Listen
DZUVEO (citrate de sufentanil)
Reason for request
Key points
Approval for reimbursement in multimodal management of acute pain insufficiently relieved by lower-step analgesics, for postoperative care or emergency medicine.
Therapeutic improvement?
No therapeutic improvement for moderate to severe acute pain.
Role in therapeutic strategy?
The current therapeutic strategy for moderate to severe acute pain is based on a multimodal analgesia approach, which consists of associating substances and technologies having different and complementary mechanisms of action, with a view to improving analgesia and reducing risks of adverse effects, particularly by reducing opioid use.
Role of the medicinal product
DZUVEO is to be administered by a healthcare professional in a medically monitored setting only. A medically monitored setting must have equipment and personnel trained to detect and manage morphine-induced respiratory depression. This medicinal product should not be used beyond 48 hours.
DZUVEO should be reserved for the management of acute pain insufficiently relieved by lower-step analgesics, for postoperative care or emergency medicine, in patients who can be closely monitored.
Clinical Benefit
| Substantial |
The Committee deems that the actual clinical benefit of DZUVEO 30 µg, sublingual tablet is significant for the multimodal management of acute pain insufficiently relieved by lower-step analgesics, for postoperative care or emergency medicine. |
Clinical Added Value
| no clinical added value |
Considering:
but in view of:
the Transparency Committee deems that DZUVEO 30 µg, sublingual tablet provides no clinical added value (CAV V) in the management of moderate to severe acute pain. |
