| CHICAGO, July 9
CHICAGO, July 9 Alzheimer's experts are set to
protest after Medicare issued draft guidelines last week saying
it would only pay for an Eli Lilly and Co diagnostic
test for the disease if patients were taking part in clinical
trials for it.
Both Lilly and the Alzheimer's Association have released
statements expressing disappointment with the decision by the
U.S. Centers for Medicare & Medicaid Services (CMS), which cited
"insufficient" evidence that the tests improve patient care.
The agency that runs Medicare did cite evidence that the
tests may be of use to rule out Alzheimer's in certain
difficult-to-diagnose cases and to help identify patients who
would be good candidates for clinical trials seeking better
treatments or prevention strategies for the disease.
Patient advocates and the company say the decision might
slow the development of future diagnostic tests for Alzheimer's
and deny patients with symptoms the chance to find out whether
they have Alzheimer's or some other disease that causes symptoms
Several experts admit there is still much to learn about
what a positive scan might mean, and say CMS's decision to cover
only scans used in clinical trials may help in the search for
treatments for the fatal, brain-wasting disease that affects 5
million Americans and 38 million people worldwide.
HINDERING TIMELY DIAGNOSIS
Lilly's compound, known as Amyvid, has already been approved
by the U.S. Food and Drug Administration, but Medicare
reimbursement is seen as critical for the company because most
people begin showing signs of dementia around age 65, the age
when Medicare coverage kicks in.
"Restricting coverage could hinder a timely and accurate
diagnosis," said Dr. Daniel Skovronsky, president and chief
executive of Avid Radiopharmaceuticals Inc, a Lilly subsidiary,
adding that "it may stifle future innovation."
In addition to Lilly, the draft guidance could affect a
similar imaging agent being developed by General Electric Co's
GE Healthcare called flutemetamol now under review by
regulators in the United States and Europe. Both are radioactive
tracers designed to light up deposits of an Alzheimer's-related
protein called beta amyloid when used in conjunction with brain
scans known as positron emission tomography, or PET.
Instead of agreeing to routinely pay for the $3,000 test,
CMS proposed "Coverage with Evidence Development," a designation
that suggests there are still gaps in the evidence over the
benefits of the test. Using this designation allows the agency
to gather more data by paying for scans in patients taking part
in clinical trials. Once those are completed, CMS could use the
data to render a decision on coverage.
"Essentially, they acknowledge that there is the possibly
that coverage is important, but they don't understand it quite
yet," said Maria Carrillo, vice president of medical and
scientific Relations at the Alzheimer's Association, which
strongly disagrees with the proposal. The decision is still
subject to change before the final rule goes into effect in
Carrillo said prior to the decision, the Alzheimer's
Association and the Society of Nuclear Medicine and Molecular
Imaging sent CMS a report detailing the limited circumstances
under which the test would be appropriate, such as helping to
rule out dementia caused by a condition known as frontotemporal
dementia - which involves shrinking of the frontal and temporal
lobes - or Alzheimer's disease.
She said she expects patients and the Alzheimer's research
community to give CMS a lot of feedback on its draft document in
the hopes of winning coverage in the final ruling, expected in
Lilly said it stands by its request for coverage of the
tests in the appropriate patients.
WHAT DOES A POSITIVE SCAN MEAN?
Dr. Sam Gandy, associate director of the Alzheimer's Disease
Research Center at Mount Sinai School of Medicine in New York,
said the decision walks a fine line between the strengths of the
test and its weaknesses.
"I think CMS found a way to do something truly constructive
while holding back what will undoubtedly be a tsunami of worried
well who, if they had access to amyloid scans, would find that
they have amyloid in their brains that is largely asymptomatic,"
"They would have no idea if or when their brains would begin
to curdle in response to the amyloid, setting them on the road
to dementia," Gandy said.
Gandy pointed to a recent study by Dr. Steven DeKosky of the
University of Virginia and Dr. Oscar Lopez of the University of
Pittsburgh, which suggested the tests were a poor predictor of
whether people over 85 will develop Alzheimer's disease.
The study, which is ongoing, showed that more than half of
cognitively normal individuals aged 85 and older who had beta
amyloid deposits in their brains remained cognitively normal two
Lilly, in its statement, says its test was not designed to
predict whether Alzheimer's would develop, only to rule out
Alzheimer's in patients with difficult diagnoses. A negative
scan for the presence of beta amyloid would be a sign for
doctors to look for other potential causes of dementia.
That still leaves the problem of what to tell patients who
have a positive scan, said Dr. Ronald Petersen, an Alzheimer's
expert at the Mayo Clinic in Minnesota.
In someone with a precursor condition to Alzheimer's known
as mild cognitive impairment, or MCI, a positive scan may mean
a higher risk of advancing to Alzheimer's more quickly than a
negative scan would indicate, he said. "The data are
accumulating, but I don't know if they are there yet," he added.
At Mayo, Petersen is conducting a study of thousands of
cognitively normal people to try to answer the question, "What
does a positive scan mean in a normal person who is 50, 60 and
70 years old?"
Currently no treatments can prevent Alzheimer's, but as
companies work on new drugs, having tests that identify the
disease will be essential, DeKosky said.
"One of the reasons for trying to do these studies now is to
know what we will actually do once we have drugs that will make
a difference," he said.