Major amyloid imaging trial launched by ACR, Alzheimer’s Association
April 17, 2015
by Lisa Chamoff, Contributing Reporter
The American College of Radiology (ACR) and the Alzheimer's Association announced on Thursday a new four-year research study to determine the value of beta-amyloid imaging in diagnosing and treating Alzheimer’s disease and other dementias.
Titled “Imaging Dementia - Evidence for Amyloid Scanning (IDEAS)”, the study has an estimated budget of $100 million and will enroll 18,488 patients age 65 and older over 24 months at roughly 200 sites throughout the U.S., according to a news release from the ACR. The study participants, who must meet appropriate use criteria developed by the Alzheimer's Association and the Society of Nuclear Medicine and Molecular Imaging, will be placed into either a subgroup for progressive, unexplained mild cognitive impairment or a subgroup for dementia of uncertain cause.
The study has two goals. The first goal is to assess the impact that amyloid PET imaging has on the short-term management of patients who meet the appropriate use criteria. Changes in management include patients using Alzheimer's or other drug therapy and receiving counseling about safety and future planning earlier. The study will also compare patients enrolled in the study to a cohort of patients who have never undergone amyloid PET imaging to see whether the patients who underwent imaging have fewer hospitalizations and emergency room visits.
Imaging can determine whether a patient might have Alzheimer’s disease or other cognitive issues, such as frontotemporal dementia, which can be clinically difficult to distinguish from Alzheimer’s, but usually does not include buildup of beta-amyloid plaque.
“Presumably, if patients with dementia or mild cognitive impairment are properly managed, with proper drug therapy and counseling about risk avoidance, they will have fewer hospitalizations,” Dr. Barry Siegel, the lead radiologist on the IDEAS study, who serves as a professor of radiology and medicine and the director of nuclear medicine at Washington University in St. Louis, told DOTmed News. “The principal goal is to demonstrate that the use of this imaging test is leading to improved outcomes for these patients.”
The announcement of the study comes nearly two years after the Centers for Medicare and Medicaid Services said there was insufficient evidence to conclude that PET scans to detect amyloid plaque in the brain improve health outcomes for Medicare beneficiaries with Alzheimer’s and related dementia. The CMS decision allowed for reimbursement of one PET scan to rule out Alzheimer’s disease, but only for patients enrolled in clinical trials under what is known as a coverage with evidence development program.
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.
Titled “Imaging Dementia - Evidence for Amyloid Scanning (IDEAS)”, the study has an estimated budget of $100 million and will enroll 18,488 patients age 65 and older over 24 months at roughly 200 sites throughout the U.S., according to a news release from the ACR. The study participants, who must meet appropriate use criteria developed by the Alzheimer's Association and the Society of Nuclear Medicine and Molecular Imaging, will be placed into either a subgroup for progressive, unexplained mild cognitive impairment or a subgroup for dementia of uncertain cause.
The study has two goals. The first goal is to assess the impact that amyloid PET imaging has on the short-term management of patients who meet the appropriate use criteria. Changes in management include patients using Alzheimer's or other drug therapy and receiving counseling about safety and future planning earlier. The study will also compare patients enrolled in the study to a cohort of patients who have never undergone amyloid PET imaging to see whether the patients who underwent imaging have fewer hospitalizations and emergency room visits.
Imaging can determine whether a patient might have Alzheimer’s disease or other cognitive issues, such as frontotemporal dementia, which can be clinically difficult to distinguish from Alzheimer’s, but usually does not include buildup of beta-amyloid plaque.
“Presumably, if patients with dementia or mild cognitive impairment are properly managed, with proper drug therapy and counseling about risk avoidance, they will have fewer hospitalizations,” Dr. Barry Siegel, the lead radiologist on the IDEAS study, who serves as a professor of radiology and medicine and the director of nuclear medicine at Washington University in St. Louis, told DOTmed News. “The principal goal is to demonstrate that the use of this imaging test is leading to improved outcomes for these patients.”
The announcement of the study comes nearly two years after the Centers for Medicare and Medicaid Services said there was insufficient evidence to conclude that PET scans to detect amyloid plaque in the brain improve health outcomes for Medicare beneficiaries with Alzheimer’s and related dementia. The CMS decision allowed for reimbursement of one PET scan to rule out Alzheimer’s disease, but only for patients enrolled in clinical trials under what is known as a coverage with evidence development program.
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.