VIZAMYL (flutémétamol,18F) - produit diagnostique de la maladie d’Alzheimer

Key points

Favourable opinion for reimbursement for Positron Emission Tomography (PET) imaging in the diagnosis of Alzheimer’s disease, with an atypical clinical presentation due to mixed presentation, including patients with an atypical form in terms of symptoms or early age of onset (subjects under 65 years of age) and in the following circumstances:

• when the cognitive impairment has been objectively confirmed and the cause of the cognitive disorder remains uncertain following assessment by a specialised physician and the investigations recommended by the guidelines 
• and when the performance of a lumbar puncture to detect and assay Aβ42, Tau and phosphoTau biomarkers in the CSF is contraindicated, cannot be performed or has provided inconclusive results (equivocal results that cannot be interpreted, results not consistent with the clinical presentation).

Unfavourable opinion for reimbursement in the other clinical situations.

What therapeutic improvement?

No clinical added value in the diagnostic strategy for Alzheimer’s disease.

 Role in the diagnostic pathway?

A diagnosis of Alzheimer's disease is made within the framework of a multidisciplinary approach. It is based, first of all, on the presence of a cognitive impairment (for example, hippocampal amnestic syndrome). In 2018, an expert consensus proposed a graduated and personalised strategy, with detection in the primary care setting, aetiological diagnosis based on a specialised consultation (geriatric, neurology, memory) supplemented by a brain MRI and first-line blood tests enabling a probable diagnosis of Alzheimer’s and related diseases. For atypical cases (mild cognitive impairment, young patient, rapid cognitive impairment, focal atrophy syndrome), lesion biomarkers, particularly in the cerebrospinal fluid (Aβ42 amyloid peptide and Tau proteins) or PET may be used. In the context of mild cognitive impairment, the consensus recommends that patients seeking a more precise diagnosis should have access to improved diagnostic accuracy via lesion markers from cerebrospinal fluid or PET scans.

Despite the efforts made during the successive neurodegenerative disease plans, it is considered that half of all Alzheimer's disease patients are not diagnosed currently. There are many reasons for this, but according to expert opinion, the most important could be a lack of detection in the primary care setting (general practitioners). The 2014-2019 neurodegenerative diseases plan specifies “the benefit of a proper diagnosis, even when there is no treatment, [in order to be able to adapt] the care pathway and support methods to preserve the patient's quality of life”.

Role of the medicinal product in the care pathway:

VIZAMYL (flutemetamol (18F)) has a role in the diagnostic strategy for Alzheimer’s disease, when the current guidelines schedule the performance of PET in patients with an atypical clinical presentation due to mixed presentation, including patients with an atypical form in terms of symptoms or early age of onset (subjects under 65 years of age) and in the following circumstances: when the cognitive impairment has been objectively confirmed and the cause of the cognitive disorder remains uncertain following assessment by a specialised physician and the investigations recommended by the guidelines and when the performance of a lumbar puncture to detect and assay Aβ42, Tau and phosphoTau biomarkers in the CSF is contraindicated, cannot be performed or has provided inconclusive results (equivocal results that cannot be interpreted, results not consistent with the clinical presentation).