published for the US setting and found that average nominal and inflation-adjusted cost-effectiveness thresholds increased over that time period. The discount rate for health would need to equal 2.43% to 2.48% (depending on the subset of CEAs analyzed) to be consistent with the observed trends in inflation-adjusted author-reported cost-effectiveness thresholds. We also found that restricting our analysis to currency years between 1995 and 2014 would result in a back-calculated discount rate for health of 2.99% to 3.28%. Conclusions We found that CEA researchers have implicitly assumed that inflation-adjusted cost-effectiveness thresholds in the United States have been increasing over time (1995–2018), which is inconsistent with the recommended and prevailing choice of equal discount rates for health and cost outcomes. Our results are sensitive to the cutoff year used in the analysis. Highlights We show visually and through equations that the recommended and prevailing practice of using equal discount rates for cost and health outcomes in cost-effectiveness analyses (CEAs) logically implies a constant inflation-adjusted cost-effectiveness threshold over time. Using data from the Tufts CEA Registry, we found that author-reported cost-effectiveness thresholds used in CEAs published for the US setting with currency years between 1995 and 2018 increased over time (both with and without adjustment for inflation). Assuming an annual discount rate for costs equal to 3%, the discount rate for health would need to equal approximately 2.5% to preserve consistency across decisions taken at different dates given the observed trends in inflation-adjusted author-reported cost-effectiveness thresholds. This finding depends on the cutoff year used in the analysis (data from currency years 1995–2014 would support use of equal discount rates, whereas data after 2014 would suggest a sharper trend toward increasing cost-effectiveness thresholds). more...

Objective This study aims to determine how population-based health-utility score (HUS) differences reflect individuals’ health preferences using responses from the Canadian EQ-5D-5L Valuation Study, including time trade-off (TTO) and discrete-choice experiment (DCE) tasks (n=1073). Study Design and Setting Cardinal TTO responses were transformed into pairwise comparisons to yield ordinal TTO responses. We investigated how EQ-5D-5L HUS differences differ from participants’ stated cardinal preferences, and determined the smallest HUS difference that may be expected to represent participants’ ordinal preferences. Results HUS differences near 0 have 30.6% (95% confidence interval: 29.1 to 31.9%) probability of representing a tie in individuals’ TTO values. Differences in EQ-5D-5L HUS of -0.054 (-0.071 to -0.029) and 0.047 (0.026 to 0.076) maximized the sensitivity and specificity of discriminating transitions to worse/better health states. For small HUS differences of +/-0.03 to +/-0.07, the magnitude of respondents’ average TTO difference on the cardinal scale was 0.17 and 0.35 whether ties were included or excluded, respectively. Absolute HUS differences between 0.043 and 0.064 had a 50% probability of representing respondents’ ordinal preferences. Conclusion A HUS needs to be large enough to reflect individuals’ stated health preferences, which may lend support to the application of a minimally important difference for decision-making. more...

Many health technology assessment committees have an explicit or implicit reference value (often referred to as a ‘threshold’) below which new health technologies or interventions are considered value for money. The basis for these reference values is unclear but one argument is that it should be based on the health opportunity costs of funding decisions. Empirical estimates of the marginal cost per unit of health produced by a healthcare system have been proposed to capture the health opportunity costs of new funding decisions. Based on a systematic search, we identified eight studies that have sought to estimate a reference value through empirical estimation of the marginal cost per unit of health produced by a healthcare system for England, Spain, Australia, The Netherlands, Sweden, South Africa and China. We review these eight studies to provide an overview of the key methodological approaches taken to estimate the marginal cost per unit of health produced by the healthcare system with the aim to help inform future estimates for additional countries. The lead author for each of these papers was invited to contribute to the current paper to ensure all the key methodological issues encountered were appropriately captured. These included consideration of the key variables required and their measurement, accounting for endogeneity of spending to health outcomes, the inclusion of lagged spending, discounting and future costs, the use of analytical weights, level of disease aggregation, expected duration of health gains, and modelling approaches to estimating mortality and morbidity effects of health spending. Subsequent research estimates for additional countries should (1) carefully consider the specific context and data available, (2) clearly and transparently report the assumptions made and include stakeholder perspectives on their appropriateness and acceptability, and (3) assess the sensitivity of the preferred central estimate to these assumptions. Supplementary Information The online version contains supplementary material available at 10.1007/s40273-021-01087-6. more...

We propose a modified quality-adjusted life year (QALY) calculation that aims to be consistent with guidance for interpreting change in patient-reported outcomes. This calculation incorporates the minimally important difference (MID) in generic preference-based health-related quality of life (HRQL) change scores to reflect what might be considered meaningful HRQL improvement/deterioration. In doing so, we review common issues in QALY calculations such as adjustment for baseline scores and standardizing for between-group differences. Using EQ-5D-5L outcome data from the Alberta TEAMCare-Primary Care Network trial in the management of depression for patients with type 2 diabetes (n = 98), this study compared results from different QALY calculation methods to investigate the impact of (i) adjusting for baseline HRQL score, (ii) standardizing between-group differences at baseline, and (iii) adjusting for ‘meaningful’ HRQL changes. The following QALY calculation methods are examined: area under curve (QALY-AUC), change from baseline (QALY-CFB), regression modelling (QALY-R), and incorporating an MID for HRQL changes from baseline (QALY-MID). The incremental QALY-AUC estimate favoured the Collaborative Care group (0.031) while the incremental QALY-CFB (−0.028) estimate favoured Enhanced Care. Adjusting for meaningful HRQL changes resulted in a crude incremental QALY-MID of −0.023; however, after adjusting for between-group differences at baseline, QALY-R and adjusted incremental QALY-MID estimates were −0.007 and −0.001, respectively. In addition, recursive regression analyses showed that very low baseline HRQL scores impact incremental QALY estimates. Uncertainty in incremental QALY estimates reflects uncertainty in the value of small within-individual change as well as the impact of small differences between groups at baseline. Applying a responder-definition approach yielded crude and adjusted QALY-MID estimates that were more in favour of Collaborative Care than QALY-CFB and QALY-R estimates, respectively, suggesting that ambiguous small changes in HRQL scores have the potential to influence QALY outcomes used in economic or non-economic applications. more...

The UK's National Institute for Health and Care Excellence (NICE) recently launched a consultation on the methods it uses to evaluate new health technologies, and has highlighted the issue of how 'modifiers', including equity weights, should be incorporated into its processes. The practice of applying equity weights to specific population subgroups, as a means for increasing the effective cost-effectiveness threshold for some new health technologies, is well established in health technology assessment. It is also the subject of extensive discussion in the academic literature. In this paper, we demonstrate that NICE's current approach to equity weighting has the effect of reducing both population health and equity-weighted population health, a fundamental problem that appears to place NICE in contravention of its principles and obligations. We consider two potential methods for modifying NICE's current approach to address this problem. We also consider the merits of NICE abandoning its current approach to equity weighting and adopting a standard 'net benefit' approach in its place. We find that adopting a standard 'net benefit' approach is the most desirable option, as it provides for the most transparency while avoiding specific issues that arise when attempting to modify NICE's current approach. Regardless of the approach NICE uses for equity weighting, we find that protecting the health of National Health Service patients requires that some new technologies be evaluated using an effective cost-effectiveness threshold lower than the 'supply-side' cost-effectiveness threshold. This poses a particular challenge for NICE, given its obligations under the 2019 'Voluntary Scheme' between the UK pharmaceutical industry, the National Health Service, and the UK Government. We conclude by making some recommendations as to how NICE can move forward with the use of 'modifiers' in its decision making. more...

