Medicare agency won't pay for Eli Lilly imaging drug for Alzheimer's diagnoses
Oct. 02--In another sales-sapping blow to Eli Lilly and Co., the Centers for Medicare and Medicaid Services has decided not to pay for patient use of a Lilly imaging drug used in Alzheimer's assessments.
The Indianapolis drugmaker said Monday that it's disappointed in the decision, which it called "contrary to expert opinion."
The CMS decision is a financial blow to Lilly's Amyvid, a new drug marketed for use in brain scans to evaluate patients for Alzheimer's disease and other brain dysfunctions. Approved by the Food and Drug Administration last year, Amyvid is the only drug of its kind on the market.
"Denying appropriate patient access (to Amyvid) is also in conflict with the administration's National Alzheimer's Project Act," Lilly said in a statement. "CMS participated in creating this plan aimed at developing new and innovative ways to diagnose, support and treat patients suffering from Alzheimer's disease -- yet the same agency is challenging the value of the only technology approved by the Food and Drug Administration for estimating beta-amyloid neuritic plaque density in the living brain, which can aid in helping doctors make a more informed diagnosis."
In a long, heavily footnoted "decision memo," the CMS, which runs the sprawling federal Medicaid and Medicare health systems for the elderly and poor, said it has concluded that there is no good evidence that imaging agents such as Amylid provide much help in diagnosing brain diseases.
"(CMS) has determined that the evidence is insufficient to conclude that the use of positron emission tomography (PET) amyloid-beta imaging is reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of ... Medicare beneficiaries with dementia or neurodegenerative disease," the memo said.
The federal agency said it will pay for Amyvid only for use in clinical trials aimed at treating or preventing Alzheimer's, identifying certain people at risk for developing the disease, or resolving cases that are difficult to diagnose.
The CMS decision "creates additional complexity" for Alzheimer's patients and their doctors, Lilly said.
"We will be evaluating all available options to ensure patients and physicians can gain access to this innovative diagnostic tool as soon as possible," Lilly said.
Amyvid is a radioactive agent that's injected into patients and travels through their bloodstream to bind to amyloid plaques in the brain that are linked to the prevalence of Alzheimer's. PET scanners pick up the signals given off the drug and create an image of the brain that helps doctors in assessing patients for Alzheimer's.
Lilly stock fell 17 cents a share in trading Monday, closing at $50.33.
(c)2013 The Indianapolis Star
Visit The Indianapolis Star at www.IndyStar.com
Distributed by MCT Information Services