Lilly Disappointed in Draft Medicare Coverage Decision for Beta-Amyloid Imaging Agents

Continued insufficient Medicare coverage would be a significant setback for patients and the Alzheimer's Disease community

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Eli Lilly and Company

Jul 03, 2013, 11:21 ET

INDIANAPOLIS, July 3, 2013 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that the Centers for Medicare & Medicaid Services (CMS) has issued a draft decision proposing Coverage with Evidence Development for the use of beta-amyloid positron emission tomography (PET) imaging agents. Beta-amyloid imaging agents are used to evaluate patients with cognitive impairment for Alzheimer's Disease and other causes of cognitive decline.¹

An Amyvid™ (Florbetapir F 18 Injection) beta-amyloid scan is for use in adults with thinking or memory problems who are being assessed for Alzheimer's Disease or other causes of these symptoms. Amyvid is used by doctors in combination with other tests. A positive Amyvid scan does not diagnose Alzheimer's Disease or other thinking or memory disorders. Amyvid is not approved to predict the development of dementia or other brain conditions in the future or for monitoring the effectiveness of treatments. Amyvid for intravenous use is supplied in 10 mL, 30 mL, or 50 mL multidose vials containing 500-1900 MBq/mL Florbetapir F 18^.2

"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. 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," said Daniel Skovronsky, M.D., Ph.D., president and CEO, Avid Radiopharmaceuticals, Inc., a wholly owned subsidiary of Eli Lilly and Company, and vice president, Tailored Therapeutics at Eli Lilly and Company. "In addition, it may stifle future innovation aimed at improving diagnosis."

A decision for Coverage with Evidence Development proposes that there are still evidentiary gaps necessary to reconcile prior to reevaluating coverage. CMS would require additional trial(s) to address these gaps, and only those patients taking part in the trials would be eligible for coverage.³ Once those studies are complete, CMS can conduct another national analysis and render a decision on coverage.

"Lilly remains steadfast in our request for Medicare coverage of beta-amyloid imaging agents for the appropriate patient population without Coverage with Evidence Development, as recommended by the Alzheimer's Association and the Society of Nuclear Medicine and Molecular Imaging," said Wei-Li Shao, senior director, Alzheimer's Business Division, Eli Lilly and Company.

A task force of experts organized by the Alzheimer's Association and the Society of Nuclear Medicine and Molecular Imaging has developed the Appropriate Use Criteria, which outline the appropriate and inappropriate use of amyloid PET imaging.⁴

The decision is currently in draft form and is subject to change before the final decision is expected in October. For now, there is a 30-day comment period in which interested parties can post their reactions to the decision at http://www.cms.gov/medicare-coverage-database/indexes/nca-open-and-closed-index.aspx.

Alzheimer's Disease is one of many possible causes of cognitive impairment, which can make diagnosis challenging.^5,6 In fact, it is estimated that up to one in five patients clinically diagnosed with probable Alzheimer's Disease during life do not exhibit Alzheimer's Disease pathology upon autopsy.^7,8 If determined through clinical assessment and scan results that Alzheimer's Disease is not the cause of a patient's cognitive impairment, their physician can avoid or discontinue unnecessary or potentially harmful treatments and investigate other possible causes.^9,10,11

About Amyvid²Amyvid is an FDA-approved radioactive diagnostic agent that is injected into the bloodstream, where it crosses the blood-brain barrier and selectively binds to amyloid plaques. The fluorine 18 (F 18) isotope produces a positron signal, which is detected by a PET scanner. Physicians who read Amyvid PET scans should complete a comprehensive training program available through live events or online at AmyvidTraining.com.

For more information about Amyvid, please see the Full Prescribing Information at http://pi.lilly.com/us/amyvid-uspi.pdf.

INDICATIONS AND USAGE:²Amyvid is approved for use in adults with thinking or memory problems who are being assessed for Alzheimer's Disease (AD) or other causes of these symptoms. Amyvid is used by doctors in combination with other tests.

Amyvid is used with a positron emission tomography (PET) scanner to show whether high levels of plaques, which are a buildup of a protein called beta-amyloid, are in the brain.

A negative Amyvid scan means that there are few to no plaques in the brain and makes it unlikely that AD is the cause of symptoms at the time of the scan.

A positive Amyvid scan means that the amount of plaque in the brain is similar to the amount seen in people with AD. This amount of plaque may also be seen in people with other conditions of the brain that cause thinking or memory problems, as well as in older people with normal thinking and memory.

A positive Amyvid scan does not diagnose AD or other thinking or memory disorders. Amyvid is not approved to predict the development of dementia or other brain conditions in the future or for monitoring the effectiveness of treatments.

