The Committee deems that the clinical benefit of JARDIANCE (empagliflozin) is substantial only as an adjunct to standard of care therapy in the treatment of adult patients with chronic kidney disease:
with an estimated glomerular filtration rate (eGFR) between 20 and 45 mL/min/1.73m² or between 45 and 90 mL/min/1.73m² with a urine albumin to creatinine ratio (UACR) of ≥ 200 mg/g,
treated with an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB or sartan) at the maximum tolerated dose.
Insufficient
The Committee deems that the clinical benefit of JARDIANCE (empagliflozin) is insufficient to justify public funding in view of the available alternatives in the other MA situations.
Clinical Added Value
minor
Considering:
the demonstrated superiority of JARDIANCE (empagliflozin) compared to placebo, in combination with the optimised standard of care therapy with an ACE inhibitor or ARB, in the EMPA-KIDNEY study, on the composite primary endpoint including kidney disease progression to ESKD, or a sustained decrease in eGFR of ≥ 40%, or a sustained decrease in eGFR to <10 mL/min/1.73 m2, or death from renal causes, or death from cardiovascular causes: 432 (13.1%) patients in the empagliflozin group versus 558 (16.9%) patients in the placebo group, HR=0.72; 95% CI [0.64; 0.82]; p<0.0001),
an effect size driven by the decrease in eGFR of ≥ 40% (8.9% versus 11.3%),
a statistically significant difference for only one of the secondary endpoints with management of the alpha risk, i.e. the time to hospitalisation for any cause (HR=0.86; 95% CI [0.78; 0.95]; p = 0.0025), and the lack of any demonstrated statistically significant difference for hospitalisation for heart failure, death from a cardiovascular cause and death from any cause,
an acceptable comparison versus placebo in view of the concomitant development of JARDIANCE (empagliflozin) in relation to other gliflozins and finerone,
the safety profile of JARDIANCE (empagliflozin) in this indication extension, which appears to be similar to that observed in the other indications of the MA,
the lack of robust quality of life results.
the Committee considers that JARDIANCE (empagliflozin) provides a minor clinical added value (CAV IV) in the current care pathway, excluding other gliflozins.
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