Favourable opinion for reimbursement in the following indication extension: “treatment ofeosinophilic oesophagitis in adults and adolescents aged 12 years and older, weighing at least 40 kg, who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy”.
Clinical Benefit
Low
The Committee deems that the clinical benefit of DUPIXENT 300 mg solution for injection (in pre-filled syringe or pre-filled pen) is low in the treatment of eosinophilic oesophagitis in adults and adolescents aged 12 years and older, weighing at least 40 kg, who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy.
Clinical Added Value
no clinical added value
Considering:
evidence of the superiority of dupilumab 300 mg solution for injection compared to placebo in two randomised phase 3 studies in patients who had mostly failed PPI therapy, but half of whom were not cortico-resistant, making it difficult to assess the benefit in the population concerned by the indication (cortico-resistant), with the size of the population also being limited,
an at best modest effect size on the DSQ scale (ref. 1) relating to dysphagia,
the debatable clinical relevance of the co-primary endpoint concerning the proportion of patients with a peak oesophageal intraepithelial eosinophil count of ≤ 6 EOS/HPF,
the absence of a demonstrated effect on food impactions and on progression to fibrosis of the oesophageal mucosa,
a long-term safety profile that remains to be determined at the dosage recommended in this indication, double that recommended in the other MA indications,
the lack of demonstrated impact on quality of life,
the Transparency Committee considers that DUPIXENT 300 mg solution for injection (in pre-filled syringe or pre-filled pen) provides no clinical added value (CAV V) in the care pathway for the treatment of eosinophilic oesophagitis in adults and adolescents aged 12 years and older, weighing at least 40 kg.
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