Feds mull covering Alzheimer’s test that uses Lilly’s Amyvid

The U.S. government is set to decide this month whether federal health insurance should cover the cost of a $3,000 test that for the first time accurately identifies the signature brain plaques of Alzheimer’s disease.

A lot is riding on the decision. Those in favor of coverage say the brain scan will reduce anguish and lower medical costs for families struggling to determine appropriate care for a relative suffering from memory loss. What’s more, the test could help create a broad base of early Alzheimer’s patients for research purposes, they say. Opponents counter that coverage would be a waste of money because Alzheimer’s remains an incurable disease and knowing whether a person has the disease is of little or no benefit.

“I wouldn’t be surprised if this decision went in either direction,” said Sean Tunis, the founder and director of the Center for Medical Technology Policy in Baltimore. “The science on this one is so early, so it’s hard to make a case from a clinical point of view that the diagnosis will make a difference. It will tilt on political dynamics more than the science.”

The test, approved last year by U.S. regulators, uses Eli Lilly and Co.’s Amyvid imaging agent to trace a brain protein linked to a disease that affects 5 million Americans, a number that patient advocates say could double by 2050. A decision in favor of coverage could also spur interest in a similar agent that General Electric Co. is developing.

Differentiating between those who suffer from Alzheimer’s and others who have lesser forms of dementia is key for determining proper treatment, said Robert Berenson, a fellow at the Urban Institute. One kind of illness frequently mistaken for Alzheimer’s is called multi-infarct dementia. For this condition, doctors can use blood thinners to keep the disease from progressing.

Memory loss can also be caused by tumors or dietary deficiencies, conditions that can be reversed before they become too damaging, said Dean Hartley, director of scientific initiatives for the Alzheimer’s Association.

“We need to make sure we can rule out Alzheimer’s,” Hartley said.

Over the last decade, attempts to develop an effective Alzheimer’s’ treatment have come up short, failing to crack an estimated $20 billion market. As a result, scientists have called for a national research effort that was recently endorsed by U.S. President Barack Obama.

Amyvid, the first drug of its kind, was approved for sale last year by U.S. regulators, and in January in Europe. It binds to beta-amyloid plaques in the brain that are a suspected cause of Alzheimer’s. The dye’s radiation allows an image to be produced using a PET scan, showing where amyloid plaques exist in the brain and how extensive they may be.

In January, after Lilly requested a determination on coverage from the Centers for Medicare and Medicaid Services, a panel of U.S. advisers said it wasn’t confident the tests would improve the health of people with Alzheimer’s. A final decision will come July 9, according to Don McLeod, an agency spokesman who declined to comment further. The agency oversees Medicare, the U.S. health program for the elderly and disabled, and Medicaid, the joint-state medical plan for the poor.

While a negative decision would limit use of the tests, approval would probably open the door for coverage by private insurers, which often follow the federal government’s lead. That would potentially result in millions of people receiving the test.

Those sorts of numbers could be especially useful for research, said Daniel Skovronsky, CEO of Lilly’s Avid Radiopharmaceuticals unit. Currently, scientists must scan each patient they recruit for Alzheimer’s trials to determine if they have the disease, according to Skovronsky. About a third of patients don’t and those scans are thrown away, wasting time and money.

“If it’s reimbursed already, then there will be people already pre-sorted,” Skovronsky said. “Most trials want to know the amyloid status of patients but, because it’s not been widely used in clinical practice, it takes time and money. That’s a drag on research.”

Deciding how such tests will be used in the future is an important issue as the Baby Boom ages. More than 60 percent of family caregivers for those with dementia rated the emotional stress of their effort as high or very high in a 2010 poll of 3,118 people in that situation, and 39 percent of caregivers suffer depression that needs to be treated, according to research published in the Journal of Clinical Epidemiology.

“You have two different emotions,” said Pamela Machado, 54, of Waterford, California. Her father, Tom Perry, was diagnosed with Alzheimer’s disease and underwent amyloid imaging. “I was happy to know what was going on, but so incredibly sad it’s confirmed. It helps prepare you, though, and you can then seek help.”