NEURACEQ (florbetaben 18F) - Alzheimer’s Disease

The clinical benefit provided by NEURACEQ (florbetaben (18F)), solution for injection is significant for Positron Emission Tomography (PET) imaging in the diagnosis of Alzheimer’s Disease, with an atypical clinical presentation due to a mixed presentation, including patients with atypical symptoms or an early age of onset (subjects under 65 years of age) and in the following circumstances:

• when the cognitive deficit has been objectively confirmed and the cause of the cognitive disorder remains uncertain after an assessment by a specialist physician and the investigations recommended by the guidelines
• and when a lumbar puncture to detect and assay the biomarkers Aβ42, Tau and phospho-Tau in the CSF is contraindicated, cannot be performed or has provided inconclusive results (equivocal results that cannot be interpreted, results inconsistent with the clinical presentation).

In view of:

• the data assessed during the initial listing application which reported diagnostic performances for florbetaben-PET compared to post-mortem histopathology in patients with an established diagnosis of Alzheimer’s Disease, Lewy Body Dementia or other dementia, with an average age of 74 years, in a phase III study with:
  • results with a sensitivity of 77.4% and a specificity of 94.2% in an intermediate analysis provided for a priori in the protocol in the first 31 patients (main analysis conducted by visual assessment, by cortical region),
  • the additional results of a post-hoc analysis not provided for a priori in the protocol in a larger group of 74 patients (visual assessment, by patient) with a sensitivity of 97.9% and a specificity of 88.9%,
• new data derived from the literature some of which deal with patients with a complex diagnosis (early atypical forms, with focal atrophy, and rapid progression) and which reported data for NEURACEQ (florbetaben (18F)) on the impact on management, institutionalisation and mortality with however associated limitations (data all descriptive without formalised statistical comparisons, no randomisation, or transposability to French practice...),
• new data suggesting a concordance between the amyloid florbetaben (18F) PET and that of flutemetamol (18F),
• new data suggesting a correlation between florbetaben (18F) PET and some CSF biomarkers without however a compelling demonstration of any advantage in terms of diagnostic performance compared to the detection and assay of CSF biomarkers (Aβ42, Tau and phospho-Tau) performed after lumbar puncture and compared to VIZAMYL (flutemetamol (18F)),

The Inter-Committee considers that NEURACEQ 300 MBq/ml (florbetaben (18F)), solution for injection provides no clinical added value (CAV V) in the diagnostic strategy of Alzheimer’s Disease.