[177Lu]Lu-DOTA-TATE versus standard of care in adult patients with gastro-enteropancreatic neuroendocrine tumours (GEP-NETs): a cost-consequence analysis from an Italian hospital perspective

Purpose To assess and compare clinical outcomes and costs, to the Italian healthcare system, of three therapeutic options approved in the management of adult patients with gastro-enteropancreatic neuroendocrine tumours (GEP-NETs). Methods We compared the efficacy, safety, and costs of [177Lu]Lu-DOTA-TATE, everolimus (both originator and generic products), and sunitinib in patients with advanced GEP-NETs (NET G1 and G2) that had progressed following treatment with somatostatin analogs (SSAs). A cost-consequence model was developed and validated by a panel of clinical experts from three NET reference centres in Italy. The clinical outcomes included in the model were median progression-free survival and the incidence of grade 3 or 4 adverse events (AEs), as reported in pivotal clinical trials. The costs for acquisition and administration of each treatment, and of managing AEs, were calculated from the perspective of the Italian national health service. Treatment costs per progression-free month were calculated separately for patients with NETs of pancreatic (PanNETs; all three treatments) and gastrointestinal (GI-NETs; [177Lu]Lu-DOTA-TATE and everolimus only) origin. Results In patients with PanNETs, total costs per progression-free month were €2989 for [177Lu]Lu-DOTA-TATE, €4975 for originator everolimus, €3472 for generic everolimus, and €5337 for sunitinib. In patients with GI-NETs, total costs per progression-free month were €3189 for [177Lu]Lu-DOTA-TATE, €4990 for originator everolimus, and €3483 for generic everolimus. Conclusions [177Lu]Lu-DOTA-TATE was associated with lower costs per progression-free month versus relevant treatment options in patients with GI-NETs or PanNETs (NET G1–G2; progressed following SSA treatment), although acquisition and administration costs are higher. These findings provide further economic arguments in the overall context of treatment decision-making.

Early Treatment with fluvoxamine among patients with COVID-19: a cost-consequence model

ABSTRACT Background Three randomized trials have been conducted indicating a clinical benefit of early treatment with fluvoxamine versus placebo for adults with symptomatic COVID-19. We assessed the cost-consequences associated with the use of this early treatment in outpatient populations. Methods Using results from the three completed trials of fluvoxamine vs. placebo for the treatment of COVID-19, we performed a meta-analysis. We conducted a cost-consequence analysis using a decision-model to assess the health system benefits of the avoidance of progression to severe COVID-19. Outcomes of relevance to resource planning decisions in the US and elsewhere, including costs and days of hospitalization avoided, were reported. We constructed a decision-analytic model in the form of a decision tree to evaluate two treatment strategies for high-risk patients with confirmed, symptomatic COVID-19, from the perspective of a third-party payer: (1) treatment with a 10-day course of fluvoxamine (100mg twice daily); (2) current standard-of-care; (3) molnupiravir 5-day course. We used a time horizon of 28 days. Results Administration of fluvoxamine to symptomatic outpatients with COVID-19 at high-risk of developing progression to severe COVID-19 complications is substantially cost-saving in the US, in the amount of $232 per eligible patient, and saves an average of 0.15 hospital days per patient treated is likely to be similarly beneficial in other settings. Fluvoxamine is cost saving in locations where total hospital costs are >$738. Molnupiravir had an additional cost to the healthcare system of $404 per patient treated. Conclusions Fluvoxamine is cost-saving for COVID-19 outpatient therapy.

Cost-Consequence Analysis of Advanced Imaging in Acute Ischemic Stroke Care

Introduction: The purpose of this study was to illustrate the potential costs and health consequences of implementing advanced CT angiography and perfusion (CTAP) as the initial imaging in patients presenting with acute ischemic stroke (AIS) symptoms at a comprehensive stroke center (CSC).Methods: A decision-simulation model based on the American Heart Association's recommendations for AIS care pathways was developed to assess imaging strategies for a 5-year period from the institutional perspective. The following strategies were compared: (1) advanced CTAP imaging: NCCT + CTA + CT perfusion at the time of presentation; (2) standard-of-care: non-contrast CT (NCCT) at the time of presentation, with CT angiography (CTA) ± CT perfusion only in select patients (initial imaging to exclude hemorrhage and extensive ischemia) for mechanical thrombectomy (MT) evaluation. Model parameters were defined with evidence-based data. Cost-consequence and sensitivity analyses were performed. The modified Rankin Scale (mRS) at 90 days was used as the outcome measure.Results: The decision-simulation modeling revealed that adoption of the advanced CTAP imaging increased per-patient imaging costs by 1.19% ($9.28/$779.72), increased per-patient treatment costs by 33.25% ($729.96/$2,195.24), and decreased other per-patient acute care costs by 0.7% (–$114.12/$16,285.85). The large increase in treatment costs was caused by higher proportion of patients being treated. However, improved outcomes lowered the other per-patient acute care costs. Over the five-year period, advanced CTAP imaging led to 1.63% (66/4,040) more patients with good outcomes (90-day mRS 0-2), 2.23% (66/2,960) fewer patients with poor outcomes (90-day mRS 3-5), and no change in mortality (90-day mRS 6). Our CT equipment utilization analysis showed that the demand for CT equipment in terms of scanner time (minutes) was 24% lower in the advanced CTAP imaging strategy compared to the standard-of-care strategy. The number of EVT procedures performed at the CSC may increase by 50%.Conclusions: Our study reveals that adoption of advanced CTAP imaging at presentation increases the demand for treatment of acute ischemic stroke patients as more patients are diagnosed within the treatment time window compared to standard-of-care imaging. Advanced imaging also leads to more patients with good functional outcomes and fewer patients with dependent functional status.

