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. 2024 Feb 9;17(2):sfae025.
doi: 10.1093/ckj/sfae025. eCollection 2024 Feb.

Dapagliflozin in chronic kidney disease: cost-effectiveness beyond the DAPA-CKD trial

Phil McEwan  1 , Jason A Davis  1 , Peter D Gabb  1 , David C Wheeler  2 , Peter Rossing  3   4 , Glenn M Chertow  5 , Ricardo Correa-Rotter  6 , Kouichi Tamura  7 , Salvatore Barone  8 , Juan Jose Garcia Sanchez  9
Affiliations

Dapagliflozin in chronic kidney disease: cost-effectiveness beyond the DAPA-CKD trial

Phil McEwan et al. Clin Kidney J. .

Abstract

Background: The Dapagliflozin and Prevention of Adverse Outcomes in CKD (DAPA-CKD) trial enrolled patients with estimated glomerular filtration rate 25-75 mL/min/1.73 m2 and urine albumin-to-creatinine ratio >200 mg/g. The Dapagliflozin Effect on CardiovascuLAR Events-Thrombolysis in Myocardial Infarction 58 (DECLARE-TIMI 58) trial enrolled patients with type 2 diabetes, a higher range of kidney function and no albuminuria criterion. The study objective was to estimate the cost-effectiveness of dapagliflozin in a broad chronic kidney disease population based on these two trials in the UK, Spain, Italy and Japan.

Methods: We adapted a published Markov model based on the DAPA-CKD trial but to a broader population, irrespective of urine albumin-to-creatinine ratio, using patient-level data from the DAPA-CKD and DECLARE-TIMI 58 trials. We sourced cost and utility inputs from literature and the DAPA-CKD trial. The analysis considered healthcare system perspectives over a lifetime horizon.

Results: Treatment with dapagliflozin was predicted to attenuate disease progression and extend projected life expectancy by 0.64 years (12.5 versus 11.9 years, undiscounted) in the UK, with similar estimates in other settings. Clinical benefits translated to mean quality-adjusted life year (QALY; discounted) gains between 0.45 and 0.68 years across countries. Incremental cost-effectiveness ratios in the UK, Spain, Italy and Japan ($10 676/QALY, $14 479/QALY, $7771/QALY and $13 723/QALY, respectively) were cost-effective at country-specific willingness-to-pay thresholds. Subgroup analyses suggest dapagliflozin is cost-effective irrespective of urinary albumin-to-creatine ratio and type 2 diabetes status.

Conclusion: Treatment with dapagliflozin may be cost-effective for patients across a wider spectrum of estimated glomerular filtration rates and albuminuria than previously demonstrated, with or without type 2 diabetes, in the UK, Spanish, Italian and Japanese healthcare systems.

Keywords: SGLT2 inhibitor; albuminuria; chronic kidney disease; cost-effectiveness; dapagliflozin.

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Conflict of interest statement

P.M., J.A.D. and P.D.G. are employees of Health Economics and Outcomes Research Ltd, Cardiff, UK. Health Economics and Outcomes Research Ltd received fees from AstraZeneca in relation to this study. D.C.W. provided ongoing consultancy services to AstraZeneca in the last 2 years and has received honoraria and/or consultancy fees from Amgen, AstraZeneca, Boehringer Ingelheim, Bayer, Eledon, Galderma, Gilead, GlaxoSmithKline, George Clinical, Janssen, Merck Sharp and Dohme, ProKidney, Takeda, Vifor and Zydus. He also reports speaking fees from Astellas, AstraZeneca and Vifor, and support for travel/meeting attendance from Astellas, AstraZeneca and Pro. He has served on DSMBs for Eledon, Galderma, Merck, ProKidney and Pathalys. He is a member of the International Society of Nephrology and National Institute of Health Research, UK. P.R. has received honoraria to Steno Diabetes Center Copenhagen for consultancy from AstraZeneca, Astellas, Bayer, Boehringer Ingelheim, Gilead, Novo Nordisk, Merck, Mundipharma, Sanofi and Vifor, and research support from AstraZeneca, Bayer and Novo Nordisk. G.M.C. received fees from AstraZeneca for service on the DAPA-CKD trial steering committee. He serves on the Board of Directors for Satellite Healthcare, a non-profit dialysis provider. He has received research grants to his institution from NIDDK, NIAID and CSL Behring. He has served on trial-steering committees with Akebia, AstraZeneca, Gilead, Sanifit and Vertex. He has served as an advisor to Applaud, Ardelyx, CloudCath, Durect, Eliaz Therapeutics, Miromatrix, Outset, Renibus, Unicycive and Vertex. He has served on DSMBs for NIDDK, Bayer, Mineralys and ReCor. He also declares stock or stock options for Applaud, Ardelyx, CloudCath, Durect, Eliaz Therapeutics, Miromatrix, Outset and Renibus. R.C.-R. has received honoraria as consultant from AstraZeneca, Boehringer Ingelheim, Bayer, Chinook, AbbVie and Novo Nordisk, and research support from AstraZeneca, Boehringer Ingelheim, Roche and Novo Nordisk. He has received speaking fees from AstraZeneca, Boehringer Ingelheim, Novo Nordisk and Amgen. K.T. has honoraria as lecture fee from Novartis, AstraZeneca, Ono, Daiichi-Sankyo, Takeda, Otsuka, Bayer and Kyowa-Kirin. He has received research support from AstraZeneca, Ono, Bayer, Kyowa-Kirin, Otsuka, Takeda and Daiichi-Sankyo. S.B. and J.J.G.S. are employees of AstraZeneca.

Figures

Graphical Abstract
Graphical Abstract
Figure 1:
Figure 1:
Model schematic for estimation of outcomes in the broad CKD population. HF: heart failure; UACR: urine albumin to creatinine ratio.
Figure 2:
Figure 2:
Subgroup analyses (top to bottom) in the UK, Spain, Italy and Japan dependent on UACR severity and T2D status. ‘Low’ and ‘elevated’ refer to albuminuria status (UACR <200 mg/g and UACR ≥200 mg/g respectively) while ‘Base’ refers to the base case analysis of 75% low and 25% elevated albuminuria. Dashed lines designate the WTP threshold of each country.
Figure 3:
Figure 3:
(a) ICER (US dollars per QALY) and (b) net monetary benefit evolution over time in the UK, Spain, Italy and Japan.
Figure 4:
Figure 4:
Incremental costs over time associated with (a) KRT and (b) HHF avoided.
Figure 5:
Figure 5:
Cost-effectiveness acceptability curves for the UK, Spain, Italy and Japan. The probability of dapagliflozin in addition to standard therapy being cost-effective at the given WTP threshold versus standard therapy only. The specified WTP threshold for each country is denoted by the corresponding-coloured dotted line parallel to the y-axis.
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