Strategic Imperative: Responding to the DoD P&T Solicitation for Newly Approved Drug Agents

Bottom Line:

The Department of Defense (DoD) is frequently the first federal payer to formally assess newly FDA-approved pharmaceutical agents through its Pharmacy & Therapeutics (P&T) Committee process. These deliberations are public and directly shape coverage decisions for over 9.6 million TRICARE beneficiaries. Pharmaceutical manufacturers must treat the DoD P&T solicitation as a critical early milestone in their product launch strategy—even if only to respond with a negative reply.

Why This Matters: DoD as a Frontline Formulary Decision-Maker

Each quarter, the Defense Health Agency (DHA) posts a publicly accessible list of drugs scheduled for review by the DoD P&T Committee, which advises on clinical effectiveness, safety, and formulary positioning. These reviews include:

●      Class reviews

●      Utilization management updates

●      Reviews of newly approved agents

Key Impact: Formulary placement decisions apply system-wide across the TRICARE Uniform Formulary (UF)—influencing drug access through:

●      Military Treatment Facilities (MTFs)

●      Mail-order pharmacy programs

●      TRICARE retail network pharmacies

Timeline: Rapid Review Post-FDA Approval

The DoD P&T Committee automatically schedules newly approved drug agents for review, regardless of commercial launch timing. Within weeks of FDA approval:

●      The drug appears in the quarterly solicitation

●      The manufacturer has one window to respond—there is no second round

The outcome of this process determines the drug’s formulary status and tier placement, which will persist unless later included in a broader therapeutic class review.

Manufacturer’s Opportunity: A Single, Strategic Shot

What’s Included in the Solicitation:

●      Request for clinical evidence and supporting safety data

●      Opportunity to submit price proposals and discounts for:

○      The DoD direct care system (MTFs)

○      TRICARE retail pharmacy agreements

Why It Matters:

●      This is the only direct opportunity to influence the Committee before a decision

●      There is no post-decision negotiation

Failing to respond sends a signal of indifference and forfeits control over a key formulary outcome.

Strategic Value of Responding—even with a Negative Reply

Even when a manufacturer is not ready to promote the product or make pricing commitments, a response is better than silence. A formal reply:

●      Demonstrates commitment to military health

●      Establishes early credibility with DoD decision-makers

●      Ensures your clinical voice is part of the evaluation

Strategic Consequence: TRICARE access can make or break early market uptake, especially in areas like oncology, mental health, and rare diseases where DoD access frequently influences follow-on decisions by VA and commercial payers.

Final Word

For any newly approved drug, proactively responding to the DoD P&T Committee’s solicitation is not optional—it is a strategic imperative. This early step opens the door to a high-impact federal customer and sets the stage for broader federal and commercial success.