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Medicare Aduhelm Coverage Policy Overrules FDA: Can Two Wrongs Make A Right?

 
• By Michael McCaughan

Plenty of people believe the US FDA should never have approved Biogen/Eisai’s Alzheimer’s therapy. But does that really mean it is okay for the Medicare agency to decide as a matter of policy that the drug has not been proven safe and effective?

Alzheimer's disease on MRI
The draft NCD from CMS had a very different reading of the data than FDA. • Source: Shutterstock

The Washington Post’s January 12 front-pageheadline on the US Centers for Medicare & Medicaid Services’ proposed policy on the beta amyloid antibody Audhelm was, to put it mildly, misleading: “Medicare plans to cover pricey Alzheimer’s drug.”

In fact (as the article itself makes very clear), Medicare is doing nothing of the kind: the Biogen, Inc./Eisai Co., Ltd. Alzheimer’s treatment will be “covered” only in...

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GLP-1 Pricing ‘Paradigm Shift’ Possible, But Would It Meet Trump’s MFN Goals?

 
• By Cathy Kelly

For the Trump Administration, the blockbuster GLP-1 drugs for obesity have become a poster child for the disparity between US and foreign prices.

Rocky Rollout Spells Trouble for Medicare Prescription Payment Plan

 
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Enrollment in the new Medicare Prescription Payment Plan was lower than expected in the first year and well below CMS expectations, and invoicing data indicates members are slow to pay.

Will International Prices Influence Medicare Price Negotiation?

 
• By Cathy Kelly

A former CMS official suggested the most likely way it could happen is through a Center for Medicare and Medicaid Innovation demonstration.

Industry Leaders Grapple With Trump’s Most Favored Nation Pricing Plan

 
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More from Government Payers

HHS Negotiating With Manufacturers On Most Favored Nation Drug Pricing

 
• By Cathy Kelly

MFN policy would would apply to all single source drugs in all insurance markets, according to HHS release. Secretary Robert F. Kennedy Jr. said the department is discussing the plan with drug sponsors.

Will International Prices Influence Medicare Price Negotiation?

 
• By Cathy Kelly

A former CMS official suggested the most likely way it could happen is through a Center for Medicare and Medicaid Innovation demonstration.

Industry Leaders Grapple With Trump’s Most Favored Nation Pricing Plan

 
• By Jessica Merrill

At the Bank of America health care conference, pharma leaders speculated on the impact of Trump’s most favored nation pricing executive order on US and European markets.