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REMINYL

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Opinions on drugs - Posted on May 21 2013

Reason for request

Re-evaluation of the Actual Benefit and Improvement in Actual Benefit pursuant to Article R-163-21 of the Social Security Code and renewal of inclusion on the list of proprietary medicinal products reimbursed by National Health Insurance.

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Clinical Benefit

Low

- Since it is impossible to identify responding patients a priori and 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 REMINYL should be considered to be low.
- In the absence of long-term clinical data, treatment with REMINYL should only be continued beyond six months after careful re-evaluation. 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 REMINYL may be continued for one further period.

- The Committee proposes that continuing treatment beyond one 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 one year.


Clinical Added Value

no clinical added value

The transparency Committee considers that REMINYL does not provide any improvement in actual benefit (IAB) in the symptomatic treatment of mild to moderately severe dementia of the Alzheimer type. This opinion is based on the available clinical data on efficacy, which reveal an effect size 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.


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