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Medicare puts brake on Lilly's Alzheimer's test

Will only reimburse new Alzheimer's diagnostic Amyvid for patients in trials

Eli Lilly HQ thumbMedicare has said it will only reimburse use of Eli Lilly's new Alzheimer's diagnostic Amyvid if patients taking it are in clinical trials, according to a draft decision by the US health insurer.

Lilly said the decision was disappointing, adding that the Centers for Medicare & Medicaid Services (CMS) are "challenging the value of an adjunctive tool that can assist physicians in making a more informed diagnosis for patients with cognitive impairment".

Amyvid (florbetapir [18F]) is an imaging agent used during positron emission tomography (PET) scanning to detect the presence or absence of beta-amyloid plaques in the brains of adult patients with cognitive impairment.

Analysts have previously suggested that without widespread reimbursement sales of Amyvid could be as low as $100m a year, but could reach $500m if it is covered for more widespread use.

Lilly won approval for the $3,000 test in the US last year at its second attempt, after a first filing was rejected on concerns that the scans achieved with the imaging agent could be hard to interpret correctly without adequate technician training. It was also given a green light in the EU in January.

The US approval kicked off a reimbursement review process at the CMS that was always going to be tough, given that approving Amyvid would overturn a 10-year restriction on PET imaging reimbursement. 

There had been hopes that CMS would change its stance on the issue given the need for additional tools to diagnose Alzheimer's and the fact that other PET imaging agents for the disease are in late-stage development, such as GE Healthcare's flutemetamol and Bayer's florbetaben.

The CMS draft decision suggests that "evidence is insufficient to conclude that the use of PET amyloid-beta imaging improves health outcomes for Medicare beneficiaries with dementia or neurodegenerative disease".

However, it said there was a role for Amyvid in clinical trials of Alzheimer's treatment or prevention strategies and to exclude the disease in certain difficult diagnoses, such distinguishing Alzheimer's from fronto-temporal dementia (FTD.

But Lilly said the restriction "could hinder a timely and accurate diagnosis, which is in conflict with the advice of Alzheimer's disease experts and with the administration's National Alzheimer's Project Act". 

"In addition, it may stifle future innovation aimed at improving diagnosis," said Daniel Skovronsky, chief executive of Lilly's Avid Radiopharmaceuticals subsidiary that originally developed Amyvid.

Amyvid is used by doctors in combination with other tests, and a positive scan does not diagnose Alzheimer's Disease or other thinking or memory disorders.

4th July 2013

From: Regulatory

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