Mixed Reaction to CMS Decision on Amyloid PET Imaging

July 19, 2013

There has been a mixed reaction to the draft decision by the Centers for Medicare & Medicaid Services (CMS) not to allow wider reimbursement for amyloid positron emission tomography (PET) for the evaluation of dementia and neurodegenerative diseases, including Alzheimer's disease.

The CMS released a statement on July 3 saying that it is proposing coverage with evidence development (CED), which allows use only for patients in clinical trials addressing the effectiveness of these scans.

The US Alzheimer's Association and Eli Lilly and Company, manufacturer of florbetapir (Amyvid), an approved tracer for amyloid imaging, both issued statements soon after, objecting to the decision and calling for the CMS to reconsider before making a final decision on the issue. But some other experts in the field agree with the CMS decision and believe it would be premature to make amyloid imaging more widely available at this stage.

Other radiopharmaceuticals affected by the decision include amyloid tracers florbetaben (Bayer Healthcare), flutemetamol (GE Healthcare), FDDNP, AZD4694 (Navidea Biopharmaceuticals), Pittsburgh compound B C11 (PIB) (GE Healthcare), and fluorodeoxyglucose.

Alzheimer's Association "Disappointed"

In its statement, the Alzheimer's Association says it is "disappointed" by the CMS decision, "particularly given the clear, scientific consensus recommendations by the Association and the Society for Nuclear Medicine and Molecular Imaging (SNMMI) regarding appropriate, limited coverage, only in specific populations."

It argues that with 5 million Americans living with Alzheimer's and more than 15 million people providing care, the need to accelerate improved care and an early and accurate diagnosis today, when scientifically supported, is critical. It adds that "the timeframe at which CMS has conducted CED processes is wholly unsuited and unacceptable to both the pace of scientific and technological innovation in the Alzheimer's field, and more importantly, the rapidly increasing needs posed by the escalating Alzheimer's epidemic.

"If the federal government follows this example and timeline, it will hinder coverage of a badly needed, already FDA approved diagnostic tool in limited populations in which sufficient evidence indicates this technology has meaningful impact," the statement adds.

It notes that a joint Alzheimer's Association/SNMMI task force has formulated scientifically driven appropriate-use criteria for amyloid PET imaging as follows:

  • Those who report persistent or progressive unexplained memory problems or confusion and who demonstrate impairments on standard tests of cognition and memory, who the dementia expert has concluded would benefit from greater certainty of the underlying pathology, and whose clinical management would change as a result of this greater certainty.

  • Individuals meeting test criteria for possible Alzheimer's but who are unusual in their clinical presentation.

  • Individuals with progressive dementia and atypically early age of onset (before age 65).

The Association says it will continue to engage the scientific and healthcare communities in order to educate CMS about the benefits of coverage for brain amyloid imaging in these limited populations as CMS develops a final decision.

Lilly added, "CMS appears to be challenging the value of an adjunctive tool that can assist physicians in making a more informed diagnosis for patients with cognitive impairment. Restricting coverage 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."

The Alternative View

But not all Alzheimer's experts agree with this view. Two who appear to be siding with the CMS are Joe Verghese, MBBS, MS, Albert Einstein College of Medicine, New York, and Malaz Boustani, MD, Indiana University Center for Aging Research, both of whom pointed out that the amyloid story is not straightforward.

"Amyloid imaging, while promising, requires further study to establish its ability to predict conversion to Alzheimer's disease. Quite a few older adults have amyloid deposits in their brain without manifesting cognitive symptoms or converting to dementia," Dr. Verghese told Medscape Medical News.

 
It is a great hypothesis but it has not been validated. Dr. Malaz Boustani
 

Dr. Boustani added: "It is a great hypothesis but it has not been validated. While it might be involved in Alzheimer's, it is certainly not the whole story."

"CMS has to look at the entire resources available and decide if there is true value to our Medicare beneficiaries of covering the cost of this test. But it has not been studied properly in the real world and the potential for unintended consequences is high," Dr. Boustani elaborated.

He asserts that amyloid scanning has been studied mostly at academic tertiary centers, which has introduced selection bias. "The studies have involved the purest cases, but very rarely do you see such patients. Most patents with dementia have lots of comorbidities."

Dr. Boustani argues further that a test should not be done unless it will lead to an intervention that can improve health outcomes, and this has not been established for the amyloid scan.

"We don't practice medicine to see if there is a pathology there or not. We need to know if we can change the patient's quality of life in the real world and we do not have data on that yet. I would not order a test unless the result would change my care and that is not the case with this test. I can diagnose Alzheimer's in more than 95% of cases without this test. Also, this is not a simple $5 test. It will put people under pressure to find the co-pay, and for uncertain benefit."

"So I believe CMS has made the right decision," he added. "They are saying 'Let's work together and get the information to demonstrate the value of these tests."

The CMS decision is currently in draft form and is subject to change before the final decision is expected in October. For now, there is a 30-day comment period in which interested parties can post their reactions to the decision.

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