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Medicare Coverage For Amyvid Complicated By PET Policy; Lilly Seeks Revision

 
• By Cathy Kelly

Under CMS’ current policy for PET scans, new imaging agents approved by FDA would have to go through a national coverage analysis before Medicare will pay for them.

Eli Lilly & Co. is pushing the Centers for Medicare and Medicaid Services to revise their Medicare national coverage policy for positron emission tomography (PET) scans to remove an obstacle to reimbursement for new imaging agents. If it is not changed, the policy could hamper future Medicare coverage for the company’s radiopharmaceutical Amyvid (florbetapir F 18 injection).

Currently under review at FDA, Amyvid is designed to find beta-amyloid in the brain by binding to amyloid plaques so they will show up on a PET scan. A negative florbetapir-PET scan is clinically useful in ruling out significant levels of beta-amyloid and also can help clinicians rule out Alzheimer’s disease

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More from United States

Medicare Negotiation Does Not Violate Due Process, Appeals Court Rules, Other Suits At Risk

 
• By Cathy Kelly

Decision in AstraZeneca’s lawsuit against the Health and Human Services Department is a precedent-setting victory for the government and a blow to manufacturer efforts to block the price negotiation program.

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• By Bridget Silverman

Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow.

Pink Sheet Podcast: A New Director For US FDA’s Biologics Center, Guidance Production Slowdowns

 
• By Derrick Gingery, Sue Sutter, and Nielsen Hobbs

Pink Sheet editors discuss the appointment of Vinay Prasad as the new director of the Center for Biologics Evaluation and Research and revelations that FDA layoffs now are hindering development of guidance documents.

US FDA Restoring Some Library Resources

 
• By Sue Sutter and Derrick Gingery

Agency staff once again have access to the Lexis-Nexis legal and news database, but are still waiting for access to journals, and laid off librarians have not been reinstated.

More from North America

Recent and Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

Most Favored Nation Pricing Policy Floated In Medicaid, Coming Back To Medicare?

 
• By Cathy Kelly

President Trump's ongoing interest in the policy, which would ensure the US government pays no more for prescription drugs than the lowest price available in comparable countries, continues to gain attention.

US FDA Advisory Committee Misperceptions Abound … At HHS

 
• By Michael McCaughan

HHS Secretary Robert F. Kennedy Jr. regularly decries the “conflicts of interest” he believes abound in advisory committees, but his concerns, as well as a recent “policy directive” eliminating industry representatives, seem driven by a misunderstanding of the panels’ jobs.