Reason for request

New indication

Key points  

Favourable opinion for reimbursement only in the treatment of severe chronic plaque psoriasis in children and adolescents from the age of 6 years, defined by: 

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

Unfavourable opinion for reimbursement in other situations. 

 What therapeutic improvement? 

No clinical added value in the therapeutic strategy on the basis of currently available data. 

Role in the care pathway? 

The treatment of moderate to severe forms of plaque psoriasis in children is not very different to that in adults, but there are fewer validated treatments in children. 

In forms resistant to topical treatments, treatment involves non-biologic systemic treatments (retinoids, ciclosporin, methotrexate) and light therapy. Calcitriol is the only vitamin D3 analogue to have a marketing authorisation in children and methotrexate only has a marketing authorisation in adults. The toxicity of these treatments limits their use over time and light therapy is not recommended in children. The prescription of acitretin is subject to a pregnancy prevention plan. 

In the event of failure of these second-line treatments, TNF antagonists (etanercept and adalimumab) or interleukin inhibitors (ustekinumab or secukinumab) are used. Etanercept (ENBREL) and ustekinumab (STELARA) have a marketing authorisation in plaque psoriasis in children from 6 years of age and adalimumab (HUMIRA) from 4 years of age.  

These treatments do not definitively cure the condition but can enable a transient and more or less complete disappearance of the lesions. The care pathway is “rotational”, due, in particular to resistance phenomena. 

Role of the medicinal product in the care pathway 

As with the other biologic therapies with an MA in paediatric psoriasis and as in adults, the Committee considers that the role of COSENTYX (secukinumab) in children and adolescents from the age of 6 years, is as second-line therapy only in the treatment of severe chronic plaque psoriasis, defined by: 

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

 Outside these situations, it has no role in the care pathway. 

 Special recommendations 

Given the risk of hypersensitivity reactions with secukinumab administered subcutaneously (see section 4.4 of the SPC), but also with other biologics, the Transparency Committee recommends that the first subcutaneous injection of this medicinal product be given in an appropriate care structure.


Clinical Benefit

Substantial

The Committee deems that the clinical benefit of COSENTYX 150 mg (secukinumab) solution for injection in pre-filled syringe or pre-filled pen and powder for solution for injection is substantial only in the treatment of chronic severe plaque psoriasis in children and adolescents from the age of 6 years, defined by: 

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

Clinical Added Value

no clinical added value null

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