CMS’s Final Ruling on Amyvid: Limited Coverage

CMS dealt the final blow to Eli Lilly’s Amyvid drug, denying most coverage of the drug for Medicare beneficiaries, until additional studies prove benefits. CMS determined that there was insufficient evidence of benefit in using the florbetapir F-18 injection in PET imaging to diagnose or treat dementia or neurodegenerative disease. As in the draft decision, CMS agreed to coverage with evidence development, outlining the limited circumstances in which it will cover an Amyvid PET scan and what trials need to address for future coverage consideration.

Amyvid (florbetapir F-18) was developed by Avid Radiopharmaceuticals (a wholly owned subsidiary of Eli Lilly) and is an injection used with PET imaging, looking for high levels of amyloid plaque in adults undergoing evaluation for Alzheimer’s disease (AD) and other causes of cognitive impairment. Observing no or few plaques helps rule out AD, while plaque presence provides evidence consistent with the disease. CMS acknowledged in its draft decision that there’s sufficient evidence that amyloid-beta (Aβ) PET imaging can rule out the disease in some cases.

In its decision, CMS confirmed details from the draft decision released in July that CMS will allow one Aβ PET scan per patient in two situations. The first is to exclude an Alzheimer’s disease diagnosis in specific scenarios, such as excluding “Alzheimer’s disease in narrowly defined and clinically difficult differential diagnoses, such as AD versus frontotemporal dementia.”

The second option for coverage is in CMS-approved clinical trials with goals to develop better AD treatment or prevention strategies or to identify subpopulations at risk for AD.

Amyvid received FDA clearance in April 2012 and was approved by the European Commission in January 2013.

Prior to the draft coverage decision, Wei-Li Shao, senior director of Eli Lilly’s Alzheimer’s Business Division said in a conference call that clinical trials could take years, blocking patient access to Amyvid’s diagnostic ability and negatively influencing patient diagnosis and treatment.

More than 5 million Americans have AD, though half are undiagnosed, according to the Alzheimer’s Association. Early diagnosis is thought to lead to better outcomes and better quality of life for both the patient and the family.

In a statement released this week, Eli Lilly said that the final decision was contrary to expert opinion and the appropriate use criteria. They also said it contradicts CMS’s statutory authority over coverage determination for diagnostics.

“Coverage with evidence development, as proposed by CMS, does not provide patients with appropriate access to these amyloid imaging brain scans. Instead it creates additional complexity for the broader community in determining the best path forward for patients,” said Eric Dozier, senior director of Eli Lilly’s Alzheimer’s Business Division. 

The Alzheimer’s Association also expressed disappointment in the ruling.

“When used in specific populations, as outlined in criteria developed by the Alzheimer’s Association and the Society for Nuclear Medicine and Molecular Imaging (SNMMI), this tool has the potential to help identify amyloid in the brain, a hallmark of Alzheimer’s disease, and resolve distressing medical uncertainty.

Eli Lilly said in its statement that it would evaluate all options to ensure Amyvid was available for patients and physicians as soon as possible.