The National Institute of Health and Care Excellence (NICE) recently published a review of discounting practice and theory as part of a consultation on its current methods guidelines. The review examines the case for revision or retention of current methods. The changes considered include eliminating favourable rates in certain special cases and the reduction of the base-case rate for costs and health effects from 3.5 to 1.5%. The review also notes the potential need to reduce the cost-effectiveness threshold to accommodate a discount rate reduction, explaining that an agreement between the UK government and the pharmaceutical industry proscribes changing NICE's threshold range until the end of 2023. We believe NICE should be commended for a useful overview of the existing literature and relevant issues. We firmly endorse NICE's view that favourable discount rates are not a good way to apply a preference for certain interventions. Similarly, we support the option of reducing the discount rate to 1.5%, which better accords with real government borrowing costs. We suggest further work to clarify the appropriate theoretical basis for the NICE's social discount rate and the sensitivity of the threshold to changes in discounting. The prospects of a necessary discount rate reduction appear to depend on whether a threshold reduction can be achieved within NICE's current range or if the range itself must be revised downwards. NICE has usefully informed the debate around discount rates. Ultimately, the path to a methodologically consistent and evidence-based revision of discounting depends on whether NICE needs to adjust the threshold too and if it is free to do so. more...

Although there have been substantial developments in the analysis of uncertainty in economic evaluations of health care programmes, the development of methods for one-way sensitivity analysis has been notably slower. Conditional incremental net benefit was recently proposed as an approach for implementing probabilistic one-way sensitivity analysis for economic evaluations comparing two strategies. In this paper, we generalise this approach to economic evaluations that compare three or more strategies. We find that ‘conditional net benefit’ may be used to conduct probabilistic one-way sensitivity analysis for economic evaluations comparing any number of strategies. We also propose the ‘conditional net benefit frontier’, which may be used to identify the most cost-effective of any number of strategies conditional upon the specific value of a parameter of interest. more...

The quality of reporting of health economic evaluations for rehabilitation services has been questioned, limiting the ability to provide accurate recommendations for health decisions.To document current overall reporting quality of the published literature for economic evaluations of rehabilitation services using the Consolidated Health Economic Evaluation Reporting Standards (CHEERS), and to identify factors that could influence the quality of reporting.Electronic literature searches were performed using MEDLINE and the NHS Economic Evaluations DatabaseProspective rehabilitation economic evaluation articles from 2013 to 2020 were selected.Data were extracted by one reviewer and independently verified by a second reviewer.Title and abstracts of 3,454 papers were reviewed. 204 papers were selected for a full text screening. From those, 129 potential papers were identified to be included in this study.Only two databases were used in data collection, and papers were selected from 2013 to 2020 only.Inconsistent reporting in health economic evaluations of rehabilitation services has continued, despite the availability of the CHEERS checklist. The methods of the analyzed studies were frequently under-reported, thereby creating challenges in determining whether the results reported were valid.IMPLICATIONS FOR REHABILITATIONVariable quality of reporting has been identified in rehabilitation research assessing cost-effectiveness.To grow as an area of expertise, the field of rehabilitation must produce research demonstrating its cost-effectiveness.Both rehabilitation clinicians and funders would benefit from full and transparent information to identify optimal solutions for effective and efficient care. more...

Although probabilistic analysis has become the accepted standard for decision analytic cost-effectiveness models, deterministic one-way sensitivity analysis continues to be used to meet the need of decision makers to understand the impact that changing the value taken by one specific parameter has on the results of the analysis. The value of a probabilistic form of one-way sensitivity analysis has been recognised, but the proposed methods are computationally intensive. Deterministic one-way sensitivity analysis provides decision makers with biased and incomplete information whereas, in contrast, probabilistic one-way sensitivity analysis (POSA) can overcome these limitations, an observation supported in this study by results obtained when these methods were applied to a previously published cost-effectiveness analysis to produce a conditional incremental expected net benefit curve. The application of POSA will provide decision makers with unbiased information on how the expected net benefit is affected by a parameter taking on a specific value and the probability that the specific value will be observed. more...

Gene expression profiling (GEP) testing using 12-gene recurrence score (RS) assay (EndoPredict®), 58-gene RS assay (Prosigna®), and 21-gene RS assay (Oncotype DX®) is available to aid in chemotherapy decision-making when traditional clinicopathological predictors are insufficient to accurately determine recurrence risk in women with axillary lymph node-negative, hormone receptor-positive, and human epidermal growth factor-receptor 2-negative early-stage breast cancer. We examined the cost-effectiveness of incorporating these assays into standard practice. A decision model was built to project lifetime clinical and economic consequences of different adjuvant treatment-guiding strategies. The model was parameterized using follow-up data from a secondary analysis of the Anastrozole or Tamoxifen Alone or Combined randomized trial, cost data (2017 Canadian dollars) from the London Regional Cancer Program (Canada) and secondary Canadian sources. The 12-gene, 58-gene, and 21-gene RS assays were associated with cost-effectiveness ratios of $36,274, $48,525, and $74,911/quality-adjusted life year (QALY) gained and resulted in total gains of 379, 284.3, and 189.5 QALYs/year and total budgets of $12.9, $14.2, and $16.6 million/year, respectively. The total expected-value of perfect information about GEP assays' utility was $10.4 million/year. GEP testing using any of these assays is likely clinically and economically attractive. The 12-gene and 58-gene RS assays may improve the cost-effectiveness of GEP testing and offer higher value for money, although prospective evidence is still needed. Comparative field evaluations of GEP assays in real-world practice are associated with a large societal benefit and warranted to determine the optimal and most cost-effective assay for routine use. more...

Objectives Objective of this study is to develop an evidence-based guideline for the noninvasive management of soft tissue disorders of the shoulder (shoulder pain), excluding major pathology. Methods This guideline is based on high-quality evidence from seven systematic reviews. Multidisciplinary experts considered the evidence of effectiveness, safety, cost-effectiveness, societal and ethical values, and patient experiences when formulating recommendations. Target audience is clinicians; target population is adults with shoulder pain. Results When managing patients with shoulder pain, clinicians should (a) rule out major structural or other pathologies as the cause of shoulder pain and reassure patients about the benign and self-limited nature of most soft tissue shoulder pain; (b) develop a care plan in partnership with the patient; (c) for shoulder pain of any duration, consider low-level laser therapy; multimodal care (heat/cold, joint mobilization, and range of motion exercise); cervicothoracic spine manipulation and mobilization for shoulder pain when associated pain or restricted movement of the cervicothoracic spine; or thoracic spine manipulation; (d) for shoulder pain >3-month duration, consider stretching and/or strengthening exercises; laser acupuncture; or general physician care (information, advice, and pharmacological pain management if necessary); (e) for shoulder pain with calcific tendinitis on imaging, consider shock-wave therapy; (f) for shoulder pain of any duration, do not offer ultrasound; taping; interferential current therapy; diacutaneous fibrolysis; soft tissue massage; or cervicothoracic spine manipulation and mobilization as an adjunct to exercise (i.e., range of motion, strengthening and stretching exercise) for pain between the neck and the elbow at rest or during movement of the arm; (g) for shoulder pain >3-month duration, do not offer shock-wave therapy; and (h) should reassess the patient's status at each visit for worsening of symptoms or new physical, mental, or psychological symptoms, or satisfactory recovery. Conclusions Our evidence-based guideline provides recommendations for non-invasive management of shoulder pain. The impact of the guideline in clinical practice requires further evaluation. Significance Shoulder pain of any duration can be effectively treated with laser therapy, multimodal care (i.e., heat/cold, joint mobilization, range of motion exercise), or cervicothoracic manipulation and mobilization. Shoulder pain (>3 months) can be effectively treated with exercises, laser acupuncture, or general physician care (information, advice, and pharmacological pain management if necessary). more...

