Bottom Line: |
DOD is often the first P&T review following FDA approval and its meeting minutes are public - yet, a lot of manufacturers ignore or neglect the invitation to prioritize military members and dependants. All pharmaceutical manufacturers with newly approved drug agents should prioritize participation in the DOD P&T solicitation as part of its product launch strategy, even if a negative reply is communicated to this important customer. |
Each quarter, the Defense Health Agency (DHA) within the Department of Defense (DOD) posts a list of pharmaceutical products the DOD Pharmacy & Therapeutics (P&T) Committee intends to include as part of a class review, utilization management review, or newly approved drug agent review. This Committee plays a pivotal role in shaping access to pharmaceutical products for active military personnel and their families. The DOD P&T process directly impacts the availability of medications through TRICARE in both the Military Health System (MHS) and commercial community retail locations.
For newly approve drug agents, a pharmaceutical manufacturer can expect to be included in the scheduled DOD P&T Committee meeting immediately after the product receives FDA approval – regardless of the manufacturer’s formal commercial launch date. The meeting will determine the product’s tier placement within the TRICARE Uniform Formulary (UF), which will subsequently apply to all TRICARE beneficiaries.
The DHA posts a solicitation to both the Committee’s website as well as the Governmentwide Point of Entry (GPE), SAM.gov. While the DOD P&T Committee makes its own independent, clinically-based recommendations on product formulary status based on its own research, it also allows pharmaceutical manufacturers to respond to the publicly posted solicitation. This solicitation requests technical information on clinical effectiveness and safety. It also includes a process to submit discounts specific to the DOD health care system as well as discounts specific to TRICARE retail agreements. This is the only opportunity for the pharmaceutical manufacturer to have a direct voice with the DOD P&T Committee and advocate for the product. Worth noting, there is no subsequent negotiation and this solicitation is the singular opportunity for which the outcome remains in effect unless the product is part of a class review or utilization management review.
A pharmaceutical manufacturer is not required to submit a proposal under the DOD P&T solicitation; however, proactive participation generally reflects well on both the product and the pharmaceutical manufacturer. A proper and thorough response illuminates how the product aligns with military health priorities and demonstrates a commitment to the health of TRICARE beneficiaries. In particular, responding to the solicitation is a strategic imperative as inclusion and positioning on the TRICARE UF can expand (or limit) access within this large patient population for a meaningful period of time.