Reason for request

Re-evaluation of the Actual Benefit and Improvement in Actual Benefit through the application of Article R-163-21 of the French Social Security Code.


Clinical Benefit


- Due to the impossibility of prior identification of responding patients and due to the desire of not wanting to deny certain patients the potential low clinical benefits observed in the short-term of symptomatic treatments of Alzheimer's disease, the actual benefit of ARICEPT should be considered as low.

- in the absence of long-term clinical data, continuing treatment with ARICEPT for more than six months must be subject to a detailed re-evaluation. If the patient has reached the objectives set for their treatment (stabilisation or slowing of cognitive decline for example) and in the absence of serious adverse effects and/or changes to the quality of life, treatment with ARICEPT may be repeated once.

- The Committee proposes that the continuation of treatment for more than one year must be decided with the carer and the patient, if possible, following a meeting with a multidisciplinary team, including the treating doctor, a geriatric and neurology specialist or a psychiatrist in relation with the network of carers managing the patient, and if the efficacy at one year was maintained.

Clinical Added Value

no clinical added value

The transparency Committee considers that ARICEPT does not provide an improvement in actual benefit (IAB V) in the symptomatic treatment of mild to moderately forms of Alzheimer's disease. This opinion is based on clinical efficacy data showing a moderate effect, at best, established in the short-term, primarily on cognitive issues, the risk of adverse effects occurring and interactions with other medicinal products and on the lack of data establishing a long-term therapeutic benefit.

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