Introduction Previously developed cesarean section (CS) and emergency CS prediction tools use antenatal and intrapartum risk factors. We aimed to develop a predictive model for the risk of emergency CS before the onset of labour utilizing antenatal obstetric and non-obstetric factors. Methods We completed a secondary analysis of data collected from the CHILD Cohort Study. The analysis was limited to term (≥37 weeks), singleton pregnant women with cephalic presentation. The sample was divided into a training and validation dataset. The emergency CS prediction model was developed in the training dataset and the performance accuracy was assessed by the area under the receiver operating characteristic curve(AUC) of the receiver operating characteristic analysis (ROC). Our final model was subsequently evaluated in the validation dataset. Results The participant sample consisted of 2,836 pregnant women. Mean age of participants was 32 years, mean BMI of 25.4 kg/m2 and 39% were nulliparous. 14% had emergency CS delivery. Each year of increasing maternal age increased the odds of emergency CS by 6% (adjusted Odds Ratio (aOR 1.06,1.02–1.08). Likewise, there was a 4% increase odds of emergency CS for each unit increase in BMI (aOR 1.04,1.02–1.06). In contrast, increase in maternal height has a negative association with emergency CS. The final emergency CS delivery predictive model included six variables (hypertensive disorders of pregnancy, antenatal depression, previous vaginal delivery, age, height, BMI). The AUC for our final prediction model was 0.74 (0.72–0.77) in the training set with a similar AUC in the validation dataset (0.77; 0.71–0.82). Conclusion The developed and validated emergency CS delivery prediction model can be used in counselling prospective parents around their CS risk and healthcare resource planning. Further validation of the tool is suggested. more...

The UK's National Institute for Health and Care Excellence (NICE) recently launched a consultation on the methods it uses to evaluate new health technologies, and has highlighted the issue of how 'modifiers', including equity weights, should be incorporated into its processes. The practice of applying equity weights to specific population subgroups, as a means for increasing the effective cost-effectiveness threshold for some new health technologies, is well established in health technology assessment. It is also the subject of extensive discussion in the academic literature. In this paper, we demonstrate that NICE's current approach to equity weighting has the effect of reducing both population health and equity-weighted population health, a fundamental problem that appears to place NICE in contravention of its principles and obligations. We consider two potential methods for modifying NICE's current approach to address this problem. We also consider the merits of NICE abandoning its current approach to equity weighting and adopting a standard 'net benefit' approach in its place. We find that adopting a standard 'net benefit' approach is the most desirable option, as it provides for the most transparency while avoiding specific issues that arise when attempting to modify NICE's current approach. Regardless of the approach NICE uses for equity weighting, we find that protecting the health of National Health Service patients requires that some new technologies be evaluated using an effective cost-effectiveness threshold lower than the 'supply-side' cost-effectiveness threshold. This poses a particular challenge for NICE, given its obligations under the 2019 'Voluntary Scheme' between the UK pharmaceutical industry, the National Health Service, and the UK Government. We conclude by making some recommendations as to how NICE can move forward with the use of 'modifiers' in its decision making. more...

Purpose Diabetes patients with non-infected neuroischemic diabetic foot ulcers (DFU) treated with sucrose octasulfate (SOS) dressing have been shown to have improved healing compared to patients wearing a similar type of dressing without SOS. This study aimed to estimate the cost-effectiveness of SOS dressing compared to conventional dressings from a Canadian public payer’s perspective. Methods We built a Markov model in a hypothetical cohort of 1,000 type 2 diabetes inpatients with DFU. The time horizon is 5-year, and the cycle length is 3-month. We incorporated effectiveness data from the Explorer trial and cohort studies, cost data (2020 Canadian dollars) from published Canadian studies and administrative data, and utility parameters from the Alberta’s Caring for Diabetes cohort. We calculated the incremental cost-effectiveness ratio (ICER) of SOS dressing compared to conventional dressings using the probabilistic analysis. Results Compared to conventional dressings, adding SOS dressing resulted in an expected increase of 0.16 quality-adjusted life years (QALYs) and an expected $5,878 decrease in health care costs over 5 years. Adding SOS dressing resulted in a cost-saving of $37,061 for every QALY gained. The probability that adding SOS dressing is cost-saving and cost-effective compared to conventional dressings was 89% and 86%, respectively, at a $50,000/QALY willingness-to-pay threshold. Conclusion SOS dressing accelerates ulcer healing and helps reduce the spending induced by persistent ulcer management and amputation. Therefore, SOS dressing is likely to be cost-effective and cost-saving, which is consistent with previous health technology assessments in other healthcare systems. more...

PurposeA range of barriers may constrain the effective implementation of strategies to deliver precision medicine. If the marginal costs and consequences of precision medicine vary at different levels of implementation, then such variation will have an impact on relative cost-effectiveness. This study aimed to illustrate the importance, and quantify the impact, of varying marginal costs and benefits on the value of implementation for a case study in precision medicine.MethodsAn existing method to calculate the value of implementation was adapted to allow marginal costs and consequences of introducing precision medicine into practice to vary across differing levels of implementation. This illustrative analysis used a case study based on a published decision-analytic model-based cost-effectiveness analysis of a 70-gene recurrence score (Mammaprint) for breast cancer. The impact of allowing for varying costs and benefits for the value of the precision medicine and of implementation strategies was illustrated graphically and numerically in both static and dynamic forms. ResultsThe increasing returns to scale exhibited by introducing this specific example of precision medicine mean that a minimum level of implementation (51%) is required for using the 70-gene recurrence score to be cost-effective at a defined threshold of €20,000 per quality adjusted life year. The observed variation in net monetary benefit implies that the value of implementation strategies was dependent on the initial and ending levels of implementation in addition to the magnitude of the increase in patients receiving the 70-gene recurrence score. In dynamic models, incremental losses caused by low implementation accrue over time unless implementation is improved. ConclusionsPoor implementation of approaches to deliver precision medicine, identified to be cost-effective using decision-analytic model-based cost-effectiveness analysis, can have a significant economic impact on health systems. Developing and evaluating the economic impact of strategies to improve the implementation of precision medicine will potentially realise the more cost-effective use of health care budgets. more...

We propose a modified quality-adjusted life year (QALY) calculation that aims to be consistent with guidance for interpreting change in patient-reported outcomes. This calculation incorporates the minimally important difference (MID) in generic preference-based health-related quality of life (HRQL) change scores to reflect what might be considered meaningful HRQL improvement/deterioration. In doing so, we review common issues in QALY calculations such as adjustment for baseline scores and standardizing for between-group differences.Using EQ-5D-5L outcome data from the Alberta TEAMCare-Primary Care Network trial in the management of depression for patients with type 2 diabetes (n = 98), this study compared results from different QALY calculation methods to investigate the impact of (i) adjusting for baseline HRQL score, (ii) standardizing between-group differences at baseline, and (iii) adjusting for 'meaningful' HRQL changes. The following QALY calculation methods are examined: area under curve (QALY-AUC), change from baseline (QALY-CFB), regression modelling (QALY-R), and incorporating an MID for HRQL changes from baseline (QALY-MID).The incremental QALY-AUC estimate favoured the Collaborative Care group (0.031) while the incremental QALY-CFB (-0.028) estimate favoured Enhanced Care. Adjusting for meaningful HRQL changes resulted in a crude incremental QALY-MID of -0.023; however, after adjusting for between-group differences at baseline, QALY-R and adjusted incremental QALY-MID estimates were -0.007 and -0.001, respectively. In addition, recursive regression analyses showed that very low baseline HRQL scores impact incremental QALY estimates.Uncertainty in incremental QALY estimates reflects uncertainty in the value of small within-individual change as well as the impact of small differences between groups at baseline. Applying a responder-definition approach yielded crude and adjusted QALY-MID estimates that were more in favour of Collaborative Care than QALY-CFB and QALY-R estimates, respectively, suggesting that ambiguous small changes in HRQL scores have the potential to influence QALY outcomes used in economic or non-economic applications. more...

Objectives: To develop an evidence-based guideline for the non-pharmacological management of persistent headaches associated with neck pain (i.e., tension-type or cervicogenic). Methods: This guideline is based on systematic reviews of high-quality studies. A multidisciplinary expert panel considered the evidence of clinical benefits, cost-effectiveness, societal and ethical values, and patient experiences when formulating recommendations. Target audience includes clinicians; target population is adults with persistent headaches associated with neck pain. Results: When managing patients with headaches associated with neck pain, clinicians should (a) rule out major structural or other pathologies, or migraine as the cause of headaches; (b) classify headaches associated with neck pain as tension-type headache or cervicogenic headache once other sources of headache pathology has been ruled out; (c) provide care in partnership with the patient and involve the patient in care planning and decision making; (d) provide care in addition to structured patient education; (e) consider low-load endurance craniocervical and cervicoscapular exercises for tension-type headaches (episodic or chronic) or cervicogenic headaches >3 months duration; (f) consider general exercise, multimodal care (spinal mobilization, craniocervical exercise and postural correction) or clinical massage for chronic tension-type headaches; (g) do not offer manipulation of the cervical spine as the sole form of treatment for episodic or chronic tension-type headaches; (h) consider manual therapy (manipulation with or without mobilization) to the cervical and thoracic spine for cervicogenic headaches >3 months duration. However, there is no added benefit in combining spinal manipulation, spinal mobilization and exercises; and (i) reassess the patient at every visit to assess outcomes and determine whether a referral is indicated. Conclusions: Our evidence-based guideline provides recommendations for the conservative management of persistent headaches associated with neck pain. The impact of the guideline in clinical practice requires validation. Significance: Neck pain and headaches are very common comorbidities in the population. Tension-type and cervicogenic headaches can be treated effectively with specific exercises. Manual therapy can be considered as an adjunct therapy to exercise to treat patients with cervicogenic headaches. The management of tension-type and cervicogenic headaches should be patient-centred. more...

For several decades, the incremental cost-effectiveness ratio has been routinely used by health technology assessment agencies around the world to summarise the results of economic evaluations of health interventions. Yet reporting and considering incremental cost-effectiveness ratios is unnecessary. Alternative summary measures exist, based on the concept of ‘net benefit’. The incremental cost-effectiveness ratio and measures of net benefit share several commonalities but some important distinctions. As a result, different methods are required to calculate and interpret incremental cost-effectiveness ratios compared to measures of net benefit. The aim of this practical application is to introduce readers to these methods, using a hypothetical example to illustrate key issues. First, the methods used to calculate each measure are described. Next, for each measure, consideration is made of whether and how each measure may be interpreted to perform the following tasks, each of which may be of interest to health technology assessment agencies: (1) identifying the single most cost-effective strategy; (2) ranking strategies from ‘most’ to ‘least’ cost-effective (on an ordinal scale); (3) determining the magnitude to which a strategy is more or less cost-effective than another strategy (on a cardinal scale); and (4) determining whether a strategy is more or less cost-effective following a sensitivity or scenario analysis. This practical application also introduces a novel approach for visually interpreting measures of net benefit using the cost-effectiveness plane, which addresses a number of limitations of the conventional cost-effectiveness ‘efficiency frontier’. By the end of this practical application, readers should have an understanding of how to calculate and interpret each measure, as well as the relative strengths and limitations of each. more...

Oncotype DX is approved in multiple countries but its cost-effectiveness is a matter of considerable health debate. Lebanon is high-middle income country according to the World Bank classification however it is facing a mounting financial and health care burden from cancer. Therefore, we conducted a costeffectiveness analysis of Oncotype DX based Lebanese on real-life data.We updated a Canadian cost-effectiveness model of Oncotype DX by incorporating Lebanese data. The patient population was a real-life cohort of 82 women diagnosed with hormone receptor - positive and HER2 - negative early breast cancer.Overall, providing Oncotype DX to only intermediate Adjuvant! Online risk patients costs an additional $83 CAD (93,883 LBP) per additional QALY. From this point, extending provision to also cover high Adjuvant! Online risk patients costs an additional $736 CAD (831,578 LBP) per additional QALY. From this point, extending provision further to also cover low Adjuvant! Online risk patients (such that Oncotype DX is provided to all patients) costs an additional $14,562 CAD (16.46m LBP) per additional QALY. Given that most women in our population-based sample were classified as intermediate Adjuvant! Online risk patients, our study focused on this subset in the second analysis. Providing Oncotype DX to intermediate Adjuvant! Online risk patients has a relatively small additional cost compared to not providing Oncotype DX, and results in a relatively large QALY gain. The incremental cost per QALY is $2,022 CAD (2.29m LBP), implying that Oncotype DX is cost-effective for intermediate Adjuvant! Online risk patients if the willingness-to-pay for a QALY is greater than 2.29m LBP.As one of the few economic evaluations to date conducted using Lebanese data, this evaluation provides information to decision makers regarding the cost-effectiveness of providing Oncotype DX to Lebanese patients. more...

The primary focus of this paper is to offer guidance on the analysis of time streams of effects that a project may have so that they can be discounted appropriately. This requires a framework that identifies the common parameters that need to be assessed, whether conducting cost-effectiveness or benefit-cost analysis. The quantification and conversion of the time streams of different effects into their equivalent health, health care cost or consumption effects avoids embedding multiple arguments in discounting policies. This helps to identify where parameters are likely to differ in particular contexts, what type of evidence would be relevant, what is currently known and how this evidence might be strengthened. The current evidence available to support the assessment of the key parameters is discussed and possible estimates and default assumptions are suggested. Reporting the results in an extensive way is recommended. This makes the assessments required explicit so the impact of alternative assumptions can be explored and analysis updated as better estimates evolve. Some projects will have effects across different countries where some or all of these parameters will differ. Therefore, the net present value of a project will be the sum of the country specific net present values rather than the sum of effects across countries discounted at some common rate. more...

