Digital variance angiography in patients undergoing lower limb arterial recanalization: cost-effectiveness analysis within the English healthcare setting.

Aim: Digital variance angiography (DVA) is a recently developed image processing method capable of improving image quality compared with the traditionally used digital subtraction angiography (DSA), among patients undergoing lower limb x-ray angiography. This study aims to explore the potential cost-effectiveness of DVA from an English National Health Service perspective. Materials & methods: A two-part economic model, consisting of a decision tree and a Markov model, was developed to consider the costs and health outcomes associated with the use of DVA as part of current practice imaging, compared with x-ray angiography using standard DSA. The model explored the impact of DVA on the development of acute kidney injury (AKI), chronic kidney disease and radiation-induced cancer over a lifetime horizon. Both deterministic and probabilistic analyses were performed to assess the cost per quality-adjusted life-year (QALY). Results: Base-case results indicate that DVA results in cost savings of £309 per patient, with QALYs also improving (+0.025) over a lifetime. As shown in sensitivity analysis, a key driver of model results is the relative risk (RR) reduction of contrast-associated acute kidney injury associated with use of DVA. The intervention also decreases the risk of carcinoma over a lifetime. Scenario analyses show that cost savings range from £310 to £553, with QALY gains ranging from 0.048 to 0.109 per patient. Conclusion: The use of DVA could result in a decrease in costs and an increase in QALYs over a lifetime, compared with existing imaging practice. The potential for this technology to offer an economically viable alternative to existing image processing methods, through a reduction in contrast media volume and radiation exposure, has been demonstrated.

Cost-effectiveness analysis of Avance® allograft for the treatment of peripheral nerve injuries in the USA.

Aim: Peripheral nerve injury (PNI) is a debilitating condition with significant associated morbidity, and which places a substantial socioeconomic burden on healthcare systems worldwide. Recently, allograft has emerged as a viable surgical alternative to autograft for the treatment of PNI. This study evaluated the cost effectiveness of allograft (Avance® Nerve Graft) compared with autograft for the peripheral nerve repair, from a US payer perspective. Methods: A Markov cohort model was developed to consider the treatment pathways followed by a patient population undergoing a single transected nerve repair with either allograft, or autograft. The marginal difference in meaningful recovery (MR) (effectiveness), and costs, between the two groups were estimated over a lifetime horizon. Deterministic and probabilistic sensitivity analyses (PSA) were performed to consider the uncertainty surrounding the base-case input parameter values and their effect on the overall incremental cost-effectiveness ratio (ICER). Results: The base-case analysis indicates that there is a small difference in the average probability of MR between the two groups (75.15% vs 70.46%; +4.69% with allograft). Allograft also results in cost savings ($12,677 vs $14,023; -$-1346 with allograft) compared with autograft. Deterministic sensitivity analysis shows that the costs of the initial surgical procedures are the main drivers of incremental cost, but that the intervention is likely to be cost saving compared with autograft regardless of the parameter variations made. Conclusion: The use of allograft with the Avance Nerve Graft has the potential to be a cost-effective alternative to autograft for the surgical treatment of PNI in the USA.

Cost-Utility Analysis of the Caresyntax Platform to Identify Patients at Risk of Surgical Site Infection Undergoing Colorectal Surgery.

BACKGROUND: Surgical site infections (SSIs) account for up to 18% of all healthcare-associated infections (HAIs). The Caresyntax data-driven surgery platform incorporates the most common risk factors for SSI, to identify high-risk surgical patients before they leave the operating theatre and treat them prophylactically with negative pressure wound therapy (NPWT). An economic analysis was performed to assess the costs and health outcomes associated with introduction of the technology in the English healthcare setting. METHODS: A hybrid decision tree/Markov model was developed to reflect the treatment pathways that patients undergoing colorectal surgery would typically follow, both over the short term (30-day hospital setting) and long term (lifetime). The analysis considered implementation of Caresyntax's platform-based SSI predictive algorithm in the hospital setting, compared with standard of care, from an English National Health Service (NHS) perspective. The base-case analysis presents results in terms of cost per quality-adjusted life-year (QALY) gained, as well as operational impact. RESULTS: The base-case analysis indicates that the intervention leads to a cost saving of £55.52m across the total NHS colorectal surgery patient population in 1 year. In addition, the intervention has a 98.36% probability of being cost effective over a lifetime horizon. The intervention results in the avoidance of 19,744 SSI events, as well 191,911 excess hospital bed days saved. CONCLUSION: Caresyntax's platform-based SSI predictive algorithm has the potential to result in cost savings and improved patient quality of life. Additionally, operational gains for the healthcare provider, including reduced infection rates and hospital bed days saved, have been shown through the economic modeling.

Early Cost-Effectiveness and Price Threshold Analyses of Resmetirom: An Investigational Treatment for Management of Nonalcoholic Steatohepatitis.

