CMS releases amyloid PET draft decision
The Centers for Medicare & Medicaid Services (CMS) has released its draft decision for coverage of amyloid PET imaging for the evaluation of dementia and neurodegenerative diseases, including Alzheimer’s. CMS is proposing coverage with evidence development (CED) as of the July 3 memo, which allows one scan to rule out Alzheimer’s pathology in the brain for patients in eligible clinical trials and it would require clinicians to provide detailed data about amyloid PET imaging to gather a body of evidence to make the case for reimbursement of procedures in this category.
CMS cited insufficient evidence that amyloid PET would likely improve patient outcomes as the primary motivation for the proposed decision. Such improvements imply the “avoidance of futile treatment or tests,” the amelioration of patients’ quality of life, or the slowing of its decline, and improved survival.
If CED were announced, CMS could make a national coverage analysis compulsory before another decision could be possible. The draft decision limited coverage of amyloid PET imaging to only those situations where Alzheimer’s disease was excluded in complex cases of differential diagnoses. An example would be to determine the pathology of disease involved in a patient’s cognitive decline, whether due to Alzheimer’s, frontotemporal dementia or other neurodegenerative diseases. CMS announced that the decision sought to “enrich clinical trials seeking better treatments or prevention strategies for Alzheimer’s disease by allowing for selection of patients on the basis of biological as well as clinical and epidemiological factors” and to address conflicting views on amyloid PET imaging.
The Society of Nuclear Medicine and Molecular Imaging (SNMMI) released a statement July 8 expressing disappointment in the potential verdict, countering that an extensive body of research has been developed to warrant more extensive coverage without the need for further data collection or conditional reimbursement. SNMMI presented FDA approval and the joint development of appropriate use criteria for amyloid scanning as evidence of amyloid imaging’s benefit.
On July 5, the Alzheimer’s Association released a position statement about the expected coverage decision echoing the disappointment of SNMMI and relating that “given the clear, scientific consensus recommendations provided to CMS” regarding appropriate and limited coverage in specific populations, there should be no need for CED status especially considering the “acute” need of the 5 million people currently living with Alzheimer’s disease in the U.S.
The CMS draft decision references a number of amyloid imaging agents, including Florbetapir, Florbetaben, Flutemetamol, FDDNP, AZD4694 (also known as NAV4694), C-11 PiB and F-18 FDG.
Eli Lilly, makers of the Amyvid radiotracer, also known as Florbetapir, put out a statement July 3 expressing that the tentative decision underestimates current data about the efficacy and utility of Amyvid and other agents used to evaluate patients with cognitive decline.
"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,” said Daniel Skovronsky, MD, PhD, president and CEO of Avid Radiopharmaceuticals, a subsidiary of Eli Lilly in the release. “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. In addition, it may stifle future innovation aimed at improving diagnosis."
The draft decision is subject to change from now until the final decision scheduled to be announced in October. CMS has opened a 30-day period of public comment for those who wish to post their response to the proposed level of coverage for amyloid PET in preparation for the upcoming national coverage decision.
To read the entire memo or post a comment, click here.