Probabilistic sensitivity analysis (PSA) demonstrates the parameter uncertainty in a decision problem. The technique involves sampling parameters from their respective distributions (rather than simply using mean/median parameter values). Guidance in the literature, and from health technology assessment bodies, on the number of simulations that should be performed suggests a 'sufficient number', or until 'convergence', which is seldom defined. The objective of this tutorial is to describe possible outcomes from PSA, discuss appropriate levels of accuracy, and present guidance by which an analyst can determine if a sufficient number of simulations have been conducted, such that results are considered to have converged. The proposed approach considers the variance of the outcomes of interest in cost-effectiveness analysis as a function of the number of simulations. A worked example of the technique is presented using results from a published model, with recommendations made on best practice. While the technique presented remains essentially arbitrary, it does give a mechanism for assessing the level of simulation error, and thus represents an advance over current practice of a round number of simulations with no assessment of model convergence. more...

In publicly funded health care systems, decision makers must continually balance often conflicting priorities of efficiency and equity. Health economists have developed a set of highly sophisticated analytical methods for assessing efficiency, but less attention has been paid to formally incorporating equity considerations into analyses. As a result, where equity is considered is often informal, ad hoc and/or simplistic. This paper is a proposal for a mechanism for formally incorporating equity within the decision process. It begins with an overview of the current literature on equity weighting. It then considers the case of a single equity domain and illustrates how this is currently applied in practice by the UK’s National Institute for Health and Care Excellence. It then proposes a more comprehensive method for considering the multi-attribute equity state, where a population exhibits more than one trait considered worthy of differential weighting. Finally, the paper proposes a mechanism by which this could be applied in practice, and concludes with a discussion of the challenges for applying multi-attribute equity weighting. Electronic supplementary material The online version of this article (doi:10.1007/s10198-017-0897-3) contains supplementary material, which is available to authorized users. more...

The volume and technical complexity of both academic and commercial research using decision analytic modelling has increased rapidly over the last two decades. The range of software programs used for their implementation has also increased, but it remains true that a small number of programs account for the vast majority of cost-effectiveness modelling work. We report a comparison of four software programs: TreeAge Pro, Microsoft Excel, R and MATLAB. Our focus is on software commonly used for building Markov models and decision trees to conduct cohort simulations, given their predominance in the published literature around cost-effectiveness modelling. Our comparison uses three qualitative criteria as proposed by Eddy et al.: "transparency and validation", "learning curve" and "capability". In addition, we introduce the quantitative criterion of processing speed. We also consider the cost of each program to academic users and commercial users. We rank the programs based on each of these criteria. We find that, whilst Microsoft Excel and TreeAge Pro are good programs for educational purposes and for producing the types of analyses typically required by health technology assessment agencies, the efficiency and transparency advantages of programming languages such as MATLAB and R become increasingly valuable when more complex analyses are required. more...

Enzalutamide (Enza) is an effective treatment for metastatic castrate-resistant prostate cancer (mCPRC). However, Enza is not cost-effective (CE) at willingness to pay (WTP) thresholds from $0-$125 000/quality adjusted life years (QALYs) and is therefore a strain on valuable health care dollars. Metformin (Met) is inexpensive (~$8.00/month) and is thought to improve prostate cancer specific and overall survival compared to those not taking Met. We hypothesized that there must be an added effect Met could provide that would make Enza CE thereby alleviating this financial strain on government health care budgets.We constructed a Markov model and performed a threshold analysis to narrow in on the added effect needed to make such a combination therapy cost-effective at various WTP thresholds.At a WTP threshold of $50 000/QALY Enza + Met is unlikely to be CE unless it increases Enza's efficacy by more than 30%. At a WTP threshold of $100 000, Enza + Met could be CE barring Met adds 18.73% to the efficacy of Enza.Enza + Met is unlikely to be CE at WTP thresholds less than $100 000/QALY; these results make sense because a therapy that is not CE at these WTP thresholds by itself is unlikely to be CE with an adjuvant therapy that keep a patient on such a treatment for even longer. Finally, our model suggests that the mCRPC setting is not the optimal place to trial adding Met as the relative costs are high and utility values low. more...

Objectives This paper introduces a framework with which to conceptualize the decision-making process in health technology assessment for new interventions with high budgetary impacts. In such circumstances, the use of a single threshold based on the marginal productivity of the healthcare system is inappropriate. The implications of this for potential partial implementation, horizontal equity, and pharmaceutical pricing are illustrated using this framework. Results Under the condition of perfect divisibility and given an objective of maximizing health, a large budgetary impact of a new treatment may imply that optimal implementation is partial rather than full, even at a given incremental cost-effectiveness ratio that would nevertheless mean the decision to accept the treatment in full would not lead to a net reduction in health. In a one-shot price-setting game, this seems to give rise to potential horizontal equity concerns. When the assumption of fixity of the incremental cost-effectiveness ratio (arising from the assumed exogeneity of the manufacturer’s price) is relaxed, it can be shown that the threat of partial implementation may be sufficient to give rise to an incremental cost-effectiveness ratio at which cost the entire potential population is treated, maximizing health at an increased level, and with no contravention of the horizontal equity principle. more...

Twenty years ago, the "Panel on Cost-effectiveness in Health and Medicine" published a landmark text setting out appropriate methods for conducting cost-effectiveness analyses of health technologies. In the two decades since, the methods used for economic evaluations have advanced substantially. Recently, a "second panel" (hereafter "the panel") was convened to update the text and its recommendations were published in November 2016. The purpose of this paper is to critique the panel's updated guidance regarding the discounting of costs and health effects. The advances in discounting methodology since the first panel include greater theoretical clarity regarding the specification of discount rates, how these rates vary with the analytical perspective chosen, and whether the healthcare budget is constrained. More specifically, there has been an important resolution of the debate regarding the conditions under which differential discounting of costs and health effects is appropriate. We show that the panel's recommendations are inconsistent with this recent literature. Importantly, the panel's departures from previously published findings do not arise from an alternative interpretation of theory; rather, we demonstrate that this is due to fundamental errors in methodology and logic. The panel also failed to conduct a formal review of relevant empirical evidence. We provide a number of suggestions for how the panel's recommendations could be improved in future. more...

The cost-effectiveness threshold in health care systems with a constrained budget should be determined by the cost-effectiveness of displacing health care services to fund new interventions. Using comparative statics, we review some potential determinants of the threshold, including the budget for health care, the demand for existing health care interventions, the technical efficiency of existing interventions, and the development of new health technologies. We consider the anticipated direction of impact that would affect the threshold following a change in each of these determinants. Where the health care system is technically efficient, an increase in the health care budget unambiguously raises the threshold, whereas an increase in the demand for existing, non-marginal health interventions unambiguously lowers the threshold. Improvements in the technical efficiency of existing interventions may raise or lower the threshold, depending on the cause of the improvement in efficiency, whether the intervention is already funded, and, if so, whether it is marginal. New technologies may also raise or lower the threshold, depending on whether the new technology is a substitute for an existing technology and, again, whether the existing technology is marginal. Our analysis permits health economists and decision makers to assess if and in what direction the threshold may change over time. This matters, as threshold changes impact the cost-effectiveness of interventions that require decisions now but have costs and effects that fall in future periods. more...

