Abstract
Methods: Resource use and outcome data were collected over follow-up for participants enrolled in LENS. Mean costs were compared at two years and per 6-months follow-up (median 4.0 years). Within trial cost-effectiveness was assessed in terms of incremental cost per case of referable disease averted. A microsimulation model, with inputs derived primarily from LENS trial data, was used to assess the incremental cost per quality adjusted life year (QALY).
Results: Fenofibrate resulted in a mean (95% confidence interval) reduction in health service costs of -£254 (-1,062 to 624) at two years and -£101 (-243 to 42) per 6-months follow-up. This was accompanied by a 4.4% (1.3% to 8.0%) absolute reduction in any referable diabetic retinopathy or treatment thereof at two years, and a 27% (9%-42%) relative reduction over follow-up. Modelled over ten years, fenofibrate use cost an additional £6 per patient for an expected QALY gain of 0.02, costing £406 per QALY versus standard care under base case assumptions. The probability of cost-effectiveness varied from 70%-79% at a threshold of £20,000 per QALY, depending on the price discount applied to anti-VEGF drugs.
Conclusions: Fenofibrate is likely to offer a cost-effective treatment for slowing progression of any diabetic retinopathy in people with early to moderate diabetic retinopathy or maculopathy.
| Original language | English |
|---|---|
| Article number | e70098 |
| Journal | Diabetic Medicine |
| Early online date | 3 Jul 2025 |
| DOIs | |
| Publication status | E-pub ahead of print - 3 Jul 2025 |
Bibliographical note
Open Access via the Wiley agreementWe are very grateful to all participants, staff at participating NHS Scotland sites, and members of the Steering Committee and Data Monitoring Committee. We greatly appreciate the support of NHS Scotland’s Diabetic Eye Screening program, the Scottish Care Information Diabetes Collaboration (SCI Diabetes), Public Health Scotland’s electronic Data Research and Innovation Service (eDRIS), the Health Informatics Centre at the University of Dundee, and PCI Pharma Services. We are also very grateful to Prof Sobha Sivaprasad, University College London, for providing clinical expert opinion on economic modelling assumptions.
Funding
LENS was primarily funded by the National Institute for Health and Care Research (NIHR), Health Technology Assessment Programme (14/49/84). The views expressed are those of the authors and not necessarily those of the NIHR or the UK’s Department of Health and Social Care. The Nuffield Department of Population Health (NDPH), University of Oxford, covered the costs of storing, packaging and preparation for mailing of study treatment. LENS is coordinated by the Clinical Trial Service Unit and Epidemiological Studies Unit (CTSU), NDPH, University of Oxford; CTSU receives funding from the UK Medical Research Council (MRC), the British Heart Foundation and Health Data Research (HDR) UK. During the conduct of the trial, David Preiss was also supported by a University of Oxford BHF Centre of Research Excellence Senior Transition Fellowship (RE/13/1/30181), MRC (MC_UU_12026) and HDR UK (OXFD1 & HDRUK2023.0025). During the LENS trial the Health Economics Research Unit, University of Aberdeen, was core funded by the Chief Scientist Office of the Scottish Government Health and Social Care Directorate.
| Funders | Funder number |
|---|---|
| National Institute for Health and Care Research | 14/49/84 |
| British Heart Foundation | RE/13/1/30181 |
| Medical Research Council | MC_UU_12026 |
Keywords
- Diabetic Retinopathy
- Fenofibrate
- Cost-effectiveness analysis
