Exploratory Cost-effectiveness Analysis Research Articles

An exploratory cost-effectiveness analysis of a novel tissue valve compared with mechanical valves for surgical aortic valve replacement in subgroups of people aged 55–64 and 65+ with aortic stenosis in the UK

ABSTRACT Objective Exploratory analysis to conceptualize and evaluate the potential cost-effectiveness and economic drivers of using a novel tissue valve compared with mechanical heart valves for surgical aortic valve replacement (SAVR) in people aged 55–64 and 65+ with aortic stenosis (AS) from a National Health Service (NHS) UK perspective. Methods A decision-analytic model was developed using a partitioned survival model. Parameter inputs were obtained from published literature. Deterministic and probabilistic sensitivity analyses (DSA and PSA) were conducted to explore the uncertainty around the parameters. Results The novel tissue valve was potentially associated with higher quality-adjusted life years (QALYs) of 0.01 per person. Potential cost savings were greatest for those aged 55–64 (£408) versus those aged 65+(£53). DSA indicated the results to be most dependent on relative differences in general mortality, procedure costs, and reoperation rates. PSA estimated around 75% of the iterations to be cost-effective at £20,000 per QALY for those aged 55–64, and 57% for those aged 65+. Conclusions The exploratory analysis suggests that the novel tissue valve could be a cost-effective intervention for people over the age of 55 with AS who are suitable for SAVR in the UK.

Is intraoperative ultrasound more efficient than magnetic resonance in neurosurgical oncology? An exploratory cost-effectiveness analysis

Intraoperative imaging is a chief asset in neurosurgical oncology, it improves the extent of resection and postoperative outcomes. Imaging devices have evolved considerably, in particular ultrasound (iUS) and magnetic resonance (iMR). Although iUS is regarded as a more economically convenient and yet effective asset, no formal comparison between the efficiency of iUS and iMR in neurosurgical oncology has been performed. A cost-effectiveness analysis comparing two single-center prospectively collected surgical cohorts, classified according to the intraoperative imaging used. iMR (2013-2016) and iUS (2021-2022) groups comprised low- and high-grade gliomas, with a maximal safe resection intention. Units of health gain were gross total resection and equal or increased Karnofsky performance status. Surgical and health costs were considered for analysis. The incremental cost-effectiveness ratio (ICER) was calculated for the two intervention alternatives. The cost-utility graphic and the evolution of surgical duration with the gained experience were also analyzed. 50 patients followed an iMR-assisted operation, while 17 underwent an iUS-guided surgery. Gross total resection was achieved in 70% with iMR and in 60% with iUS. Median postoperative Karnofsky was similar in both group (KPS 90). Health costs were € 3,220 higher with iMR, and so were surgical-related costs (€ 1,976 higher). The ICER was € 322 per complete resection obtained with iMR, and € 644 per KPS gained or maintained with iMR. When only surgical-related costs were analyzed, ICER was € 198 per complete resection with iMR and € 395 per KPS gained or maintained. This is an unprecedented but preliminary cost-effectiveness analysis of the two most common intraoperative imaging devices in neurosurgical oncology. iMR, although being costlier and time-consuming, seems cost-effective in terms of complete resection rates and postoperative performance status. However, the differences between both techniques are small. Possibly, iMR and iUS are complementary aids during the resection: iUS real-time images assist while advancing towards the tumor limits, informing about the distance to relevant landmarks and correcting neuronavigation inaccuracy due to brain shift. Yet, at the end of resection, it is the iMR that reliably corroborates whether residual tumor remains.

Adolescents accept digital mental health support in schools: A co-design and feasibility study of a school-based app for UK adolescents

Schools in the UK are required to provide frontline mental health promotion and prevention to adolescents, but with few resources. School-hosted mHealth is one option which could meet needs. This study co-designed and feasibility tested a self-help, school hosted, digital intervention for adolescents showing early symptoms of deteriorating mental health. Via extensive co-design, we produced a youth-targeted web-app (MindMate2) and a low-intensity parent component (Partner2U). Feasibility was tested in four UK high schools with n = 31 young people (15-17y). We specified rules for progression to an effectiveness trial, tested candidate primary outcome measures and conducted an exploratory cost-effectiveness analysis. Co-design produced MindMate2U to be a six-week, self-help, smartphone-delivered program targeting risk and protective factors for adolescent mental health. Young people's MindMate2U account was set up by school after which they progressed independently through six topics of their choosing. User ratings (n = 19) and post- intervention interviews (n = 6) showed resource acceptability. We met our recruitment, retention and pre-post measure completion targets and identified the Strengths and Difficulties Questionnaire as the most sensitive outcome measure. This study established the feasibility of a co-designed, mental health app as a low-burden, school-hosted resource for symptomatic young people and opens up new possibilities for the integration of mHealth in schools. Support via schools to parents of symptomatic young people may need to be universal rather than targeted. Following some refinements of MindMate2U, a phase 2 randomised controlled trial is warranted to test its effectiveness.