BACKGROUND: Nonalcoholic steatohepatitis (NASH) is characterized by inflammation and hepatocellular damage caused by accumulation of fat in the liver. Resmetirom (MGL-3196) is an orally administered, small-molecule, liver-targeted, selective thyroid hormone receptor-ß agonist. This early analysis explored the potential cost effectiveness of resmetirom for the treatment of NASH from a US commercial payer perspective. METHODS: An early economic model was developed to reflect the clinical pathways typically followed by patients with NASH and liver fibrosis. Use of resmetirom, compared with placebo, was assessed. The Markov model structure was informed by a previous modeling study and a randomized, double-blind, placebo-controlled, phase II trial of resmetirom. Costs and outcomes were assessed over a lifetime time horizon with results presented in terms of cost per quality-adjusted life-year (QALY) gained. RESULTS: Resmetirom treatment resulted in increased costs of US$66,764 per patient, while increasing QALYs by 1.24. The incremental cost-effectiveness ratio was US$53,929 per QALY gained, indicating resmetirom treatment would potentially be cost effective at a willingness-to-pay (WTP) threshold of US$100,000. Results indicated that resmetirom would reduce the lifetime number of cases of decompensated cirrhosis (- 87), hepatocellular carcinoma (- 59), and liver transplants (- 30) per 1,000 patients compared with placebo. Resmetirom treatment remained cost effective at a US$100,000 WTP threshold up to a daily price point of US$72.00. CONCLUSION: Resmetirom is a potentially cost-effective treatment option for patients with NASH and liver fibrosis based on an analysis performed from a US commercial payer perspective. Future economic analyses of the technology should, however, focus on overcoming the limitations of existing modeling methodology.

Cost-Effectiveness Analysis of a Medial Meniscus Replacement Prosthesis for the Treatment of Patients with Medial Compartment Pain in the United Kingdom.

BACKGROUND: The most common intra-articular knee injury is a meniscal tear, which commonly occurs secondary to trauma following twisting or hyperflexion. Treatment options for meniscal tears can either be surgical or non-surgical, and range from rest, exercise, bracing and physical therapy to surgical intervention, including meniscal repair and partial meniscectomy. In patients with persistent pain following loss of meniscus tissue, treatment can include partial replacement or meniscal allograft transplantation. The NUsurface® prosthesis has been developed as a treatment option for patients experiencing persistent knee pain post medial meniscus (MM) surgery. OBJECTIVE: The aim of this study was to assess the cost effectiveness of MM replacement using NUsurface for the treatment of patients with medial compartment pain following previous partial medial meniscectomy, from a UK health service perspective. METHODS: An economic decision-analytic model was developed to assess the cost per quality-adjusted life-year (QALY) gained associated with the introduction of MM replacement using NUsurface compared with non-surgical standard of care, over a lifetime time horizon. The model structure was primarily informed by a previous clinical trial (VENUS) and was developed based on the clinical pathways typically followed by patients with this condition, with treatment pathways and probabilities of clinical progression adjusted depending on whether patients were receiving the intervention or undergoing current practice. A hypothetical cohort of adult patients (mean age of 50 years) was modelled, with clinical data sourced from the VENUS study as well as relevant UK literature. Both deterministic and probabilistic sensitivity analyses were carried out to explore uncertainty in the model results. RESULTS: The base-case probabilistic results indicate that MM replacement using NUsurface is likely to be cost effective across a range of willingness-to-pay (WTP) thresholds (95% probability of being cost effective at the National Institute for Health and Care Excellence (NICE)-recommended £20,000 WTP threshold). Although per-patient costs increase, QALYs are also gained, with the incremental cost per QALY (probabilistic value = £5011) being below £20,000. Deterministic sensitivity analyses indicate that the parameters that have the greatest impact on results are the failure rate in the control group (current practice), utility scores, and the cost of undergoing MM replacement using NUsurface. CONCLUSIONS: Based on the analysis presented, MM replacement with the NUsurface prosthetic implant is likely to be a cost-effective use of UK health care service resources compared with current standard care.

Cost-Effectiveness Analysis of Intravascular Targeted Temperature Management after Cardiac Arrest in England.

BACKGROUND: Targeted temperature management (TTM) has been shown to improve neurological outcomes and survival in patients resuscitated from cardiac arrest; however, the cost effectiveness of multiple TTM methods is not well studied. OBJECTIVE: This study aimed to evaluate the cost effectiveness of intravascular temperature management (IVTM) using Thermogard XP compared with surface cooling methods after cardiac arrest in the England from the perspectives of the UK national health service and Personal Social Services. METHODS: We developed a multi-state Markov model that evaluated IVTM (Thermogard XP) compared with surface cooling using two different devices (Blanketrol III and Arctic Sun 5000) over a short-term and lifetime time horizon. Model input parameters were obtained from the literature and local databases. We assumed a hypothetical cohort of 1000 patients who required TTM after cardiac arrest per year in the England. The outcomes were costs (in £, year 2019 values) and quality-adjusted life-years (QALYs), discounted at 3.5% annually. Deterministic and probabilistic sensitivity analyses were undertaken to examine the effect of alternative assumptions and uncertainty in model parameters on the results. RESULTS: The cost-effectiveness analysis determined that Thermogard XP resulted in direct cost savings of £2339 and £2925 (per patient) compared with Blanketrol III and Arctic Sun 5000, respectively, and a gain of 0.98 QALYs over the patient lifetime. The probabilistic sensitivity analysis demonstrated that the probability of Thermogard XP being cost saving would be 69.2% and 65.3% versus the Arctic Sun 5000 and Blanketrol III, respectively. CONCLUSION: Implementation of IVTM using Thermogard XP can lead to cost savings and improved patient quality of life versus surface cooling methods.

