The Request for Information in the Cost Review Study Process is the process for the Board collect additional information on the drugs selected for the Cost Review Study Process, as outlined in COMAR 14.01.04.04 .
We are posting a request for Information for the following drugs selected for the Cost Review Study Process (posted on Thursday, July 25, 2024).
Farxiga (dapagliflozin)
Drug Brand Name: Farxiga
Active Moiety or Active Ingredient: dapagliflozin
Application Number: NDA202293
NDC 11s in the Cost Review Study Process
Approved Therapeutic Alternatives
Jardiance (empagliflozin)
Drug Brand Name: Jardiance
Active Moiety or Active Ingredient: empagliflozin
Application Number: NDA204629
NDC 11s in the Cost Review Study Process
Approved Therapeutic Alternatives
Ozempic (semaglutide)
Drug Brand Name: Ozempic
Active Moiety or Active Ingredient: semaglutide
Application Number: NDA209637
NDC 11s in the Cost Review Study Process
Approved Therapeutic Alternatives
Trulicity (dulaglutide)
Drug Brand Name: Trulicity
Active Moiety or Active Ingredient: dulaglutide
Application Number: BLA125469
NDC 11s in the Cost Review Study Process
Approved Therapeutic Alternatives
Entities that are eligible to respond to the Request for Information are Manufacturers, Carriers, HMOs, MCOs, Pharmacy Benefit Managers, and Wholesale Distributors. Certain entities have received a direct Request for Information by e-mail from the Board. An entity that has not received a Request for Information from the Board may submit relevant information in accordance with COMAR 14.01.04.04.
Submitters should provide information responsive to this Request for Information within 30 days of the date of posting (Posted: Thursday, July 25, 2024; Due Date: Monday, August 26, 2024). Submitters may request one 30- day extension to the Board, in writing, on or before the expiration of the initial submission period.
Submitters may use the attached, optional template to support the submission of data for the Request for Information; however, submitters may submit in any format. For Word or Excel templates, please contact rfi.pdab@maryland.gov.
RFI Submission Template Forms:
There will be a public Technical Assistance Session for entities submitting data for the Request for Information on Wednesday, July 31, 2024, at 12PM ET to answer technical questions that submitters may have. Please register here. We will post the recording of the session. Please submit any written questions ahead of the meeting to rfi.pdab@maryland.gov.
