Favourable opinion for reimbursement in the “treatment of severe, chronic pain in adults who require intrathecal (IT) analgesia”.
Clinical Benefit
Moderate
The clinical benefit of PRIALT 100 mcg/mL (ziconotide) solution for infusion is moderate in the MA indication.
Clinical Added Value
no clinical added value
Considering:
the known analgesic properties of ziconotide and clinical data suggestive of the efficacy of the product in the management of severe pain,
the potential impact of this non-opioid analgesic on the care or life pathway of patients requiring intrathecal analgesia,
the lack of clinical data enabling a conclusion to be reached with respect to the superiority of ziconotide in terms of efficacy and/or safety compared to the analgesics used in the management of severe, chronic pain,
the need for hospital management to initiate treatment and close monitoring of the patient by a physician experienced in the intrathecal administration of ziconotide,
the Committee deems thatPRIALT 100 mcg/mL (ziconotide) solution for infusion provides no clinical added value (CAV V) in the care pathway for the treatment of severe, chronic pain in adults who require intrathecal analgesia, particularly with opioids.
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