The USP Helps Shape Plan Formularies

The US Pharmacopeia Convention (USP) is a nonprofit organization that disseminates public compendial quality standards for medicines and maintains two drug classification systems: the Medicare Model Guidelines (MMG) for Part D plans and the Drug Classification (DC) for non-Part D plans.

Statute required Part D plan formularies to include at least two drugs per class. The Centers for Medicare and Medicaid Services (CMS) determines the categories and classes of clinical concern—commonly known as the six protected classes¹—and requires Part D plans to cover “all or substantially all drugs” within each class in their formularies.

Under a cooperative agreement with CMS, USP updates these drug categories and classes every three years in the MMG. These updates, made in consultation with manufacturers and other stakeholders, adjust for the market entrance of new Part D eligible drugs and for drugs with newly approved indications.

New Draft MMG v. 10.0 is Open for Comment

On June 1, USP released the draft MMG version 10.0 (v.10.0) for public comment. The finalized v.10.0 is expected in September.

To prepare this draft, USP reviewed existing drugs and new drugs approved since the last iteration of the classification system in 2023. The adjustments to categories and classes in the final MMG v.10.0 will be effective for plan years 2028 through 2030.²

The USP MMG v. 10.0 draft proposes the following changes:

New Classes:

• Cardiovascular Agents category added:
  • Cardiac Myosin Inhibitors class
  • Endothelin Receptor Antagonist class
  • Dyslipidemics, PCSK9 Inhibitors class
• Central Nervous System Agents category added:
  • Amyotrophic Lateral Sclerosis (ALS) Agents class
• Dermatological Agents category added:
  • Dermatological Agents, Other class
• Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers) category added:
  • Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers), Other class
• Inflammatory Bowel Disease Agents category changed:
  • Aminosalicylates to Aminosalicylates and/or Prodrugs class
• Otic Agents category added:
  • Otic Agents, Combinations class
• Respiratory Tract/Pulmonary Agents category added:
  • Interleukin-5 (IL-5) Antagonists class

Removed Classes:

• Category removed from Antivirals category:
  • Antiviral, Coronavirus Agents class were removed

Drugs Added, Moved, or Removed:

• 155 first-time drug/combination classifications
• 16 drug/combination removals
• Over 100 drug/combination classification changes (e.g., moves, additional classifications, salt form
  adjustments)

How to Engage and Considerations for Stakeholders

USP has not released its methodology for determining the above changes, so additional engagement may be required to assess reasoning behind these adjustments; to make arguments tied to mechanism of action, standard of care, or unmet need; and to inquire if certain drug exclusions were intentional.

USP has invited stakeholders, including life sciences companies, to engage and offer feedback on the proposed updates through June 30, 2026. Stakeholders have two opportunities to offer feedback (via modelguidelines@USP.org) on the proposed revisions:

• One-on-One Meetings with the USP: Stakeholders can email the USP to request a 30-minute meeting to review the USP’s proposed changes.
• Comment Submission: Stakeholders can submit comments to USP MMG mailbox

For both feedback formats, stakeholders should be prepared to offer evidence for their requested changes, understanding the benefits and tradeoffs.

Avalere Health can help life sciences companies and other stakeholders organize proactively in preparation for engagement with USP as well as contemplate other considerations based on the current policy environment.

For planning engagement with the USP MMG v. 10.0 draft, and to learn more about how Avalere Health can support you, connect with us.

1. The protected classes are anticonvulsants, antidepressants, antineoplastics, antipsychotics, antiretrovirals, and immunosuppressants.

2. Contracting delays disrupted the finalization of MMG v.9.0; MMG v.10.0 will be a return to the regular three-year cycle (2028-2030)