Once-Weekly Subcutaneous Semaglutide 2.4 mg Injection is Cost-Effective for Weight Management in the United Kingdom
Tóm tắt
The objective of the current preliminary study was to present the cost-effectiveness analyses submitted to the National Institute for Health and Care Excellence (NICE) (TA10765) that deemed semaglutide 2.4 mg subcutaneous (s.c.) injection a cost-effective option for weight management in the United Kingdom (UK) alongside diet and exercise (D&E). The study was conducted from the National Health Service (NHS) and Personal Social Services perspective and based on the NICE reference case. The clinical safety and efficacy of semaglutide 2.4 mg s.c. injection were obtained from the Semaglutide Treatment Effect in People with Obesity (STEP) 1 trial. The previously published and validated Core Obesity Model was used to project lifetime occurrence of obesity complications, their costs and quality of life consequences over 40 years. The base case cohort had a mean starting age of 48 years and BMI of 38.7 kg/m2. The confidential NHS price for semaglutide 2.4 mg s.c. injection was provided by Novo Nordisk. The incremental cost-effectiveness ratios (ICERs) were expressed as cost/quality-adjusted life-year (QALY). Uncertainty was assessed through sensitivity analyses, including a scenario analysis using clinical data from the STEP 2 trial and a previously published and validated Core Diabetes Model to investigate a cohort with type 2 diabetes at baseline. Semaglutide 2.4 mg s.c. injection showed higher total costs and health benefits compared with D&E, with an ICER of £14,827/QALY gained. The probabilistic sensitivity analysis showed that semaglutide 2.4 mg s.c. injection was cost-effective in 90% of cases at a willingness-to-pay threshold of £20,000/QALY. The ICER from the scenario analysis for the diabetic population was £16,613/QALY gained, using the Core Diabetes Model. Semaglutide 2.4 mg s.c. injection is a cost-effective therapy compared to D&E alone for patients with obesity and weight-related comorbidities in the UK. Sensitivity and scenario analyses confirm the robustness of the analyses.
Tài liệu tham khảo
WHO Expert Consultation. Appropriate body-mass index for Asian populations and its implications for policy and intervention strategies. Lancet. 2004;363(9403):157–63.
Bray GA, Kim KK, Wilding JPH, World Obesity Federation. Obesity: a chronic relapsing progressive disease process A position statement of the World Obesity Federation. Obes Rev. 2017;18(7):715–23.
National Health Service. Health Survey for England 2019: overweight and obesity in adults and children; 2020. https://files.digital.nhs.uk/9D/4195D5/HSE19-Overweight-obesity-rep.pdf.
Janssen F, Bardoutsos A, Vidra N. Obesity prevalence in the long-term future in 18 European countries and in the USA. Obes Facts. 2020;13(5):514–27.
Public Health England. Health matters: obesity and the food environment; 2017. https://www.gov.uk/government/publications/health-matters-obesity-and-the-food-environment/health-matters-obesity-and-the-food-environment--2. Accessed 19 Oct 2022.
European Medicines Agency. Wegovy: EPAR-Product Information 2022. https://www.ema.europa.eu/en/medicines/human/EPAR/wegovy#authorisation-details-section.
Wilding JPH, Batterham RL, Calanna S, Davies M, Van Gaal LF, Lingvay I, et al. Once-weekly semaglutide in adults with overweight or obesity. N Engl J Med. 2021;384(11):989–1002.
Davies M, Faerch L, Jeppesen OK, Pakseresht A, Pedersen SD, Perreault L, et al. Semaglutide 2.4 mg once a week in adults with overweight or obesity, and type 2 diabetes (STEP 2): a randomised, double-blind, double-dummy, placebo-controlled, phase 3 trial. Lancet. 2021;397(10278):971–84.
Wadden TA, Bailey TS, Billings LK, Davies M, Frias JP, Koroleva A, et al. Effect of subcutaneous semaglutide vs placebo as an adjunct to intensive behavioral therapy on body weight in adults with overweight or obesity: the STEP 3 randomized clinical trial. JAMA. 2021;325(14):1403–13.
Rubino D, Abrahamsson N, Davies M, Hesse D, Greenway FL, Jensen C, et al. Effect of continued weekly subcutaneous semaglutide vs placebo on weight loss maintenance in adults with overweight or obesity: the STEP 4 randomized clinical trial. JAMA. 2021;325(14):1414–25.
National Institute for Health and Care Excellence. Semaglutide for managing overweight and obesity [ID3850]; 2022. https://www.nice.org.uk/guidance/indevelopment/gid-ta10765.
