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Background Heartburn, chest pain, and regurgitation are characteristics of gastroesophageal reflux disease. The standard treatment in Norway is proton pump inhibitors (PPIs), but surgical alternatives such as Nissen fundoplication are pursued when medical management proves ineffective. RefluxStop is an implantable device presenting a new approach to restoration of the antireflux barrier. The aim of this study is to evaluate the cost-effectiveness of RefluxStop against Nissen fundoplication and PPI-based medical management (MM) in Norway. Methods A Markov model was adapted from a published cost-effectiveness analysis developed for the UK NHS assessing the cost-effectiveness of RefluxStop in comparison with PPI-based MM and Nissen fundoplication. The perspective of the Norwegian healthcare payer, lifetime horizon, one-month cycle length, and a 4% annual discount rate for costs and health-benefits were used. Health states included in the model were initial MM, MM relapse, follow-on surgery, reoperations, MM with a higher dose, Barrett’s esophagus, esophageal cancer, and death. Adverse events related to MM and surgeries were included with benefits measured in quality-adjusted life-years (QALYs). Norwegian diagnostic-related group tariffs and literature were used as sources for unit costs. Clinical efficacy data for RefluxStop was based on an ongoing clinical study and comparator treatments were informed by published studies. Deterministic and probabilistic sensitivity analyses were used to address uncertainty of the parameter estimates. Results Compared to PPI-based MM and Nissen fundoplication, the base case incremental cost-effectiveness ratios (ICERs) of RefluxStop were NOK 68,262 and NOK 79,543 per QALY gained, respectively. The results of the model were robust to variation in individual inputs with exception of monthly failure rate of RefluxStop relative to Nissen fundoplication. RefluxStop demonstrated a significantly high probability of cost-effectiveness at the cost-effectiveness threshold of NOK 275,000 per QALY gained, with probabilities of 100% and 92% against PPI-based MM and Nissen fundoplication, respectively. Conclusion The RefluxStop device is highly likely to be cost-effective compared to PPI-based MM and Nissen fundoplication in Norway. Further study is required to assess the real-world long-term safety and efficacy of this novel device.

Background The winter pressure often experienced by NHS hospitals in England is considerably contributed to by severe cases of seasonal influenza resulting in hospitalisation. The prevention planning and commissioning of the influenza vaccination programme in the UK does not always involve those who control the hospital budget. The objective of this study was to describe the direct medical costs of secondary care influenza-related hospital admissions across different age groups in England during two consecutive influenza seasons. Methods The number of hospital admissions, length of stay, and associated costs were quantified as well as determining the primary costs of influenza-related hospitalisations. Data were extracted from the Hospital Episode Statistics (HES) database between September 2017 to March 2018 and September 2018 to March 2019 in order to incorporate the annual influenza seasons. The use of international classification of disease (ICD)-10 codes were used to identify relevant influenza hospitalisations. Healthcare Resource Group (HRG) codes were used to determine the costs of influenza-related hospitalisations. Results During the 2017/18 and 2018/19 seasons there were 46,215 and 39,670 influenza-related hospital admissions respectively. This resulted in a hospital cost of £128,153,810 and £99,565,310 across both seasons. Results showed that those in the 65+ year group were associated with the highest hospitalisation costs and proportion of in-hospital deaths. In both influenza seasons, the HRG code WJ06 (Sepsis without Interventions) was found to be associated with the longest average length of stay and cost per admission, whereas PD14 (Paediatric Lower Respiratory Tract Disorders without Acute Bronchiolitis) had the shortest length of stay. Conclusion This study has shown that influenza-related hospital admissions had a considerable impact on the secondary healthcare system during the 2017/18 and 2018/19 influenza seasons, before taking into account its impact on primary health care.

