Quality-adjusted Life Year Gain Research Articles

Interventions and Innovation to Prevent Surgical Site Infection in Colorectal Surgery: A Cost-Effectiveness Analysis

BackgroundSurgical site infection (SSI), particularly in colorectal surgery, continues to cause substantial morbidity and cost. Both process- and product-based interventions have been proposed and implemented. No cost-effectiveness analysis of such interventions has been published. Materials and methodsThis study used a decision-analytic model to evaluate the cost-effectiveness of strategies for the prevention of SSI. Costs, utilities, and transition probabilities were obtained from literature review. We used a lifetime time horizon, captured with explicit event modeling for a year plus quantification of enduring health outcomes. We represented costs in 2017 US dollars and health effects in Quality-Adjusted Life Years (QALYs). Deterministic and probabilistic sensitivity analyses were performed. ResultsBoth process- and device-based strategies were dominant—clinically superior and also less expensive—compared with no intervention. Two types of double-ring wound protection barrier devices with greater anticontamination functionality were found to be both clinically superior and cost-saving compared with bundled process measures and simpler single-ring devices. Gains in QALYs were 230 per 1000 patients, and cost savings were 2.2 million dollars per 1000 patients, driven primarily by the high cost of SSI. ConclusionsWe found process-based interventions and wound protection devices to be superior to no intervention in the prevention of SSI. Double ring devices offered a distinct advantage over simpler devices, with small reductions in SSI risk leading to substantial cost savings. Further innovation in device-based wound protection devices may offer increased prevention of SSI at acceptable cost-effectiveness levels.

Cost-effectiveness of a care manager collaborative care programme for patients with depression in primary care: economic evaluation of a pragmatic randomised controlled study

ObjectiveTo evaluate the cost-effectiveness of a care manager (CM) programme compared with care as usual (CAU) for treatment of depression at primary care centres (PCCs) from a healthcare as well...

Early cost-utility estimation of the surgical correction of pectus excavatum with the Nuss bar.

The surgical correction of pectus excavatum (PE) with a Nuss bar provides satisfactory outcomes, but its cost-effectiveness is yet unproven. We prospectively analysed early outcomes and costs for Nuss bar placement. Fifty-four patients aged 16 years or older (6 females and 48 males; mean age, 17.9 years; range 16.0-29.4 years) with a PE filled out a Short Form-36 Health Survey (SF-6D) preoperatively and 1 year after a Nuss procedure. Costs included professional fees and fees for the operating room, materials and hospital care. Changes in the responses to the SF-36 or its domains were compared using the Wilcoxon signed rank test and the utility test results were calculated preoperatively and postoperatively from the SF-6D. The quality-adjusted life years (QALYs) were calculated from the results of these tests. Significant improvements in physical functioning, social functioning, mental health and health transition (all P < 0.05) were noted. The other SF-36 subgroups showed improvement; however, the improvement was not significant. The SF-6D utility showed improvement from 0.76 preoperatively to 0.79 at the 1-year follow-up (P = 0.096). The mean direct costs were €8805. The 1-year discounted QALY gain was 0.03. The estimated cost-utility ratio was €293 500 per QALY gained. Despite a significant improvement in many domains of the SF-36, the results of the SF-6D cost-utility analysis showed only a small improvement in cost-effectiveness (> €80 000/QALY) for patients with PE 1 year after Nuss bar placement. Based on this discrepancy, general health outcome measurements as the basis for cost-utility analysis in patients with PE may not be the best way forward.

Estimating costs and health outcomes of publicly funded tick-born encephalitis vaccination: A cost-effectiveness analysis

BackgroundThe number of notified cases of Tick-Borne Encephalitis (TBE) in Sweden has been increasing the past years despite the increased use of TBE-vaccine not subsidized by the healthcare system. Stockholm County is a high endemic area and an earlier study has shown that low-income households have lower vaccination coverage even when they are at high risk. This paper aims to determine the cost-effectiveness of a publicly funded TBE vaccination program in Stockholm. MethodsIn three different cohorts with individuals aged 3, 40 or 50 years, long-term costs and health outcomes of an out-of-pocket strategy (53% of the cohort is vaccinated on their own expenses) and a structured vaccination program (full cohort is vaccinated covered by the publicly funded health care system), were estimated using a Markov model. The Markov model predicts the costs and effects in term of Quality-adjusted Life Years (QALYs) over a lifetime horizon using a third-party healthcare payer perspective. The primary results are presented as an incremental cost effectiveness ratio (ICER) indicating the additional cost required to achieve one additional QALY with the structured vaccination program. ResultsThe results show that the structured vaccination program is associated with a gain in QALYs and increased costs compared with an out-of-pocket strategy. The calculated ICERs were 27 761, 99 527 and 160 827 SEK/QALY in cohorts of age 3, 40 and 50, respectively. The sensitivity analyses showed that the results are robust when varying different parameters. ConclusionGiven the setting of Stockholm county, this analysis shows a cost per QALY of a free vaccinations program, especially for children of 3 years old, below generally acceptable cost-effectiveness thresholds in Sweden.

