Board Selected Drugs from the May 20, 2024 PDAB Meeting are listed below.
Public written comment: Written public comments are due for the following Board Selected Drugs by close of business, Monday, July 22, 2024.
Comments can be sent to comments.pdab@maryland.gov with the subject line: Board Selected Drugs (Drug Name).
Comments are shared publicly and will be posted as they are received.
Farxiga (dapagliflozin)
Drug Brand Name: Farxiga
Active Moiety or Active Ingredient: dapagliflozin
Application Number: NDA202293
Jardiance (empagliflozin)
Drug Brand Name: Jardiance
Active Moiety or Active Ingredient: empagliflozin
Application Number: NDA204629
Ozempic (semaglutide)
Drug Brand Name: Ozempic
Active Moiety or Active Ingredient: semaglutide
Application Number: NDA209637
Trulicity (dulaglutide)
Drug Brand Name: Trulicity
Active Moiety or Active Ingredient: dulaglutide
Application Number: BLA125469
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. Comment period ends July 22, 2024.
- The Request for Information (RFI) for each drug in the Cost Review Study process will be posted on the website and the deadline will be based on when the RFI is posted. More information about the RFI Process will be posted on the website shortly.
- The Requests for Information (RFIs) for Farxiga (dapagliflozin), Jardiance (empagliflozin), Ozempic (semaglutide), Trulicity (dulaglutide) will be posted together, and the RFIs for Dupixent (dupilumab) Skyrizi (risankizumab) will be posted separately at a later date.
Request for Information:
Board Staff is seeking Public Input on the Request for Information (RFI) Data Collection Forms, which are the forms that entities will use to provide data as part of the Request for Information in the Cost Review Study Process, as outlined in
COMAR 14.01.04.04 . We are seeking input in the development of the RFI forms. You can submit input by close of business Friday, July 12, 2024. Staff will schedule a feedback session on Friday, July 12, 2024 at 1PM on the development of the RFI Data Collection Forms for the Cost Review Study Process for stakeholders interested in providing input. To submit your feedback or register for the feedback session, please contact support.pdab@maryland.gov
Draft Forms:
