por Loren Bonner
, DOTmed News Online Editor | June 11, 2012
From the June 2012 issue of HealthCare Business News magazine
Siemens’ subsidiary PETNET Solutions Inc., the largest chain of radiopharmacies in the U.S., entered a deal last November with Eli Lilly to gain U.S. manufacturing and distribution rights for Amyvid. PETNET is gearing up to launch the Phase I of this deal with Eli Lilly involving Amyvid in early June. This will entail the manufacture and distribution of the biomarker at nine PETNET sites across the U.S, according to Jeff Bell, a spokesperson for Siemens Healthcare. Phase II will kick off toward the end of the summer, with Phase III coming by year’s end.
GE Healthcare has two more PET imaging agents in the pipeline for FDA approval that can also detect amyloid plaque. These also promise to help clinicians characterize the stages of Alzheimer’s and spot the disease early, and will ultimately play a role in developing new treatments for disease.
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Although this is all welcome news for PET industry players, any significant uptick in the use of PET on brain imaging will depend on whether the Center for Medicare and Medicaid Services deems the drugs worthy of reimbursement.
“They have to prove to CMS that it does something that they are not already able to do, that literally could add another 18 months [to the reimbursement process], even when they have FDA approval before there’s reimbursement,” says Webster.
He adds that these new PET imaging agents to study Alzheimer’s will most likely benefit big centers that carry out Alzheimer’s research because they can show CMS that the radiotracers not only help diagnose patients, but manage their therapy better.
PET/CT holds strong
PET imaging is initiated by injecting a patient with a radiopharmaceutical. Most procedures use FDG—a molecule of glucose attached artificially to an A18 fluorine atom—and that emits a positron that combines with the electron and highlights an image on a scanner.
When FDG gained traction as a favorable oncology agent, reimbursement quickly followed. PET/CT joined in almost immediately because, even though dedicated PET technology provided information about the metabolic activity, it wasn’t able to supply the anatomical details to improve the detection of abnormalities on a scan the way CT could.
Currently, research efforts are focused on how quantitation can help PET/CT in the clinical setting, particularly as it applies to cancer.
GE Healthcare says that quantitation capabilities for PET are needed to take PET/CT from a diagnostic and staging modality, to one that can monitor therapy and treatment effectively.