Inclusion of health-related quality-of-life data in oncology drug reimbursement submissions in Canada: A review of submissions to the pan-Canadian Oncology Drug Review.

94 Background: For health technologies, and cancer treatments specifically, economic evaluation is often used to assess the value of new treatments. The preferred approach to economic evaluation is often cost-utility analysis (CUA). In CUA, incremental costs and benefits of a new treatment and a standard of care are calculated with benefits quantified using the quality-adjusted life-year (QALY); the QALY attempts to account for the quantity and quality of life (using a utility weight). The utility weight often comes from a generic, preference-based measure of health-related quality of life (HRQoL), such as the 5-dimension EuroQol measure (EQ-5D). Many submissions for reimbursement by manufacturers, and indeed many clinical trials, still do not include HRQoL data which may result in lower quality submissions and thus, sub-optimal decisions. Methods: We reviewed submissions to the pan-Canadian Oncology Drug Review (pCODR), the body charged with making reimbursement recommendations in Canada. We reviewed submissions from those first recorded (August 2012) to the present (June 2018). Only submissions that were completed (status listed as 'Notification to Implement Issued') were included. Upon completion, three documents are produced by pCODR: the final recommendation from the pCODR Expert Review Committee, the final clinical guidance report, and the final economic guidance report. All three documents were searched for how HRQoL was incorporated into the economic evaluation. Results: In total, 135 submissions were made to pCODR over the period. Of these, 107 (79.3%) had been completed and met the criteria for inclusion. In most studies, the incremental gain in QALYs from the new technology was small (in 2017 submissions the mean QALY gain was 1.1 QALYs). In addition, few studies reported an original measure of HRQoL, with most citing previously completed studies of variable relevance and quality. Conclusions: Our results indicate that manufacturers should improve the collection of HRQoL data of patients alongside clinical trials. This would enhance the focus on patients and improve decision-making around reimbursement of treatments.

Cost-Effectiveness Analysis of Adalimumab for the Treatment of Uveitis Associated with Juvenile Idiopathic Arthritis

To investigate the cost effectiveness of adalimumab in combination with methotrexate, compared with methotrexate alone, for the management of uveitis associated with juvenile idiopathic arthritis (JIA). A cost-utility analysis based on a clinical trial and decision analytic model. Children and adolescents 2 to 18 years of age with persistently active uveitis associated with JIA, despite optimized methotrexate treatment for at least 12 weeks. The SYCAMORE (Randomised controlled trial of the clinical effectiveness, SafetY and Cost effectiveness of Adalimumab in combination with MethOtRExate for the treatment of juvenile idiopathic arthritis associated uveitis) trial (identifier, ISRCTN10065623) of methotrexate (up to 25 mg weekly) with or without fortnightly administered adalimumab (20 or 40 mg, according to body weight) provided data on resource use (based on patient self-report and electronic records) and health utilities (from the Health Utilities Index questionnaire). Surgical event rates and long-term outcomes were based on data from a 10-year longitudinal cohort. A Markov model was used to extrapolate the effects of treatment based on visual impairment. Medical costs to the National Health Service in the United Kingdom, utility of defined health states, quality-adjusted life-years (QALYs), and incremental cost per QALY. Adalimumab in combination with methotrexate resulted in additional costs of £39 316, with a 0.30 QALY gain compared with methotrexate alone, resulting in an incremental cost-effectiveness ratio of £129 025 per QALY gained. The probability of cost effectiveness at a threshold of £30 000 per QALY was less than 1%. Based on a threshold analysis, a price reduction of 84% would be necessary for adalimumab to be cost effective. Adalimumab is clinically effective in uveitis associated with JIA; however, its cost effectiveness is not demonstrated compared with methotrexate alone in the United Kingdom setting.

Parental Health Spillover in Cost-Effectiveness Analysis: Evidence from Self-Harming Adolescents in England.

