KAPRUVIA (difélikéfaline) - Prurit associé à une maladie rénale chronique
Opinions on drugs -
Posted on
Jan 12 2023
Reason for request
First assessment
Key points
Approval of reimbursement of KAPRUVIA (difelikefalin) for the “treatment of moderate to severe pruritus associated with chronic kidney failure in adult haemodialysis patients.”
Clinical Benefit
Moderate
The Committee deems that the actual clinical benefit of KAPRUVIA (difelikefalin) is moderate in the marketing authorisation indication.
Clinical Added Value
minor
Considering:
the medical need for an effective therapeutic option with an acceptable safety;
evidence of superiority of difelikefalin versus placebo in two phase III double-blind studies in a study cohort composed of adult haemodialysis patients suffering from moderate to severe pruritus (primary outcome measure: at least 3-point improvement of the WI-NRS score at W12 was respectively 51.0% versus 27.6% in the KALM-1 study and 54.0% versus 42.2% in the KALM-2 study);
the acceptable safety profile according to the data from the studies available, particularly characterised by adverse gastrointestinal and neurological effects;
But in view of:
the choice of a routinely used clinically relevant primary outcome measure, but the reproducibility and robustness of which are debatable;
an effect size which can be described as modest;
a greater proportion of patients from the placebo group achieving the primary outcome measures in the KALM-1 study (27.6%) demonstrating a placebo effect which may be non-negligible in dermatological conditions;
the missing data management by sensitivity analyses: confirming the findings obtained in the KALM-1 study, but non-significant in the most conservative sensitivity analysis of the KALM-2 study,
the Committee deems that KAPRUVIA (difelikefalin) provides minor clinical added value (CAV IV) in the current therapeutic strategy which includes the relevant comparators (see clinically relevant comparators).
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