Reason for request

Re-assesment of the Clinical Added Value

Maintenance of the favourable opinion for reimbursement in a limited indication for the treatment of severe chronic forms of adult plaque psoriasis, defined by:

-    failure (insufficient response, contraindication or intolerance) of at least two treatments including non-biological systemic treatments and light therapy

-    and an extensive form and/or psychosocial impact.

Unfavourable opinion for reimbursement in the other clinical situations.


Clinical Benefit

Substantial

The clinical benefit of TREMFYA 100 mg solution for injection in pre-filled syringe remains substantial only in the treatment of adult plaque psoriasis, in patients with severe chronic plaque psoriasis, defined by:

  • failure (insufficient response, contraindication or intolerance) of at least two treatments including non-biological systemic treatments and light therapy
  • and an extensive form and/or significant psychosocial impact.

 

 

Insufficient

In other forms, the clinical benefit remains insufficient to justify reimbursement by public funding.


Clinical Added Value

minor

TREMFYA 100 mg (guselkumab) solution for injection provides minor clinical added value (CAV IV) compared to COSENTYX (secukinumab) in the treatment of adult plaque psoriasis, in patients with severe chronic plaque psoriasis, defined by:

  • failure (insufficient response, contraindication or intolerance) of at least two treatments including non systemic treatments and light therapy,
  • and an extensive form and/or with significant psychosocial impact.

 

 


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