This article presents alternative parental health spillover quantification methods in the context of a randomised controlled trial comparing family therapy with treatment as usual as an intervention for self-harming adolescents, and discusses the practical limitations of those methods. The trial followed a sample of 754 participants aged 11-17years. Health utilities are measured using answers to the EuroQoL 5 Dimensions 3 Levels (EQ-5D-3L) for the adolescent and the Health Utility Index (HUI2) for one parent at baseline, 6 and 12months. We use regression analyses to evaluate the association between the parent's and adolescent's health utilities as part of an explanatory regression model including health-related and demographic characteristics of both the adolescent and the parent. We then measure cost-effectiveness over a 12-month period as mean incremental cost-effectiveness ratios using various spillover quantification methods. We propose an original quantification based on the use of a household welfare function along with an equivalence scale to generate a health gain within the family to be added to the adolescent's quality-adjusted life-year gain. We find thatthe parent's health utility increased over the duration of the trial and issignificantly and positively associated with adolescent's health utility at 6 and 12months but not at baseline. When considering the adolescent's health gain only, the incremental cost-effectiveness ratio is £40,453 per quality-adjusted life-year. When including the health spillover to one parent, the incremental cost-effectiveness ratio estimates range from £27,167 per quality-adjusted life-year to £40,838 per quality-adjusted life-year and can be a dominated option depending on the quantification method used. According to the health spillover quantification method considered, the incremental cost-effectiveness ratios vary from within the National Institute for Health and Care Excellence(NICE) cost-effectiveness threshold range to not being cost-effective.

PMS43 - AN ECONOMIC VALUE FRAMEWORK TO ASSESS THE COST EFFECTIVENESS OF FRACTURE PREVENTION TREATMENTS IN PATIENTS WITH OSTEOPOROSIS AT IMMINENT RISK OF FRACTURE

Osteoporotic fractures increase the risk of subsequent fracture. This risk is distinctly elevated immediately after the fragility fracture (‘imminent risk’) and can remain elevated for 10 years, highlighting the importance of early identification and treatment. Treatment sequences for new bone-forming agents are being assessed for use in patients at imminent risk of fracture. Here, we describe a new cost-effectiveness model framework relevant to the use of bone-forming agents. We developed a Markov-microsimulation model to simulate the projected treatment pathway, quality adjusted life years (QALYs) and lifetime costs of a patient with a fragility fracture, with treatment sequencing and time since fracture as factors. The patient could switch treatment when a lack of response was confirmed, or at any time point, dependent on clinical practice. In each 6-month cycle, we assessed risk of subsequent hip, vertebral and non-hip/non-vertebral fracture, remaining without subsequent fracture, or death. Fracture risk was derived from FRAX® and imminent fracture risk algorithms, and was updated for each patient in the event of subsequent fracture. Hypothetical examples were used for illustrative purposes. Treatment with a bone-forming agent immediately after fragility fracture was compared with treatment given 2 years after fracture. In an illustrative 75-year old woman with an initial vertebral fracture, the 10-year cumulative risk of a subsequent fracture was 11% lower for immediate treatment versus treatment after 2 years, fracture-related costs were 6% lower, QALY gain was 0.0172 and total costs were £1,758 higher. Similar values were derived with a lifetime perspective. This new economic modelling framework allows an estimation of the consequences of recurring fragility fractures over time and of the utility of flexible treatment sequencing. Our model will enable future evaluation of the cost effectiveness of individual treatment strategies.

PRS49 - COST-EFFECTIVENESS OF THE FIXED-DOSE COMBINATION TIOTROPIUM + OLODATEROL VERSUS TIOTROPIUM BASED ON THE DYNAGITO TRIAL RESULTS IN FRANCE

