Advanced imaging that detects plaque in the brain should be covered by Medicare and private insurers for select people with dementia to help diagnose or rule out Alzheimer’s disease, advocates and doctors said.
The recommendations released today are the first to help govern the burgeoning field of brain imaging and may increase the use of the practice to improve care for the 5 million Americans affected with Alzheimer’s. The Alzheimer’s Association and the Society of Nuclear Medicine and Molecular Imaging crafted the proposal to address which patients might benefit from the PET scan technology that detects the plaque.
While amyloid plaque is a hallmark of Alzheimer’s disease, not everyone with it has the mind-robbing condition. PET scans require a drug injected into patients to highlight the plaque for doctors. Eli Lilly & Co. (LLY)’s Amyvid is the only compound currently approved for use with PET scans for this purpose.
“This is going to become much more ubiquitous and available over the next few years,” said Maria Carrillo, vice president of medical and scientific relations at the Chicago- based Alzheimer’s Association. “It’s something physicians can refer their patients for if they need additional information.”
Lilly’s drug isn’t now covered by Medicare, the U.S. insurance program for the elderly and disabled, though the agency plans a hearing on Jan. 30. Products from General Electric Co. (GE), Piramal Enterprises Ltd. and Navidea Biopharmaceuticals Inc. (NAVB) are expected to reach the market in the next two years.
The costs of the scans vary depending on where they are done and who conducts them, though prices for standard PET imaging range from $1,000 to $3,000.
Alzheimer’s is the sixth-leading cause of death in the U.S., according to the Alzheimer’s Association. The number of people with the disease is expected to double within 20 years as the world’s population ages, to as many as 65.7 million people in 2030 and 115 million by 2050, the Geneva-based World Health Organization said last April. There is no treatment to cure or slow the disease. Current therapies address only symptoms.
While Alzheimer’s is the most common cause of dementia in the elderly, memory problems may also stem from drug side effects, strokes, thyroid problems and vitamin deficiencies.
The guidelines identify three groups of patients who should have insurance access to the brain imaging technology, the two organizations said. People with unexplained, worsening memory loss or confusion, those with possible Alzheimer’s disease who have unusual symptoms and those with progressive dementia that develops before the age of 65 may benefit, they said.
The groups said such brain scans shouldn’t be used for people 65 or older with conventional signs of Alzheimer’s, those without symptoms or those with unconfirmed complaints about memory loss. People who already meet the criteria for Alzheimer’s disease won’t get additional benefit from the imaging, the groups said. It also can’t predict future risk in people with few or inconsistent signs of dementia, they said.
The goal of screening is to rule out Alzheimer’s or help manage treatment for those who most likely have it, based on the imaging and other tests, Carrillo said. If there are no amyloid plaques, then doctors can look for other causes of dementia, which may be manageable or even reversible, she said.
For those with the condition, the imaging may help speed a diagnosis, she said.
“It can definitely take two or three years sometimes to get a diagnosis,” Carrillo said in a telephone interview. “That’s really not helpful. These people have been robbed of two years of knowing a definitive diagnosis.”
In that time, patients could have been given medicine to ease symptoms, participating in clinical trials or getting their personal affairs in order, she said.
It’s also important for those conducting the imaging scans to have proper training, said Frederic Fahey, president of the Society of Nuclear Medicine and Molecular Imaging. Eventually, the information gathered from the scans may help develop new treatments for Alzheimer’s disease, he said in a statement.
The technology also shouldn’t be used to determine how severe dementia is, to look for disease in people without symptoms who have a family history, or non-medical reasons like insurance or legal questions.
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