By Ransdell Pierson
Jan 30 A Medicare advisory panel expressed
skepticism on Wednesday that radioactive imaging agents like
Eli Lilly and Co's Amyvid can improve health outcomes of
people with early symptoms of memory problems.
The medical panel's lack of confidence could deter U.S.
reimbursement for recently approved Amyvid, which is used to
detect plaques in the brain made of beta amyloid protein. Its
wholesale cost is $1,600 per dose.
Although the brain plaque is considered by many researchers
to be a hallmark of Alzheimer's disease, some panel members
questioned whether Amyvid and similar imaging agents now in
development could be reliably used to diagnose Alzheimer's or
risk of developing it.
The Medicare Evidence Development & Coverage Advisory
Committee (MEDCAC) met in an all-day review of the imaging
technique. It involves use of PET scans (Positron Emission
Tomography), which measure the decay of injected radioactive
tracers like Amyvid.
Of 12 voting members, eight voted they had low or
low-to-intermediate confidence that PET imaging of brain beta
amyloid changes health outcomes. Three members voted they had
intermediate confidence, while one voted intermediate to high
The U.S. Medicare insurance program for the elderly and
disabled already reimburses use of PET scans to detect and
analyze a wide number of cancers. But the agency, relying on its
medical advisory panel, is evaluating whether to reimburse
patients for Lilly's product.
Medicare reimbursement for drugs is doubly important to
drugmakers because it typically paves the way for reimbursement
by private insurers.
Lilly declined to speculate whether the panel's skeptical
reaction to its product would harm Amyvid's reimbursement
chances with the U.S. Centers for Medicare & Medicaid Services
"That's for CMS to decide," said Wei-Li Shao, senior
director of Alzheimer's business at Lilly. But he said much of
the information presented at the meeting supported the value of
Lilly's imaging agent.
"One in five patients told they have Alzheimer's don't
actually have it," he said, and could avoid unnecessary
treatment for the disease if Amyvid shows the absence of brain
"It's a hard diagnosis, so it's important to get that
right," Shao said.
The FDA in April 2012 approved use of Amyvid (florbetapir F
18 injection). Prior to Amyvid, the amount of brain plaque could
be determined only with a brain biopsy at autopsy.
Lilly, which is developing a number of experimental
treatments for Alzheimer's disease, bought Avid
Radiopharmaceuticals in late 2010 to acquire Amyvid. It paid
$300 million for the privately held company, and agreed to pay
an additional $500 million to Avid stockholders if regulatory
and commercial milestones for the product were achieved.
Lilly's experimental Alzheimer's treatment, solanezumab,
last summer failed to slow cognitive decline in two big
late-stage trials that enrolled patients with mild to moderate
But when data from the two trials was combined and analyzed,
the drug slowed cognitive decline by more than 30 percent in
patients with mild symptoms.
The infused drug is now being tested in several independent
trials among patients with very mild symptoms or no symptoms of
the progressive memory-robbing disease, or who have a high
family risk of developing Alzheimer's.
The trials will select many patients based upon whether
patients have brain plaque, as detected by PET scans and Amyvid.
Lilly shares closed down 0.3 percent at $54.15 on Wednesday,
amid slight declines for the drug sector.