Combinations of long-acting bronchodilators are recommended to reduce the rate of chronic obstructive pulmonary disease (COPD) exacerbations. Evidence from a recent head-to-head trial, DYNAGITO, suggests that the fixed dose combination tiotropium+olodaterol (TIO+OLO) produces a reduction in the risk of exacerbating compared with tiotropium monotherapy (TIO). This study assessed the cost-effectiveness of TIO+OLO versus TIO in the French setting. A recently developed COPD patient-level simulation model was used to estimate the lifetime effects and costs for 15,000 patients receiving either TIO+OLO or TIO by applying the difference in annual exacerbation rate as observed in the DYNAGITO trial. The unit costs for treatment medication, COPD maintenance treatment, COPD exacerbations (moderate and severe) and pneumonias were obtained from relevant sources in France. The main outcomes were the annual exacerbation rate, quality-adjusted life-years (QALYs) and lifetime costs. Analyses were performed from a societal perspective. Patients receiving TIO+OLO benefitted from QALYs gain as compared to those treated with TIO: on average + 0.042 QALYs per patient over lifetime (PSA: 0.043 (95% UI: -0.015; 0.102)). The higher treatment medication costs for TIO+OLO versus TIO (+€1,640) were not completely compensated by the reduction in exacerbation costs (-€1,540), but the resulting difference in total costs between TIO + OLO versus TIO was small +€123 (PSA: €131 (95% UI: -€1021; €1026). The base case cost-effectiveness ratio (ICER) of TIO+OLO vs OLO was €2,900 per QALY. This finding was consistent across all sensitivity analyses conducted. On the basis of the results of the DYNAGITO trial, TIO+OLO is cost-effective versus TIO in COPD patients in France with a low cost per QALY.

PSY101 - LONG-TERM COST-EFFECTIVENESS OF EUROFIT VERSUS WAITING LIST

Male obesity is on the rise, but few men take part in weight loss programmes. One reason for this could be the absence of gender-sensitised interventions for men. This study aims to investigate the long-term cost-effectiveness of EuroFIT, a gender sensitised weight loss and healthy living programme for male football (soccer) fans, compared to waiting list. A Markov model was developed to represent the benefits of physical activity in reducing the incidence of 4 chronic health conditions (colorectal cancer, type 2 diabetes, coronary heart disease and stroke) and mortality. The model employed a 5-year time horizon from a societal perspective and measured health gains in terms of quality adjusted life years (QALYs). Data was obtained from 4 pragmatic randomised controlled trials evaluating EuroFIT conducted in England, Netherlands, Portugal and Norway, epidemiological and cohort studies, and reviews of the literature. Parameter uncertainty was assessed using deterministic and probabilistic sensitivity analysis. Uncertainty was presented using cost-effectiveness acceptability curves (CEACs). A lifetime horizon was used in a sensitivity analysis. Preliminary evidence suggests that over a 5-year time horizon the average cost per participant for the EuroFIT group is €10 lower than for the waiting list, while the average QALY gain is 0.014. CEACs show that the probability of EuroFIT being cost-effective compared to waiting list is 95% at 10,000 € per QALY. Sensitivity analysis suggests that EuroFIT is €16 cheaper and results in a gain of 0.2 QALYs compared to waiting list over a lifetime horizon with a 90% probability of being cost-effective at 13,000 € per QALY. This analysis shows that EuroFIT,a gender sentisied weight loss and healthy living programme, is cost-effective at 5 years and over a lifetime as compared to waiting list.

PSY94 - COST-EFFECTIVENESS MODEL COMPARING THERAPEUTIC STRATEGIES FOR TREATING IRON DEFICIENCY ANAEMIA (IDA) IN INFLAMMATORY BOWEL DISEASE (IBD)

A cost-effectiveness model was developed to evaluate use of ferric maltol (FM) to treat IDA in patients with IBD from a National Health Service perspective. A Markov model was developed to evaluate a hypothetical cohort of patients initiating therapy. FM was compared with ferric carboxymaltose (primary comparator), oral iron, iron isomaltoside, and iron sucrose in separate analyses. The model included four health states: on primary treatment, off primary treatment/on secondary therapy, discontinuation after secondary therapy, and mortality. In all living health states, patients could be in the following anaemia categories, based on their haemoglobin level: stable (non-anaemic), mild, moderate, and severe. As there was mixed evidence available, Bayesian network meta-analysis (NMA) of Phase 3 randomized controlled trials was performed. Overall cost calculations associated with each treatment included drug costs, routine medical care and hospitalization costs, adverse event related costs, and mortality costs. Utility values were obtained from FM’s AEGIS trials' patient-level data, and were mapped to EQ-5D values, which varied by health state (on and off treatment with stable, mild, moderate, or severe anaemia). The economic endpoint was quality-adjusted life years (QALYs). Overall, FM-treated patients showed slight dominance over the included comparators. In the base case analysis, FM was associated with a gain of 0.09 QALYs and cost savings of £2,212 versus ferric carboxymaltose. Deterministic and probabilistic sensitivity analyses generally showed consistency with base case findings. Deterministic sensitivity analysis exhibited greatest sensitivity to variations in utility values. When additional scenarios were explored, incremental cost effectiveness ratios were most sensitive to variations in time horizon and utility sources. NMA data were applied in the economic analysis, where ferric maltol appeared to be cost-saving and associated with a small QALYs gain versus the included comparators. Sensitivity analyses supported the findings, contributing to the robustness of the economic case.

Quality-Adjusted Life Years After Hip and Knee Arthroplasty: Health-Related Quality of Life After 12,782 Joint Replacements.

Background:The quality-adjusted life year (QALY) is the preferred outcome measurement for cost-effectiveness analysis in health care. QALYs measure patient health-related quality of life with use of a value between 0 and 1. Few studies have provided original data delineating QALYs after hip and knee arthroplasty. In the present study, we evaluated patient utility preoperatively and 2 years after total hip arthroplasty, hip resurfacing, revision hip arthroplasty, total knee arthroplasty, unicompartmental knee arthroplasty, and revision knee arthroplasty.Methods:A single-hospital joint registry, which enrolled patients from 2007 to 2011, was retrospectively examined for all patients who underwent primary or revision hip or knee arthroplasty and who had preoperative and 2-year postoperative Short Form-36 (SF-36), Short Form-12 (SF-12), or EuroQol 5-Dimension (EQ-5D) scores available. Patient age, body mass index (BMI), sex, American Society of Anesthesiologists (ASA) score, and Charlson Comorbidity Index were recorded. QALYs were determined from the EQ-5D index and the Short Form-6 Dimension (SF-6D) index.Results:Five thousand, four hundred and sixty-three patients underwent total hip arthroplasty, with a mean annual increase (and standard deviation) of 0.25 ± 0.2 QALY; 843 patients underwent hip resurfacing, with a mean annual increase of 0.24 ± 0.17 QALY; 5,398 patients underwent primary total knee arthroplasty, with a mean annual increase of 0.17 ± 0.19 QALY; and 240 patients underwent medial unicompartmental knee arthroplasty, with a mean annual increase of 0.16 ± 0.17 QALY. Aseptic revision arthroplasty (440 hips, 323 knees) was associated with a smaller QALY gain than primary arthroplasty. Patient age, BMI, female sex, ASA category, and higher preoperative health-related quality of life were negative predictors for QALY gain after primary arthroplasty. Forty additional hip procedures and 35 additional knee procedures were also analyzed.Conclusions:Primary hip and knee arthroplasty, on average, result in substantially increased patient quality of life. Revision hip and knee replacement result in a lower, but still positive, gain in quality of life. However, there is a considerable variation in patient outcomes across all procedures. Our results may be used to improve the certainty of future cost-effectiveness analyses of hip and knee arthroplasty.Level of Evidence:Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Ranolazine in patients with type 2 diabetes and chronic angina: A cost-effectiveness analysis and assessment of health-related quality-of-life

BackgroundType 2 diabetes (T2D) is associated with a high burden of angina. Ranolazine has been shown to reduce angina frequency versus placebo in patients with T2D and stable angina. We sought to estimate the cost-effectiveness of ranolazine when added to standard-of-care (SoC) versus SoC alone in patients with T2D and stable, but symptomatic coronary disease despite treatment with 1–2 antianginals. MethodsA Markov model was developed and evaluated using cohort simulation. The model utilized a US societal perspective, 1-month cycle length and 1-year time horizon and was developed to estimate the cost-effectiveness of ranolazine versus SoC. Patients entered the model in 1 of 4 angina frequency health states based on baseline Seattle Angina Questionnaire Angina Frequency scores (100 = no; 61–99 = monthly; 31–60 = weekly; 0–30 = daily) and could transition between health states (first cycle only) or to death (any cycle) based on probabilities derived from the Type 2 Diabetes Evaluation of Ranolazine in Subjects with Chronic Stable Angina trial. ResultsOur model estimated patients treated with ranolazine lived a mean of 0.728 quality adjusted life years (QALYs) at a cost of $16,654. Those not receiving ranolazine lived a mean of 0.702 QALYs and incurred costs of $15,476. The incremental cost-effectiveness ratio for the addition of ranolazine to SoC was $45,308/QALY. Short Form-36 data suggest improvements in patients' bodily pain drove the gain in QALYs associated with ranolazine (2.73 versus 3.96, p = 0.01). ConclusionOur model suggests the addition of ranolazine to SoC is likely cost–effective from a US societal perspective for the treatment of patients with T2D and stable, symptomatic coronary disease despite treatment with 1–2 antianginals.