Objectives Gastroesophageal reflux disease (GERD) is estimated to affect up to one-quarter of the Italian population, generating immense treatment costs. An emergent surgical treatment involving implantation of a nonactive device, RefluxStop, is offered at a number of hospitals in Italy and several other European countries. Published clinical outcomes of this device from the Conformité Européenne (CE)-mark clinical trial and real-world settings are consistently encouraging and with a favorable safety profile. This study evaluated the cost-effectiveness of RefluxStop compared with the current medical and surgical standards of care in Italy. Methods A Markov model recently developed for use in the United Kingdom was adapted to the Italian healthcare payer’s perspective, covering the GERD treatment field. The model incorporated a lifetime horizon, one-month cycle length, and a 3% annual discount rate. Standards of care to be compared to the RefluxStop procedure included proton pump inhibitor (PPI)-based medical management, laparoscopic Nissen fundoplication, and magnetic sphincter augmentation (MSA). The mutually exclusive health states of the model comprised PPI use, PPI relapse, follow-on surgery, reoperation, high-dose PPI, Barrett’s esophagus, esophageal cancer, and death. The model included adverse events (AEs) associated with PPIs and surgeries and quantified the benefits in terms of quality-adjusted life years (QALYs). Unit costs were derived from the Italian diagnosis-related group (DRG) tariffs and the literature. Additional clinical efficacy data on standard-of-care treatments were derived from published literature. Model uncertainty was evaluated using deterministic and probabilistic sensitivity analyses. Results RefluxStop demonstrated a lifetime cost difference relative to PPIs, Nissen fundoplication, and MSA of €8,788, €5,312, and €376 per patient, respectively. The corresponding QALY gains per patient were 2.87, 0.79, and 2.20, respectively. Base-case analysis established corresponding incremental cost-effectiveness ratios (ICERs) of €3,067, €6,712, and €171 per QALY gained, against PPIs, Nissen fundoplication, and MSA, respectively. At a cost-effectiveness threshold of €50,000 per QALY gained, RefluxStop was predicted to be cost-effective against both PPIs and MSA with a probability of 100% and against Nissen fundoplication with a probability of 97%. Sensitivity analysis confirmed the robustness of the model. Conclusion The implementation of RefluxStop in the Italian national health service is highly likely to be cost-effective compared to standard medical and surgical options for GERD, providing an opportunity for healthcare optimization in Italy.

People suffering from neurogenic bowel dysfunction (NBD) and an ineffective bowel regimen often suffer from fecal incontinence (FI) and related symptoms, which have a huge impact on their quality of life. In these situations, transanal irrigation (TAI) has been shown to reduce these symptoms and improve quality of life. To investigate the long-term cost-effectiveness of initiating TAI in patients with NBD who have failed standard bowel care (SBC). A deterministic Markov decision model was developed to project the lifetime health economic outcomes, including quality-adjusted life years (QALYs), episodes of FI, urinary tract infections (UTIs), and stoma surgery when initiating TAI relative to continuing SBC. A data set consisting of 227 patients with NBD due to spinal cord injury (SCI), multiple sclerosis, spina bifida and cauda equina syndrome was used in the analysis. In the model a 30-year old individual with SCI was used as a base-case. A probabilistic sensitivity analysis was applied to evaluate the robustness of the model. The model predicts that a 30-year old SCI patient with a life expectancy of 37 years initiating TAI will experience a 36% reduction in FI episodes, a 29% reduction in UTIs, a 35% reduction in likelihood of stoma surgery and a 0.4 improvement in QALYs, compared with patients continuing SBC. A lifetime cost-saving of £21,768 per patient was estimated for TAI versus continuing SBC alone. TAI is a cost-saving treatment strategy reducing risk of stoma surgery, UTIs, episodes of FI and improving QALYs for NBD patients who have failed SBC.

ObjectiveTo assess the cost-effectiveness of transcatheter aortic valve implantation (TAVI) compared with medical management in patients with severe aortic stenosis who are ineligible for conventional aortic valve replacement (SAVR) from the perspective of the UK National Health Service.DesignProbabilistic decision analytical model.MethodsA decision analytical model was developed to assess the costs and benefits associated with both interventions over a 10-year time horizon. A literature review was performed to identify relevant clinical evidence. Health-related quality of life and mortality were included using data from the PARTNER clinical trial (cohort B). Unit costs were taken from national databases. Costs and benefits were discounted at 3.5% per year, and extensive sensitivity analyses (probabilistic and deterministic) were performed to explore the impact of uncertainty on the cost-effectiveness estimates.Main outcome measureIncremental cost-effectiveness ratio (ICER) with benefits expressed as quality-adjusted life years (QALYs).ResultsThe base case ICER was approximately £16 100 per QALY gained. At a cost-effectiveness threshold of £20 000 per QALY gained, the probability that TAVI was cost-effective compared with medical management was 1.00. The results were robust to changes in key clinical parameters as well as choice of baseline survival data. The observed PARTNER survival data only have to be extrapolated for 2 years to generate an ICER below £30 000 per QALY gained, which is the upper value of the threshold range used by the National Institute for Health and Clinical Excellence in the UK.ConclusionsTAVI is highly likely to be a cost-effective treatment for patients with severe aortic stenosis who are currently ineligible for SAVR.