Optimal Surveillance Strategies for Early-Stage Cutaneous Melanoma Post Primary Tumor Excision: An Economic Evaluation.

Background. Consensus on standardized active surveillance or follow-up care by clinicians is lacking leading to considerable variation in practice across countries. An important structural modelling consideration is that self-examination by patients and their partners can detect melanoma recurrence outside of active surveillance regimes. Objectives. To identify candidate melanoma surveillance strategies for American Joint Committee on Cancer (AJCC) stage I disease and compare them with the current recommended practice in a cost-utility analysis framework. Methods. In consultation with UK clinical experts, a microsimulation model was built in TreeAge Pro 2019 R1.0 (Williamstown, MA, USA) to evaluate surveillance strategies for AJCC stage IA and IB melanoma patients separately. The model incorporated patient behaviors such as self-detection and emergency visits to examine suspicious lesions. A National Health Service (NHS) perspective was taken. Model input parameters were taken from the literature and where data were not available, local expert opinion was sought. Probabilistic sensitivity analysis, one-way sensitivity analysis on pertinent parameters and value of information was performed. Results. In the base-case probabilistic sensitivity analysis, less intensive surveillance strategies for AJCC stage IA and IB had lower total lifetime costs than the current National Institute for Health and Care Excellence (NICE) recommended strategy with similar effectiveness in terms of quality-adjusted life years and thereby likely to be cost-effective. Many strategies had similar effectiveness due to the relatively low chance of recurrence and the high rate of self-detection. Sensitivity and scenario analyses did not change these findings. Conclusions. Our model findings suggest that less resource intensive surveillance may be cost-effective compared with the current NICE surveillance guidelines. However, to advocate convincingly for changes, better evidence is required.

Economic Analysis of the CADScor System for Ruling Out Coronary Artery Disease in England.

BACKGROUND: Coronary artery disease (CAD) is the most common type of heart and circulatory disease and is the leading cause of death worldwide. The current diagnostic pathway can lead to patient complications and is also extremely costly. A new medical device, the CADScor System (Acarix AB), was developed for the acoustic detection of CAD before patients undergo invasive diagnostic procedures. OBJECTIVES: Our objective was to assess the cost utility of the CADScor System for the diagnosis of CAD at an early stage in the diagnostic testing pathway in England. METHODS: A two-part economic model, consisting of a decision tree and Markov model, was developed to consider the cost utility (cost per quality-adjusted life-year [QALY] gained) of introducing the CADScor System for the diagnosis of CAD. The decision tree component explored the short-term costs and diagnostic outcomes associated with introduction of the test compared with the existing testing pathway. A Markov model was developed to explore the longer-term health and economic implications of the condition and original diagnosis, with costs and health effects estimated over different time horizons. Parameter uncertainty was explored in deterministic and probabilistic sensitivity analyses. RESULTS: Base-case results indicated that the CADScor System would result in cost savings (- £131 per patient) and a marginal increase in QALYs (0.00001) over a 1-year time horizon. Probabilistic results indicated that the intervention had a > 99% probability of being cost effective at a willingness-to-pay threshold of £20,000 per QALY gained and 100% probability of being cost saving. Results from the deterministic sensitivity analyses indicated that variations in parameters related to the accuracy and cost of the CADScor System, and the prevalence of CAD, had the greatest impact on the overall results. The overall cost saving was estimated to be over £12.3 million per 100,000 eligible patient population. CONCLUSIONS: The CADScor System is a potentially cost-saving test for the diagnosis of CAD. When initiated before the use of non-invasive cardiac imaging tests such as computed tomography coronary angiography, the test reduced costs to the healthcare service over various time horizons.

Cost-effectiveness analysis of pressurized intraperitoneal aerosol chemotherapy (PIPAC) in patients with gastric cancer and peritoneal metastasis.

OBJECTIVE: The aim of this study was to assess the cost-effectiveness of pressurized intraperitoneal aerosol chemotherapy with low-dose cisplatin and doxorubicin (PIPAC C/D) for the treatment of advanced gastric cancer. METHODS: A Partitioned Survival Model followed by state transition Markov model was developed to estimate the costs and effectiveness of the use of PIPAC C/D versus palliative chemotherapy in the UK. The intervention was assessed at two different levels of care, including upfront therapy (PIPAC C/D plus Oxaliplatin in combination with Capecitabine (XELOX) chemotherapy versus first-line chemotherapy alone) and second-line therapy (PIPAC C/D alone versus second-line chemotherapy (ramucirumab monotherapy)). Data from multiple sources, including published literature and UK-based databases, were used to inform the economic model. RESULTS: For the upfront therapy analysis, the estimated total costs in the intervention and comparator arms were £32,606 (SD: £3877) and £17,844 (SD: £920), respectively. PIPAC C/D plus XELOX led to an increase of 0.46 in quality-adjusted life-years (QALYs) gained. The incremental cost per QALY gained was £31,868. For the second-line therapy analysis, the use of PIPAC C/D led to an increase of 0.19 in QALYs and a £21,474 reduction in costs, meaning the intervention was a dominant strategy. CONCLUSIONS: The cost-effectiveness results for the upfront therapy analysis indicate that PIPAC C/D plus chemotherapy is a cost-effective strategy. Additionally, PIPAC C/D alone as a second-line therapy has the potential to reduce costs and improve clinical outcomes for patients with advanced gastric cancer with peritoneal metastasis.

