Quote this publication Share Print

EXELON

-
Opinions on drugs - Posted on May 21 2013

Reason for request

Re-assessment of the actual benefit and improvement in actual benefit pursuant to Article R-163-21 of the Social Security Code (in Alzheimer's disease) and renewal of inclusion on the list of proprietary medicinal products refundable by National Health Insurance.

-


Actual benefit

Faible

- Although it is impossible to identify responding patients a priori but in order not to deprive certain patients of the possible slight clinical benefit observed in the short-term with medicinal products for the symptomatic treatment of Alzheimer’s disease, the actual benefit of EXELON should be considered to be low.
- In the absence of long-term clinical data, treatment with EXELON should only be continued beyond six months after careful re-assessment. If the patient has achieved the objectives set for his treatment (for instance, stabilisation or slowing of cognitive decline) and if no serious adverse effects or effects on quality of life have occurred, treatment with EXELON may be continued for one further period.

- The Committee proposes that continuing treatment beyond 1 year should be decided after discussions with the carer and the patient if possible, following a multidisciplinary team meeting involving the treating doctor, geriatrician and neurologist or psychiatrist, taking into account the care network under which the patient is being treated, and on condition that efficacy has been maintained for 1 year.


Improvement in actual benefit

V (absence)

The Transparency Committee considers that EXELON does not provide any improvement in actual benefit (IAB V) in the symptomatic treatment of mild to moderately severe forms of Alzheimer's disease. This opinion is based on the available clinical data on efficacy, which reveals a degree of effect that is at best modest, established over the short-term and mainly on cognitive disorders, the risk of onset of adverse effects and drug interactions and on the lack of data demonstrating long-term therapeutic benefit.


Contact Us

Évaluation des médicaments

See also