Reason for request

Inclusion on the list of medicines reimbursed by National Insurance and approved for use by hospitals in the extension of indication of “Symptomatic Treatment of Mild to Moderately Severe Forms of Dementia in Patients with Idiopathic Parkinson’s Disease.”

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Clinical Benefit

Moderate

The actual benefit achieved with this proprietary medicinal product in this indication is moderate.


Clinical Added Value

minor

Given the modest benefit observed and the risk of by no means negligible adverse reactions, Exelon provides a minor improvement in actual benefit (IAB IV) to patients with mild to moderately severe dementia associated with idiopathic Parkinson’s disease. The Commission notes that patients with visual hallucinations may particularly benefit from rivastigmine.


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