Cost-effectiveness of an enhanced Paramedic Acute Stroke Treatment Assessment (PASTA) during emergency stroke care: Economic results from a pragmatic cluster randomized trial.

BACKGROUND: The Paramedic Acute Stroke Treatment Assessment (PASTA) trial evaluated an enhanced emergency care pathway which aimed to facilitate thrombolysis in hospital. A pre-planned health economic evaluation was included. The main results showed no statistical evidence of a difference in either thrombolysis volume (primary outcome) or 90-day dependency. However, counter-intuitive findings were observed with the intervention group showing fewer thrombolysis treatments but less dependency. AIMS: Cost-effectiveness of the PASTA intervention was examined relative to standard care. METHODS: A within trial cost-utility analysis estimated mean costs and quality-adjusted life years over 90 days' time horizon. Costs were derived from resource utilization data for individual trial participants. Quality-adjusted life years were calculated by mapping modified Rankin scale scores to EQ-5D-3L utility tariffs. A post-hoc subgroup analysis examined cost-effectiveness when trial hospitals were divided into compliant and non-compliant with recommendations for a stroke specialist thrombolysis rota. RESULTS: The trial enrolled 1214 patients: 500 PASTA and 714 standard care. There was no evidence of a quality-adjusted life year difference between groups [0·007 (95% CI: -0·003 to 0·018)] but costs were lower in the PASTA group [-£1473 (95% CI: -£2736 to -£219)]. There was over 97.5% chance that the PASTA pathway would be considered cost-effective. There was no evidence of a difference in costs at seven thrombolysis rota compliant hospitals but costs at eight non-complaint hospitals costs were lower in PASTA with more dominant cost-effectiveness. CONCLUSIONS: Analyses indicate that the PASTA pathway may be considered cost-effective, particularly if deployed in areas where stroke specialist availability is limited.Trial Registration: ISRCTN12418919 www.isrctn.com/ISRCTN12418919.

Budget Impact of the Vest™ High Frequency Chest Wall Oscillation System for Managing Airway Clearance in Patients with Complex Neurological Disorders: A US Healthcare Payers' Perspective Analysis.

OBJECTIVE: As a recognized therapy to improve airway clearance, high-frequency chest wall oscillation (HFCWO) is used to manage reduced vital capacity in patients with complex neuromuscular disorders (cNMD). This study aimed to investigate the budget impact of HFCWO versus chest wall physical therapy (CWPT) from a US-commercial payer perspective. METHODS: In combination with a previously developed cost-effectiveness model, a budget impact model was developed to evaluate the incremental budgetary impact associated with introducing a HFCWO device over a 5-year time horizon. The model compared the cost implications associated with the commonly used CWPT procedure, as the current scenario, with a new scenario consisting of 80% of market share for HFCWO. The resource use and costs included in the analyses were costs associated with the HFCWO device (Vest™ System) and its consumables, patient training, and medical services such as hospitalization, medications, emergency room, and outpatient visits. The primary outcome measures included total and incremental budgetary impact per member per year (PMPY). RESULTS: In a hypothetical plan of 1,000,000 members (men: 49.2%), 2099 patients with cNMD were estimated to be eligible to receive airway clearance services over 5 years. The new scenario (HFCWO and CWPT [US$24 PMPY]) was cost-saving compared with the current scenario (CWPT only [$34 PMPY]) with a cost reduction of US$9.46 PMPY. The model estimated a net cost-saving of US$1,594,131 and US$9,591,343 over 1 and 5 years, respectively. CONCLUSION: This study suggests the HFCWO technique to manage the reduction in vital capacity in patients with cNMD would lead to favorable budget impact results.

Continuous Monitoring of Respiratory Rate with Wearable Sensor in Patients Admitted to Hospital with Pneumonia Compared with Intermittent Nurse-Led Monitoring in the United Kingdom: A Cost-Utility Analysis.

BACKGROUND: Respiratory rate (RR) is one of the most important physiologic measures for predicting patients' deterioration of clinical condition and final prognosis. In several studies, RR has been the most important predictor of patients' prognoses. OBJECTIVES: The objective of this study was to conduct a cost-utility analysis to estimate the cost and effectiveness of automatic respiratory rate monitoring (ARRM) with a non-invasive sensor (RespiraSense™) plus intermittent nurse-led RR monitoring (ARRM strategy) compared with intermittent nurse-led RR monitoring (IM strategy) in patients admitted to hospital in the UK with pneumonia. METHODS: A decision analytic model was developed based on a hypothetical cohort of patients who were admitted to hospital with pneumonia. After admission, the patients could be monitored with either ARRM or IM strategies. The outcomes of interest included total costs and total effectiveness of each strategy, including length of stay (LoS) in hospital, LoS in intensive care unit, quality-adjusted life-years (QALYs), deaths, and incremental cost per QALY gained. An incremental cost of £20,000 or less per QALY gained was considered cost effective. A lifetime time horizon (38 years) was used to capture the long-term benefits. Probabilistic and deterministic sensitivity analyses were performed. RESULTS: Total costs of patient care in ARRM and IM strategies were £1986.9 million and £2079.4 million, respectively. Total incremental QALYs lived were 3548 higher in the intervention arm (ARRM), meaning that the ARRM strategy was dominant (i.e., less costly [£92.6 million less] and more effective). The results were stable in probabilistic and most of the deterministic sensitivity analyses. Results from threshold analysis indicated that a minimum of 7 and 10% improvement in percentage of early detection of respiratory compromise is required for ARRM to become cost effective and cost saving, respectively. CONCLUSIONS: Our results indicate that ARRM using RespiraSense, in addition to intermittent nurse-led monitoring of RR, in patients admitted to the hospital with pneumonia could be a cost-saving and cost-effective intervention if the minimum clinical thresholds are met.

