Alliance and Partners Urge USP to Include “Disease Modifying Therapies” Class in Medicare Model Guidelines
Published July 1, 2026
Yesterday, the Alliance for Aging Research and partner advocacy organizations submitted a comment letter to the United States Pharmacopeia’s (USP) in response to its draft Medicare Model Guidelines V.10.0 (the “MMG V.10.0”). The MMG are a USP–developed classification system for the Centers for Medicare & Medicaid Services (CMS), which groups Medicare Part D–covered prescription drugs into categories and classes to guide Part D formulary design.
The letter urges the USP to create a new class within the “Antidementia Agents” Category for “Disease Modifying Therapies” to distinguish FDA-approved treatment options that target the underlying disease from those approved for symptomatic treatment. These therapies are currently listed in a general, catch-all “Antidementia Agents, Other” class. In addition to the Alliance, the letter was signed by the LEAD Coalition (Leaders Engaged on Alzheimer’s Disease), the Partnership to Fight Chronic Disease, and Voices of Alzheimer’s.
Disease-modifying therapies (DMTs) for Alzheimer’s disease represent a monumental shift from merely managing symptoms to directly altering the disease’s underlying biology. These treatments—primarily monoclonal antibodies (mAbs)—target toxic amyloid-beta proteins in the brain to slow cognitive and functional decline.
The letter states:
“For MMG V.10.0, our organizations urge USP to create a new class within the ‘Antidementia Agents’ Category for ‘Disease Modifying Therapies’ (DMTs) to distinguish FDA-approved treatment options that target the underlying disease from those approved for symptomatic treatment. With a self-administered, subcutaneous option under Part D now available, the need for USP to distinguish DMTs from symptomatic treatments has only grown more critical. Although the USP-Drug Classification lists mAbs in a separate ‘Disease Modifying Therapies’ class, SC lecanemab is currently listed as a proposed addition to the ‘Antidementia Agents, Other’ class for the MMG V.10.0, inappropriately grouping it with symptomatic agents.”
The letter argues that Part D eligible DMTs will expand the landscape beyond the current, high-resource infrastructure requirements for IV treatment administration, and significantly improve treatment access in underserved communities. There are several DMTs in the pipeline for Alzheimer’s disease as well as related neurodegenerative disorders, including subcutaneous and oral formulations. These drugs may be available for patients well before 2031, which is when the MMG will be updated next. If the USP does not act now to establish this class for 2028, these drugs will be mistakenly grouped into the ‘Antidementia Agents, Other’ catch-all class with symptomatic therapies, which will be detrimental for patient access. Introducing this class now would send a clear signal to drug sponsors, clinicians, and insurers that USP recognizes and prioritizes the clinical distinctiveness of DMTs.
The final USP MMG v10.0 publication is anticipated to be released in September 2026.