Oral Semaglutide Versus Empagliflozin, Sitagliptin and Liraglutide in the UK: Long-Term Cost-Effectiveness Analyses Based on the PIONEER Clinical Trial Programme

Introduction: High levels of physical, cognitive, and psychosocial impairments are anticipated for those recovering from the COVID-19. In the UK, ~50% of survivors will require additional rehabilitation. Despite this, there is currently no evidence-based guideline available in England and Wales that addresses the identification, timing and nature of effective interventions to manage the morbidity associated following COVID-19. It is now timely to accelerate the development and evaluation of a rehabilitation service to support patients and healthcare services. Nuffield Health have responded by configuring a scalable rehabilitation pathway addressing the immediate requirements for those recovering from COVID-19 in the community.Methods and Analysis: This long-term evaluation will examine the effectiveness of a 12-week community rehabilitation programme for COVID-19 patients who have been discharged following in-patient treatment. Consisting of two distinct 6-week phases; Phase 1 is an entirely remote service, delivered via digital applications. Phase 2 sees the same patients transition into a gym-based setting for supervised group-based rehabilitation. Trained rehabilitation specialists will coach patients across areas such as goal setting, exercise prescription, symptom management and emotional well-being. Outcomes will be collected at 0, 6, and 12 weeks and at 6- and 12-months. Primary outcome measures will assess changes in health-related quality of life (HR-QOL) and COVID-19 symptoms using EuroQol Five Dimension Five Level Version (EQ-5D-5L) and Dyspnea-12, respectively. Secondary outcome measures of the Duke Activity Status Questionnaire (DASI), 30 s sit to stand test, General Anxiety Disorder-7 (GAD-7), Patient Health Questionnaire-9 (PHQ-9), Patient Experience Questionnaire (PEQ) and Quality Adjusted Life Years (QALY) will allow for the evaluation of outcomes, mediators and moderators of outcome, and cost-effectiveness of treatment.Discussion: This evaluation will investigate the immediate and long-term impact, as well as the cost effectiveness of a blended rehabilitation programme for COVID-19 survivors. This evaluation will provide a founding contribution to the literature, evaluating one of the first programmes of this type in the UK. The evaluation has international relevance, with the potential to show how a new model of service provision can support health services in the wake of COVID-19.Trial Registration: Current Trials ISRCTN ISRCTN14707226Web: http://www.isrctn.com/ISRCTN14707226

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Long-term Cost-effectiveness of Insulin Degludec Versus Insulin Glargine U100 in the UK: Evidence from the Basal-bolus Subgroup of the DEVOTE Trial (DEVOTE 16)

Applied Health Economics and Health Policy ◽

10.1007/s40258-019-00494-3 ◽

2019 ◽

Vol 17 (5) ◽

pp. 615-627 ◽

Cited By ~ 3

Author(s):

Richard F. Pollock ◽

◽

William J. Valentine ◽

Steven P. Marso ◽

Andreas Andersen ◽

...

Keyword(s):

Cost Effectiveness ◽

Insulin Glargine ◽

Insulin Degludec ◽

The Uk ◽

Basal Bolus

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106. Long-Term Safety of Rituximab: Pooled Analysis of the Rheumatoid Arthritis Global Clinical Trial Programme Over 11 Years

Rheumatology ◽

10.1093/rheumatology/keu101.027 ◽

2014 ◽

Vol 53 (suppl_1) ◽

pp. i97-i98

Author(s):

Ronald F. van Vollenhoven ◽

Paul Emery ◽

Clifton O. Bingham ◽

Edward Keystone ◽

Roy M. Fleischmann ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Clinical Trial ◽

Pooled Analysis ◽

Global Clinical Trial ◽

Clinical Trial Programme

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Switching from sitagliptin to liraglutide to manage patients with type 2 diabetes in the UK: A long-term cost-effectiveness analysis

Diabetes Obesity and Metabolism ◽

10.1111/dom.13318 ◽

2018 ◽

Vol 20 (8) ◽

pp. 1921-1927 ◽

Cited By ~ 3

Author(s):

Anthony H. Barnett ◽

Simon Arnoldini ◽

Barnaby Hunt ◽

Gowri Subramanian ◽

Christina Stentoft Hoxer

Keyword(s):

Type 2 Diabetes ◽

Cost Effectiveness ◽

Cost Effectiveness Analysis ◽

Effectiveness Analysis ◽

The Uk

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Clinical Trials and the Drive to Material Standardisation

Science & Technology Studies ◽

10.23987/sts.59226 ◽

2017 ◽

pp. 30-44 ◽

Cited By ~ 4

Author(s):

Catherine M. Montgomery

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

External Validity ◽

Three Dimensions ◽

Material Objects ◽

Pragmatic Trials ◽

Positive Effects ◽

Ethnographic Data ◽

The Uk

There have long been calls to reduce the bureaucratization of clinical trials and make them more ‘sensible’, with the focus on approvals and guidelines. Here, I focus on the mundane environments of a multi-centre clinical trial to ask how ‘sensible’ it is to standardize trials at the level of material objects. Drawing on ethnographic data collected in the UK, South Africa and Vietnam, I present three vignettes of material standardisation. While acknowledging some positive effects, I argue that standardising in this way may be antithetical to sustainable and relevant clinical research. Three dimensions of this are discussed: 1) the external validity of evidence from pragmatic trials 2) the gap between experimentation and implementation and 3) long-term site capacity to conduct research. Drawing on the literature on ‘situated standardisation’, the paper concludes by suggesting a greater acknowledgement of the need for trials not only to be ‘sensible’ but also ‘situated’.

