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 confidence.
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 (CMS).
"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 plaque.
"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 Alzheimer's disease.
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.
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