Trulicity
Overview
- Drug Brand Name: Trulicity
- Active moiety or active ingredient: dulaglutide
- Application Number: BLA125469
- Trulicity NDC 11s in the Cost Review Study Process - PDF - 86.52 KB
Trulicity Cost Review Study Process
Trulicity was selected for Cost Review by the Board at the May 20, 2024 Board Meeting.
Relevant Information:
The 60 day comment period was posted on May 23, 2024 and comments were accepted until July 22, 2024.
Relevant Information:
Comments received on Trulicity during the 60 day comment period - PDF - 1.17 MB
The request for information for Trulicity was distributed/posted on July 25, 2025. The Board may collect additional information on the drugs selected for the Cost Review Study Process, as outlined in COMAR 14.01.04.04
The draft Trulicity dossier was posted on August 20, 2025 and comments were accepted through September 4, 2025.
Dossier Information
- August 20, 2025 Trulicity Dossier - PDF - 3.46 MB
- Exhibit 1: Pricing History_REDACTED - PDF - 323.09 KB
- Exhibit 2: RFI Submissions (NON-PUBLIC--TRADE SECRET, CONFIDENTIAL, AND PROPRIETARY)
- Exhibit 3: Trulicity Therapeutic Alternative Pricing_REDACTED - XLSX - 306.31 KB
- Exhibit 4: Trulicity Therapeutic Alternative Medical Claims Data Base (MCDB) Statistics - XLSX - 150.18 KB
- Exhibit 5
- Exhibit 6
The final Trulicity dossier was posted on November 4, 2025 for discussion at the November 17, 2025 Board Meeting.
Dossier Information
- November 4, 2025 Trulicity Dossier - PDF - 3.63 MB
- Exhibit 1 Pricing History REDACTED - PDF - 323.09 KB
- Exhibit 2 RFI Submissions (NON-PUBLIC--TRADE SECRET, CONFIDENTIAL, AND PROPRIETARY)
- Exhibit 3 Trulicity Therapeutic Alternative Pricing REDACTED - XLSX - 306.31 KB
- Exhibit 4 Trulicity Therapeutic Alternative Medical Claims Data Base (MCDB) Statistics - XLSX - 150.18 KB
- Exhibit 5
- Exhibit 6
At the November 17, 2025 PDAB meeting, the Board made a preliminary determination that use of Trulicity: has created an affordability challenge for the State health care system; and that the use creating the affordability challenge was consistent with the labeling approved by the FDA or standard medical practice.
The circumstances under which the prescription drug product has led to an affordability challenge are:
- the percentage change in WAC over certain periods is substantially larger than the percentage change in inflation (rate of increase in inflation) ( closed session); and
- total gross spending for Trulicity for state and local governments exceeds 2.27 % of gross prescription drug spend for state and local governments (public session).
Trulicity Policy Review Process
The Policy Review, Final Action, Upper Payment Limits Authority is guided by COMAR 14.01.05.
Trulicity Policy Review Process
An informational Hearing for Trulicity took place on December 16, 2025.
Read the archived informational hearing notice - PDF - 139.38 KB
The Board discussed the Trulicity preliminary policy options at the February 23, 2026 Board meeting.