VERASEAL (fibrinogene humain 80 UI/mL et thrombine humaine 500 UI/mL)
Reason for request
Favourable opinion for reimbursement in supportive treatment in adults where standard surgical techniques are insufficient:
- for improvement of haemostasis;
- as suture support: in vascular surgery.
What therapeutic improvement?
No clinical added value in the therapeutic strategy.
Role in the care pathway?
Any surgical procedure must end with the achievement of complete and careful haemostasis of the surgical area. The first-line management of surgical haemostasis uses conventional methods. Surgeons have access to a variety of tools, from the simplest to the most elaborate:
- vessel sutures and ligation (stitches, staples or clips).
- via the production of high-frequency alternating electric currents: mono and bipolar electrocoagulation, which uses tissue resistance to the passage of the current to generate a localised rise in temperature; electrocoagulation using argon plasma, which uses the thermal effect and an ionised argon jet on tissue.
- based on the capacity of radiation to stimulate tissue molecules in order to obtain a local temperature rise (infrared photocoagulator, etc.).
When these conventional surgical haemostasis techniques are insufficient, surgical haemostatics can be used in addition to haemostasis.
Role of the medicinal product in the care pathway
Considering efficacy data that, although limited, is similar to that found with other surgical haemostatics, including fibrin sealants, the Transparency Committee considers that VERASEAL (fibrinogen/thrombin) is a last-line supportive treatment in salvage situations, in addition to conventional methods, in the same way as other surgical haemostatics, for improvement of haemostasis or as suture support in vascular surgery where standard surgical techniques are insufficient.
The Committee deems that the clinical benefit of VERASEAL is substantial:
Clinical Added Value
|no clinical added value
The Committee considers that VERASEAL (fibrinogen/thrombin) provides no clinical added value (CAV V) in the current surgical strategy for adults: