Cost-effectiveness of etanercept in patients with severe ankylosing spondylitis in Germany

Objectives. To estimate the cost-effectiveness of etanercept (ETN) plus usual care (including NSAIDs) compared with usual care alone (including NSAIDs) in patients with severe AS in Germany. Methods. A mathematical model previously applied to the UK was adapted using resource use and cost data (for 2007) from the national database of the German Collaborative Arthritis Centres. Social health insurance (SHI) and societal perspectives were analysed. Assumptions on initial response and changes in health-related quality of life were based on Phase III randomized controlled trials. Initial treatment response according to British Society for Rheumatology guidelines were assumed as a conservative estimate in the German context. Long-term disease progression was based on the available literature. Incremental cost-effectiveness ratios (ICERs) were expressed as euros/quality-adjusted life year (QALY), for a cohort of 1000 patients over 25 years. Sensitivity analyses explored uncertainty in results. Results. In the base case, ETN plus usual care (including NSAIDs) yielded 1475 more QALYs at an additional cost of €80 827 668 (SHI) or €32 657 590 (societal) leading to an ICER of €54 815/QALY and €22 147/QALY, respectively. Over a shorter time horizon of 10 years, the ICERs were €59 006 and €29 815 for SHI and societal viewpoints, respectively. Assumptions having the largest impact on results included withdrawal rates from ETN, quality of life, disease costs and initial response. Conclusions. Cost-effectiveness for ETN in patients with severe AS in Germany differs according to the cost perspective. Study estimates were higher than in the UK but comparable with reported cost-effectiveness of anti-TNF treatments in patients with RA in German

Generating EQ-5D-5L health utility scores from BASDAI and BASFAI : A mapping study in patients with axial spondyloarthritis using longitudinal UK registry data

Acknowledgments: We are grateful to the staff of the British Society for Rheumatology Biologics Register in Axial Spondyloarthritis. Claudia Zabke, Maureen Heddle, Nafeesa Nazlee and Barry Morris, and to the recruiting staff at the clinical centres, details of which are available at: https://www.abdn.ac.uk/iahs/research/epidemiology/spondyloarthritis.php#panel1011 Funding/Support: The British Society for Rheumatology Biologics Register in Ankylosing. Spondylitis (BSRBR-AS) is funded by the British Society for Rheumatology (BSR), which in turn has received funding from the manufacturers of the biologic therapies included in the study (Abbvie, Pfizer and UCB). Pharmaceutical companies providing funds to BSR do not have a role in the oversight of the study, but they do receive advance notice of publications on which they can comment. They do not have access to the data collected but can request analyses of the data, for which additional funds are provided.Peer reviewedPostprin

Cost comparison of insulin glargine with insulin detemir in a basal-bolus regime with mealtime insulin aspart in type 2 diabetes in Germany

Objective: To compare the treatment costs of insulin glargine (IG; Lantus®) to detemir (ID; Levemir®), both combined with bolus insulin aspart (NovoRapid®) in type 2 diabetes (T2D) in Germany

Generating EQ-5D-5L health utility scores from BASDAI and BASFI : a mapping study in patients with axial spondyloarthritis using longitudinal UK registry data

Acknowledgements We are grateful to the staff of the British Society for Rheumatology Biologics Register in Axial Spondyloarthritis. Claudia Zabke, Maureen Heddle, Nafeesa Nazlee and Barry Morris, and to the recruiting staff at the clinical centres, details of which are available at: https://www.abdn.ac.uk/iahs/research/epidemiology/spondyloarthritis.php#panel1011. Funding The British Society for Rheumatology Biologics Register in Ankylosing. Spondylitis (BSRBR-AS) is funded by the British Society for Rheumatology (BSR), which in turn has received funding from the manufacturers of the biologic therapies included in the study (Abbvie, Pfizer and UCB). Pharmaceutical companies providing funds to BSR do not have a role in the oversight of the study, but they do receive advance notice of publications on which they can comment. They do not have access to the data collected but can request analyses of the data, for which additional funds are provided.Peer reviewedPublisher PD

Practical Application of Outcomes Based Pricing Models in Scotland

Based on consultation with the expert advisory group, the objective of this report is to make recommendations on the next steps necessary to understand the practical application of an Outcomes Based Pricing (OBP) scheme in Scotland

Generating EQ-5D-5L health utility scores from BASDAI and BASFI:a mapping study in patients with axial spondyloarthritis using longitudinal UK registry data

