JARDIANCE (empagliflozin) - Aged 10 years and above with type 2 diabetes

The Committee deems that the clinical benefit of JARDIANCE (empagliflozin) 10 mg and 25 mg filmed tablets is substantial only in the indication for “treatment of children aged 10 years and above with type 2 diabetes mellitus insufficiently controlled by metformin as monotherapy, as an adjunct to diet and exercise, only in combination:

• as dual therapy only with metformin,
• as triple therapy only with metformin and insulin”.

Considering:

• the results of a randomised, double-blind trial in parallel groups, conducted in 158 patients from 10 to 18 years old having demonstrated a superiority of empagliflozin all strengths 10 mg or 25 mg versus placebo, on an intermediate laboratory endpoint, HbA1c variation, with no interpretable result for each of the empagliflozin strengths,
• demonstration of the efficacy on this endpoint only as dual therapy in combination with metformin or as triple therapy with metformin and basal insulin, with an effect size that appears to be modest, as has been observed in adults,
• the absence of data on morbidity and mortality in this population of children and adolescents; however, in adults, the EMPAREG-OUTCOME study demonstrated the superiority of empagliflozin compared to placebo for the reduction ofmajor cardiac events (death from
  cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke), and the
  EMPA-KIDNEY study demonstrated an efficacy of empagliflozin compared to placebo in chronic kidney disease,
• the absence of quality of life data, in this disease with a marked impact on quality of life,
• the safety profile of empagliflozin, which appears to be favourable in the paediatric and adolescent population, with limited follow-up however,

the Committee deems that JARDIANCE (empagliflozin) provides no clinical added value (CAV V) in the current care pathway, which includes clinically relevant comparators (see section 5.2) in the treatment of children aged 10 years and above with type 2 diabetes mellitus insufficiently controlled by metformin as monotherapy, as an adjunct to diet and exercise, only in combination (dual therapy with metformin and triple therapy with metformin and insulin).