- Comment
- Open access
- Published:
Recent UK type 2 diabetes treatment guidance represents a near whole population indication for SGLT2-inhibitor therapy
Cardiovascular Diabetology volume 22, Article number: 302 (2023)
Abstract
Recent type 2 diabetes guidance from the UK’s National Institute for Health and Care Excellence (NICE) proposes offering SGLT2-inhibitor therapy to people with established atherosclerotic cardiovascular disease (ASCVD) or heart failure, and considering SGLT2-inhibitor therapy for those at high-risk of cardiovascular disease defined as a 10-year cardiovascular risk of > 10% using the QRISK2 algorithm. We used a contemporary population-representative UK cohort of people with type 2 diabetes to assess the implications of this guidance. 93.1% of people currently on anti-hyperglycaemic treatment are now recommended or considered for SGLT2-inhibitor therapy under the new guidance, with the majority (59.6%) eligible on the basis of QRISK2 rather than established ASCVD or heart failure (33.6%). Applying these results to the approximately 2.20 million people in England currently on anti-hyperglycaemic medication suggests 1.75 million people will now be considered for additional SGLT2-inhibitor therapy, taking the total cost of SGLT2-inhibitor therapy in England to over £1 billion per year. Given that older people, those of non-white ethnic groups, and those at lower cardiovascular disease risk were underrepresented in the clinical trials which were used to inform this guidance, careful evaluation of the impact and safety of increased SGLT2-inhibitor prescribing across different populations is urgently required. Evidence of benefit should be weighed against the major cost implications for the UK National Health Service.
Recent type 2 diabetes guidance from the UK’s National Institute for Health and Care Excellence (NICE) proposes offering SGLT2-inhibitor therapy to people with established atherosclerotic cardiovascular disease (ASCVD) or heart failure, and considering SGLT2-inhibitor therapy for those at high-risk of cardiovascular disease defined as a 10-year cardiovascular risk of > 10% using the QRISK2 algorithm [1]. The guidance applies irrespective of glycaemic control and both for people initiating first-line anti-hyperglycaemic treatment and those established on therapy. By including those without established ASCVD, this guidance goes beyond the evidence from clinical trials of the cardiovascular benefit of SGLT2-inhibitors in which a majority of participants (57–85%) had established cardiovascular disease [2]. The implications of this proposal on national prescribing are not reported.
We used a contemporary population-representative UK cohort of people with type 2 diabetes (n = 568,524) actively registered with a GP practice in February 2020 (using Clinical Practice Research Datalink) to assess the implications of this guidance. 93.1% of people currently on anti-hyperglycaemic treatment are now recommended or considered for SGLT2-inhibitor therapy under the new guidance, with the majority (59.6%) eligible on the basis of QRISK2 rather than established ASCVD or heart failure (33.6%) (Fig. 1). Prescribing of SGLT2-inhibitors at the time of evaluation was limited to 14.9% of people on anti-hyperglycaemic treatment, of whom a minority had established ASCVD or heart failure (26.6%).
Applying these results to the approximately 2.20 million people in England currently on anti-hyperglycaemic medication suggests 1.75 million people not currently receiving SGLT2-inhibitor therapy will now be considered for additional SGLT2-inhibitor therapy under the new guidance. Full implementation (prescribing of SGLT2-inhibitor therapy to all those recommended or considered for them) could increase the total cost of SGLT2-inhibitor prescribing from £147 million [3] to over £1 billion per year. Lower rates of prescribing among those considered for SGLT2-inhibitor therapy still represent substantial cost increases: approximately £700 million for 80% uptake, and £580 million for 60% uptake. For context, total annual spending on cholesterol-lowering drugs in the whole population with and without diabetes is around £215 million [4]. The cost of SGLT2-inhibitors is likely to reduce substantially when generic forms become available, as has been the case for statins [5].
The updated NICE guidance represents a potential near population-level intervention of SGLT2-inhibitor initiation for people with type 2 diabetes. Recommendations are based on extrapolation of trial evidence to people at lower cardiovascular risk. Given that older people and non-white ethnic groups are under-represented in trials, careful evaluation of changes in SGLT2-inhibitor prescribing across different populations, and the impact and safety of these changes [6], is urgently required. A full economic analysis is needed to assess the benefit (reduction in ASCVD/heart failure events) against the major cost implications for the UK National Health Service (NHS). If guidelines are adhered to, increases in SGLT2-inhibitor prescribing could near double the £1 billion annual spend on diabetes drug prescribing [7].
