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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. Socialized medicine works great for white people in Scandanavia. It works well in Costa Rica for a population that is partly white and partly mestizo. I don't really see Obamacare as something aimed against whites. I think that is a Republican canard designed to elicit support from white people for republican candidates who don't care about them any more than democrats care about the non-whites they pander to with their phony maneuvers. But what is different between Costa Rica nd the Scandanavian nations on one hand and the US on the other? SIZE. Maybe the US is just too damn big. Maybe it just needs to be divided into smaller self governing pieces like when the old Holy Roman Empire was dismantled. Maybe we are always trying the same set of solutions for different kinds of people as if we were all the same. Oh-- I know-- that is liberal dogma, that we are all the same. Which is the most idiotic American notion going right back to the propaganda of 1776. All men are different and their differences are myriad and that which is different is not equal. The state which pretends men are all the same is going to force men to be the same. That is what America does here, that is what we do in our stupid overseas wars, that is how we destroy true diversity and true difference, and we are all as different groups of folks, feeling the pains of how capitalism is grinding us down into equally insignificant proletarian microconsumers with no other identity whether we like it or not. And the Marxists had this much right about the War of Independence: it was fundamentally a war of capitalist against feudal systems. America has been about big money since day one and whatever gets in the way is crushed. Health care is just another market and Obamacare, to the extent that it Rationalizes and makes more uniform a market which should actually be really different in nature and delivery from place to place-- well that will serve the interests of the biggest capitalist stakeholders in health care which is not Walmart for Gosh Sakes it is the INSURANCE INDUSTRY. CUI BONO Obamacare? The insurance industry. So republicans drop the delusion pro capitalist scales from your eyes this has almost nothing to do with race or "socialism" it has to do mostly with what the INSURANCE INDUSTRY wants to have happen in order to make their lives and profits easier.

  2. Read the article - the reason they can't justify staying is they have too many medicare/medicaid patients and the re-imbursements for transporting these patient is so low.

  3. I would not vote for Bayh if he did run. I also wouldn't vote for Pence. My guess is that Bayh does not have the stomach to oppose persons on the far left or far right. Also, outside of capitalizing on his time as U. S. Senator (and his wife's time as a board member to several companies) I don't know if he is willing to fight for anything. If people who claim to be in the middle walk away from fights with the right and left wing, what are we left with? Extremes. It's probably best for Bayh if he does not have the stomach for the fight but the result is no middle ground.

  4. JK - I meant that the results don't ring true. I also questioned the 10-year-old study because so much in the "health care system" has changed since the study was made. Moreover, it was hard to get to any overall conclusion or observation with the article. But....don't be defensive given my comments; I still think you do the best job of any journalist in the area shedding light and insight on important health care issues.

  5. Probably a good idea he doesn't run. I for one do not want someone who lives in VIRGINIA to be the governor. He gave it some thought, but he likes Virginia too much. What a name I cannot say on this site! The way these people think and operate amuses me.

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