(ed from J Obstet Gynaecol Can 2017;39(1):10–17) Noninvasive prenatal testing (NIPT) using cell-free DNA (cfDNA) is an exciting new technology with many potential clinical benefits. However, the commercialization of these tests and the potential economic benefits to the laboratories that perform the testing have led to concern that the limitations are being downplayed and the benefits overstated. more...

Background Overconsumption of sugar-sweetened beverages (SSBs) contributes to childhood and adult obesity and numerous related diseases, including heart disease, strokes, cancers, and type 2 diabetes. It also increases healthcare costs. Sugary drink taxes have been implemented in several countries to curb sugar intake. However, there is a concern that sugary drink taxes are regressive. This study assessed the health and financial impacts of a simulated sugary drink tax across different income groups in Canada. Methods A proportional multi-state life table-based Markov model simulated the 2016 Canadian population by income quintile. The model applied a 20 % tax on sugary drinks and determined the effects on type 2 diabetes and BMI-related diseases compared to no intervention. The income-specific parameters modelled included: population demographics; cross- and own-price elasticities; mean BMI; sugary drink consumption; mortality; and disease epidemiology. Results A 20 % sugary drink tax was estimated to reduce the consumption of sugary drinks by an average of around 15 %, with a greater reduction in the lowest income quintile. The estimated mean reduction in BMI ranged from 0.21 to 0.33, dependent upon sex and income quintile; these reductions were greater among the lower income quintiles for both females and males. The 20 % sugary drink tax was estimated to avert approximately 690,000 DALYs over a lifetime among the 2016 Canadian adult population; estimated DALYs averted were approximately 156,000, 140,000, 137,000, 134,000, and 125,000 for the lowest through to the highest income quintile, respectively. Lifetime health care savings were estimated to be $2.27bn, $2.16bn, $2.17bn, $2.12bn, and $1.98bn for the lowest through to the highest income quintile, respectively. The estimated annual tax burden for the 2016 Canadian population was $1.4bn. The average absolute tax burden was estimated to be $39.00 to $44.30 per person, with the middle-income quintile bearing the heaviest absolute tax burden. The lowest income quintile would pay the highest proportion of income in tax, implying that the tax is regressive. Conclusions Low-income Canadians would gain the most health benefit from a sugary drinks tax. However, the lowest income quintile would also pay the largest proportion of income in tax. A tax on sugary drinks is therefore financially regressive but forecast to reduce health disparities across Canada. more...

The UK Department of Health and Social Care recently held a consultation on proposals to revise the methods for the appraisal of cost-effectiveness of vaccines as applied by the Joint Committee on Vaccination and Immunisation (JCVI). This presents a useful opportunity to review the current methods applied by the JCVI and examine the proposals for their improvement. Reviewing such methods is timely as there is mounting evidence that key elements of the health economic appraisal of all healthcare interventions in the UK need to be revised. In particular, there is a need to reassess both the cost-effectiveness threshold used to judge if an intervention is cost-effective and the discount rates used to assess the present value of health gains that occur in the future. Accordingly, we critically appraise the methods and their proposed changes. Overall, the 27 recommendations made within the recent consultation on proposed changes indicate a sensible and carefully considered approach to methods reform. We identify 11 recommendations that deserve further comment or reconsideration. In particular, there are reasons to question the basis for the proposed reduction of the discount rate from 3.5% to 1.5%. We also find that aspects of the current methods for considering uncertainty in the cost-effectiveness of vaccines require revision. Both the discounting and uncertainty analyses recommendations do not appear to be well grounded in economic theory, empirically justified or consistent with the methods set out by the National Institute for Health and Care Excellence. more...

In July 2018, the UK Minister of Public Health announced that human papillomavirus vaccination would be extended to 12-year-old boys. This decision was informed by updated evidence from the Joint Committee on Vaccination and Immunisation (JCVI) published earlier that month. Vaccination of boys had been found not to be cost-effective in a series of analyses conducted for the JCVI, including the most recent assessment prior to the minister’s announcement. These analyses were conducted under the standard methods for cost-effectiveness analysis recommended by the JCVI, which are primarily based on guidelines from the National Institute of Health and Care Excellence. Although the JCVI concluded they were unable to advise extending vaccination on the basis of standard appraisal methods, their most recent round of assessment also considered analyses using nonstandard appraisal methods. In particular, the JCVI noted that vaccination of boys was likely to be cost-effective when a lower discount rate of 1.5% is applied to costs and health effects, as opposed to the 3.5% rate usually employed. The JCVI stated that they were supportive of applying such alternative methods, and on this basis, they would advise extending vaccination to boys. This commentary explains the JCVI’s application of nonstandard appraisal methods and considers whether it was justified. We conclude that the JCVI was not justified in applying the lower discount rate. We voice concerns that a willingness to endorse a politically popular intervention may have driven the JCVI to depart from a fair and consistent application of healthcare rationing. more...

Recent evidence suggests that less frequent repositioning of long-term care residents at moderate/high risk of developing pressure ulcers (PrUs) is non-inferior to current repositioning standards in preventing PrUs. However, the long-term health and economic consequences of less frequent repositioning have not been adequately estimated. Our objective is to estimate the cost-effectiveness of different repositioning strategies (2-, 3-, or 4-hour intervals). We conducted a cost-utility analysis using a lifetime horizon based on data from a randomized clinical trial and from the literature. We updated a published PrU decision model with resource utilization, unit costs, and epidemiological estimates from the literature and from a small observational study. The Ontario Ministry of Health and Long-Term Care perspective was taken. We estimated the reduction in costs at 3-hour vs 2- or 4-hour repositioning at CAN$5,425 (95% Credible Interval (CrI): $922 – $12,166), or CAN$3,296 (95%CrI: −$483 – $9,738) per resident across their lifetime respectively. The gain in the expected Quality Adjusted Life Years (QALYs) between 3-hour and 2- or 4-hour repositioning strategies were 0.008, (95% CrI: 0.005 – 0.016) and 0.009 (95%CrI: 0.007 – 0.018) respectively. Repositioning at 3-hour intervals was the dominant strategy with respect to the incremental cost-effectiveness ratio against both 2- and 4-hour strategies. Sensitivity analysis showed a 99% probability that the 3-hourly repositioning was a dominant strategy. We concluded that repositioning at 3-hour intervals for residents at moderate or high risk of PrUs and who were cared for on high-density foam mattresses appeared to be the most cost-effective strategy. more...