BACKGROUND: Preference-based health-state utility values (HSUVs), such as the EuroQol five-dimensional questionnaire (EQ-5D-5L), are needed to calculate quality-adjusted life-years (QALYs) for cost-effectiveness analyses. However, these are rarely used in clinical trials of interventions in axial spondyloarthritis (axSpA). In these cases, mapping can be used to predict HSUVs. OBJECTIVE: To develop mapping algorithms to estimate EQ-5D-5L HSUVs from the Bath Ankylosing Disease Activity Index (BASDAI) and the Bath Ankylosing Spondylitis Functional Index (BASFI). METHODS: Data from the British Society for Rheumatology Biologics Register in Ankylosing Spondylitis (BSRBR-AS) provided 5122 observations with complete BASDAI, BASFI, and EQ-5D-5L responses covering the full range of disease severity. We compared direct mapping using adjusted limited dependent variable mixture models (ALDVMMs) and optional inclusion of the gap between full health and the next feasible value with indirect response mapping using ordered probit (OPROBIT) and generalised ordered probit (GOPROBIT) models. Explanatory variables included BASDAI, BASFI, and age. Metrics to assess model goodness-of-fit and performance/accuracy included Akaike and Bayesian information criteria (AIC/BIC), mean absolute error (MAE) and root mean square error (RMSE), plotting predictive vs. observed estimates across the range of BASDAI/BASFI and comparing simulated data with the original data set for the preferred/best model. RESULTS: Overall, the ALDVMM models that did not formally include the gap between full health and the next feasible value outperformed those that did. The four-component mixture models (with squared terms included) performed better than the three-component models. Response mapping using GOPROBIT (no squared terms included) or OPROBIT (with squared terms included) offered the next best performing models after the three-component ALDVMM (with squared terms). Simulated data of the preferred model (ALDVMM with four-components) did not significantly underestimate uncertainty across most of the range of EQ-5D-5L values, however the proportion of data at full health was underrepresented, likely due in part to model fitting on a small number of observations at this point in the actual data (4%). CONCLUSIONS: The mapping algorithms developed in this study enabled the generation of EQ-5D-5L utilities from BASDAI/BASFI. The indirect mapping equations reported for the EQ-5D-5L facilitate the calculation of the EQ-5D-5L utility scores using other UK and country-specific value sets. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s10198-022-01429-x

Comparing inpatient management of chronic pelvic pain flares before and after the COVID-19 pandemic

Patients with chronic pelvic pain (CPP) may experience pain exacerbations requiring hospital admissions. Due to the effects of backlogged elective surgeries and outpatient gynaecology appointments resulting from the COVID-19 pandemic, we hypothesised that there would be an increased number of women admitted with CPP flares. We conducted a retrospective review of all acute gynaecology admissions at the Royal Infirmary of Edinburgh from July to December 2018 (pre-COVID) and 2021 (post-COVID lockdown). We collected information on the proportion of emergency admissions due to CPP, inpatient investigations and subsequent management. Average total indicative hospital inpatient costs for women with CPP were calculated using NHS National Cost Collection data guidance. There was no significant difference in the number of emergency admissions due to pelvic pain before (153/507) and after (160/461) the COVID-19 pandemic. As high as 33 and 31% had a background history of CPP, respectively. Across both timepoints, investigations in women with CPP had low diagnostic yield: <25% had abnormal imaging findings and 0% had positive vaginal swab cultures. Women with CPP received significantly more inpatient morphine, pain team reviews and were more likely to be discharged with strong opioids. Total yearly inpatient costs were £170,104 and £179,156 in 2018 and 2021, respectively. Overall, emergency admission rates for managing CPP flares was similar before and after the COVID-19 pandemic. Inpatient resource use for women with CPP remains high, investigations have low diagnostic yield and frequent instigation of opiates on discharge may risk dependence. Improved community care of CPP is needed to reduce emergency gynaecology resource utilisation

Exercise as an Airway Clearance Technique in people with Cystic Fibrosis (ExACT-CF):rationale and study protocol for a randomised pilot trial

BACKGROUND: Chest physiotherapy is an established cornerstone of care for people with cystic fibrosis (pwCF), but is often burdensome. Guidelines recommend at least one chest physiotherapy session daily, using various airway clearance techniques (ACTs). Exercise (with huffs and coughs) may offer an alternative ACT, however the willingness of pwCF to be randomised into a trial needs testing. The 'ExACT-CF: Exercise as an Airway Clearance Technique in people with Cystic Fibrosis' trial will test the feasibility of recruiting pwCF to be randomised to continue usual care (chest physiotherapy) or replace it with exercise ACT (ExACT) for 28-days. Secondary aims include determining the short-term clinical impact (and safety) of stopping routine chest physiotherapy and replacing it with ExACT, and effects on physical activity, sleep, mood, quality of life and treatment burden, alongside preliminary health economic measures and acceptability.METHODS: Multi-centre, two-arm, randomised (1:1 allocation using minimisation), pilot trial at two sites. Fifty pwCF (≥10 years, FEV 1 &gt;40% predicted, stable on Elexacaftor/Tezacaftor/Ivacaftor (ETI)) will be randomised to an individually-customised ExACT programme (≥once daily aerobic exercise of ≥20-minutes duration at an intensity that elicits deep breathing, with huffs and coughs), or usual care. After baseline assessments, secondary outcomes will be assessed after 28-days, with additional home lung function and exacerbation questionnaires at 7, 14 and 21-days, physical activity and sleep monitoring throughout, and embedded qualitative and health-economic components. Feasibility measures include recruitment, retention, measurement completion, adverse events, interviews exploring the acceptability of trial procedures, and a trial satisfaction questionnaire. DISCUSSION: Co-designed with the UK CF community, the ExACT-CF pilot trial is the first multi-centre RCT to test the feasibility of recruiting pwCF stable on ETI into a trial investigating ExACT. This pilot trial will inform the feasibility, design, management, likely external validity for progression to a main phase randomised controlled trial.REGISTRATION: Clinicaltrials.gov ( NCT05482048).</p