Optimal surveillance strategies for patients with stage 1 cutaneous melanoma post primary tumour excision: three systematic reviews and an economic model.

BACKGROUND: Malignant melanoma is the fifth most common cancer in the UK, with rates continuing to rise, resulting in considerable burden to patients and the NHS. OBJECTIVES: The objectives were to evaluate the effectiveness and cost-effectiveness of current and alternative follow-up strategies for stage IA and IB melanoma. REVIEW METHODS: Three systematic reviews were conducted. (1) The effectiveness of surveillance strategies. Outcomes were detection of new primaries, recurrences, metastases and survival. Risk of bias was assessed using the Cochrane Collaboration's Risk-of-Bias 2.0 tool. (2) Prediction models to stratify by risk of recurrence, metastases and survival. Model performance was assessed by study-reported measures of discrimination (e.g. D-statistic, Harrel's c-statistic), calibration (e.g. the Hosmer-Lemeshow 'goodness-of-fit' test) or overall performance (e.g. Brier score, R2). Risk of bias was assessed using the Prediction model Risk Of Bias ASsessment Tool (PROBAST). (3) Diagnostic test accuracy of fine-needle biopsy and ultrasonography. Outcomes were detection of new primaries, recurrences, metastases and overall survival. Risk of bias was assessed using the Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2) tool. Review data and data from elsewhere were used to model the cost-effectiveness of alternative surveillance strategies and the value of further research. RESULTS: (1) The surveillance review included one randomised controlled trial. There was no evidence of a difference in new primary or recurrence detected (risk ratio 0.75, 95% confidence interval 0.43 to 1.31). Risk of bias was considered to be of some concern. Certainty of the evidence was low. (2) Eleven risk prediction models were identified. Discrimination measures were reported for six models, with the area under the operating curve ranging from 0.59 to 0.88. Three models reported calibration measures, with coefficients of ≥ 0.88. Overall performance was reported by two models. In one, the Brier score was slightly better than the American Joint Committee on Cancer scheme score. The other reported an R2 of 0.47 (95% confidence interval 0.45 to 0.49). All studies were judged to have a high risk of bias. (3) The diagnostic test accuracy review identified two studies. One study considered fine-needle biopsy and the other considered ultrasonography. The sensitivity and specificity for fine-needle biopsy were 0.94 (95% confidence interval 0.90 to 0.97) and 0.95 (95% confidence interval 0.90 to 0.97), respectively. For ultrasonography, sensitivity and specificity were 1.00 (95% confidence interval 0.03 to 1.00) and 0.99 (95% confidence interval 0.96 to 0.99), respectively. For the reference standards and flow and timing domains, the risk of bias was rated as being high for both studies. The cost-effectiveness results suggest that, over a lifetime, less intensive surveillance than recommended by the National Institute for Health and Care Excellence might be worthwhile. There was considerable uncertainty. Improving the diagnostic performance of cancer nurse specialists and introducing a risk prediction tool could be promising. Further research on transition probabilities between different stages of melanoma and on improving diagnostic accuracy would be of most value. LIMITATIONS: Overall, few data of limited quality were available, and these related to earlier versions of the American Joint Committee on Cancer staging. Consequently, there was considerable uncertainty in the economic evaluation. CONCLUSIONS: Despite adoption of rigorous methods, too few data are available to justify changes to the National Institute for Health and Care Excellence recommendations on surveillance. However, alternative strategies warrant further research, specifically on improving estimates of incidence, progression of recurrent disease; diagnostic accuracy and health-related quality of life; developing and evaluating risk stratification tools; and understanding patient preferences. STUDY REGISTRATION: This study is registered as PROSPERO CRD42018086784. FUNDING: This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol 25, No. 64. See the NIHR Journals Library website for further project information.