O51 BIOSYNTHETIC MESH VERSUS NON-ABSORBABLE SYNTHETIC MESH IN COMPLEX ABDOMINAL WALL REPAIR (CAWR): A UK NHS COST-CONSEQUENCE ANALYSIS OF MANAGEMENT STRATEGIES

Aim CAWR is marked by high complication and hernia recurrence rates. Different management strategies of CAWR may result in a significant reduction in quality of life and increased financial burden. The use of certain non-absorbable synthetic meshes in CAWR may be associated with an increased risk of adverse events for certain patients. Recent evidence suggests that biosynthetic meshes may contribute to lower complications and may be more cost-effective. Material and Methods To compare the cost between a synthetic mesh, and a bio-synthetic mesh in the management of patients undergoing CAWR. A cost-consequence model was developed to simulate clinical pathways for patients undergoing CAWR with different management strategies. Clinical parameters were informed by literature review and expert opinion. Adverse events associated with the use of a mesh, resource utilisation and re-admissions were compared between patient management strategies over a period of two years. Costing information were gathered from national tariffs using NICE methodology. Results Use of a biosynthetic mesh was associated with a significant reduction in total costs (£15,489 / €17,953) compared to a synthetic mesh at two years. Cost-savings were driven by a lower rate adverse events (hernia recurrence [2% vs.8%] and sepsis [5% vs. 12%] respectively), and resource utilisation after the initial procedure in the management of complications. There was no difference in the intra-procedural time and complications. Conclusions The use of a certain biosynthetic mesh is likely to be highly cost saving compared to a certain synthetic mesh in high-risk patients undergoing CAWR. Well conducted comparative clinical studies are needed to inform robust economic modelling.

A Cost–Consequence Analysis of Preemptive SLCO1B1 Testing for Statin Myopathy Risk Compared to Usual Care

There is a well-validated association between SLCO1B1 (rs4149056) and statin-associated muscle symptoms (SAMS). Preemptive SLCO1B1 pharmacogenetic (PGx) testing may diminish the incidence of SAMS by identifying individuals with increased genetic risk before statin initiation. Despite its potential clinical application, the cost implications of SLCO1B1 testing are largely unknown. We conducted a cost–consequence analysis of preemptive SLCO1B1 testing (PGx+) versus usual care (PGx−) among Veteran patients enrolled in the Integrating Pharmacogenetics in Clinical Care (I-PICC) Study. The assessment was conducted using a health system perspective and 12-month time horizon. Incremental costs of SLCO1B1 testing and downstream medical care were estimated using data from the U.S. Department of Veterans Affairs’ Managerial Cost Accounting System. A decision analytic model was also developed to model 1-month cost and SAMS-related outcomes in a hypothetical cohort of 10,000 Veteran patients, where all patients were initiated on simvastatin. Over 12 months, 13.5% of PGx+ (26/193) and 11.2% of PGx− (24/215) participants in the I-PICC Study were prescribed Clinical Pharmacogenetics Implementation Consortium (CPIC) guideline-concordant statins (Δ2.9%, 95% CI −4.0% to 10.0%). Differences in mean per-patient costs for lipid therapy prescriptions, including statins, for PGx+ compared to PGx− participants were not statistically significant (Δ USD 9.53, 95% CI −0.86 to 22.80 USD). Differences in per-patient costs attributable to the intervention, including PGx testing, lipid-lowering prescriptions, SAMS, laboratory and imaging expenses, and primary care and cardiology services, were also non-significant (Δ− USD 1004, 95% CI −2684 to 1009 USD). In the hypothetical cohort, SLCO1B1-informed statin therapy averted 109 myalgias and 3 myopathies at 1-month follow up. Fewer statin discontinuations (78 vs. 109) were also observed, but the SLCO1B1 testing strategy was 96 USD more costly per patient compared to no testing (124 vs. 28 USD). The implementation of SLCO1B1 testing resulted in small, non-significant increases in the proportion of patients receiving CPIC-concordant statin prescriptions within a real-world primary care context, diminished the incidence of SAMS, and reduced statin discontinuations in a hypothetical cohort of 10,000 patients. Despite these effects, SLCO1B1 testing administered as a standalone test did not result in lower per-patient health care costs at 1 month or over 1 year of treatment. The inclusion of SLCO1B1, among other well-validated pharmacogenes, into preemptive panel-based testing strategies may provide a better balance of clinical benefit and cost.

