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VECTARION (almitrine bismesilate)
Opinions on drugs -
Posted on
Mar 12 2021
Reason for request
Reevaluation
Unfavourable opinion for reimbursement in supportive treatment in addition to mechanical ventilation in the most serious cases of acute respiratory distress syndrome (ARDS) with refractory hypo-xemia and hypercapnia despite optimised artificial respiratory support (protective ventilation, ventral decubitus, etc.), and/or in the absence of another accessible appropriate respiratory support device (e.g.: CO2 removal, veno-venous ECMO, etc.)
Role in the care pathway?
The treatment of ARDS primarily consists of mechanical ventilation and, if necessary or if mechanical ventilation fails, supportive therapies for the most serious cases. These therapies may be non-pharmacological (ventral decubitus, high-frequency ventilation and extracorporeal oxygenation methods) or pharmacological (primarily inhaled nitric oxide [Noi], although this is used off-label).
Role of the medicinal product in the care pathway
Considering:
- the absence of robust and recent new data having demonstrated an efficacy of almitrine in the recently modified MA indication;
- its safety profile, marked, in particular, by peripheral neuropathies (important potential risk with the injectable formulation), and its mechanism of action, involving potential harmful effects on the pulmonary circulation;
- current French recommendations that do not mention this drug in the management of ARDS;
The Committee considers that VECTARION (almitrine) no longer has a role in the care pathway in view of the alternatives.
Clinical Benefit
| Insufficient |
The Committee deems that the clinical benefit of VECTARION (almitrine bismesylate) is insufficient to justify public funding cover in the MA indication in view of the available alternatives. |
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