A Nighttime Telemedicine and Medication Delivery Service to Avert Pediatric Emergencies in Haiti: An Exploratory Cost-Effectiveness Analysis.

ABSTRACT.We sought to compare the costs of a nighttime pediatric telemedicine and medication delivery service per disability-adjusted life year (DALY) averted to the costs of current hospital emergency care per DALY averted from a societal perspective. We studied a nighttime pediatric telemedicine and medication delivery service and hospital emergency care in a semi-urban and rural region of Haiti. Costs of the two services were enumerated to represent the financial investments of both providers and patients. DALYs averted were calculated to represent the “years lives lost” and “years lost to disability” from diarrheal, respiratory, and skin (bacterial and scabies etiologies) disease among children from 0 to 9 years old. The incremental cost-effectiveness ratio was estimated and compared with the per capita gross domestic product (GDP) of Haiti ($1,177). Cost-effectiveness was defined as an incremental cost-effectiveness ratio less than three times the per capita GDP of Haiti ($3,531). The total costs of the nighttime telemedicine and medication delivery service and hospital emergency care to society were $317,898 per year and $89,392 per year, respectively. The DALYs averted by the service and hospital emergency care were 199.76 and 22.37, respectively. Correspondingly, the incremental cost-effectiveness ratio is estimated at $1,288 signifying that the service costs an additional $1,288 to avert one additional DALY. A scaled nighttime pediatric telemedicine and medication delivery service is likely a cost-effective alternative to hospital emergency care for pre-emergency pediatric conditions in Haiti, and possibly in similar lower-middle-income countries.

Assessing the effectiveness of a community health advisor plus screen to save educational intervention on stool-based testing adherence in an African American safety net clinic population: study protocol for a randomized pragmatic trial

BackgroundColorectal cancer (CRC) is the second most deadly cancer affecting US adults and is also one of the most treatable cancers when detected at an earlier clinical stage of disease through screening. CRC health disparities experienced by African Americans are due in part to the later stage of diagnosis, suggesting the importance of improving African Americans’ CRC screening participation. The national Screen to Save (S2S) initiative employs a community health educator to deliver CRC screening education which can be tailored for specific populations, and such approaches have increased CRC screening rates in disadvantaged and racial/ethnic minority populations.Methods/designIn this trial emphasizing stool-based CRC screening, focus groups informed the development of an adapted S2S video and brochure tailored for African Americans and identified preferred motivational text messages for a multicomponent community health advisor (CHA) intervention. A CHA hired from the community was trained to deliver a 6-week CRC educational intervention consisting of an initial face-to-face meeting followed by 5 weeks of calls and texts. Interested eligible persons are enrolled primarily through recruitment by two partnering community health centers (CHCs) and secondarily through various outreach channels and, after consenting and completing a baseline survey, are randomly assigned to one of two study arms. The CHCs are blinded to study arm assignment. Intervention arm participants receive the brochure and CHA intervention while participants assigned to the control group receive only the brochure. All participants receive a stool-based CRC screening test from their health center, and the primary outcome is the completion of the screening test at 12 months. Secondary objectives are to estimate the effect of the intervention on mediating factors, explore the effect of moderating factors, and perform a cost-effectiveness analysis of the CHA intervention.DiscussionThe TUNE-UP study will enhance understanding about CRC screening in African Americans obtaining primary health care through CHCs and is one of the very few studies to examine a CHA intervention in this context. A better understanding of the mechanisms by which the intervention affects patient beliefs and behaviors will help focus future research while the exploratory cost-effectiveness analysis will inform CHCs’ decision-making about implementing a CHA program to increase screening and reduce cancer health disparities.Trial registrationClinicalTrials.govNCT04304001. Registered on March 11, 2020.

