SNMMI has been working together with the Alzheimer’s Association to develop the clinical trial that CMS has deemed necessary to reconcile the evidentiary gaps they outlined in the final coverage decision. The groups have also had discussions with CMS, which approved the study protocol with requirements.

CMS will reimburse the participating PET facilities for the costs associated with the scans. The FDA has approved three amyloid PET imaging radiopharmaceuticals for use with the scans: Amyvid, from Eli Lilly and Company; Vizamyl, from GE Healthcare; and Neuraceq, from Piramal Imaging. Manufacturers will ask CMS to set pass-through costs and then the average sales price will likely be established after the trial is over. The manufacturers have supported the design and implementation of the study through the Medical Imaging & Technology Alliance.


Siegel says the trial is designed to be neutral with respect to which of the three FDA-approved amyloid imaging agents is used for the scan. At the moment, none of the drugs has an average sale price established. Manufacturers will ask CMS to set pass-through costs and then set the average sales price after the trial is over.

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