PURPOSE: To develop an evidence-based guideline for the management of grades I-III neck pain and associated disorders (NAD).METHODS: This guideline is based on recent systematic reviews of high-quality studies. A multidisciplinary expert panel considered the evidence of effectiveness, safety, cost-effectiveness, societal and ethical values, and patient experiences (obtained from qualitative research) when formulating recommendations. Target audience includes clinicians; target population is adults with grades I-III NAD RECOMMENDATION 1: Clinicians should rule out major structural or other pathologies as the cause of NAD. Once major pathology has been ruled out, clinicians should classify NAD as grade I, II, or III.RECOMMENDATION 2: Clinicians should assess prognostic factors for delayed recovery from NAD.RECOMMENDATION 3: Clinicians should educate and reassure patients about the benign and self-limited nature of the typical course of NAD grades I-III and the importance of maintaining activity and movement. Patients with worsening symptoms and those who develop new physical or psychological symptoms should be referred to a physician for further evaluation at any time during their care.RECOMMENDATION 4: For NAD grades I-II ≤3 months duration, clinicians may consider structured patient education in combination with: range of motion exercise, multimodal care (range of motion exercise with manipulation or mobilization), or muscle relaxants. In view of evidence of no effectiveness, clinicians should not offer structured patient education alone, strain-counterstrain therapy, relaxation massage, cervical collar, electroacupuncture, electrotherapy, or clinic-based heat.RECOMMENDATION 5: For NAD grades I-II >3 months duration, clinicians may consider structured patient education in combination with: range of motion and strengthening exercises, qigong, yoga, multimodal care (exercise with manipulation or mobilization), clinical massage, low-level laser therapy, or non-steroidal anti-inflammatory drugs. In view of evidence of no effectiveness, clinicians should not offer strengthening exercises alone, strain-counterstrain therapy, relaxation massage, relaxation therapy for pain or disability, electrotherapy, shortwave diathermy, clinic-based heat, electroacupuncture, or botulinum toxin injections.RECOMMENDATION 6: For NAD grade III ≤3 months duration, clinicians may consider supervised strengthening exercises in addition to structured patient education. In view of evidence of no effectiveness, clinicians should not offer structured patient education alone, cervical collar, low-level laser therapy, or traction. RECOMMENDATION 7: For NAD grade III >3 months duration, clinicians should not offer a cervical collar. Patients who continue to experience neurological signs and disability more than 3 months after injury should be referred to a physician for investigation and management. RECOMMENDATION 8: Clinicians should reassess the patient at every visit to determine if additional care is necessary, the condition is worsening, or the patient has recovered. Patients reporting significant recovery should be discharged. more...

Over recent years, the UK’s National Institute for Health and Care Excellence (NICE) has implemented or proposed several amendments to its methods and processes for the economic evaluation of healt... more...

The National Institute for Health and Clinical Excellence (NICE) recently recommended differential discounting of costs and health effects in the economic appraisal of health care interventions in certain circumstances. The recommendation was published in an amendment to NICE’s Guide to the Methods of Technology Appraisal. The amendment states that differential discounting should be applied where “treatment effects are both substantial in restoring health and sustained over a very long period (normally at least 30 years).” Renewed interest in differential discounting from NICE is welcome; however, the recommendation’s selective application of differential discounting raises a number of concerns. The stated criteria for applying differential discounting are ambiguous. The rationale for the selective application of differential discounting has not been articulated by NICE and is questionable. The selective application of differential discounting leads to several inconsistencies, the most concerning of which is the lower valuation of health gains for those with less than 30 years remaining life expectancy, which can be interpreted as age discrimination. Furthermore, the discount rates chosen by NICE do not appear to be informed by recent advances in the theoretical understanding of differential discounting. NICE’s apparent motivation for recommending differential discounting was to ensure a favorable cost-effectiveness ratio for a pediatric oncology drug. While flexibility may be appropriate to allow some interventions that exceed conventional cost-effectiveness thresholds to be adopted, the selective adjustment of appraisal methods is problematic and without justification. more...

Non-invasive prenatal testing (NIPT) is an exciting technology with the potential to provide a variety of clinical benefits, including a reduction in miscarriages, via a decline in invasive testing. However, there is also concern that the economic and near-future clinical benefits of NIPT have been overstated and the potential limitations and harms underplayed. NIPT, therefore, presents an opportunity to explore the ways in which a range of social pressures and policies can influence the translation, implementation, and use of a health care innovation. NIPT is often framed as a potential first tier screen that should be offered to all pregnant women, despite concerns over cost-effectiveness. Multiple forces have contributed to a problematic translational environment in Canada, creating pressure towards first tier implementation. Governments have contributed to commercialization pressure by framing the publicly funded research sector as a potential engine of economic growth. Members of industry have an incentive to frame clinical value as beneficial to the broadest possible cohort in order to maximize market size. Many studies of NIPT were directly funded and performed by private industry in laboratories lacking strong independent oversight. Physicians' fear of potential liability for failing to recommend NIPT may further drive widespread uptake. Broad social endorsement, when combined with these translation pressures, could result in the "routinization" of NIPT, thereby adversely affecting women's reproductive autonomy. Policymakers should demand robust independent evidence of clinical and public health utility relevant to their respective jurisdictions before making decisions regarding public funding for NIPT. more...

Background Patients who undergo prolonged surgical procedures are at risk of developing pressure ulcers. Recent systematic reviews suggest that pressure redistribution overlays on operating tables significantly decrease the associated risk. Little is known about the cost effectiveness of using these overlays in a prevention program for surgical patients. Methods Using a Markov cohort model, we evaluated the cost effectiveness of an intraoperative prevention strategy with operating table overlays made of dry, viscoelastic polymer from the perspective of a health care payer over a 1-year period. We simulated patients undergoing scheduled surgical procedures lasting ≥90 min in the supine or lithotomy position. Results Compared with the current practice of using standard mattresses on operating tables, the intraoperative prevention strategy decreased the estimated intraoperative incidence of pressure ulcers by 0.51%, corresponding to a number-needed-to-treat of 196 patients. The average cost of using the operating table overlay was $1.66 per patient. Compared with current practice, this intraoperative prevention strategy would increase slightly the quality-adjusted life days of patients and by decreasing the incidence of pressure ulcers, this strategy would decrease both hospital and home care costs for treating fewer pressure ulcers originated intraoperatively. The cost savings was $46 per patient, which ranged from $13 to $116 by different surgical populations. Intraoperative prevention was 99% likely to be more cost effective than the current practice. Conclusion In patients who undergo scheduled surgical procedures lasting ≥90 min, this intraoperative prevention strategy could improve patients’ health and save hospital costs. The clinical and economic evidence support the implementation of this prevention strategy in settings where it has yet to become current practice. more...

Appropriate decisions based on cost-effectiveness evaluations of health care technologies depend upon the cost-effectiveness threshold and its rate of growth as well as some social rate of time preference for health. The concept of the cost-effectiveness threshold, social rate of time preference for consumption and social opportunity cost of capital are briefly explored before the question of how a social rate of time preference for health might be established is addressed. A more traditional approach to this problem is outlined before a social decision making approach is developed which demonstrates that social time preference for health is revealed through the budget allocations made by a socially legitimate higher authority. The relationship between the social time preference rate for health, the growth rate of the cost-effectiveness threshold and the rate at which the higher authority can borrow or invest is then examined. We establish that the social time preference rate for health is implied by the budget allocation and the health production functions in each period. As such, the social time preference rate for health depends not on the social time preference rate for consumption or growth in the consumption value of health but on growth in the cost-effectiveness threshold and the rate at which the higher authority can save or borrow between periods. The implications for discounting and the policies of bodies such as NICE are then discussed. more...