PIN25 - Cost-Effectiveness Analysis of Fecal Microbiota Transplantation in Patients With Clostridium Difficile Infection in Hong Kong

Clostridium difficile infection (CDI) caused by ribotype 002 strain is associated with poor outcomes in Hong Kong. Fecal microbiota transplantation (FMT) is an effective but costly treatment for CDI. We aimed to examine potential cost-effectiveness of ribotype-guided FMT in patients with initial CDI from the perspective of healthcare provider in Hong Kong. A decision-analytic model was designed to simulate outcomes of ribotype-guided FMT versus standard treatment (metronidazole) in patients with initial CDI in the hospital setting. Outcome measures included incidences of recurrence CDI, refractory CDI and mortality; direct medical cost; and quality-adjusted life year (QALY) loss for CDI. Sensitivity analysis was performed to examine robustness of base-case results. Comparing to standard treatment in base-case analysis, ribotype-guided FMT group reduced mortality (11.4% versus 17.1%), refractory (17.1% versus 17.3%), recurrence CDI (16.4% versus 16.6%), cost (USD9,018 versus USD10,199) (USD1=HKD7.8), and saved 0.486 QALYs. One-way sensitivity analysis found the ribotype-guided FMT group to remain cost-effective when patient acceptance rate of FMT was >0.6% and ribotype 002 prevalence was >0.07%. In probabilistic sensitivity analysis, ribotype-guided FMT gained higher QALYs at 100% of simulations with mean QALY gain of 0.400 QALYs (95%CI: 0.395-0.405; p<0.001). The ribotype-guided group was less costly in 99.86% of time, and mean cost-saving was USA967 (95% CI: 957-977; p<0.001). Ribotype-guided FMT appears to be effective and cost-saving in patients with initial CDI in Hong Kong. The cost-effectiveness of ribotype-guided FMT is subject to patient acceptance of FMT and prevalence of ribotype with high risk for poor outcomes.

Structured physiotherapy including a work place intervention for patients with neck and/or back pain in primary care: an economic evaluation

A cluster-randomized controlled trial, WorkUp, was conducted for working-aged patients at risk of sick leave or on short-term sick leave due to acute/subacute neck and/or back pain in Sweden. The purpose of WorkUp was to facilitate participants to stay at work or in case of sick leave, return-to-work. The aim of this study was to study whether the WorkUp trial was cost-effective. Patients in the intervention and reference group received structured evidence-based physiotherapy, while patients in the intervention group also received a work place dialogue with the employer as an add-on. The participants, 352 in total, were recruited from 20 physiotherapeutic units in primary healthcare in southern Sweden. The economic evaluation was performed both from a healthcare and a societal perspective with a 12-month time frame with extensive univariate sensitivity analyses. Results were presented as incremental cost–effectiveness ratios (ICER) with outcomes measured as quality-adjusted life-years (QALY) and proportion working for at least 4 weeks in a row without reported sick leave at 12-month follow-up. From the healthcare perspective, the ICER was €23,606 (2013 price year) per QALY gain. From the societal perspective the intervention was dominating, i.e.. less costly and more effective than reference care. Bootstrap analysis showed that the probability of the intervention to be cost-effective at €50,000 willingness-to-pay per QALY was 85% from the societal perspective. Structured evidence-based physiotherapeutic care together with workplace dialogue is a cost-effective alternative from both a societal and a healthcare perspective for acute/subacute neck and/or back pain patients.Trial registration ClinicalTrials.gov: NCT02609750.

Cost-effectiveness of SelectMDx for prostate cancer in four European countries: a comparative modeling study.

Low specificity of prostate-specific antigen results in a considerable number of unnecessary prostate biopsies in current practice. SelectMDx® predicts significant prostate cancer upon biopsy and is used to reduce the number of unnecessary initial prostate biopsies. Furthermore, potential overtreatment of insignificant prostate cancer can be reduced. Besides the diagnostic accuracy of the test, also the context in a specific country determines the potential health benefit and cost-effectiveness. Therefore, the health benefit and cost-effectiveness of SelectMDx were assessed in France, Germany, Italy, and Spain. A decision model was used to compare the current standard of care in which men undergo initial prostate biopsy in case of an elevated prostate-specific antigen, to a strategy in which SelectMDx was used to select men for biopsy. Model inputs most relevant to each of the four countries were obtained. With use of the model long-term quality-adjusted life years (QALYs) and healthcare costs were calculated for both strategies. In all four countries, the SelectMDx resulted in QALY gain and cost savings compared with the current standard of care. In France, SelectMDx resulted in 0.022 QALYs gained and cost savings of €1217 per patient. For Germany, the model showed a QALY gain of 0.016 and a cost saving of €442. In Italy, the QALY gain and cost savings were 0.031 and €762. In Spain 0.020 QALYs were gained and €250 costs were saved. The results of the model showed that with SelectMDx, QALYs could be gained while saving healthcare costs in the initial diagnosis of prostate cancer. The significant presence of overtreatment in the current standard of care in all four countries was the main factor that resulted in the beneficial outcomes with SelectMDx.

