Reason for request

New indications

  • Key points

Favourable opinion for reimbursement in the indication extension for the treatment of symptoms of:

-    seasonal allergic rhinitis in children aged 2 to 5 years

-    perennial allergic rhinitis in children and adolescents aged 2 to 17 years.

  • What therapeutic improvement?

No clinical added value.

  • Role in the care pathway?

In case of allergy, the first measure to be implemented is avoidance of the allergen as far as possible, which can be difficult in the event of allergy to pollens. In children and adolescents, as in adults, the medicinal treatment of allergic rhinitis first involves oral or nasal antihistamines and cromones, then nasal corticosteroids.

In the 2016 ARIA recommendations, inhaled corticosteroid + oral or intranasal antihistamine combinations are proposed in patients with moderate to severe forms. However, the level of evidence for these recommendations is low. If these treatments fail, a short course of oral corticosteroids may be prescribed. In severe rhinitis not responding to corticosteroid therapy, allergen immunotherapy may be envisaged.

Role of the medicinal product in the care pathway:

NASACORT is an option following the failure of anti-H1 antihistamines in non-severe allergic rhinitis. It may be prescribed from the onset in the event of severe allergic rhinitis.

The lowest effective dose of nasal corticosteroids must be sought.


Clinical Benefit

Low

The clinical benefit of NASACORT 55 µg per dose (triamcinolone acetonide), nasal spray, suspension is low in the indication extension to the treatment of symptoms of:

-  seasonal allergic rhinitis in children aged 2 to 5 years

-    perennial allergic rhinitis in children and adolescents aged 2 to 17 years.


Clinical Added Value

no clinical added value

Considering:

  • the demonstration of the superiority of triamcinolone acetonide compared to placebo in only one of the two studies conducted and only one of the two co-primary endpoints studied (nasal score assessing nasal congestion, rhinorrhoea and sneezing), in paediatric patients with perennial allergic rhinitis,
  • the low size effect observed on reduction of the nasal score compared to placebo,
  • the absence of data in seasonal allergic rhinitis,
  • the absence of data in children aged over 12 years in perennial allergic rhinitis,
  • the absence of quality of life data,
  • the risks in terms of growth retardation in children and adverse effects related to systemic absorption in the event of prolonged treatment,
  • the absence of comparison with the other nasal corticosteroids available,

NASACORT 55 µg/ml (triamcinolone acetonide), nasal spray, suspension provides no clinical added value (CAV V) in the care pathway for the treatment of symptoms of seasonal allergic rhinitis in children aged 2 to 5 years and perennial allergic rhinitis in children and adolescents aged 2 to 17 years.

 


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