Reason for request

Re-assessment 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 EBIXA should be considered as low.

- in the absence of long-term clinical data, continuing treatment with EBIXA for more than six months must be subject to a detailed re-assessment. If the patient has reached the treatment objectives (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 EBIXA may be repeated once.

Clinical Added Value

no clinical added value

The transparency Committee considers that EBIXA does not provide an improvement in actual benefit (IAB V) in the symptomatic treatment of Alzheimer's disease and in the treatment of patients with a moderate to severe form of the disease. This opinion is based on available 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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