Cost-Effectiveness of Insulin Degludec vs. Insulin Glargine U100 in Type 1 and Type 2 Diabetes Mellitus in a UK Setting.

BackgroundUnderstanding which therapeutic innovations in diabetes represent the best value requires rigorous economic evaluation. Data from randomised controlled trials and observational studies indicate that insulin degludec has a hypoglycemia advantage versus insulin glargine 100 units/mL (glargine U100), the most widely prescribed basal insulin analogue in the UK. This analysis was done to more rigorously assess cost-effectiveness in a UK setting.MethodsData from two double-blinded, randomised, two-period crossover trials in type 1 (SWITCH 1) and type 2 (SWITCH 2) diabetes mellitus were used to assess the cost-effectiveness of degludec vs. glargine U100 with an economic model. Cost-effectiveness was analysed over a 1-year time horizon based on the different rates of hypoglycaemia and actual doses of insulin used, rather than glycaemic control due to the treat-to-target trial design.ResultsIn type 1 diabetes mellitus, degludec was highly cost-effective compared with glargine U100, with an incremental cost-effectiveness ratio of £984 (increased costs of only £23/year and improvement in participant health of 0.0232 quality-adjusted life-years (QALYs)). In type 2 diabetes mellitus, it was estimated that quality of life was improved (0.0065 QALYs gain) with degludec compared with glargine U100 at an increased annual cost of £117 (incremental cost-effectiveness ratio, £17,939). One-way sensitivity analyses showed that the results were robust to changes in parameters in both type 1 and type 2 diabetes mellitus.ConclusionsThe rigorous design of the SWITCH trials, coupled with a representative patient population and a definition of hypoglycaemia that is relevant for real-world patients, makes the results of these trials highly generalisable. The within-trial analysis has the added value of being able to include doses and event rates directly from the trials. This short-term economic analysis estimated that IDeg would be cost-effective relative to IGlar U100 in both type 1 and type 2 diabetes mellitus in the UK.Trial RegistrationSWITCH 1 (NCT02034513); SWITCH 2 (NCT02030600).FundingNovo Nordisk, Søborg, Denmark.Electronic supplementary materialThe online version of this article (10.1007/s13300-018-0478-1) contains supplementary material, which is available to authorised users.

Pre-exposure prophylaxis (PrEP) for MSM in low HIV incidence places: should high risk individuals be targeted?

Pre-exposure prophylaxis (PrEP) targeting high-risk men who have sex with men (MSM) has been shown to be a cost-effective HIV control measure. However, the approach could be a challenge in low HIV incidence places with a low proportion of high-risk MSM. To examine the impact of PrEP in such setting in Asia, we developed an epidemic model and conducted cost-effectiveness analysis using empirical multicentre clinical and HIV sequence data from HIV-infected MSM in Hong Kong, in conjunction with behavioural data of local MSM. Without PrEP, the HIV incidence (per 100 person-years) would increase from 1.1 to 1.6 between 2011 and 2021. PrEP could avert 3–63% of total new infections in a five-year period (2017–2021), the variability of which depends on the implementation strategies and combination with test-and-treat. However, under current market drug price in 2016, the incremental cost per quality-adjusted life-year gained (QALYG) of PrEP (USD1583136/QALYG) is almost 3 times higher than test-and-treat intervention alone (USD396874/QALYG). Assuming 93% fall of PrEP drug price and in combination with test-and-treat, putting 30% of MSM on non-targeting PrEP would be more feasible, cost-effective (USD268915/QALYG), and could avert more new infections (40%). PrEP could contribute to HIV epidemic control in a low incidence place.

Screening women aged 65 years or over for abdominal aortic aneurysm: a modelling study and health economic evaluation.

