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Amyvid backers respond to MEDCAC meeting

by Loren Bonner , DOTmed News Online Editor
Despite a lack of support from an advisory panel, backers of the PET amyloid imaging drug Amyvid are urging the Centers for Medicare and Medicaid Services to evaluate the evidence and provide coverage for the U.S. Food and Drug Administration-approved indication.

On Wednesday, the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC ) — a panel that has the ability to influence Medicare coverage decisions — heard testimony from several experts about how Amyvid was able to increase physician confidence in diagnosing Alzheimer's disease and change the management of patients experiencing cognitive impairment. However, the MEDCAC panel was not convinced that there was enough evidence to determine whether the drug could change health outcomes for Medicare beneficiaries.

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While disappointed, backers of the drug remain steadfast in their belief that the Eli Lilly & Co. drug, which received FDA approval last spring, provides significant value to clinicians and patients.

"We encourage CMS to weigh the totality of evidence and make a positive coverage decision," Wei-Li Shao, senior director of Alzheimer's Business at Lilly, told DOTmed News.

In a statement from the Medical Imaging & Technology Alliance (MITA), the OEM lobby encouraged CMS to consider diagnostic endpoints — not therapeutic ones — as the basis for its coverage decision, which is expected to be drafted in July.

"Thanks to PET imaging procedures, diseases that once eluded the medical community can now be better understood and detected earlier than ever before, which gives us hope of eventually finding an effective treatment," said Gail Rodriguez, executive director of MITA.

The Society of Nuclear Medicine and Molecular Imaging (SNMMI) said in a statement that they believe the evidence, together with FDA approval, "supports the ability of beta-amyloid imaging to change patient management, leading to better outcomes for patients."

SNMMI and the Alzheimer's Association co-released appropriate use criteria for brain amyloid imaging earlier this week, which CMS might consider in their decision since many of the criteria address some of the concerns from the MEDCAC panelists.


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