An exploratory cost-effectiveness analysis: Comparison between a midwife-led birth unit and a standard obstetric unit within the same hospital in Belgium

ObjectiveThe objective of this study was to compare midwife-led and consultant-led obstetrical care for women with uncomplicated low-risk pregnancies. We estimated costs and maternal outcomes in both units to achieve a cost-effectiveness ratio. DesignThe cost-analysis was made according to the “intention to treat” concept in order to minimize bias associated with the non-randomization of participants. At the obstetric-led unit, women received care from both midwives and medical staff while those in the alternative structure called ‘Le Cocon’ only received care from midwives. SettingThe obstetric-led unit of the Erasme University-Hospital in Brussels and its alongside midwife-led unit. ParticipantsThe study population included all low-risk pregnant women from 1 March 2014 until 31 October 2015 who were affiliated to the MLOZ (Mutualités Libres-Onafhankelijke Ziekenfondsen; third Belgian statutory health care insurer). InterventionsThe cost calculation involved a bottom-up approach. The health care consumption of each participant was obtained from MLOZ's data. The study included costs occurred the beginning of pregnancy until 3 months post-partum. Clinical data were extracted from the patient medical records. FindingsCompared to the traditional obstetric-led unit, the alternative midwife-led unit was associated with a cost reduction for the national payer (∆ = −€397.39, p = 0.046) and for the patient (∆ = − €44.19, p = 0.016). There were no significant differences in rates of caesarean, instrumental birth and epidural analgesia between MLU and OLU. A sensitivity analysis was performed (Appendix C) but does not change the overall results and conclusions. Key conclusionsDue to the small size of the samples, no statistical differences were found. More analysis is needed to evaluate the cost-effectiveness regarding the use of epidural analgesia, caesarean and instrumental birth rates in the midwife-led unit. Implications for practiceGiven the economical findings, this could contribute to reduce health expenditures for both women (out of pocket) and state (public payer via health care insurers).

An intervention to improve pneumococcal vaccination uptake in high risk 50-64 year olds vs. expanded age-based recommendations: an exploratory cost-effectiveness analysis

ABSTRACT In the U.S., pneumococcal polysaccharide vaccine (PPSV23) uptake among high-risk adults aged <65 years is consistently low and improvement is needed. One barrier to improved vaccine coverage is the complexity of the adult vaccination schedule. This exploratory analysis compared the cost-effectiveness of strategies to increase pneumococcal vaccine uptake in high-risk adults aged 50–64 years. We used a Markov model to compare strategies for non-immunocompromised 50–64 year olds: 1) current pneumococcal polysaccharide vaccine (PPSV23) recommendations; 2) current recommendations enhanced by an intervention; 3) PPSV23 plus pneumococcal conjugate vaccine (PCV13) for high-risk patients with no intervention; or 4) both vaccines for all 50-year-olds with no intervention. Parameters included CDC data and other US data, varied extensively in sensitivity analyses. In the analysis, vaccinating high-risk individuals with PPSV23/PCV13 was the least costly strategy, with total costs of $424/person. Vaccinating all 50 year olds with PPSV23/PCV13 cost $40 more and gained 0.00068 quality-adjusted life years (QALY), or $57,786/QALY gained. Current recommendations with or without an intervention program were more expensive and less effective than other strategies. In multi-way sensitivity analyses, the current recommendations/intervention program strategy was favored at a $100,000/QALY threshold only if non-bacteremic pneumococcal pneumonia rate or PCV13 serotype coverage were substantially lower than base case values. Thus, an intervention program to improve pneumococcal vaccine uptake among high-risk 50–64 year-olds was not cost-effective in most scenarios. High-risk individuals receiving both PCV13 and PPSV23 could be economically favorable, and vaccinating all 50-year-olds with both vaccines could be considered.

Meta-Analysis Comparing the Efficacy, Safety, and Cost-Benefit of Direct Acting Oral Anticoagulants Versus Enoxaparin Thromboprophylaxis to Prevent Venous Thromboembolism Among Hospitalized Patients

Venous thromboembolism (VTE) is a potentially fatal complication of hospitalization. Thromboprophylaxis using subcutaneous low molecular weight heparin (LMWH) can result in local irritation, pain, and ecchymoses, leading to nonadherence. Direct acting oral anticoagulants (DOACs) are an alternative, but their efficacy and safety for short-term inpatient-only use versus LMWH, in medically hospitalized patients, has not been rigorously assessed. We performed a systematic review with meta-analyses and exploratory cost effectiveness analysis of Phase III randomized controlled trials comparing DOACs to LMWH for VTE prophylaxis to determine the risk and benefit of each. The primary efficacy end point (composite of total VTE and any-cause mortality) occurred in 1,321 of 10,978 (11.4%) of patients receiving DOAC prophylaxis and 1,084 of 10,600 (10.2%) with LMWH (odds ratio [OR] 0.84; 95% confidence interval [CI] 0.63 to 1.13). The primary safety end point (composite of major bleeding and clinically relevant bleeding) occurred in 519 of 16,131 (3.2%) of patients receiving DOACs and 381 of 14,616 (2.6%) with LMWH (OR 1.12; 95%CI 0.83 to 1.53). Subgroup analyses for efficacy (n = 9,233) and safety (n = 12,584) was conducted on patients randomized to Apixaban or LMWH. The primary efficacy end point occurred in 294 of 4618 (6.4%) patients on Apixaban and 383 of 4615 (8.3%) on Enoxaparin (OR 0.82; 95% CI 0.55 to 1.24). Major and clinically relevant bleeding occurred in 157 of 6278 (2.50%) and 185 of 6,306 (2.9%), respectively (OR 0.86; 95% CI 0.58 to 1.26). Exploratory cost effectiveness analysis suggested that Apixaban compared with Enoxaparin thromboprophylaxis could result in long-term cost savings. In conclusion, this systematic review of randomized controlled trials and meta-analysis, stratified by type of patients and drug, indicates noninferiority of DOACs in efficacy, safety, and cost for short-term VTE thromboprophylaxis among patients hospitalized for medical illness.