Abdominal aortic aneurysm (AAA) screening programmes have been established for men in the UK to reduce deaths from AAA rupture. Whether or not screening should be extended to women is uncertain. To evaluate the cost-effectiveness of population screening for AAAs in women and compare a range of screening options. A discrete event simulation (DES) model was developed to provide a clinically realistic model of screening, surveillance, and elective and emergency AAA repair operations. Input parameters specifically for women were employed. The model was run for 10 million women, with parameter uncertainty addressed by probabilistic and deterministic sensitivity analyses. Population screening in the UK. Women aged ≥ 65 years, followed up to the age of 95 years. Invitation to ultrasound screening, followed by surveillance for small AAAs and elective surgical repair for large AAAs. Number of operations undertaken, AAA-related mortality, quality-adjusted life-years (QALYs), NHS costs and cost-effectiveness with annual discounting. AAA surveillance data, National Vascular Registry, Hospital Episode Statistics, trials of elective and emergency AAA surgery, and the NHS Abdominal Aortic Aneurysm Screening Programme (NAAASP). Systematic reviews of AAA prevalence and, for elective operations, suitability for endovascular aneurysm repair, non-intervention rates, operative mortality and literature reviews for other parameters. The prevalence of AAAs (aortic diameter of ≥ 3.0 cm) was estimated as 0.43% in women aged 65 years and 1.15% at age 75 years. The corresponding attendance rates following invitation to screening were estimated as 73% and 62%, respectively. The base-case model adopted the same age at screening (65 years), definition of an AAA (diameter of ≥ 3.0 cm), surveillance intervals (1 year for AAAs with diameter of 3.0-4.4 cm, 3 months for AAAs with diameter of 4.5-5.4 cm) and AAA diameter for consideration of surgery (5.5 cm) as in NAAASP for men. Per woman invited to screening, the estimated gain in QALYs was 0.00110, and the incremental cost was £33.99. This gave an incremental cost-effectiveness ratio (ICER) of £31,000 per QALY gained. The corresponding incremental net monetary benefit at a threshold of £20,000 per QALY gained was -£12.03 (95% uncertainty interval -£27.88 to £22.12). Almost no sensitivity analyses brought the ICER below £20,000 per QALY gained; an exception was doubling the AAA prevalence to 0.86%, which resulted in an ICER of £13,000. Alternative screening options (increasing the screening age to 70 years, lowering the threshold for considering surgery to diameters of 5.0 cm or 4.5 cm, lowering the diameter defining an AAA in women to 2.5 cm and lengthening the surveillance intervals for the smallest AAAs) did not bring the ICER below £20,000 per QALY gained when considered either singly or in combination. The model for women was not directly validated against empirical data. Some parameters were poorly estimated, potentially lacking relevance or unavailable for women. The accepted criteria for a population-based AAA screening programme in women are not currently met. A large-scale study is needed of the exact aortic size distribution for women screened at relevant ages. The DES model can be adapted to evaluate screening options in men. This study is registered as PROSPERO CRD42015020444 and CRD42016043227. The National Institute for Health Research Health Technology Assessment programme.

Utility gains from reductions in the modifiable burden of lung cancer attributable to residential radon in Canada.

The objective of this analysis is to estimate the modifiable burden of disease according to the annual number of lung cancer deaths prevented and the associated periodgain in quality-adjusted life years (QALYs) for the 2012 populations in Canada from reductions in residential radon exposures. Two postulated interventions for residential radon mitigation in new construction are assessed, corresponding to a 50% reduction and an 85% reduction in radon nationally, in the provinces/territories, and in 17 census metropolitan areas in Canada. Data were derived from two recent Canadian radon surveys conducted by the Radiation Protection Bureau, Health Canada, along with Canadian mortality and quality of life data. Analyses adopted a lifetime horizon and a discount rate of 1.5%. A period life-table analysis was conducted using age- and sex-specific all-cause and lung cancer mortality rates, adjusted for smoking, and the BEIR VI exposure-age-concentration model for radon-attributable risk of lung cancer mortality. A reduction in residential radon by 50% could prevent 681 lung cancer deaths, associated with a gain of 15,445 QALYs in the Canadian population at a discount rate of 1.5%; a reduction in radon by 85% could prevent 1263 lung cancer deaths, associated with a gain of 26,336 QALYs. On a per population basis, the Yukon was estimated to benefit most from radon mitigation. The magnitude of QALY gains in Canada estimated under the two radon mitigation scenarios is appreciable but varies considerably across provinces due to variability in indoor radon concentrations and smoking rates.