Background Three recent randomized controlled trials demonstrated that, in patients with symptomatic paroxysmal atrial fibrillation (PAF), first-line pulmonary vein isolation with cryoballoon catheter ablation reduces atrial arrhythmia recurrence compared to initial antiarrhythmic drug (AAD) therapy. This study aimed to evaluate the cost-effectiveness of first-line cryoablation compared to first-line AADs from a German healthcare payer perspective. Methods Individual patient-level data from 703 participants with untreated PAF enrolled into three randomized clinical trials (Cryo-FIRST, STOP AF First and EARLY-AF) were used to derive parameters for the cost-effectiveness model (CEM). The CEM structure consisted of a hybrid decision tree and Markov model. The decision tree (one-year time horizon) informed initial health state allocation in the first cycle of the Markov model (40-year time horizon; three-month cycle length). Health benefits were expressed in quality-adjusted life years (QALYs). Cost inputs were sourced from German diagnosis-related groups and the Institute for the Hospital Remuneration System (InEK). Costs and benefits were discounted at 3% per annum. Results Cryoablation was cost-effective, incurring ~ €200 per patient while offering an increase in QALYs (~ 0.18) over a lifetime. This produced an average incremental cost-effectiveness ratio of ~ €1,000 per QALY gained. Individuals were expected to receive ~ 1.2 ablations over a lifetime, regardless of initial treatment. However, those initially treated with cryoablation as opposed to AADs experience 0.9 fewer re-ablations and a 45% reduction in time spent in AF health states. Conclusion Initial rhythm control with cryoballoon ablation in symptomatic PAF is a cost-effective treatment option in a German healthcare setting.

Purpose A number of measures have been proposed to evaluate meaningful within-person change in the Oxford Hip and Oxford Knee scores (OHS and OKS), however there is evidence of lower baseline scores being associated with higher change scores, that is, these instruments potentially demonstrate baseline dependency. The study aim was to identify and quantify the impact of baseline dependency for the OHS and OKS. Patients & methods The data were collated from the National Health Service in England including the OHS, OKS, EQ-5D-3L and a global transition item (GTI). Change scores, including the minimally important change (MIC) were derived and categorised by the GTI and baseline scores for the OHS and OKS. Baseline dependency was evaluated using different baseline categories (OHS/OKS, EQ-5D quartiles and split-item method). Results A total of 387,524 records were extracted. Although the overall MIC were in-line with previous research, the results showed these measures varied by pre-operative scores. Baseline dependency was present irrespective of the method employed to categorise change scores. Conclusions The MICs for both the OHS and OKS show distinct baseline dependencies. The use of a single MIC for either instrument is unlikely to capture the full range of meaningful change experienced by individual patients and therefore has implications for the interpretation of interventional outcomes with these instruments. A multifaceted approach involving multiple sources of patient-relevant measures is recommended to provide more robust measures for the evaluation of patient outcomes and healthcare services.

