Medicare Coverage For Amyvid Complicated By PET Policy; Lilly Seeks Revision
Under CMS’ current policy for PET scans, new imaging agents approved by FDA would have to go through a national coverage analysis before Medicare will pay for them.
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FDA Review Of GE’s Vizamyl Shows Caution In The Face Of Alzheimer’s Disease Unknowns
Regulators approved the PET imaging agent for estimating neuritic plaque density in the brain despite the apparent limited clinical utility of the class.
Lilly Amyvid’s Full-Color Advertising Has FDA Seeing Red
Color pictures of a PET brain image shouldn’t be used to promote a product that actually generates a black-and-white scan for doctors, FDA says.
Amyvid Approval Just The Start Of A Critical Year For Alzheimer’s
One way or another, it is an important time in the Alzheimer’s disease space. Two potential disease altering therapies are set to divulge Phase III results that will answer important questions about the course of the illness, whether they are successful or not, and a promising cognition booster may get the Phase II readout it needs to head into a pivotal trial.