Favourable opinion for reimbursement in the prevention of postpartum haemorrhage due to uterine atony following vaginal delivery.
What therapeutic improvement?
No clinical added value in the current strategy for prevention of postpartum haemorrhage due to uterine atony.
Role in the care pathway?
The French National Association of Gynaecologists and Obstetricians (CNGOF) and the World Health Organisation (WHO) recommend the administration of preventive uterotonic agents such as oxytocin in the prevention of postpartum haemorrhage following vaginal delivery, although oxytocin has no MA in this preventive indication.
Role of the medicinal product in the care pathway
PABAL (carbetocin) is a first-line treatment option in the same way as products containing oxytocin (although off-label) in the prevention of postpartum haemorrhage due to uterine atony following vaginal delivery.
Clinical Benefit
Substantial
The clinical benefit of PABAL (carbetocin) is high in the prevention of postpartum haemorrhage due to uterine atony following vaginal delivery.
Clinical Added Value
no clinical added value
Considering:
demonstration of a non-inferiority of PABAL (carbetocin) compared to oxytocin in a phase III study and data from a meta-analysis suggesting a comparable efficacy between carbetocin and oxytocin overall,
the relevance of the primary endpoints used in these studies, i.e., postpartum blood loss ≥ 500 mL or ≥ 1000 mL or use of additional uterotonics,
the absence of data demonstrating a superiority of PABAL (carbetocin) compared to oxytocin whereas this analysis was scheduled,
the medical need already met by oxytocin,
the Transparency Committee considers that PABAL (carbetocin) provides no clinical added value (CAV V) in the strategy for prevention of postpartum haemorrhage due to uterine atony.
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