Reason for request

Re-assessment of the actual benefit and the improvement in actual benefit

Insufficient clinical benefit: these medicinal products no longer have a role in the treatment of Alzheimer’s disease

   

  • ARICEPT, EXELON and REMINYL have Marketing Authorisation in the symptomatic treatment of mild to moderately severe Alzheimer’s disease. EXELON is also indicated in mild to moderately severe dementia in patients with idiopathic Parkinson’s disease. EBIXA has Marketing Authorisation in the treatment of adults with moderate to severe Alzheimer’s disease.
  • In view of:

 - the absence of clinical relevance of the symptomatic effects of these medicinal products,

 - the absence of demonstrated effectiveness on behaviour disorders, quality of life, time of entry into an institution, mortality, progress of the disease, burden of illness on caregivers,

 - their safety profile,

 - the high risk of drug interactions in elderly patients,

 ARICEPT, EBIXA, EXELON and REMINYL no longer have a role in the therapeutic strategy.

  • HAS recommends that these medicinal products be removed from the list of reimbursable products.

 


Clinical Benefit

Insufficient

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Therapeutic use

-

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Évaluation des médicaments

See also