Malignant melanoma is the deadliest of skin cancers; in the UK, > 2500 people die from it every year. Initially, the cancer is removed surgically, which cures it for most people, but, for some, the cancer returns. For this reason, after a melanoma is removed, patients are followed up to see if the melanoma reoccurs or if new melanomas have developed. It is felt that early cancer detection improves the chance of future treatment working. A key question is how best to follow up patients after initial melanoma surgery. This study concentrates on the earliest stage of melanoma (American Joint Committee on Cancer stage I), which accounts for more than 7 out of 10 of all melanoma diagnoses. The study also investigates if new ways of follow-up could be at least as good as current practice and a better use of NHS money. We systematically reviewed studies comparing different ways of organising follow-up, and then methods to identify those patients at high risk of developing a further melanoma and how good different tests are at detecting this cancer. We then compared different possible follow-up strategies. For each strategy, we considered its impact on quality and length of life, and how well it used NHS resources. We found little evidence to support a change in how follow-up should be organised currently. There were some ways of organising follow-up that might be better than current care, but further research is needed. We found that new research on whether or not follow-up should be performed by a cancer nurse specialist, rather than a dermatologist or surgeon, would be worthwhile. We also found that more research could be worthwhile on how frequently melanoma recurs and spreads, as well as how accurately a diagnosis of further cancer is made and how to identify those most at risk of further melanoma spread.

Cost-Effectiveness of Tisagenlecleucel in Paediatric Acute Lymphoblastic Leukaemia (pALL) and Adult Diffuse Large B-Cell Lymphoma (DLBCL) in Switzerland.

INTRODUCTION: The purpose of the present analysis was to explore the cost-effectiveness of tisagenlecleucel in relapsed or refractory (r/r) paediatric acute lymphoblastic leukaemia (pALL) and r/r adult diffuse large B-cell lymphoma (DLBCL) in Switzerland against a range of historical standard-of-care treatments. METHODS: Two cost-utility models were constructed for the two licensed indications using similar methodologies but indication-specific data. Clinical efficacy data were based on pooled analyses of clinical trials for tisagenlecleucel (pALL: ELIANA, ENSIGN, B2101J; DLBCL: JULIET, NCT02030834) and published data for comparator treatments. Treatment effects were compared based on matching-adjusted indirect comparison (MAIC) analyses. Four clinical lymphoma and leukaemia experts provided Switzerland-specific input regarding comparators, diagnostic and therapeutic procedures, clinical evidence and costs, which were used to inform the models. The base case analysis reflected the perspective of the Swiss mandatory health insurance system. Deterministic, probabilistic and scenario analyses were carried out to explore the robustness of results. RESULTS: The base case analysis resulted in incremental costs of CHF 31,961-CHF 36,419 per quality-adjusted life year (QALY) gained for pALL across the different comparators and CHF 113,179 for DLBCL (1 CHF = 1.09 USD). Incremental costs per life-year gained ranged between CHF 33,906-CHF 97,399 across the two indications. Including productivity gains, tisagenlecleucel was shown to be dominant (more effective and less costly) over all the comparators for pALL and to result in incremental costs per life-year gained of CHF 57,324 for DLBCL. CONCLUSION: Using hypothetical willingness-to-pay thresholds of CHF 100,000-150,000 per QALY gained, the present analysis has shown tisagenlecleucel to be a cost-effective treatment option in pALL and DLBCL.

Cost-utility analysis of normothermic liver perfusion with the OrganOx metra compared to static cold storage in the United Kingdom.

BACKGROUND: Rising numbers of patients on the liver transplant waiting list has led to the utilization of organs from higher-risk donors that are more likely to be discarded and are prone to post-transplant complications. Storage and transportation of these livers at low temperatures can cause damage. OrganOx metra is a portable device intended to preserve and maintain the donated liver in normothermic conditions for up to 24 h prior to transplantation. OBJECTIVE: To evaluate the cost-utility of normothermic machine perfusion with OrganOx metra in liver transplantation compared to the current practice of static cold storage (SCS). METHODS: A de novo decision analytic model (a decision tree along with a Markov model), based on current treatment pathways, was developed to estimate the costs and outcomes. Results from a randomized clinical trial and national standard sources were used to inform the model. Costs were estimated from the National Health Service and Personal Social Services perspective. Deterministic and probabilistic sensitivity analyses (PSA) were conducted to explore uncertainty surrounding input parameters. RESULTS: Over a lifetime time horizon, liver transplantation with OrganOx metra was more costly and more effective than the current practice of static cold storage. The total costs per patient were £37,370 vs £46,711, and the total effectiveness per patient was 9.09 QALYs vs 10.27 QALYs for SCS and OrganOx metra groups, respectively. The estimated ICER was £7,876 per each QALY gained. Results from the PSA showed that use of OrganOx metra has 99% probability of being cost-effective at a £20,000 willingness-to-pay threshold. OrganOx metra led to the utilization of 54 additional livers with patients experiencing lower rates of early allograft dysfunction and adverse events. CONCLUSIONS: Use of OrganOx metra for the perfusion and transportation of livers prior to transplantation is a cost-effective strategy. KEY POINTS FOR DECISION MAKERS Introduction of OrganOx metra into NHS could increase the utilisation of donated livers with patients experiencing lower rates of early allograft dysfunction and adverse events, compared with current practice. Results of the economic analysis indicate that the OrganOx metra is highly likely to be cost-effective and result in improved patient outcomes.

Long-term Cost-Effectiveness of Dexcom G6 Real-time Continuous Glucose Monitoring Versus Self-Monitoring of Blood Glucose in Patients With Type 1 Diabetes in the U.K.