Personalising adherence-enhancing interventions using a smart inhaler in patients with COPD: an exploratory cost-effectiveness analysis

Four inhaler adherence clusters have been identified using the INCA audio device in COPD patients: (1) regular use/good technique, (2) regular use/frequent technique errors, (3) irregular use/good technique, and (4) irregular use/frequent technique errors. Their relationship with healthcare utilization and mortality was established, but the cost-effectiveness of adherence-enhancing interventions is unknown. In this exploratory study, we aimed to estimate the potential cost-effectiveness of reaching optimal adherence in the three suboptimal adherence clusters, i.e., a theoretical shift of clusters 2, 3, and 4 to cluster 1. Cost-effectiveness was estimated over a 5-year time horizon using the Irish healthcare payer perspective. We used a previously developed COPD health-economic model that was updated with INCA trial data and Irish national economic and epidemiological data. For each cluster, interventions would result in additional quality-adjusted life years gained at reasonable investment. Cost-effectiveness was most favorable in cluster 3, with possible cost savings of €845/annum/person.

Snakebite: An Exploratory Cost-Effectiveness Analysis of Adjunct Treatment Strategies.

.The cost-effectiveness of the standard of care for snakebite treatment, antivenom, and supportive care has been established in various settings. In this study, based on data from South Indian private health-care providers, we address an additional question: “For what cost and effectiveness values would adding adjunct-based treatment strategies to the standard of care for venomous snakebites be cost-effective?” We modeled the cost and performance of potential interventions (e.g., pharmacologic or preventive) used adjunctively with antivenom and supportive care for the treatment of snakebite. Because these potential interventions are theoretical, we used a threshold cost-effectiveness approach to explore this forward-looking concept. We examined economic parameters at which these interventions could be cost-effective or even cost saving. A threshold analysis was used to examine the addition of new interventions to the standard of care. Incremental cost-effectiveness ratios were used to compare treatment strategies. One-way, scenario, and probabilistic sensitivity analyses were conducted to analyze parameter uncertainty and define cost and effectiveness thresholds. Our results suggest that even a 3% reduction in severe cases due to an adjunct strategy is likely to reduce the cost of overall treatment and have the greatest impact on cost-effectiveness. In this model, for example, an investment of $10 of intervention that reduces the incidence of severe cases by 3%, even without changing antivenom usage patterns, creates cost savings of $75 per individual. These findings illustrate the striking degree to which an adjunct intervention could improve patient outcomes and be cost-effective or even cost saving.

An exploratory cost-effectiveness analysis of systemic treatments for cutaneous T-cell lymphoma

Purpose: To conduct an exploratory cost-effectiveness analysis of systemic treatment options for more advanced cutaneous T-cell lymphoma (CTCL).Methods: A cost-effectiveness model compared systemic bexarotene, denileukin diftitox, interferon-α, methotrexate, pralatrexate, romidepsin, vorinostat, and extracorporeal photopheresis (ECP) treatment of CTCL. Treatment effectiveness data were extracted from published studies and/or US product labeling. Overall response, the primary effectiveness measure, was defined as the proportion of patients achieving complete or partial response. Costs were based on wholesale acquisition cost (medications) and Medicare reimbursement rates (ECP, medication administration, adverse drug effect treatment). The perspective of the study was from that of a payer.Results: Methotrexate was the lowest cost option [mean $436; standard deviation (SD) $284], followed by interferon-α (mean $32,174; SD $27,582), denileukin difitox (mean $40,107; SD $18,598), and ECP (mean $40,985; SD $45,633). Other treatments had costs greater than $50,000, ranging from vorinostat ($65,958; SD $40,637) to bexarotene ($239,424; SD $178,881). The incremental cost-effectiveness ratio per successfully treated patient was $396,725 (interferon) and $213,416 (ECP). Denileukin diftitox, romidepsin, and vorinostat were less effective and cost more than methotrexate.Conclusion: Methotrexate is the most cost-effective option for CTCL; however, its low cost is offset by its limited effectiveness in advanced stages of CTCL. ECP and interferon appear the next most cost-effective therapies.