The National Institute for Health and Clinical Excellence (NICE) invited the manufacturer of alitretinoin (Basilea Pharmaceuticals Ltd, Basel, Switzerland) to submit evidence for the clinical and cost effectiveness of this drug for the treatment of patients with severe chronic hand eczema (CHE), as part of the Institute’s single technology appraisal (STA) process. The Centre for Reviews and Dissemination and the Centre for Health Economics at the University of York were commissioned to act as the Evidence Review Group (ERG). This article provides a description of the company submission, the ERG review and NICE’s subsequent decisions. The ERG produced a critical review of the evidence for the clinical and cost effectiveness of the technology based upon the manufacturer’s submission to NICE. The ERG also independently searched for relevant evidence and modified the manufacturer’s decision analytic model to examine the impact of altering some of the key assumptions. The main clinical effectiveness data were derived from a single-placebo randomized controlled trial (RCT) of daily treatment with alitretinoin for 12–24 weeks, with follow-up for a further 24 weeks, in patients with severe CHE unresponsive to topical corticosteroids. A significantly greater proportion of patients achieved ‘clear’ or ‘almost clear’ hands by week 24 with alitretinoin than those using placebo: 48% with alitretinoin 30 mg (p < 0.001); 28% with alitretinoin 10 mg (p < 0.005); 17% with placebo. Most patients who responded remained in remission during the 24-week follow-up period. The most commonly reported adverse event was dose-dependent headache, with rates of 20% in the alitretinoin 30 mg group and 11 % in the alitretinoin 10 mg group, respectively. Serious adverse events were rare, although alitretinoin was associated with increases in both total cholesterol and triglycerides. No direct or indirect comparisons of alitretinoin with any of the relevant treatment comparators (psoralen + UVA [PUVA], ciclosporin or azathioprine) were available. In the manufacturer’s original submission to NICE, the base-case incremental cost-effectiveness ratios (ICERs) reported for alitretinoin were £8614 per QALY versus ciclosporin, -£469 per QALY versus PUVA (with alitretinoin dominant) and £10 612 per QALY versus azathioprine (year 2007–8 values). In response to a request from the ERG, the manufacturers provided a revised model that compared alitretinoin only with placebo, for which the ICER was reported to be £12 931. However, the omission of adverse events entirely from this revised model, in combination with a number of other factors, led the ERG to conclude that the model underestimated the costs of treatment associated with alitretinoin. Estimates of health-related quality of life (HR-QOL) were the primary source of uncertainty, with the use of values from an alternative source producing ICERs of around £30 000 per QALY gained. The ERG concluded that, although the evidence presented indicates that alitretinoin is efficacious in the treatment of severe CHE, it gives little indication of alitretinoin’s efficacy relative to likely alternative treatment options or its efficacy and safety in the longer term. Although the ICERs estimated by the manufacturer suggested that alitretinoin may be cost effective for use in the UK NHS, utilizing the alternative HR-QOL estimates resulted in a 2-fold increase in the ICER. Thus, there was considerable uncertainty as to the true ICER of alitretinoin versus the relevant treatment comparators. TheAppraisal Committee recommended that alitretinoin be provided to those patients with severe CHE and a Dermatology Life Quality Index (DLQI) score of at least 15. They recommended that treatment be stopped as soon as an adequate response was observed, or if CHE remained severe at 12 weeks, or if response was inadequate at 24 weeks. more...

IntroductionAlthough stochastic analysis has become the accepted standard for decision analytic cost effectiveness models, deterministic one-way sensitivity analysis continues to be used to meet the needs of decision makers to understand the impact that changing the value taken by one specific parameter has on the results of the analysis. However, there are a number of problems with this approach.MethodsWe review the reasons why deterministic one-way sensitivity analysis will provide decision makers with biased and incomplete information. We then describe a new method - stochastic one-way sensitivity analysis (SOWSA), and apply this to a previously published cost effectiveness analysis, to produce a stochastic tornado diagram and conditional incremental net benefit curve. We then discuss how these outputs should be interpreted and the potential barriers to the implementation of SOWSA.ResultsThe results illustrate the shortcomings of the current approaches to deterministic one-way sensitivity analysis. For SOWSA, the expected costs and outcomes are captured, along with the sampled value of the parameter and these are linked to the probability that the parameter takes that value – which can be read off the probability distribution for the parameter used in the stochastic analysis. From these results it is possible to gain insights into probability that a parameter will take a value that will change a decision.ConclusionsAlthough a well-used technique, one-way deterministic sensitivity analysis has a number of shortcomings that may contribute to incorrect conclusions being drawn about the importance of certain parameter values on model results. By providing fuller information on uncertainty in model results, it is hoped that the methods here will lead to more informed decision making. Although, as with all developments in the presentation of analytic results to decision makers, care will be required to ensure that the decision makers understand the information provided to them. more...

IntroductionEconomic evaluations are a growing field of interest in the rehabilitation area. Research has questioned the quality of reporting of health economic evaluations. Poor reporting hinders the ability to provide accurate information for health care decision making. Therefore, the objectives of this study are to document on overall reporting quality of the published literature for rehabilitation economic evaluations; to identify if reporting quality has improved in health economic evaluations within the field of rehabilitation therapy since the publication of the Consolidated Health Economic Evaluation Reporting Standards (CHEERS); and to identify factors that could influence the reporting trends.MethodsWe searched databases for economical evaluations performed in the rehabilitation area published between 2013 and 2018. Study selection was performed by two independent reviewers using Covidence software. Data extraction was conducted by one reviewer using Microsoft Excel and independently verified by another reviewer. The quality of reporting was evaluated independently by two reviewers using the CHEERS checklist.ResultsThe search of the literature resulted in a total of 2195 published articles. Of these, 117 were considered to be potentially relevant. Independent review of these 117 articles led to the inclusion of 88 articles. This study is ongoing and complete results will be presented at the conference. Fifty papers have been analyzed in full. In general, the quality of reporting of the economical evaluations in the rehabilitation field was poor. The total mean and median for the CHEERS checklist was 17 points (out of 25) (range 8-24). Most of the analyzed studies did not report important methodological features of the economical evaluation as evaluated by the CHEERS checklist.ConclusionsThe quality of reporting of economic evaluations in the rehabilitation field is poor and inconsistent. Commonly the methods of the analyzed studies are under reported, thereby creating challenges in determining whether the information presented is sound. more...

Sugammadex 16 mg kg⁻¹ can be used for the immediate reversal of neuromuscular block 3 min after administration of rocuronium and could be used in place of succinylcholine for emergency intubation. We have systematically reviewed the efficacy and cost-effectiveness and made an economic assessment of sugammadex for immediate reversal. The economic assessment investigated whether sugammadex appears cost-effective under various assumptions about the value of any reduction in recovery time with sugammadex, the likelihood of a 'can't intubate, can't ventilate' (CICV) event, the age of the patient, and the length of the procedure. Three trials were included in the efficacy review. Sugammadex administered 3 or 5 min after rocuronium produced markedly faster recovery than placebo or spontaneous recovery from succinylcholine-induced block. No published economic evaluations were found. Our economic analyses showed that sugammadex appears more cost-effective, where the value of any reduction in recovery time is greater, where the reduction in mortality compared with succinylcholine is greater, and where the patient is younger, for lower probabilities of a CICV event and for long procedures which do not require profound block throughout. Because of the lack of evidence, the value of some parameters remains unknown, which makes it difficult to provide a definitive assessment of the cost-effectiveness of sugammadex in practice. The use of sugammadex in combination with high-dose rocuronium is efficacious. Further research is needed to clarify key parameters in the analysis and to allow a fuller economic assessment. more...