National Institute for Health and Care Excellence. NICE health technology evaluations: the manual [PMG36]; 2022. https://www.nice.org.uk/process/pmg36/resources/nice-health-technology-evaluations-the-manual-pdf-72286779244741.
National Institute for Health and Care Excellence. Obesity: clinical assessment and management [QS127]; 2016. https://www.nice.org.uk/guidance/qs127.
Lopes S, Johansen P, Lamotte M, McEwan P, Olivieri AV, Foos V. External validation of the core obesity model to assess the cost-effectiveness of weight management interventions. Pharmacoeconomics. 2020;38(10):1123–33.
Lopes S, Meincke HH, Lamotte M, Olivieri AV, Lean MEJ. A novel decision model to predict the impact of weight management interventions: the Core Obesity Model. Obes Sci Pract. 2021;7(3):269–80.
Lopes S, Grand T, Johansen P, Lamotte M, Olivieri A. IDF21-0653 exploring different ways to predict mortality in a cost-effectiveness model for obesity. Diabetes Res Clin Pract. 2022;186.
World Health Organization. Obesity: preventing and managing the global epidemic. Report of a WHO consultation. World Health Organ Tech Rep Ser. 2000;894:i–xii, 1–253.
Palmer AJ, Roze S, Valentine WJ, Minshall ME, Foos V, Lurati FM, et al. The CORE Diabetes Model: Projecting long-term clinical outcomes, costs and cost-effectiveness of interventions in diabetes mellitus (types 1 and 2) to support clinical and reimbursement decision-making. Curr Med Res Opin. 2004;20(Suppl 1):S5–26.
Personal Social Services Research Unit. Unit Costs of Health and Social Care 2020; 2020. https://www.pssru.ac.uk/project-pages/unit-costs/unit-costs-2020/.
Soltoft F, Hammer M, Kragh N. The association of body mass index and health-related quality of life in the general population: data from the 2003 Health Survey of England. Qual Life Res. 2009;18(10):1293–9.
Rubino DM, Greenway FL, Khalid U, O’Neil PM, Rosenstock J, Sorrig R, et al. Effect of weekly subcutaneous semaglutide vs daily liraglutide on body weight in adults with overweight or obesity without diabetes: the STEP 8 randomized clinical trial. JAMA. 2022;327(2):138–50.
Garvey WT, Batterham RL, Bhatta M, Buscemi S, Christensen LN, Frias JP, et al. Two-year effects of semaglutide in adults with overweight or obesity: the STEP 5 trial. Nat Med. 2022;28(10):2083–91.
Ara R, Blake L, Gray L, Hernandez M, Crowther M, Dunkley A, et al. What is the clinical effectiveness and cost-effectiveness of using drugs in treating obese patients in primary care? A systematic review. Health Technol Assess. 2012;16(5):iii–xiv, 1–195.
Wilding JPH, Batterham RL, Davies M, Van Gaal LF, Kandler K, Konakli K, et al. Weight regain and cardiometabolic effects after withdrawal of semaglutide: the STEP 1 trial extension. Diabetes Obes Metab. 2022;24(8):1553–64.
Kim N, Wang J, Burudpakdee C, Song Y, Ramasamy A, Xie Y, et al. Cost-effectiveness analysis of semaglutide 2.4 mg for the treatment of adult patients with overweight and obesity in the United States. J Manag Care Spec Pharm. 2022;28(7):740–52.
Hippisley-Cox J, Coupland C, Brindle P. Development and validation of QRISK3 risk prediction algorithms to estimate future risk of cardiovascular disease: prospective cohort study. BMJ. 2017;357: j2099.
Hippisley-Cox J, Coupland C. Development and validation of QDiabetes-2018 risk prediction algorithm to estimate future risk of type 2 diabetes: cohort study. BMJ. 2017;359: j5019.
Hayes AJ, Leal J, Gray AM, Holman RR, Clarke PM. UKPDS outcomes model 2: a new version of a model to simulate lifetime health outcomes of patients with type 2 diabetes mellitus using data from the 30 year United Kingdom Prospective Diabetes Study: UKPDS 82. Diabetologia. 2013;56(9):1925–33.
ONS. National life tables: UK; 2020. https://www.ons.gov.uk/peoplepopulationandcommunity/birthsdeathsandmarriages/lifeexpectancies/datasets/nationallifetablesunitedkingdomreferencetables/current.
ONS. Mortality statistics—underlying cause, sex and age for England and Wales 2019; 2019. https://www.nomisweb.co.uk/datasets/mortsa.