Bottom line: |
The Defense Health Agency (DHA) process of adding a drug, conducting a class review, or reevaluating access controls for the TRICARE Uniform Formulary is multi-layered, multi-month process - with key distinctions from the commercial segment. |
Product Identification. On a schedule of its own making, the DHA identifies drugs for class review or utilization management review. For newly approved drugs, any drug receiving FDA-approval during the previous quarter may be included in the upcoming meeting. Products included in a meeting’s agenda are listed on the DOD P&T Committee website.
Solicitation Issuance. A solicitation inviting manufactures to submit a proposal with both technical information and DOD-specific pricing is posted to SAM.gov with a link to that post also included on the DOD P&T Committee website. Although pharmaceutical manufacture submissions are voluntary, participation is highly recommended and can be critical to a product’s formulary placement.
Data Assessment. In advance of the meeting, the DHA Formulary Management Branch reviews each submission in detail. If a manufacturer did not choose to submit a proposal, then the DHA Formulary Management Branch will independently gather its own information. Supplementary information or data (i.e., clinical trial results, safety reports, cost-effectiveness analyses, etc.) may be requested from the manufacturer. Additionally, the team may also seek the perspective of other experts or advisors. Ultimately, the DHA Formulary Management Branch makes initial recommendations to the DOD P&T Committee.
Committee Discussion. The DOD P&T Committee gathers for a two-day, in-person meeting to discuss each product on the agenda for safety, efficacy, cost-effectiveness, and potential impact on the formulary. It documents its process, considerations, and votes for product placement on the TRICARE Uniform Formulary (which is the label for the DOD national formulary, regardless of care channel) that culminates into a final recommendation to include tier placement for each product reviewed. These recommendations are then sent to the DHA Uniform Formulary Beneficiary Advisory Panel (commonly referred to as the BAP).
Independent Review. The BAP meets to review and comment on DOD P&T Committee recommendations. It is an advisory committee that includes up to 15 individuals from a variety of TRICARE Formulary stakeholders such as nongovernmental organizations / associations to represent the interests of beneficiaries, contractors for the TRICARE retail pharmacy program and mail-order pharmacy program, and TRICARE network providers. The BAP’s opinion and input is provided as a supplement to the DOD P&T Committee’s original recommendations before being sent to the Director of DHA for final approval.
Publication. Once the Director of DHA approves additions, modifications, or deletions to the TRICARE Formulary, the drug with its formulary status, tier placement, and other controls (i.e., step therapy status, prior authorization criteria, etc.) is published for general use within the health system.