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Lilly drug for Alzheimer's gets limited Medicare coverage

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Medicare will pay the costs of brain imaging that uses a Eli Lilly and Co. drug to help diagnose Alzheimer’s disease only for patients participating in approved clinical studies, regulators proposed.

But Lilly officials said they will push ahead with the first-of-a-kind imaging chemical, despite the mostly negative ruling by Medicare officials.

There isn’t enough evidence to show the scan will benefit all people with dementia, though in some cases it may help diagnose whether a patient has Alzheimer’s, the most common form of dementia, the Centers for Medicare & Medicaid Services said last week in its proposed coverage decision.

The decision had been eagerly anticipated by the industry. Lilly says the drug should help reduce misdiagnosis of the disease.

Medicare, the U.S. health plan for the elderly and disabled, will reimburse patients for a scan if they are part of an approved clinical trial for the prevention, treatment or better diagnosis of Alzheimer’s, the agency said.

The $3,000 test, approved last year by the U.S. Food and Drug Administration, uses Lilly’s Amyvid imaging agent to trace a brain protein linked to Alzheimer’s. The disease affects 5 million Americans, a number that patient advocates say may double by 2050. In younger patients or those where the diagnosis is unclear, the benefit of the scan may be greatest, scientists have said.

In its proposed decision, the agency set out criteria for clinical studies that would allow Medicare recipients to be covered for the costs of the brain scans, including whether using the test would spare unnecessary treatments or improve the patients’ quality of life.

The ruling is an unexpected setback for the product after European Union regulators endorsed the chemical in January. The U.S. Food and Drug Administration approved the drug for sale in 2011.

"Lilly remains steadfast in our request for Medicare coverage of beta-amyloid imaging agents for the appropriate patient population," said Wei-Li Shao, director of the company's Alzheimer's business, in a statement.

Eli Lilly and Co. paid $300 million in 2010 to acquire the drug and its developer, Avid Radiopharmaceuticals Inc.

Avid Radiopharmaceuticals CEO Daniel Skovronsky said in a statement the Medicare ruling "may stifle future innovation aimed at improving diagnosis."

Doctors currently diagnose Alzheimer's disease by observing patients and administering physical and mental tests. The disease is the sixth-leading cause of death in the U.S. and the most common form of dementia, a term for brain disorders that affect memory, judgment and other mental functions.

Alzheimer's attacks neurons in the brain, leading to problems with memory, thinking and behavior. There is no cure for the disease, and scientists are not even sure what causes it.

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  1. In reality, Lilly is maintaining profit by cutting costs such as Indiana/US citizen IT workers by a significant amount with their Tata Indian consulting connection, increasing Indian H1B's at Lillys Indiana locations significantly and offshoring to India high paying Indiana jobs to cut costs and increase profit at the expense of U.S. workers.

  2. I think perhaps there is legal precedence here in that the laws were intended for family farms, not pig processing plants on a huge scale. There has to be a way to squash this judges judgment and overrule her dumb judgement. Perhaps she should be required to live in one of those neighbors houses for a month next to the farm to see how she likes it. She is there to protect the people, not the corporations.

  3. http://www.omafra.gov.on.ca/english/engineer/facts/03-111.htm Corporate farms are not farms, they are indeed factories on a huge scale. The amount of waste and unhealthy smells are environmentally unsafe. If they want to do this, they should be forced to buy a boundary around their farm at a premium price to the homeowners and landowners that have to eat, sleep, and live in a cesspool of pig smells. Imagine living in a house that smells like a restroom all the time. Does the state really believe they should take the side of these corporate farms and not protect Indiana citizens. Perhaps justifiable they should force all the management of the farms to live on the farm itself and not live probably far away from there. Would be interesting to investigate the housing locations of those working at and managing the corporate farms.

  4. downtown in the same area as O'malia's. 350 E New York. Not sure that another one could survive. I agree a Target is needed d'town. Downtown Philly even had a 3 story Kmart for its downtown residents.

  5. Indy-area residents... most of you have no idea how AMAZING Aurelio's is. South of Chicago was a cool pizza place... but it pales in comparison to the heavenly thin crust Aurelio's pizza. Their deep dish is pretty good too. My waistline is expanding just thinking about this!

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