Restricting access to florbetapir: Medicare coverage criteria for diagnostics and drugs are inconsistent: Table 1

Abstract

Medicare's decision to restrict coverage of florbetapir, a diagnostic agent for Alzheimer's disease, exemplifies an inconsistent approach to technology evaluation. Joshua Cohen and colleagues call for consistency Joshua P Cohen research associate professor 1 , Jinghui Dong research associate 1 , Christine Y Lu instructor 2 , Ranjana Chakravarthy research analyst Center for the Study of Drug Development, for her help with our literature search and discussion of the Amyvid/florbetapir case.

Radiolabeling of [ 11 C]FPS-ZM1, a Receptor for Advanced Glycation End products-targeting Positron Emission Tomography radiotracer, Using a [ 11 C]CO 2 -to-[ 11 C]CO Chemical Conversion

“…In our previous report, the [ 11 As a next step, we examined the effect of the amount of 2 (0.32-1.24 mmol) after either 3 hours (entries 10-11, Table 1) or 24 hours (entries 12-13, Table 1) of synthesis time. When the amount of 2 was lowered from 0.64 mmol to 0.32 mmol while keeping constant lithium equivalents, [ 11 C]CO production dropped from 57% to 8% after 3 hours (entries 9 and 10, Table 1) and from 38% to 14% after 24 hours (entries 8 and 12, Table 1).…”

“…[7] The deposition of insoluble Aβ plaques, however, almost certainly occurs too late in the AD disease process for successful therapeutic intervention and also does not always correlate with AD diagnosis or loss of cognition [8,9] thus limiting the diagnostic utility of Aβ-targeting radiotracers. [10,11] An alternative strategy aims at detecting hyperphosphorylated tau protein, the main component of the neurofibrillary tangles (NFTs), [12] via the use of specific radiotracers such as [ 18 F]T808. [13] Nevertheless, the accumulation of tau NFTs is also observed in frontotemporal dementia, [14] and, additionally, may not be present in sufficient amounts to be accurately detected by PET until late stage disease.…”

“…[17] Although these in vivo results showed a good uptake in healthy animals, an assessment in a Tg2576 mouse model might more accurately predict the biodistribution profile of the RAGE radiotracer in a pathological state. Moreover, the use of 11 C allows the authentic labelling of the unmodified compound, retaining its pharmacodynamic and pharmacokinetic profile. A 11 C-labelled analogue of FPS-ZM1 ([ 11 C]FPS-ZM1) was therefore developed for testing with AD animal models.…”

“…The aims of this work were to: i) optimise the [11 C]CO2-to-[ 11 C]CO conversion via [ 11 C]1 by studying the variables involved in the [ 11 C]CO production such as temperature, reaction time, reagent stability and sample preparation; ii) employ the produced [ 11 C]CO to radiolabel…”

Clinical Use and Utility of Amyloid Imaging

“…The U.S. Centers for Medicare and Medicaid Services decided in 2013 to restrict amyloid imaging coverage by arguing that the evidence for clinical use was insufficient at that time. Although this decision was acknowledged by some authors (53), it was criticized by others as an example of a misbalance in the Medicare coverage criteria between drugs and diagnostics (54). However, instead of broadly covering amyloid imaging, Medicare decided to cover one amyloid scan per patient for those enrolled in a coverage-of-evidence program.…”