Board Selected Drugs from the May 20, 2024 PDAB Meeting are listed below.
Ozempic (semaglutide)
Drug Brand Name: Ozempic
Active Moiety or Active Ingredient: semaglutide
Application Number: NDA209637
DOSSIER INFORMATION* (POSTED 11/4/2025)- UPDATED (NEW)
*Also posted as meeting materials for the November 17, 2025 Board Meeting
Dossier Information (Posted 8/20/2025)
The Prescription Drug Affordability Board requested comment on the drug, the dossier, whether use of the drug has created an affordability challenge for the State health care system or high out-of-pocket costs for patients, and, if so, how. Comments were accepted through through September 4, 2025.
Ozempic Comments Received from the following entities:
AbbVie
Kerstin Haskell
Let My Doctors Decide Action Network
Maryland Health Benefit Exchange
Maryland Health Care for All Coalition
Novo Nordisk
Partnership to Advance Cardiovascular Health
Value of Care Coalition
Trulicity (dulaglutide)
Drug Brand Name: Trulicity
Active Moiety or Active Ingredient: dulaglutide
Application Number: BLA125469
DOSSIER INFORMATION* (POSTED 11/4/2025)- UPDATED (NEW)
*Also posted as meeting materials for the November 17, 2025 Board Meeting
Dossier Information (Posted 8/20/2025)
The Prescription Drug Affordability Board requested comment on the drug, the dossier, whether use of the drug has created an affordability challenge for the State health care system or high out-of-pocket costs for patients, and, if so, how. Comments were accepted through through September 4, 2025.
Trulicity Comments Received from the following entities:
AbbVie
Let My Doctors Decide Action Network
Lilly
Maryland Health Benefit Exchange
Maryland Health Care for All Coalition
National Minority Quality Forum
Partnership to Advance Cardiovascular Health
Value of Care Coalition
Farxiga (dapagliflozin)
Drug Brand Name: Farxiga
Active Moiety or Active Ingredient: dapagliflozin
Application Number: NDA202293
DOSSIER INFORMATION* (POSTED 7/18/2025)- UPDATED (NEW)
*Also posted as meeting materials for the July 28, 2025 Board Meeting
Dossier Information (Posted 6/18/2025)- ARCHIVED
The Prescription Drug Affordability Board requested comment on the drug, the dossier, whether use of the drug has created an affordability challenge for the State health care system or high out-of-pocket costs for patients, and, if so, how. Comments were accepted through through July 3, 2025.
Farxiga Comments Received from the following entities:
Jardiance (empagliflozin)
Drug Brand Name: Jardiance
Active Moiety or Active Ingredient: empagliflozin
Application Number: NDA204629
DOSSIER INFORMATION* (POSTED 7/18/2025)- UPDATED (NEW)
*Also posted as meeting materials for the July 28, 2025 Board Meeting
Dossier Information (Posted 6/18/2025)- ARCHIVED
The Prescription Drug Affordability Board requested comment on the drug, the dossier, whether use of the drug has created an affordability challenge for the State health care system or high out-of-pocket costs for patients, and, if so, how. Comments were accepted through through July 3, 2025.
Written Comment PacketJardiance Comments Received from the following entities:
Dupixent (dupilumab)
Drug Brand Name: Dupixent
Active Moiety or Active Ingredient: dupilumab
Application Number: BLA761055
Skyrizi (risankizumab)
Drug Brand Name: Skyrizi
Active Moiety or Active Ingredient: risankizumab
Application Number: BLA761105
Timeline Information for Cost Review:
- Public Comment period for all six drugs began on May 23, 2024. The 60 day comment period ended July 22, 2024 (see Archived 60-day comment period information below).
- The Request for Information (RFI) for each drug in the Cost Review Study process can be found on the RFI page. RFI submissions for Farxiga, Jardiance, Ozempic and Trulicity concluded in 2024. The PDAB is currently accepting RFI submissions for Skyrizi and Dupixent through June 27, 2025.
ARCHIVED- 60 DAY COMMENT PERIOD
Public written comment: Written public comments were due for the following Board Selected Drugs by close of business, Monday, July 22, 2024.
Comments Received (Packet)
- Abbvie
- Chase Brexton
- Ensuring Access Through Collaborative Health
- Lilly
- National Psorasis Foundation
- Novo Nordisk
- Value of Care Coaltion