Reason for request

First assessment

Key points

Unfavourable opinion for reimbursement in the debridement of chronic or difficult-to-heal wounds when instrumental/surgical treatment is not desired. 

Role in the care pathway? 

When instrumental or surgical methods are not used, the most appropriate dressings for desloughing are alginate-based ones in the event of highly exuding wounds, or hydrogel-based ones. Hydrocolloids can be used irrespective of healing phase.

Role of the medicinal product in the care pathway

Considering:

  • firstly, the medical need to achieve debridement of chronic or difficult-to-heal wounds if instrumental or surgical techniques are not used, currently met by the available dressings, in particular hydrogels, and in the event of highly exuding wounds, alginates, which are specifically indicated in the desloughing phase, and hydrocolloids, which can be used for every healing phase, including desloughing,
  • secondly, the results of the VenUS II study not having demonstrated the superiority of SERILIA larval therapy compared to a hydrogel-based dressing (clinically relevant comparator) on the primary endpoint (time to complete healing),

the Transparency Committee considers that, on the basis of currently available data, the benefit of SERILIA larval therapy medicinal products has not been demonstrated in the debridement of chronic or difficult-to-heal wounds when instrumental/surgical treatment is not desired. Consequently, these medicinal products have no role in the care pathway.


Clinical Benefit

Insufficient

The Committee deems that the clinical benefit of SERILIA (Lucilia sericata) larval therapy is insufficient to justify public funding cover in the MA indication in view of the available alternatives.


Clinical Added Value

Not applicable

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