Analysis

Restricting access to florbetapir: Medicare coverage criteria for diagnostics and drugs are inconsistent

BMJ 2015; 351 doi: https://doi.org/10.1136/bmj.h3333 (Published 03 July 2015) Cite this as: BMJ 2015;351:h3333
  1. Joshua P Cohen, research associate professor1,
  2. Jinghui Dong, research associate1,
  3. Christine Y Lu, instructor2,
  4. Ranjana Chakravarthy, research analyst1
  1. 1Tufts University, 75 Kneeland Street, Suite 1100, Boston, MA 02111, United States
  2. 2Harvard Medical School, Boston, MA 02215, United States
  1. Correspondence to: J P Cohen joshua.cohen{at}tufts.edu
  • Accepted 10 June 2015

Medicare’s decision to restrict coverage of florbetapir, a diagnostic agent for Alzheimer’s disease, exemplifies an inconsistent approach to technology evaluation. Joshua Cohen and colleagues call for consistency

Alzheimer’s disease is the most common cause of dementia, accounting for 60-80% of all cases in the United States.1 It is clinically diagnosed based on the presence of cognitive impairment that severely interferes with the activities of daily living. A pathological diagnosis is only possible after verification of the presence of amyloid β plaques in brain tissue. Misdiagnosis may lead to unnecessary treatment, worsening outcomes, and inefficient or inappropriate use of healthcare resources.

In April 2012 florbetapir 18F, marketed as Amyvid by Eli Lilly, became the first radioactive diagnostic agent to be approved by the Food and Drug Administration for positron emission tomography (PET) of the brain to evaluate amyloid β neuritic plaque density. Subsequently two similar PET agents, flutemetamol 18F (Vizamyl, GE Healthcare) and florbetaben 18F (Neuraceq, Piramel Imaging) were approved. The European Medicines Agency has also granted marketing authorization to all three agents. Although they are considered to be both drugs and diagnostics, their use is for diagnostic purposes only.

All three agents can rule out Alzheimer’s disease but cannot provide a positive diagnosis. The FDA and European Medicines Agency labels for florbetapir include two important caveats—that a positive scan does not definitively establish a diagnosis of Alzheimer’s disease and that the safety and effectiveness of florbetapir have not been established for predicting the onset of dementia.2

Florbetapir scans cost approximately $3000 (£1890; €2640) for those who don’t have insurance to cover the cost. Medicare coverage is statutorily limited to items and services that are considered “reasonable and necessary” for the diagnosis or treatment of an illness or injury.3 Diagnostics are covered under the same …

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