OBJECTIVE: A long-term health economic analysis was performed to establish the cost-effectiveness of real-time continuous glucose monitoring (RT-CGM) (Dexcom G6) versus self-monitoring of blood glucose (SMBG) alone in U.K.-based patients with type 1 diabetes (T1D). RESEARCH DESIGN AND METHODS: The analysis used the IQVIA CORE Diabetes Model. Clinical input data were sourced from the DIAMOND trial in adults with T1D. Simulations were performed separately in the overall population of patients with baseline HbA1c ≥7.5% (58 mmol/mol), and a secondary analysis was performed in patients with baseline HbA1c ≥8.5% (69 mmol/mol). The analysis was performed from the National Health Service health care payer perspective over a lifetime time horizon. RESULTS: In the overall population, G6 RT-CGM was associated with a mean incremental gain in quality-adjusted life expectancy of 1.49 quality-adjusted life years (QALYs) versus SMBG (mean [SD] 11.47 [2.04] QALYs versus 9.99 [1.84] QALYs). Total mean (SD) lifetime costs were also pounds sterling (GBP) 14,234 higher with RT-CGM (GBP 102,468 [35,681] versus GBP 88,234 [39,027]) resulting in an incremental cost-effectiveness ratio of GBP 9,558 per QALY gained. Sensitivity analyses revealed that the findings were sensitive to changes in the quality-of-life benefit associated with reduced fear of hypoglycemia and avoidance of fingerstick testing as well as the HbA1c benefit associated with RT-CGM use. CONCLUSIONS: For U.K.-based T1D patients, the G6 RT-CGM device is associated with significant improvements in clinical outcomes and, over patient lifetimes, is a cost-effective disease management option relative to SMBG on the basis of a willingness-to-pay threshold of GBP 20,000 per QALY gained.

Economic evaluation of surgical treatments for women with stress urinary incontinence: a cost-utility and value of information analysis.

OBJECTIVES: Stress urinary incontinence (SUI) and stress-predominant mixed urinary incontinence (MUI) are common conditions that can have a negative impact on the quality of life of patients and serious cost implications for healthcare providers. The objective of this study was to assess the cost-effectiveness of nine different surgical interventions for treatment of SUI and stress-predominant MUI from a National Health Service and personal social services perspective in the UK. METHODS: A Markov microsimulation model was developed to compare the costs and effectiveness of nine surgical interventions. The model was informed by undertaking a systematic review of clinical effectiveness and network meta-analysis. The main clinical parameters in the model were the cure and incidence rates of complications after different interventions. The outcomes from the model were expressed in terms of cost per quality-adjusted life-years (QALYs) gained. In addition, expected value of perfect information (EVPI) analyses were conducted to quantify the main uncertainties facing decision-makers. RESULTS: The base-case results suggest that retropubic mid-urethral sling (retro-MUS) is the most cost-effective surgical intervention over a 10-year and lifetime time horizon. The probabilistic results show that retro-MUS and traditional sling are the interventions with the highest probability of being cost-effective across all willingness-to-pay thresholds over a lifetime time horizon. The value of information analysis results suggest that the largest value appears to be in removing uncertainty around the incidence rates of complications, the relative treatment effectiveness and health utility values. CONCLUSIONS: Although retro-MUS appears, at this stage, to be a cost-effective intervention, research is needed on possible long-term complications of all surgical treatments to provide reassurance of safety, or earlier warning of unanticipated adverse effects. The value of information analysis supports the need, as a first step, for further research to improve our knowledge of the actual incidence of complications.

Economic analysis of Electrical Muscle Stimulator with Multipath technology for the treatment of stress urinary incontinence: a UK-based cost-utility analysis.

Background: Stress urinary incontinence (SUI) is a debilitating and highly prevalent condition in the UK. The condition is associated with a significant economic burden for affected patients and society. Current treatment options for SUI include minimally invasive therapies, medication and surgical intervention for the most serious cases. Electrical Muscle Stimulator with Multipath technology is a recently developed device for the treatment of SUI that relies on neuromuscular external electrical stimulation (NEES) technology. The clinical efficacy of the device has been proven in previous studies, but existing evidence surrounding its economic viability is limited.Objectives: To assess the cost-utility of the Electrical Muscle Stimulator with Multipath technology Therapy device for the treatment of SUI amongst women in a UK setting.Methods: An economic model was developed to consider the cost-utility (cost per quality-adjusted life-year [QALY] gained) of Electrical Muscle Stimulator with Multipath technology compared with current practice. A Markov model was developed, with costs and health effects estimated over the lifetime of the patient in the base-case analysis. The model was developed to reflect the treatment pathways typically followed by patients with SUI in the UK. Parameter uncertainty was explored in deterministic and probabilistic sensitivity analyses.Results: Base-case results indicate that Electrical Muscle Stimulator with Multipath technology results in cost savings and QALY gains over the patient's lifetime. In the "cure" analysis, the intervention is £250 less costly and leads to a 0.03 QALY gain per patient, while in the "improvement analysis", the intervention is £327 less costly and leads to a 0.13 QALY gain per patient. Results from the probabilistic sensitivity analyses show that the likelihood of Electrical Muscle Stimulator with Multipath technology being cost-effective is greater than 74% across all willingness-to-pay thresholds in the two analyses presented.Conclusions: Electrical Muscle Stimulator with Multipath technology is a potentially cost-effective treatment option for patients with SUI who have failed first-line treatment. It could reduce costs to the health care service and improve quality-of-life for selected patients over their lifetime.