An Exploratory Cost-Effectiveness Analysis of the Connected Health Intervention to Improve Care for People with Dementia: A Simulation Analysis

Many people with dementia live in the community; thus, supporting informal caregivers is critical. The Connected Health intervention facilitates collection and sharing of patient data among informal caregivers and providers to identify emerging patient needs and support rapid decision-making. This study estimates the costs of care of dementia using time-driven activity based costing of an exemplar patient. Intervention costs and health utility values were derived from a feasibility study of the intervention. A Markov model produced estimates of the cost-effectiveness of the intervention under four scenarios: (1) a minimal effect of the intervention on disease progression; (2) moderate effects on disease progression, and minimal effects on quality of life (QOL) and cost; (3) minimal effects on disease progression and QOL, and a moderate effect on cost; (4) moderate effects on disease progression and cost, with minimal effects on QOL. Cost estimates of formal and informal care ranged from €3713 to €7614 per month. Intervention costs were €484 per month. Under scenarios 2, 3 and 4, the cost per quality-adjusted life year of the intervention falls below €45,000, the threshold below which the Health Information and Quality Authority in Ireland generally accepts interventions as cost-effective. The results suggest that the intervention would be cost-effective with limited reductions in rates of disease progression and cost of care, and with minimal improvements in quality of life. Future research should consider the specific experiences of intervention patients.

Comparative effectiveness and cost-effectiveness of Chuna manual therapy versus conventional usual care for nonacute low back pain: study protocol for a pilot multicenter, pragmatic randomized controlled trial (pCRN study)

BackgroundWhile Chuna manual therapy is a Korean manual therapy widely used primarily for low back pain (LBP)-related disorders in Korea, well-designed studies on the comparative effectiveness of Chuna manual therapy are scarce.Methods/designThis study is the protocol for a three-armed, multicenter, pragmatic randomized controlled pilot trial. Sixty severe nonacute LBP patients (pain duration of at least 3 weeks, Numeric Rating Scale (NRS) ≥5) will be recruited at four Korean medicine hospitals. Participants will be randomly allocated to the Chuna group (n = 20), usual care group (n = 20), or Chuna plus usual care group (n = 20) for 6 weeks of treatment. Usual care will consist of orally administered conventional medicine, physical therapy, and back pain care education. The trial will be conducted with outcome assessor and statistician blinding. The primary endpoint will be NRS of LBP at week 7 post randomization. Secondary outcomes include NRS of leg pain, the Oswestry Disability Index (ODI), the Patient Global Impression of Change (PGIC), the Credibility and Expectancy Questionnaire, lumbar range of motion (ROM), the EuroQol-5 Dimension (EQ-5D) health survey, the Health Utility Index III (HUI-III), and economic evaluation and safety data. Post-treatment follow-ups will be conducted at 1, 4, and 10 weeks after conclusion of treatment.DiscussionThis study will assess the comparative effectiveness of Chuna manual therapy compared to conventional usual care. Costs and effectiveness (utility) data will be analyzed for exploratory cost-effectiveness analysis. If this pilot study does not reach a definite conclusion due to its small sample size, these results will be used as preliminary results to calculate sample size for future large-scale clinical trials and contribute in the assessment of feasibility of a full-scale multicenter trial.Trial registrationClinical Research Information Service (CRIS), KCT0001850. Registered on 17 March 2016.

The Clinical and Cost Effectiveness of Ustekinumab for the Treatment of Psoriatic Arthritis: A Critique of the Evidence.

