From the June 2015 issue of HealthCare Business News magazine


While no cure for Alzheimer’s currently exists, imaging amyloid with PET tracers allows physicians to rule out the disease or assess its progress. In some cases, patients diagnosed with Alzheimer’s disease later undergo an amyloid scan that yields no betaamyloid plaque in the brain. Recognizing an inaccurate diagnosis allows the physician to modify treatment and rethink the root cause of the patient’s dementia.

Amyloid imaging could also be a valuable tool in selecting candidates for, and measuring the success of, disease modifying drugs (DMDs) being developed by researchers. In that way, amyloid tracers could play a vital role in facilitating the discovery of a new drug that actually reverses the beta-amyloid plaque buildup that makes Alzheimer’s so debilitating.


Therapeutic breakthroughs with other radiopharmaceuticals provide plenty of reason for optimism. Bayer’s Xofigo, a bone treatment agent developed for castration resistant prostate patients is one example pushing that therapeutic envelope. Unlike other drugs developed to treat the pain of bone metastases, Xofigo has been shown to actually decrease their size.

There are plenty of FDA-approved amyloid tracers currently on the market, such as GE’s Vizamyl, Eli Lilly’s Amyvid, and Piramal’s Neuraceq. Partnerships exist between those vendors and pharmaceutical companies researching therapeutic amyloid solutions.

Knowing which patients have amyloid buildup would be a helpful first step in monitoring the success of drugs designed to reduce it. Unfortunately, obtaining reimbursement for the use of those tracers in the clinical setting has been a challenge. In 2013, CMS issued a national coverage decision on all amyloid imaging in dementia and neurodegenerative disease. Their conclusion was that insufficient evidence existed to declare PET amyloid imaging reasonable or necessary in the diagnosis or treatment of neurodegenerative disease.

But it wasn’t a complete disappointment. CMS did see sufficient evidence for using PET amyloid imaging to exclude Alzheimer’s disease in difficult to diagnose patients. That could mean younger patients with earlier onset, or other unique cases that may enrich the clinical trials conducted by pharmaceutical companies. That reimbursement came under the umbrella of coverage for evidence development (CED) studies. Through CED coverage, researchers can accumulate the body of evidence they need to illustrate the benefits of amyloid imaging, and the value of earlier detection of Alzheimer’s.

June 2015 Magazine

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