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Evaluating the Long-Term Cost-Effectiveness of Once-Weekly Semaglutide Versus Once-Daily Liraglutide for the Treatment of Type 2 Diabetes in the UK

Advances in Therapy ◽

10.1007/s12325-020-01337-7 ◽

2020 ◽

Vol 37 (5) ◽

pp. 2427-2441 ◽

Cited By ~ 1

Author(s):

Pierre Johansen ◽

Barrie Chubb ◽

Barnaby Hunt ◽

Samuel J. P. Malkin ◽

Anna Sandberg ◽

...

Keyword(s):

Type 2 Diabetes ◽

Cost Effectiveness ◽

Once Daily ◽

The Uk

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PMD23 Long-Term Clinical Effectiveness and Cost-Effectiveness of Catheter-Based Renal Denervation in the UK. A Model-Based Projection Based on the Symplicity HTN-2 Trial

Value in Health ◽

10.1016/j.jval.2012.08.872 ◽

2012 ◽

Vol 15 (7) ◽

pp. A349 ◽

Cited By ~ 1

Author(s):

J.B. Pietzsch ◽

B.P. Geisler ◽

R.L. Akehurst

Keyword(s):

Cost Effectiveness ◽

Renal Denervation ◽

Clinical Effectiveness ◽

Model Based ◽

The Uk

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Evaluation of the long-term cost-effectiveness of once-weekly semaglutide versus dulaglutide for treatment of type 2 diabetes mellitus in the UK

Diabetes Obesity and Metabolism ◽

10.1111/dom.13564 ◽

2018 ◽

Vol 21 (3) ◽

pp. 611-621 ◽

Cited By ~ 15

Author(s):

Adie Viljoen ◽

Christina S. Hoxer ◽

Pierre Johansen ◽

Samuel Malkin ◽

Barnaby Hunt ◽

...

Keyword(s):

Diabetes Mellitus ◽

Type 2 Diabetes ◽

Type 2 Diabetes Mellitus ◽

Cost Effectiveness ◽

The Uk

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Protocol for the economic evaluation of a complex intervention to improve the mental health of maltreated infants and children in foster care in the UK (The BeST? services trial)

BMJ Open ◽

10.1136/bmjopen-2017-020066 ◽

2018 ◽

Vol 8 (3) ◽

pp. e020066 ◽

Cited By ~ 2

Author(s):

Manuela Deidda ◽

Kathleen Anne Boyd ◽

Helen Minnis ◽

Julia Donaldson ◽

Kevin Brown ◽

...

Keyword(s):

Public Health ◽

Mental Health ◽

Health Economic ◽

Economic Evaluation ◽

Foster Care ◽

Cost Effectiveness ◽

Health Research ◽

Public Health Research ◽

The Uk

IntroductionChildren who have experienced abuse and neglect are at increased risk of mental and physical health problems throughout life. This places an enormous burden on individuals, families and society in terms of health services, education, social care and judiciary sectors. Evidence suggests that early intervention can mitigate the negative consequences of child maltreatment, exerting long-term positive effects on the health of maltreated children entering foster care. However, evidence on cost-effectiveness of such complex interventions is limited. This protocol describes the first economic evaluation of its kind in the UK.Methods and analysisAn economic evaluation alongside the Best Services Trial (BeST?) has been prospectively designed to identify, measure and value key resource and outcome impacts arising from the New Orleans intervention model (NIM) (an infant mental health service) compared with case management (CM) (enhanced social work services as usual). A within-trial economic evaluation and long-term model from a National Health Service/Personal Social Service and a broader societal perspective will be undertaken alongside the National Institute for Health Research (NIHR)–Public Health Research Unit (PHRU)-funded randomised multicentre BeST?. BeST? aims to evaluate NIM compared with CM for maltreated children entering foster care in a UK context. Collection of Paediatric Quality of Life Inventory (PedsQL) and the recent mapping of PedsQL to EuroQol-5-Dimensions (EQ-5D) will facilitate the estimation of quality-adjusted life years specific to the infant population for a cost–utility analysis. Other effectiveness outcomes will be incorporated into a cost-effectiveness analysis (CEA) and cost-consequences analysis (CCA). A long-term economic model and multiple economic evaluation frameworks will provide decision-makers with a comprehensive, multiperspective guide regarding cost-effectiveness of NIM. The long-term population health economic model will be developed to synthesise trial data with routine linked data and key government sector parameters informed by literature. Methods guidance for population health economic evaluation will be adopted (lifetime horizon, 1.5% discount rate for costs and benefits, CCA framework, multisector perspective).Ethics and disseminationEthics approval was obtained by the West of Scotland Ethics Committee. Results of the main trial and economic evaluation will be submitted for publication in a peer-reviewed journal as well as published in the peer-reviewed NIHR journals library (Public Health Research Programme).Trial registration numberNCT02653716; Pre-results.

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