Favourable opinion for reimbursement in the following indication: “This medicinal product should be used for the disinfection of healthy skin prior to invasive medical procedures (including surgery) and has a bactericidal and levuricidal activity.
PERPRUP is indicated in adults, adolescents and children aged 1 year or older.”
Clinical Benefit
Substantial
The clinical benefit of PERPRUP (povidone-iodine, isopropyl alcohol) 7.25 mg/ml + 633 mg/ml solution for cutaneous application is substantial in the MA indication.
Clinical Added Value
no clinical added value
Considering:
the medical need partially met by alcohol solutions containing povidone-iodine and chlorhexidine given the care-related infections that occur despite the use of these antiseptic solutions,
data relative to the PREVAIL-FX proprietary medicinal product, solution containing 8.3% povidone-iodine and 72.5% isopropyl alcohol (antiseptic solution with the same composition as PERPRUP but non-sterile) contained in an applicator device similar to that of PERPRUP, derived from the SUR-19IPVPV01 prospective study conducted on healthy skin prior to an invasive medical procedure, demonstrating a reduction in the number of cutaneous micro-organisms on the abdomen and the groin compared to the baseline value higher than the expected activity standards, 10 minutes and 6 hours after application to the skin,
but:
the lack of evidence of the efficacy of PERPRUP on a relevant clinical endpoint, such as reduction of the incidence of postoperative site infections,
the lack of robust comparative data versus the available alternatives France,
the Committee deems thatPERPRUP (iodine povidone, isopropyl alcohol) 7.25 mg/ml + 633 mg/ml solution for cutaneous applicationprovides no clinical added value (CAV V) compared to the other available antiseptic alcohol solutions containing povidone-iodine.
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