A Cost-Consequence Analysis of Different Screening Procedures in Alzheimer’s Disease: Results from the MOPEAD Project

Background: For care planning and support, under-detection and late diagnosis of Alzheimer’s disease (AD) is a great challenge. Models of Patient-Engagement for Alzheimer’s Disease (MOPEAD) is an EU-funded project aiming at testing different strategies to improve this situation. Objective: To make a cost-consequence analysis of MOPEAD. Methods: Four screening strategies were tested in five countries (Germany, the Netherlands, Slovenia, Spain, and Sweden): 1) a web-approach; 2) Open-House initiative; 3) in primary care; and 4) by diabetes specialists. Persons-at-risk of AD in all strategies were offered referral to a hospital-based specialist. The primary health-economic outcome was the cost per true-positive case (TP) of AD from the screened population. Results: Of 2,847 screened persons, 1,121 screened positive (39%), 402 were evaluated at memory clinics (14%), and 236 got an AD diagnosis (8%). The cost per TP of those screened was 3,115€ with the web-approach, 2,722€ with the Open-House, 1,530€ in primary care, and 1,190€ by diabetes specialists. Sensitivity analyses that more likely reflect the real-world situation confirmed the results. The number-needed-to-screen was 30 with the web-approach, 8 with the Open-House and primary care, and 6 with the diabetes specialists. There were country differences in terms of screening rates, referrals to memory clinics, staff-types involved, and costs per TP. Conclusion: In primary care and by the diabetes specialist, the costs per TP/screened population were lowest, but the capacity of such settings to identify cases with AD-risk must be discussed. Hence new diagnostic strategies such as web-solutions and Open-House initiatives may be valuable after modifications.

Lee Silverman Voice Treatment versus standard speech and language therapy versus control in Parkinson’s disease: preliminary cost-consequence analysis of the PD COMM pilot randomised controlled trial

Background The PD COMM pilot randomised controlled trial compared Lee Silverman Voice Treatment (LSVT® LOUD) with standard NHS speech and language therapy (SLT) and a control arm in people with Parkinson’s disease (PwPD) with self-reported problems with voice or speech. This analysis compares costs and quality of life outcomes between the trial arms, and considers the validity of the alternative outcome measures for economic evaluations. Methods A comparison of costs and outcomes was undertaken alongside the PD COMM pilot trial involving three arms: LSVT® LOUD treatment (n = 30); standard NHS SLT (n = 30); and a control arm (n = 29) excluded from receiving therapy for at least 6 months after randomisation unless deemed medically necessary. For all trial arms, resource use and NHS, social care and patient costs and quality of life were collected prospectively at baseline, 3, 6, and 12 months. Total economic costs and outcomes (EQ-5D-3L, ICECAP-O) were considered over the 12-month follow-up period from an NHS payer perspective. Quality of life measures for economic evaluation of SLT for people with Parkinson’s disease were compared. Results Whilst there was no difference between arms in voice or quality of life outcomes at 12 months, there were indications of differences at 3 months in favour of SLT, which need to be confirmed in the main trial. The estimated mean cost of NHS care was £3288 per patient per year for the LSVT® LOUD arm, £2033 for NHS SLT, and £1788 for the control arm. EQ-5D-3L was more strongly correlated to voice impairment than ICECAP-O, and was sensitive to differences in voice impairment between arms. Conclusions The pilot did not identify an effect of SLT on disease-specific or economic outcomes for PwPD at 12 months; however, there appeared to be improvements at 3 months. In addition to the sample size not powered to detect difference in cost-consequence analysis, many patients in the control arm started SLT during the 12-month period used for economic analysis, in line with the study protocol. The LSVT® LOUD intervention was more intense and therefore more costly. Early indications suggest that the preferred economic outcome measure for the full trial is EQ-5D-3L; however, the ICECAP-O should still be included to capture a broader measure of wellbeing. Trial registration International Standard Randomised Controlled Trial Number Register: ISRCTN75223808. Registered 22 March 2012.