Cost-Effectiveness of Canagliflozin Added to Standard of Care for Treating Diabetic Kidney Disease (DKD) in Patients with Type 2 Diabetes Mellitus (T2DM) in England: Estimates Using the CREDEM-DKD Model

Abstract

Introduction: On the basis of reductions in diabetic kidney disease (DKD) progression and major adverse cardiovascular events observed in the landmark CREDENCE trial, canagliflozin 100 mg received an extension to its EU marketing authorisation in July 2020 to include the treatment of DKD in people with type 2 diabetes mellitus (T2DM) making it the first pharmacological therapy to receive regulatory authorisation for treatment of DKD since the RENAAL and IDNT trials in nearly 20 years. Efficient allocation of limited healthcare resources requires evaluation not only of clinical safety and efficacy but also economic consequences. The study aim was to estimate the cost-effectiveness of canagliflozin when added to current standard of care (SoC) versus SoC alone from the perspective of the NHS in England.

Methods: A microsimulation model was developed using patient-level data from CREDENCE, including risk equations for the key clinical outcomes of start of dialysis, hospitalisation for heart failure, nonfatal myocardial infarction, nonfatal stroke, and all-cause mortality. DKD progression was modelled using estimated glomerular filtration rate and urinary albumin-to-creatinine ratio evolution equations. Risk for kidney transplant was sourced from UK-specific sources given the near absence of events in CREDENCE. Patient characteristics and treatment effects were sourced from CREDENCE. Unit costs (£2019) and disutility weights were sourced from the literature and discounted at 3.5% annually. The time horizon was 10 years in the base case, and sensitivity analysis was performed.

Results: Canagliflozin was associated with sizable gains in life-years and quality-adjusted life-year (QALYs) over 10 years, with gains increasing with simulation duration. Cost offsets associated with reductions in cardiovascular and renal complications were sufficient to achieve overall net cost savings. The findings were generally confirmed in the sensitivity analyses.

Conclusion: Model results suggest that adding canagliflozin 100 mg to SoC can improve patient outcomes while reducing overall net costs from the NHS perspective in England.

Trial registration: ClinicalTrials.gov identifier, NCT02065791.

Keywords: Albuminuria; CREDENCE; Canagliflozin; Chronic kidney disease (CKD); Cost-effectiveness; Diabetes; Diabetic kidney disease (DKD); Diabetic nephropathy; Dialysis.

Figures

Fig. 1

CREDEM-DKD model structure. *Optionally, doubling of serum creatinine can also be simulated. AE adverse event, CVD cardiovascular disease, CREDEM-DKD CREDENCE Economic Model of DKD, CREDENCE Canagliflozin and Renal Endpoints in Diabetes with Established Nephropathy Clinical Evaluation, DoSCr doubling of serum creatinine, eGFR estimated glomerular filtration rate, HF heart failure, HHF hospitalization for heart failure, Hx history, ICER incremental cost-effectiveness ratio, MI myocardial infarction, LY life-year, QALY quality-adjusted life-year, RRT renal replacement therapy, UACR urine albumin-to-creatinine ratio

Fig. 2

Progression of DKD stages over time. RRT renal replacement therapy

Fig. 3

Cumulative incidence of renal and CV outcomes, by study arm. HHF hospitalization for heart failure, MI myocardial infarction

Fig. 4

Cost-effectiveness scatter plot of canagliflozin 100 mg + SoC versus SoC alone

Fig. 5

Cost-effectiveness acceptability curve of canagliflozin 100 mg + SoC versus SoC alone

Fig. 6

Estimated total costs, total QALYs, and NMBs, by scenario. * Willingness-to-pay of £30,000 per QALY. eGFR estimated glomerular filtration rate, HR hazard ratio, NMB net monetary benefit, QALY quality adjusted life-years