CMS has agreed to consider a request from Eli Lilly & Co. to expand the number of positron emission tomography (PET) tracers that can be covered by Medicare to include agents that image beta-amyloid plaques to diagnose dementia and other neurodegenerative diseases.

Lilly’s Amyvid (florbetapir F18) was approved in April as the first clinically available PET agent for beta-amyloid imaging and launched in June at a cost of $1,600 per patient-ready dose Also see "Amyvid Approval Just The Start Of A Critical Year For Alzheimer’s" - Pink Sheet, 16 April, 2012..

Amyvid is currently not covered by Medicare. The program currently pays for only four radioisotopes for certain defined uses in PET, and some uses of PET with those agents are subject to coverage with evidence development policies while others are considered to be nationally “non covered.”

CMS opened a national coverage analysis (NCA) for PET agents used in imaging beta-amyloid plaques on Oct. 9. The NCA is in response to a June 29 letter from Lilly’s Daniel Skovronsky, global brand development leader; Wei-Li Shao, senior director, Alzheimer’s business unit; and Derek Asay, director government strategy, federal accounts and quality. The agency will accept comments on Lilly’s request until Nov. 8; it is scheduled to release a proposed decision memo on the issue July 9, 2013 and a final decision by Oct. 7, 2013.

In the letter, Lilly specifically requests Medicare coverage for PET scans with a beta-amyloid detecting agent as a “diagnostic test for the purpose of estimating beta-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease and other causes of cognitive decline.” Lilly also recommends that coverage be limited in a way that tracks current labeling for Amyvid, which states that a negative scan “reduces the likelihood that a patient’s cognitive impairment is due to Alzheimer’s disease” but that “a positive Amyvid scan does not establish a diagnosis of AD or other cognitive disorder.”

In support of its request, Lilly emphasizes the importance of correctly diagnosing neurodegenerative disease, noting that “false positive [Alzheimer’s] diagnoses may lead to unnecessary treatment, worsening of patient outcomes, and inefficient or inappropriate use of health care resources; all aspects of medical care CMS has expressed an interest in controlling.”

The company included results of an unpublished study indicating that physicians changed their initial clinical diagnoses 80% of the time or more after being presented with the results of an Amyvid PET scan. Lilly also noted that a clinical trial designed to test the potential for Amyvid PET to change a patient’s clinical diagnosis and management is under way in approximately 200 patients. Results “will likely be published during the course of the national coverage analysis,” the company said.

CMS opened a separate NCA in July to reconsider its coverage policy for all PET radiopharmaceuticals Also see "Medicare Coverage Of PET Pharmaceutical Agents Needs Revamp, Industry Says" - Pink Sheet, 20 August, 2012.. Lilly submitted comments to CMS in favor of that reconsideration request. CMS also recently announced that its Medicare Evidence Development and Coverage Advisory Committee will meet Jan. 30, 2013 to consider the use of beta-amyloid PET imaging for the management of dementia and neurodegenerative disease, with a focus on the clinical impact of the technology on health outcomes.

Medicare Coverage Decision For Amyvid Due July 2013

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