CMS proposed more required trials before approval for Alzheimer's imaging agents like Amyvid. Medicare may cover only one beta-amyloid PET scan for certain patients.
CMS delivered a blow to Eli Lilly and Company and the Alzheimer’s disease community last week when it issued its draft decision to require additional trials of imaging agents like Amyvid to address what it sees as evidentiary gaps, before approving Medicare coverage. In the interim, CMS proposes allowing one beta-amyloid PET scan per patient, for those enrolled in specific CMS-approved clinical studies.
Amyvid (florbetapir F-18), developed by Avid Radiopharmaceuticals (a wholly owned subsidiary of Lilly), is an injection used with PET imaging for adults being evaluated for Alzheimer’s disease and other causes of cognitive impairment, to look for high levels of amyloid plaques. Observing no plaques helps rule out Alzheimer’s disease, while the presence of amyloid plaques provides evidence consistent with the disease. CMS acknowledged in its draft decision that there’s sufficient evidence that beta-amyloid PET imaging can rule out Alzheimer’s disease in some cases.
CMS’s coverage with evidence development (CED) ruling was one that Lilly disagreed with.
“A decision by CMS to implement a decision with CED would not only be disappointing, but discouraging to the Alzheimer’s disease community,” Wei-Li Shao, senior director of Lilly’s Alzheimer’s Business Division, said during a conference call in May. “We believe that a CED decision would not be the right decision for the patients and should not be applied in this case especially when the FDA has expressly evaluated and endorsed this for this specific population.”
Amyvid received FDA clearance in April 2012 and was approved by the European Commission in January 2013.
Shao said that additional trials could take years, negatively impacting patients by blocking their access to Amyvid’s diagnostic ability that could influence their diagnosis and treatment. He also said that a CED decision would be a disincentive to fostering medical innovation and further investment. “To foster future innovation, you need a predictable pathway to coverage,” he said.
Alzheimer’s disease continues to be one of the most significant health challenges in the United States, with approximately one in nine Americans over age 65 suffering from the disease, said Shao. However, one in five diagnosed with probable Alzheimer’s disease doesn’t have the pathology, which can only be verified on autopsy. “A good diagnosis is the cornerstone for a good treatment plan,” he said during the call, adding that those who are incorrectly diagnosed with Alzheimer’s disease spend their lives planning for a disease they don’t have. Shao said that Amyvid is the first tool to allow evidence of amyloid plaque, the defining characteristic of Alzheimer’s disease, to be seen in living patients.
Industry organizations also expressed their displeasure at the draft ruling. The Society of Nuclear Medicine and Molecular Imaging and the Alzheimer’s Association jointly developed Appropriate Use Criteria for specific indications and populations who can benefit from beta-amyloid PET imaging.
“SNMMI believes that sufficient evidence exists to support immediate coverage, which would change patient management, leading to better health outcomes for patients and assisting families making care decisions,” according to an SNMMI statement released this week.
The Medical Imaging and Technology Alliance also expressed disappointment in the ruling. “We believe the Appropriate Use Criteria, and the clinical evidence used to support them, are sufficient,” Gail Rodriguez, executive director of MITA, said in a statement this week.
The draft decision is open to public comments for 30 days, and CMS will issue a final decision, likely in October.