Effect of an Enhanced Paramedic Acute Stroke Treatment Assessment on Thrombolysis Delivery During Emergency Stroke Care: A Cluster Randomized Clinical Trial.

Importance: Rapid thrombolysis treatment for acute ischemic stroke reduces disability among patients who are carefully selected, but service delivery is challenging. Objective: To determine whether an enhanced Paramedic Acute Stroke Treatment Assessment (PASTA) intervention increased hospital thrombolysis rates. Design, Setting, and Participants: This multicenter, cluster randomized clinical trial took place between December 2015 and July 2018 in 3 ambulance services and 15 hospitals. Clusters were paramedics based within ambulance stations prerandomized to PASTA or standard care. Patients attended by study paramedics were enrolled after admission if a hospital specialist confirmed a stroke and paramedic assessment started within 4 hours of onset. Allocation to PASTA or standard care reflected the attending paramedic's randomization status. Interventions: The PASTA intervention included additional prehospital information collection, a structured hospital handover, practical assistance up to 15 minutes after handover, a predeparture care checklist, and clinician feedback. Standard care reflected national guidelines. Main Outcomes and Measures: Primary outcome was the proportion of patients receiving thrombolysis. Secondary outcomes included time intervals and day 90 health (with poor status defined as a modified Rankin Score >2, to represent dependency or death). Results: A total of 11 478 patients were screened following ambulance transportation; 1391 were eligible and approached, but 177 did not consent. Of 1214 patients enrolled (mean [SD] age, 74.7 [13.2] years; 590 women [48.6%]), 500 were assessed by 242 paramedics trained in the PASTA intervention and 714 were assessed by 355 paramedics continuing with standard care. The paramedics trained in the PASTA intervention took a mean of 13.4 (95% CI, 9.4-17.4) minutes longer (P < .001) to complete patient care episodes. There was less thrombolysis among the patients in the PASTA group, but this was not significant (PASTA group, 197 of 500 patients [39.4%] vs the standard care group, 319 of 714 patients [44.7%]; adjusted odds ratio, 0.81 [95% CI, 0.61-1.08]; P = .15). Time from a paramedic on scene to thrombolysis was a mean of 8.5 minutes longer in the PASTA group (98.1 [37.6] minutes) vs the standard care group (89.4 [31.1] minutes; P = .01). Poor health outcomes did not differ significantly but occurred less often among patients in the PASTA group (313 of 489 patients [64.0%]) vs the standard care group (461 of 690 patients [66.8%]; adjusted odds ratio, 0.86 [95% CI, 0.60-1.20]; P = .39). Conclusions and Relevance: An enhanced paramedic assessment did not facilitate thrombolysis delivery. The unexpected combination of thrombolysis and health outcomes suggests possible alternative influences on treatment decisions by the intervention, requiring further evaluation. Trial Registration: ISRCTN Registry Identifier: ISRCTN12418919.

Surgical treatments for women with stress urinary incontinence: a systematic review of economic evidence.

BACKGROUND: Surgical interventions for the treatment of stress urinary incontinence (SUI) in women are commonly employed following the failure of minimally invasive therapies. Due to the limited information available on the relative cost-effectiveness of available surgeries for treating SUI, a de novo economic analysis was conducted to assess costs and effects of all relevant surgeries. To inform the economic analysis, the objective of this review was to identify and assess the quality of existing economic evaluation studies on different surgical interventions for the treatment of SUI in women. METHODS: The following databases were searched during the review process: Medical Literature Analysis and Retrieval System Online (MEDLINE), MEDLINE In-Process, Excerpta Medica Database (Embase), National Health Service Economic Evaluation Database (NHS EED), and Health Management Information Consortium and Cost-Effectiveness Analysis Registry (CEA registry). The key criteria for inclusion were that the study population included women with SUI and that the surgical interventions considered were utilised as either a primary or a follow-up surgery. The review included only full economic evaluations. Studies were quality assessed using the Drummond checklist for economic evaluations. No quantitative synthesis of the results by meta-analysis was conducted due to the high methodological heterogeneity. RESULTS: Twenty-six economic evaluations were included, of which 13 were model-based analyses. Surgical treatments assessed most frequently were mid-urethral slings and open and laparoscopic colposuspension. There were some differences in the methodological approaches taken, including differences in type of economic analysis, perspective, time horizon, types of resource use, and costs and outcomes that were included in the analysis. The majority of studies conducted a cost-utility analysis from a health system perspective and applied a time horizon of between 1 and 5 years. The cost-effectiveness results suggest that single-incision mini-sling and mid-urethral slings are among the most cost-effective options. CONCLUSIONS: The review has shown that methods used for the economic evaluation of surgical treatments for SUI vary widely in terms of study design, analysis type, compared alternatives, time horizon, costing methodologies and effect outcomes. Future economic evaluation studies on surgical treatments for SUI may be improved by the application of available guidelines. SYSTEMATIC REVIEW REGISTRATION: Registered in PROSPERO in 2016, CRD42016049339.