IMPORTANT SAFETY INFORMATION:²What is the most important information I should know about Amyvid?

Risk for Misreading Scans and Other Errors
- Errors may happen when Amyvid scan images are read. In clinical studies, a scan read as negative, when it was actually positive, accounted for most of these errors. An Amyvid scan only indicates whether beta-amyloid plaques, which are a buildup of proteins in the brain, are present at the time of the scan. Even if the scan is negative, it is possible to develop plaques in the future
Radiation Risk
- Amyvid, like other radioactive diagnostic agents, adds to overall, long-term combined radiation exposure. Long-term combined radiation exposure may increase risk of cancer

IMPORTANT SAFETY INFORMATION:
What are the most common side effects of Amyvid?

Headache
Muscle or joint pain
Tiredness
Nausea

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/safety/medwatch or call 1-800-FDA-1088.

What should I tell my doctor before taking Amyvid?

Tell your doctor if you are pregnant or breast-feeding
Tell your doctor about any prescription or over-the-counter medicines you are taking

Amyvid is available by prescription only.

See Prescribing Information.

AM CON ISI 28MAR2013

About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers—through medicines and information—for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.com. P-LLY

This press release contains certain forward-looking statements about Amyvid™ (Florbetapir F 18 Injection), a radioactive diagnostic agent indicated for brain imaging of beta-amyloid plaques in patients with cognitive impairment who are being evaluated for Alzheimer's Disease and other causes of cognitive decline. This release reflects Lilly's current beliefs; however, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. There is no guarantee that future study results and patient experience will be consistent with study findings to date or that Amyvid will prove to be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's filings with the United States Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.

¹Centers for Medicare & Medicaid Services. Proposed decision memo for beta amyloid positron emission tomography in dementia and neurodegenerative disease (CAG-00431N). http://www.cms.gov/medicare-coverage-database/details/nca-proposed-decision-memo.aspx?NCAId=265&NcaName=Beta+Amyloid+Positron+Emission+Tomography+in+Dementia+and+Neurodegenerative+Disease&CoverageSelection=National&KeyWord=beta-amyloid&KeyWordLookUp=Title&KeyWordSearchType=And&bc=gAAAABAACAAAAA%3d%3d&. Published July 3, 2013. Accessed July 3, 2013.
² Amyvid™ (Florbetapir F 18 Injection) [package insert]. Indianapolis, IN: Lilly USA, LLC; 2012.
³ Centers for Medicare & Medicaid Services. Draft guidance for the public, industry, and CMS staff coverage with evidence development in the context of coverage decisions. http://www.cms.gov/medicare‐coverage‐database/details/medicare‐coveragedocument‐details.aspx?MCDId=23. Published November 29, 2012. Accessed June 17, 2013.
⁴ Johnson KA, Minoshima S, Bohnen NI, et al. Appropriate use criteria for amyloid PET: a report of the Amyloid Imaging Task Force, the Society of Nuclear Medicine and Molecular Imaging, and the Alzheimer's Association [published online ahead of print January 28, 2013]. Alzheimers Dement. doi:10.1016/j.jalz.2013.01.002.
⁵ Balasa M, Gelpi E, Antonell A, et al; for the Neurological Tissue Bank/University of Barcelona/Hospital Clínic NTB/UB/HC Collaborative Group. Clinical features and APOE genotype of pathologically proven early-onset Alzheimer disease. Neurology. 2011;76(20):1720–1725.
⁶ Alzheimer's Association. 2012 Alzheimer's disease facts and figures. Alzheimers Dement. 2012;8(2):131–168.
⁷ Lim A, Tsuang D, Kukull W, et al. Clinico-neuropathological correlation of Alzheimer's disease in a community-based case series. J Am Geriatr Soc. 1999;47(5):564–569.
⁸ Petrovitch H, White LR, Ross GW, et al. Accuracy of clinical criteria for AD in the Honolulu-Asia Aging Study, a population-based study. Neurology. 2001;57(2):226–234.
⁹ Alzheimer's Association. 2011 Alzheimer's disease facts and figures. Alzheimers Dement. 2011;7(2):208–244.
¹⁰ Boise L, Neal MB, Kaye J. Dementia assessment in primary care: results from a study in three managed care systems. J Gerontol A Biol Sci Med Sci. 2004;59(6):621–626.
¹¹ Mendez MF, Shapira JS, McMurtray A, et al. Preliminary findings: behavioral worsening on donepezil in patients with frontotemporal dementia. Am J Geriatr Psychiatry. 2007;15(1):84–87.