Medicare’s Final Coverage Decision On Alzheimer’s Drugs: Thoughts From A Former CMS Chief

Mark McClellan discusses whether CMS’s pending final version of the Medicare national coverage determination on Alzheimer’s drugs might change from the draft and whether the decision should be viewed as a precedent for drugs granted accelerated approvals.

National Medicare Coverage Policy Coming In April • Source: Alamy

In its upcoming final national coverage determination, the Centers for Medicare and Medicaid Services seems unlikely to withdraw its decision that Medicare will only cover amyloid-directed monoclonal antibody drugs for Alzheimer’s disease in the context of a randomized clinical trial, former CMS administrator Mark McClellan suggests.

A draft version of the national coverage determination on the drug class was released on 11 January, triggering concerns that...

More from Medicare

33 States Agree To Standardized Access Policies In Medicaid Sickle Cell Payment Demo

 

States also agreed to fund patient travel to specialized treatment centers as part of their participation in the Medicaid demo of CMS-negotiated outcomes-based contracts for Vertex/CRISPR's Casgevy and bluebird bio's Lyfgenia.

Part B Negotiation Proposal Would Lower Prices In MA, Private Plans Too, Stakeholders Complain

 
• By 

The issue is attracting more attention as the 2028 deadline for implementing Medicare negotiated prices for Part B drugs approaches.

Medicaid Changes Could Have Major Impact on Recent Coverage Improvements

 
• By 

Insurance trade groups warned that the Big Beautiful Bill destabilize Medicaid and result in the largest ever roll-back in health care coverage in the US.

Kennedy Appears Ill-Informed On Major Pharma Priorities, Creating Unique Lobbying Dynamics

 

The Health and Human Services Secretary made incorrect statements about the status of key industry priorities at a recent House hearing, which actually may be a good thing for drug sponsors.

More from Government Payers

England’s NHS Plan Eyes Cancer Vaccine Boost, Single Formulary & ‘Pay For Impact’ Drug Deal

 

The creation of a single national formulary for medicines prescribing that could impact industry is among the action points in the UK government’s new 10-year health plan for the National Health Service in England.

Kennedy Appears Ill-Informed On Major Pharma Priorities, Creating Unique Lobbying Dynamics

 

The Health and Human Services Secretary made incorrect statements about the status of key industry priorities at a recent House hearing, which actually may be a good thing for drug sponsors.

US Budget Bill Eases IRA Price Controls But Coverage Losses Will Impact Pharma

 
• By 

The legislation expected to be signed by President Trump is a mixed bag for pharmaceutical manufacturers depending on their product mix and manufacturing situation.