Article Text
Abstract
Objectives To assess the long-term cost-effectiveness of insulin pumps and Dose Adjustment for Normal Eating (pumps+DAFNE) compared with multiple daily insulin injections and DAFNE (MDI+DAFNE) for adults with type 1 diabetes mellitus (T1DM) in the UK.
Methods We undertook a cost–utility analysis using the Sheffield Type 1 Diabetes Policy Model and data from the Relative Effectiveness of Pumps over Structured Education (REPOSE) trial to estimate the lifetime incidence of diabetic complications, intervention-based resource use and associated effects on costs and quality-adjusted life years (QALYs). All economic analyses took a National Health Service and personal social services perspective and discounted costs and QALYs at 3.5% per annum. A probabilistic sensitivity analysis was performed on the base case. Further uncertainties in the cost of pumps and the evidence used to inform the model were explored using scenario analyses.
Setting Eight diabetes centres in England and Scotland.
Participants Adults with T1DM who were eligible to receive a structured education course and did not have a strong clinical indication or a preference for a pump.
Intervention Pumps+DAFNE.
Comparator MDI+DAFNE.
Main outcome measures Incremental costs, incremental QALYs gained and incremental cost-effectiveness ratios (ICERs).
Results Compared with MDI+DAFNE, pumps+DAFNE was associated with an incremental discounted lifetime cost of +£18 853 (95% CI £6175 to £31 645) and a gain in discounted lifetime QALYs of +0.13 (95% CI −0.70 to +0.96). The base case mean ICER was £142 195 per QALY gained. The probability of pump+DAFNE being cost-effective using a cost-effectiveness threshold of £20 000 per QALY gained was 14.0%. All scenario and subgroup analyses examined indicated that the ICER was unlikely to fall below £30 000 per QALY gained.
Conclusions Our analysis of the REPOSE data suggests that routine use of pumps in adults without an immediate clinical need for a pump, as identified by National Institute for Health and Care Excellence, would not be cost-effective.
Trial registration number ISRCTN61215213.
- health economics
- general diabetes
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Footnotes
Contributors DJP contributed to the design of all of the health economic analyses and conducted all statistical and modelling analyses used in this paper. AB oversaw the design and implementation of the modelling analyses. SD, oversaw the design and implementation of the economic analysis of the trial data and contributed to the estimation of the treatment costs used in the long-term economic analyses. AB, SD, NW, JE, SH and MC contributed to the design of the trial. NW, JE and SH provided clinical input into the design of the economic analyses. MC designed the statistical analysis plan. EL implemented the statistical analysis plan, parts of which were used in the economic evaluation. HB and DW contributed to data collection for the economic analyses. AB and HB designed and developed previous versions of the economic model used in these analyses. DJP wrote the first draft. All authors approved the final draft. DJP is the guarantor.
Funding This research was funded by the UK Health Technology Assessment Programme (project number 08/107/01). The research was sponsored by Sheffield Teaching Hospitals NHS Foundation Trust. The clinical sites taking part were: Cambridge University Hospitals NHS Foundation Trust, Dumfries and Galloway Royal Infirmary, NHS Greater Glasgow and Clyde, Harrogate and District NHS Foundation Trust, King’s College Hospital NHS Foundation Trust, NHS Lothian, Nottingham University Hospitals NHS Trust and Sheffield Teaching Hospitals NHS Foundation Trust. We also acknowledge the financial support of the Research and Development Programmes of the Department of Health for England and the Scottish Health and Social Care Directorates, which supported the costs of consumables and of Medtronic UK Ltd, which provided the insulin pumps for the trial.
Disclaimer The views and opinions expressed herein are those of the authors and do not necessarily reflect those of the HTA, NIHR, NHS, the Department of Health or Medtronic UK Ltd.
Competing interests SH reports personal fees from Sanofi Aventis and personal fees and other from NovoNordisk and Eli Lilly, outside the submitted work. JE reports personal fees from Astra Zeneca, Merck Sharpe Dohme and Takeda, personal fees and non-financial support from Eli Lilly, Novonordisk and Sanofi, outside the submitted work. NW reports receiving two days of consultancy fees from Novo Nordisk on topics including alternatives to network meta-analysis, unrelated to REPOSE.
Patient consent Obtained.
Ethics approval Research Ethics Committee (REC) North West, Liverpool East.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement Requests for patient level data and statistical code should be made to the corresponding author and will be considered by the REPOSE trial management group who, although specific consent for data sharing was not obtained, will release data on a case-by-case basis following the principles for sharing patient level data as described by Smith et al (2015). The presented data do not contain any direct identifiers; we will minimise indirect identifiers and remove free-text data to minimise the risk of identification.
Collaborators Simon Heller was the chief investigator. Norman Waugh was the deputy chief investigator. Stephanie Amiel, Mark Evans, Fiona Green, Peter Hammond, Alan Jaap, Brian Kennon, Robert Lindsay and Peter Mansell were site principal investigators and contributed to the study design and data interpretation. Jane Baillie, Anita Beckwith, Helen Brown, Karen Callaby, Katy Davenport, Sarah Donald, Jackie Elliott, Leila Faghahati, Sara Hartnell, Allison Housden, Kalbir Kaur Pabla, Nicola Croxon, Sheena Macdonald, Muna Mohammed, Vicky Steel, Katy Valentine, Pamela Young, Ann Boal, Patsy Clerkin, Lynn Doran, Joanne Flynn, Emma Gibb, Hilary Peddie, Bernie Quinn, Helen Rogers, Janice Shephard, Janet Carling, Ann Collins, Laura Dinning, Christine Hare, Joyce Lodge, Sutapa Ray, Debora Brown, Jenny Farmer, Alison Cox, Chris Cheyette, Pratik Choudhary, Linda East, June Ellul, Katherine Hunt, Kimberley Shaw, Ben Stothard, Lucy Diamond, Lindsay Aniello, Debbie Anderson, Kathy Cockerell, Vida Heaney, Alison Hutchison, Nicola Zammitt, Gayna Babington, Gail Bird, Janet Evans, Tasso Gazis, Nicola Maude, Karen Nunnick, Dawn Spick, Laura Fenn, Carla Gianfrancesco, Valerie Gordon, Linda Greaves, Susan Hudson, Valerie Naylor, Chloe Nisbet, Carolin Taylor, Karen Towse and Candice Ward contributed at sites to participant recruitment, intervention delivery and data collection. Cindy Cooper, Gemma Hackney, Diana Papaioannou, Emma Whatley and David White provided central trial management, oversight and monitoring. Mike Bradburn, Michael Campbell, Munya Dimairo and Ellen Lee contributed to the statistics. Hasan Basarir, Alan Brennan, Simon Dixon and Daniel Pollard contributed to the health economics. Nina Hallowell, Jackie Kirkham, Julia Lawton and David Rankin designed and undertook the qualitative work. Katharine Barnard led the quantitative psychosocial work. Timothy Chater and Kirsty Pemberton provided data management. Fiona Allsop and Lucy Carr provided central administration. Pamela Royle conducted literature searches and exploratory analyses. Gill Thompson and Sharon Walker provided central DAFNE support. Pauline Cowling conducted the fidelity assessment. Henry Smithson provided user representation on the management group.