Dear Dr. Roche and Ms. Kaplan:
USAgainstAlzheimer's, the national mobilization network committed to stopping Alzheimer's disease by 2020, encourages the Centers for Medicare & Medicaid Services (CMS) to remove the blanket national non-coverage policy for new Food and Drug Administration (FDA) approved PET radiopharmaceuticals (Section. 220.6 of the NCD). At the same time, USAgainstAlzheimer's urges that coverage decisions made at either the national or local levels carefully consider the full body of evidence to ensure access to reasonable and necessary care for beneficiaries while guarding against inappropriate and unnecessary testing.
The field of Alzheimer's disease exemplifies the need for a more discriminating CMS approach to PET technologies, one that does not begin with a presumption of non-coverage of any new FDA-approved PET radiopharmaceuticals. It is increasingly clear that preventing and treating Alzheimer's disease will require treatments that identify at-risk patient populations in the presymptomatic or mildly symptomatic but pre-dementia stages of the disease. Effective PET and other advanced diagnostic tools are essential to identifying targeted patients and measuring the impact of a therapy during these early stages of the disease course. Last year, the National Institute on Aging (NIA) and the Alzheimer's Association issued updated criteria and guidelines for diagnosing Alzheimer's disease, the first updated guidance on this topic in nearly 30 years. The use of functional imaging modalities, including PET scans, is an important element in the use of these new guidelines.
Earlier this year, the FDA approved Eli Lilly and Company's radiopharmaceutical Amyvid™ to detect beta-amyloid plaque levels in patients being evaluated for Alzheimer's disease. While Amyvid™ alone is not intended as a diagnostic tool for Alzheimer's, it provides patients, their families, and their physicians with information that is useful in developing differential diagnoses and informing treatment and therapies. The current blanket non-coverage policy on all new PET radiopharmaceuticals, however, effectively prevents any Medicare patient presenting signs of cognitive impairment from having access to this diagnostic tool without consideration of its clinical value in light of the available evidence.
In addition to the current comment request, USAgainstAlzeheimer's is aware of a request made by Lilly focused narrowly and specifically on beta-amyloid imaging. Given the recent FDA approval and subsequent availability of Amyvid™ and the recently adopted National Plan to Address Alzheimer's Disease that establishes as a national goal the prevention and effective treatment of the disease by 2025, now is a critical time for CMS to revisit the issue and consider the body of available evidence demonstrating the value of such an approach.
On behalf of the more than 5 million Americans currently suffering from Alzheimer's and the tens of millions more who stand to develop this disease in the coming years, we respectfully urge the agency to remove the blanket national non-coverage policy on all new PET radiopharmaceuticals and to revisit the beta-amyloid coverage request specifically as quickly as possible.