Availability of data and materials
Requests to access data provided by Clinical Practice Research Datalink (CPRD) should be directed to CPRD.
Abbreviations
- ASCVD:
-
Atherosclerotic cardiovascular disease
- GP:
-
General practice
- NICE:
-
National Institute for Health and Care Excellence
- NHS:
-
National Health Service
- SGLT2-inhibitor:
-
Sodium-glucose transport protein 2 inhibitor
References
National Institute for Health and Care Excellence (NICE). Type 2 diabetes in adults: management NICE guideline (NG28). https://www.nice.org.uk/guidance/ng28. Accessed 15 Mar 2022.
National Institute for Health and Care Excellence (NICE). Type 2 diabetes [B] Pharmacological therapies with cardiovascular and other benefits in people with type 2 diabetes. https://www.nice.org.uk/Guidance/NG28/evidence. Accessed 15 Mar 2022.
Openprescribing. Prescription data for Canagliflozin, Dapagliflozin, and Empagliflozin. 2020. https://openprescribing.net/. Accessed 15 Mar 2022.
NHS Digital. Prescriptions dispensed in the community—statistics for england, 2007–2017. 2018. https://digital.nhs.uk/data-and-information/publications/statistical/prescriptions-dispensed-in-the-community/prescriptions-dispensed-in-the-community-england---2007---2017. Accessed 15 Mar 2022.
Zarate MOD, Mentzakis E, Fraser SD, Roderick P, Rutter P, Ornaghi C. Price versus clinical guidelines in primary care statin prescribing: a retrospective cohort study and cost simulation model. J Royal Soc Med. 2021;115(3):100–11.
Dennis JM, Henley WE, McGovern AP, Farmer AJ, Sattar N, Holman RR, et al. Time trends in prescribing of type 2 diabetes drugs, glycaemic response and risk factors: a retrospective analysis of primary care data, 2010–2017. Diabetes Obes Metab. 2019;21(7):1576–84.
Stedman M, Lunt M, Livingston M, Fryer AA, Moreno G, Bailey S, et al. The costs of drug prescriptions for diabetes in the NHS. Lancet. 2019;393(10168):226–7.
Acknowledgements
Not applicable.
Funding
This research was funded by the Medical Research Council (UK) (MR/N00633X/1), and supported by EFSD/Novo Nordisk. JMD, KGY and RH are supported by Research England’s Expanding Excellence in England (E3) fund. BMS is supported by the NIHR Exeter Clinical Research Facility. This study was supported by the National Institute for Health and Care Research Exeter Biomedical Research Centre. The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. The funders had no role in any part of the study or in any decision about publication.
Author information
Authors and Affiliations
Consortia
Contributions
The concept and design were developed by APM, JMD, KGY and NJT. KGY and RH undertook the analysis, with support from JMD, APM, NJT and BMS. All authors provided support for the analysis and interpretation of results, critically revised the article, and approved the final article.
Corresponding author
Ethics declarations
Ethics approval and consent to participate
This study is based in part on data from the Clinical Practice Research Datalink (CPRD) obtained under licence from the UK Medicines and Healthcare products Regulatory Agency. The data is provided by patients and collected by the NHS as part of their care and support. The study was approved by the MHRA Independent Scientific Advisory Committee; eRAP protocol number: 22_002000.
Consent for publication
Not applicable.
Competing interests
APM declares previous research funding from Pfizer and Boehringer-Ingelheim outside the submitted work. All other authors declare no other relationships or activities that could appear to have influenced the submitted work.
Additional information
Publisher's Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Rights and permissions
Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
About this article
Cite this article
Young, K.G., Hopkins, R., Shields, B.M. et al. Recent UK type 2 diabetes treatment guidance represents a near whole population indication for SGLT2-inhibitor therapy. Cardiovasc Diabetol 22, 302 (2023). https://doi.org/10.1186/s12933-023-02032-x
Received:
Accepted:
Published:
DOI: https://doi.org/10.1186/s12933-023-02032-x