Health-related quality of life (HRQoL) measures in the form of health utilities are valuable for economic evaluations of the effectiveness of food allergy interventions. However, traditional HRQoL instruments lack the sensitivity to generate health utilities that capture the impact that food allergies, such as peanut allergies, may have on children's mental health and daily activities. This study used mapping and discrete choice experiment (DCE) methods to generate health utilities from the Food Allergy Quality of life Questionnaire-Parent Form (FAQLQ-PF), which were then applied to clinical trial data. Health utilities (HU) were generated using two methods: mapping and DCE. Parents of children with peanut allergies (N=159) completed the FAQLQ-PF and EQ-5D-Y-Proxy-1 questionnaires. Mapping algorithms were developed once the FAQLQ-PF responses were mapped onto the EQ-5D-3L utilities. A composite DCE with time trade-off and a vignette was conducted among parents without peanut allergic children (N=767). The utilities derived from the mapping and DCE methods were applied to clinical trial data (PEPITES and PEOPLE) for an epicutaneous peanut patch (DBV712). The mapping algorithm showed an association of 0.199 between FAQLQ-PF and EQ-5D-3L utilities. The DCE disutilities were highest for severe food-related anxiety, emotional distress, and social limitations. Once applied to the clinical trial data, the HU derived from the mapping algorithm demonstrated statistically significant HRQoL improvements for the intervention group at 36 months. Using the DCE-derived utilities, statistically significant HRQoL improvements for the intervention group were demonstrated at both 24- and 36-months. The effect size analysis demonstrated that the DCE-derived utilities were more responsive than mapped utilities. DCE-derived utilities demonstrated greater responsiveness to changes in HRQoL compared with mapped utilities, suggesting their potential use in economic evaluations and HTA submissions for peanut allergy interventions. The DCE-derived health utilities showed greater sensitivity to changes in HRQoL. These utilities can be used in health technology assessments to better capture the impact of peanut allergy treatments on children's quality of life.

Introduction Three randomised controlled trials (RCTs) have demonstrated that first-line cryoballoon pulmonary vein isolation decreases atrial tachycardia in patients with symptomatic paroxysmal atrial fibrillation (PAF) compared with antiarrhythmic drugs (AADs). The aim of this study was to develop a cost-effectiveness model (CEM) for first-line cryoablation compared with first-line AADs for the treatment of PAF. The model used a Danish healthcare perspective. Methods Individual patient-level data from the Cryo-FIRST, STOP AF and EARLY-AF RCTs were used to parameterise the CEM. The model structure consisted of a hybrid decision tree (one-year time horizon) and a Markov model (40-year time horizon, with a three-month cycle length). Health-related quality of life was expressed in quality-adjusted life years (QALYs). Costs and benefits were discounted at 3% per year. Model outcomes were produced using probabilistic sensitivity analysis. Results First-line cryoablation is dominant, meaning it results in lower costs (-€2,663) and more QALYs (0.18) when compared to first-line AADs. First-line cryoablation also has a 99.96% probability of being cost-effective, at a cost-effectiveness threshold of €23,200 per QALY gained. Regardless of initial treatment, patients were expected to receive ∼ 1.2 ablation procedures over a lifetime horizon. Conclusion First-line cryoablation is both more effective and less costly (i.e. dominant), when compared with AADs for patients with symptomatic PAF in a Danish healthcare system.

IntroductionThree recent randomised controlled trials have demonstrated that pulmonary vein isolation as an initial rhythm control strategy with cryoablation reduces atrial arrhythmia recurrence in patients with symptomatic paroxysmal atrial fibrillation (PAF) compared with antiarrhythmic drug (AAD) therapy. The aim of this study was to evaluate the cost-effectiveness of first-line cryoablation compared with first-line AADs for treating symptomatic PAF in an English National Health Service (NHS) setting.MethodsIndividual patient-level data from 703 participants with PAF enrolled into Cryo-FIRST (Catheter Cryoablation Versus Antiarrhythmic Drug as First-Line Therapy of Paroxysmal Atrial Fibrillation), STOP AF First (Cryoballoon Catheter Ablation in an Antiarrhythmic Drug Naive Paroxysmal Atrial Fibrillation) and EARLY-AF (Early Aggressive Invasive Intervention for Atrial Fibrillation) were used to derive the parameters applied in the cost-effectiveness model (CEM). The CEM comprised a hybrid decision tree and Markov structure. The decision tree had a 1-year time horizon and was used to inform the initial health state allocation in the first cycle of the Markov model (40-year time horizon; 3-month cycle length). Health benefits were expressed in quality-adjusted life years (QALYs). Costs and benefits were discounted at 3.5% per year. Model outcomes were generated using probabilistic sensitivity analysis.ResultsThe results estimated that cryoablation would yield more QALYs (+0.17) and higher costs (+£641) per patient over a lifetime than AADs. This produced an incremental cost-effectiveness ratio of £3783 per QALY gained. Independent of initial treatment, individuals were expected to receive ~1.2 ablations over a lifetime. There was a 45% relative reduction in time spent in AF health states for those initially treated with cryoablation.DiscussionAF rhythm control with first-line cryoablation is cost effective compared with first-line AADs in an English NHS setting.