The National Institute for Health and Care Excellence (NICE) invited the manufacturer of ustekinumab (Janssen) to submit evidence for the clinical and cost effectiveness of ustekinumab for the treatment of active psoriatic arthritis (PsA) as part of the Institute's single technology appraisal (STA) process. The Centre for Reviews and Dissemination and the Centre for Health Economics Technology Appraisal Group at the University of York were commissioned to act as the independent Evidence Review Group (ERG). This article provides a description of the ERG review of the manufacturer's evidence submission, and summarises the NICE Appraisal Committee's final guidance (TA340) issued in June 2015. The manufacturer presented evidence on ustekinumab for two patient populations: (1) a tumour necrosis factor-α (TNFα)-inhibitor-naïve population who had not previously received any TNFα inhibitors (biologics); and (2) a TNFα-inhibitor-exposed population who had previously received at least one TNFα inhibitor. The clinical evidence for ustekinumab was derived from two randomised controlled trials (PSUMMIT 1 and 2), in which a total of 927 patients who had not responded to previous disease-modifying antirheumatic drug therapies received ustekinumab 45 mg, ustekinumab 90 mg, or placebo. These data suggested that ustekinumab is more effective than placebo over 16-24 weeks in terms of both joint and skin response. In the absence of head-to-head comparisons between different biologics (ustekinumab, golimumab, etanercept, adalimumab and infliximab), the manufacturer conducted a network meta-analysis to estimate the relative efficacy of treatments for the TNFα-inhibitor-naïve population. Results of this analysis were marked as academic in confidence and are therefore not reported. For the TNFα-inhibitor-exposed population, the clinical analysis was limited to ustekinumab versus conventional management only, and was based on a subgroup of 180 patients from the PSUMMIT 2 trial. The ERG raised concerns relating to the lack of data on the long-term efficacy of ustekinumab, the limited data available for the exposed population, and the lack of consideration of the sequential use of treatments. Based on the manufacturer's original model, the ERG found ustekinumab to be dominated by golimumab in the anti-TNF-inhibitor-naïve population, and had an incremental cost-effectiveness ratio (ICER) of £29,843/quality-adjusted life-years versus conventional management in the exposed population. The ERG's analyses highlighted the fact that there is significant uncertainty around the model results. In addition, the ERG's exploratory cost-effectiveness analysis, which incorporated the sequential use of TNFα inhibitors, suggested that ustekinumab would not be cost effective if it were used as second-line treatment. The initial NICE recommendations asserted that ustekinumab was not recommended for treating active PsA. However, the manufacturer submitted a post-consultation model that included a Patient Access Scheme (PAS), halving the unit cost of ustekinumab 90 mg to £2147 (the same as a 45 mg dose). The NICE final recommendations were that, dependent on the inclusion of the PAS, ustekinumab is recommended as an option, along or in combination with methotrexate, for treating active PsA in adults only when treatment with TNFα inhibitors is contraindicated but would otherwise be considered, or the person has previously had treatment with one or more TNFα inhibitors, which has failed.

Exploratory cost-effectiveness analysis of cardiac resynchronization therapy with systematic device optimization vs. standard (non-systematic) optimization: a multinational economic evaluation.

:BackgroundRecent studies provide evidence of improved clinical benefits associated with cardiac resynchronization therapy (CRT) optimization. Our analysis explores the cost-effectiveness of systematically optimized (SO, 3 times a year) vs. non-systematically optimized (NSO, less than 3 times a year) CRT, whatever the echo optimization method used (manual or SonR® automatic).A longitudinal cohort model was developed to predict clinical and economic outcomes for SO vs. NSO strategies over 5 years. The analysis was performed from the payer perspective. Data from CLEAR study post-hoc analysis was used with 199 pts with CRT pacemaker (CRT-P). The main economic outcome measure was incremental cost-effectiveness (ICER) expressed as cost per Quality Adjusted Life Years (QALY) gained. To assess the impact of data uncertainty, a sensitivity analysis was performed. The model also predicts outcomes for the two optimization strategies for CRT-D therapy vs. optimal medical treatment (OPT).ResultsAt 1 year, ICERs for SO CRT vs. NSO CRT-P range between € 22,226 (Spain) and € 26,977 (Italy). Therefore, on the basis of a Willingness-To-Pay of €30,000 per QALY, the SO method develops into a cost effective strategy from 1 year, onwards. These favorable outcomes are supported by the sensitivity analysis. Systematic optimization of CRT-D might also improve the cost-effectiveness of this device therapy by 27 % to 30 % dependent on the country analyzed, at 5 years.ConclusionsOur economic evaluation shows promising health economic benefits associated with SO CRT. These preliminary findings need further confirmation.Electronic supplementary materialThe online version of this article (doi:10.1186/s13561-015-0057-3) contains supplementary material, which is available to authorized users.

Medicare's intensive behavioral therapy for obesity: an exploratory cost-effectiveness analysis.

