Eli Lilly (Switzerland)

<h3>Objectives</h3> PET tracers represent the gold-standard for indicating the presence of Alzheimer’s disease (AD) pathology, but are costly and not widely accessible. Thus, establishing the interchangeability of CSF and PET for patient identification (PI) may overcome barriers to inequitable access for AD modifying therapies. <h3>Methods</h3> AD Neuroimaging Initiative participants with MCI/AD dementia and available CSF data, amyloid-PET and/or tau-PET scans were included. Agreement between PET and CSF- based PI, the non-inferiority of CSF to amyloid-PET for PI, and clinical/cognitive trajectories were evaluated. <h3>Results</h3> Fujirebio-Lumipulse Aβ42/40 (N=288) and Roche-Elecsys P-tau181/Aβ42 (N=251) CSF-assays ruled-in the same participants as amyloid-PET (Positive Predictive Values (PPV) of 89.58% and 93.53%, respectively) and met non-inferiority criteria. Roche-Elecsys P-tau181/Aβ42 (N=127) ruled-out, but not in, the same participants as neocortical tau-PET (negative predictive value (NPV) 98.08%; PPV=64.00%), although a Youden’s Index-based CSF threshold resulted in &gt;80% positive and negative percent agreements. CSF+/tau-PET− had faster clinical/cognitive decline than CSF−/tau-PET−. CSF achieved 81.33%PPV and 94.23%NPV vs early tau-PET. <h3>Conclusions</h3> CSF assays are non-inferior to Aβ-PET for identifying patients with AD pathology. Alternative thresholds for CSF assays, derived against tau instead of amyloid pathology, may better align with neocortical tau-PET. Further consideration of CSF strategies for tau are warranted. Disclosed at ISPOR-2023.

ABSTRACTLifelong learning through continuing professional development (CPD) and medical education is critical for healthcare professionals to stay abreast of knowledge and skills and provide an optimal standard of care to patients. In Europe, CPD and medical education are fragmented as there are numerous models, providers and national regulations and a lack of harmonisation of qualitative criteria. There is continued debate on the appropriate role of pharmaceutical companies in the context of medical education. Accrediting bodies such as European Accreditation Council for Continuing Medical Education do not permit active involvement of the pharmaceutical industry due to concerns around conflicts of interest and potential for bias. However, many examples of active collaboration between pharmaceutical companies and medical societies and scientific experts exist, demonstrating high integrity, clear roles and responsibilities, and fair and balanced content. Medical education experts from 16 pharmaceutical companies met to develop a set of quality principles similar to standards that have been established for clinical trials and in alignment with existing principles of accrediting bodies. This paper outlines their proposal for a framework to improve and harmonise medical education quality standards in Europe, and is also an invitation for all stakeholders to join a discussion on this integrative model.