Ozempic
Overview
- Drug Brand Name: Ozempic
- Active moiety or active ingredient: semaglutide
- Application Number: NDA209637
- Ozempic NDC 11s in the Cost Review Study Process - PDF - 88.47 KB
Ozempic Cost Review Study Process
Ozempic 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.
Comments received on Ozempic during the 60 day comment period. - PDF - 1.03 MB
The request for information for Ozempic 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 Ozempic dossier was posted on August 20, 2025 and comments were accepted through September 4, 2025.
Dossier Information:
- August 20, 2025 Ozempic Dossier - PDF - 3.93 MB
- Exhibit 1: Pricing History_REDACTED - PDF - 295.1 KB
- Exhibit 2: RFI Submissions (NON-PUBLIC--TRADE SECRET, CONFIDENTIAL, AND PROPRIETARY)
- Exhibit 3: Ozempic Therapeutic Alternative Pricing_REDACTED - XLSX - 306.33 KB
- Exhibit 4: Ozempic Therapeutic Alternative Medical Claims Data Base (MCDB) Statistics - XLSX - 150.18 KB
- Exhibit 5
- Exhibit 6
The final Ozempic dossier was posted on November 4, 2025 for discussion at the November 17, 2025 Board Meeting.
Dossier Information:
- November 4, 2025 Ozempic Dossier - PDF - 10.04 MB
- Exhibit 1 Pricing History REDACTED - PDF - 295.1 KB
- Exhibit 2 RFI Submissions (NON-PUBLIC--TRADE SECRET, CONFIDENTIAL, AND PROPRIETARY)
- Exhibit 3 Ozempic Therapeutic Alternative Pricing REDACTED - XLSX - 306.33 KB
- Exhibit 4 Ozempic Therapeutic Alternative Medical Claims Data Base (MCDB) Statistics - XLSX - 150.18 KB
- Exhibit 5
- Exhibit 6
- Written Comments Received - PDF - 2.37 MB
At the November 17, 2025 PDAB meeting, the Board made a preliminary determination that use of Ozempic: 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:
(1) total gross spending for Ozempic for state and local governments exceeds 4.87% of gross prescription drug spend for state and local governments (public session).
In accordance with COMAR 14.01.04.05F(3), staff posted the draft Ozempic Cost Review Study Report and requested public written comment. Comments were submitted in accordance with COMAR 14.01.01.05B(4) by close of business, Friday, May 1, 2026 to [email protected]
- Draft Ozempic Cost Review Study Report - PDF - 13.65 MB
- Appendix A Excel Exhibits:
- Written Comment Packet - PDF - 921.65 KB
Info goes here
Ozempic Policy Review Process
The Policy Review, Final Action, Upper Payment Limits Authority is guided by COMAR 14.01.05.
Ozempic Policy Review Process
An informational Hearing for Ozempic took place on December 16, 2025.
Read the archived informational hearing notice - PDF - 139.38 KB
The Board discussed the Ozempic preliminary policy options at the February 23, 2026 Board meeting.
Relevant Materials:
Upper Payment Limit Policy Actions
Ozempic Upper Payment Limit Policy Actions
Staff posted a proposed version of the Ozempic: Calculations and Analyses Underpinning Potential UPL Values on April 22, 2026. Comments were submitted in accordance with COMAR 14.01.01.05B(4) by close of business, Friday, May 1, 2026 to [email protected]
Ozempic: Calculation and Analysis Underpinning Potential UPL Values was also discussed at the May 18, 2026 Board Meeting.
Relevant Materials:
Ozempic- Consideration of Upper Payment Limit- Presentation - PDF - 235.67 KB
Ozempic: Calculations and Analysis Underpinning Potential UPL Values - PDF - 195.36 KB
The PDAB solicited comments on draft proposed regulations: COMAR 14.01.07.02- Upper Payment Limit for Ozempic under COMAR 14.0101.05B(4) (posted April 22, 2026). Comments were accepted to [email protected] by Friday, May 1, 2026.
- Draft COMAR 14.01.07.02- Upper Payment Limit for Ozempic - PDF - 95.24 KB
- Written Comments Received May 1, 2026 - PDF - 1.11 MB
The PDAB reviewed the following relevant information at the May 18, 2026 Board Meeting
The Board approved to establish an Upper Payment Limit for Ozempic by adopting COMAR 14.01.07.02 as drafted and authorizing staff to submit it for review and publication in accordance with the Administrative Procedure Act at the May 18, 2026 meeting.
Non-Upper Payment Limit Policy Actions
Ozempic Non-Upper Payment Limit Policy Actions
The following Non-UPL policies were discussed at the May 18, 2026 Board meeting.
- Ozempic- Non-UPL Policies- Presentation - PDF - 255.06 KB
- Non-UPL Policy- Plan Design and PBM Reform Study and Recommendations - PDF - 66.57 KB
- Non-UPL Policy- GLP-1 Study and Recommendations - PDF - 72.41 KB
- Non-UPL Policy- Bulk Purchasing/Subscription Model - PDF - 60.49 KB
- Non-UPL Policy- Patient Navigator Program - PDF - 84.82 KB
- Non-UPL Policy- State Participation in CMMI Models - PDF - 69.01 KB
The Board Adopted a slate of NON-UPL policies for Ozempic in the following order: GLP-1 Study, Bulk/Purchasing Subscription Model, Plan Design and PBM Reform Study, and State Participation in CMMI Models: Balance and GENEROUS at the May 18, 2026 Board meeting.