Medicare coverage recently was expanded to include intensive behavioral therapy for obese individuals in primary care settings. To examine the potential cost effectiveness of Medicare's intensive behavioral therapy for obesity, accounting for uncertainty in effectiveness and utilization. A Markov simulation model of type 2 diabetes was used to estimate long-term health benefits and healthcare system costs of intensive behavioral therapy for obesity in the Medicare population without diabetes relative to an alternative of usual care. Cohort statistics were based on the 2005-2008 National Health and Nutrition Examination Survey. Model parameters were derived from the literature. Analyses were conducted in 2014 and reported in 2012 U.S. dollars. Based on assumptions for the maximal intervention effectiveness, intensive behavioral therapy is likely to be cost saving if costs per session equal the current reimbursement rate ($25.19) and will provide a cost-effectiveness ratio of $20,912 per quality-adjusted life-year if costs equal the rate for routine office visits. The intervention is less cost effective if it is less effective in primary care settings or if fewer intervention sessions are supplied by providers or used by participants. If the effectiveness of the intervention is similar to lifestyle interventions tested in other settings and costs per session equal the current reimbursement rate, intensive behavioral therapy for obesity offers good value. However, intervention effectiveness and the pattern of implementation and utilization strongly influence cost effectiveness. Given uncertainty regarding these factors, additional data might be collected to validate the modeling results.

PMD45 Optar Study: Transcatheter Aortic Valve Implantation (TAVI) versus Optimal Medical Treatment (OMT) in prohibitive Surgical Risk Patients with Severe Aortic Stenosis (AS) – An Exploratory Cost-Effectiveness Analysis

PMD45 Optar Study: Transcatheter Aortic Valve Implantation (TAVI) versus Optimal Medical Treatment (OMT) in prohibitive Surgical Risk Patients with Severe Aortic Stenosis (AS) – An Exploratory Cost-Effectiveness Analysis

Abstracts

The aim of this systematic review, using standard methodology,was to assess the clinical and cost-effectiveness of bone-anchored hearing aids (BAHAs) for people who are bilaterally deaf. Prospective studies comparing BAHAs versus conventional hearing aids [air conduction hearing aid (ACHA) or bone conduction hearing aid (BCHA)], unaided hearing or ear surgery; and unilateral versus bilateral BAHAs were eligible. Twelve clinical effectiveness studies were included. No eligible comparisons with ear surgery were identified. Overall quality was rated as weak for all included studies. There appeared to be some audiological benefi ts of BAHAs compared with BCHAs and improvements in speech understanding in noise compared with ACHAs, however ACHAs may produce better audiological results for other outcomes; the limited evidence reduces certainty. Hearing is improved with BAHAs compared with unaided hearing. Improvements in QoL with BAHAs were identifi ed by a hearing-specifi c instrument but not generic QoL measures. Studies comparing unilateral with bilateral BAHAs suggested benefi ts of bilateral BAHAs in many, but not all, situations. A decision analytic model was developed to estimate the costs and benefits of unilateral BAHAs over a ten year time horizon. The incremental cost per user receiving BAHA, compared with BCHA, was £16,344 for children and £13,281 for adults. In an exploratory analysis the incremental cost per QALY gained was between £118,898 and £55,424 for children and between £98,790 to £46,051 for adults for BAHAs compared with BCHA, depending on the assumed QoL gain and proportion of each modelled cohort using their hearing aid for eight or more hours per day. Deterministic sensitivity analysis suggested results were highly sensitive to the assumed proportion of people using BCHA for eight or more hours per day. Exploratory cost effectiveness analysis suggests that BAHAs are unlikely to be a cost effective option where the benefi ts are similar for BAHAs and their comparators. The greater the benefit from aided hearing and the greater the difference in the proportion of people using the hearing aid for eight hours or more per day, the more likely BAHAs are to be a cost effective option. The inclusion of other dimensions of QoL may also increase the likelihood of BAHAs being a cost effective option. A national audit of BAHAs is needed to provide clarity on the many areas of uncertainty surrounding BAHAs.

Bone-anchored hearing aids (BAHAs) for people who are bilaterally deaf: a systematic review and economic evaluation

A bone-anchored hearing aid (BAHA) consists of a permanent titanium fixture, which is surgically implanted into the skull bone behind the ear, and a small detachable sound processor that clips onto the fixture. BAHAs are suitable for people with conductive or mixed hearing loss who cannot benefit fully from conventional hearing aids. To assess the clinical effectiveness and cost-effectiveness of BAHAs for people who are bilaterally deaf. Nineteen electronic resources, including MEDLINE, EMBASE and The Cochrane Library (inception to November 2009). Additional studies were sought from reference lists and clinical experts. Inclusion criteria were applied by two reviewers independently. Data extraction and quality assessment were undertaken by one reviewer and checked by a second. Prospective studies of adults or children with bilateral hearing loss were eligible. Comparisons were BAHAs versus conventional hearing aids [air conduction hearing aid (ACHA) or bone conduction hearing aid (BCHA)], unaided hearing and ear surgery; and unilateral versus bilateral BAHAs. Outcomes included hearing measures, validated measures of quality of life (QoL), adverse events and measures of cost-effectiveness. For the review of cost-effectiveness, full economic evaluations were eligible. Twelve studies were included (seven cohort pre-post studies and five cross-sectional 'audiological comparison' studies). No prospective studies comparing BAHAs with ear surgery were identified. Overall quality was rated as weak for all included studies and meta-analysis was not possible due to differences in outcome measures and patient populations. There appeared to be some audiological benefits of BAHAs compared with BCHAs and improvements in speech understanding in noise compared with ACHAs; however, ACHAs may produce better audiological results for other outcomes. The limited evidence reduces certainty. Hearing is improved with BAHAs compared with unaided hearing. Improvements in QoL with BAHAs were identified by a hearing-specific instrument but not generic QoL measures. Studies comparing unilateral with bilateral BAHAs suggested benefits of bilateral BAHAs in many, but not all, situations. Prospective case series reported between 6.1% and 19.4% loss of implants. Most participants experienced no or minor skin reactions. A decision analytic model was developed. Costs and benefits of unilateral BAHAs were estimated over a 10-year time horizon, applying discount rates of 3.5%. The incremental cost per user receiving BAHA, compared with BCHA, was £ 16,409 for children and £ 13,449 for adults. In an exploratory analysis the incremental cost per quality-adjusted life-year (QALY) gained was between £ 55,642 and £ 119,367 for children and between £ 46,628 and £ 100,029 for adults for BAHAs compared with BCHA, depending on the assumed QoL gain and proportion of each modelled cohort using their hearing aid for ≥ 8 or more hours per day. Deterministic sensitivity analysis suggested that the results were highly sensitive to the assumed proportion of people using BCHA for ≥ 8 hours per day, with very high incremental cost-effectiveness ratio values (£ 500,000-1,200,000 per QALY gained) associated with a high proportion of people using BCHA. More acceptable values (£ 15,000-37,000 per QALY gained) were associated with a low proportion of people using BCHA for ≥ 8 hours per day (compared with BAHA). The economic evaluation presented in this report is severely limited by a lack of robust evidence on the outcome of hearing aid provision. This has lead to a more restricted analysis than was originally anticipated (limited to a comparison of BAHA and BCHA). In the absence of useable QoL data, the cost-effectiveness analysis is based on potential utility gains from hearing, that been inferred using a QoL instrument rather than measures reported by hearing aid users themselves. As a result the analysis is regarded as exploratory and the reported results should be interpreted with caution. Exploratory cost-effectiveness analysis suggests that BAHAs are unlikely to be a cost-effective option where the benefits (in terms of hearing gain and probability of using of alternative aids) are similar for BAHAs and their comparators. The greater the benefit from aided hearing and the greater the difference in the proportion of people using the hearing aid for ≥ 8 hours per day, the more likely BAHAs are to be a cost-effective option. The inclusion of other dimensions of QoL may also increase the likelihood of BAHAs being a cost-effective option. A national audit of BAHAs is needed to provide clarity on the many areas of uncertainty surrounding BAHAs. Further research into the non-audiological benefits of BAHAs, including QoL, is required.

Cost–effectiveness of a primary care intervention for depressed females

Background: To date, there is little information about the differential impact of primary care interventions by gender. We conducted an exploratory cost–effectiveness analysis by gender of an intervention to improve recognition and guideline-concordant treatment of depression in primary care. Methods: Primary care practices that did not employ an onsite mental healthcare specialist were randomized to enhanced (intervention) versus usual care. All subjects met study criteria for current major depression. Medical Outcomes Study SF-36 scores were converted into quality-adjusted life years (QALYs) to compare the 1-year effectiveness of enhanced versus usual care by gender. Based on results of previous studies, antidepressant acceptors beginning a new depression treatment episode were the focus of the analysis. Statistical analyses included multivariate regression models controlling for sociodemographic and clinical covariates. Results: In the main analysis, enhanced care for females was more expensive and more effective than usual care, at an additional cost of $5244 per QALY. For males, enhanced care was essentially cost and outcome neutral compared to usual care. The cost–effectiveness ratio estimates were robust to sensitivity analyses. Psychological side effects to the intervention may partially explain the limited effect of the intervention on outcomes for males. Limitations: We consider these results exploratory because the SF-36 to quality-adjusted life year conversion formula is preliminary and because of the relatively small sample size. Conclusions: The estimated cost–effectiveness ratio of this depression intervention is within the acceptable range for females, but not males. If replicated, these exploratory findings suggest that interventions to improve primary care depression treatment may need to be modified to improve their effectiveness in males while maintaining their effectiveness in females.