Jardiance
Overview
- Drug Brand Name: Jardiance
- Active moiety or active ingredient: empagliflozin
- Application Number: NDA204629
Jardiance Cost Review Study Process
Jardiance was selected for Cost Review by the Board on May 20, 2024.
Relevant information:
- Presentation of findings from the drugs referred to the Stakeholder Council
- Written comments concerning list of therapeutic alternatives (30 days)
- Comments concerning Board selection of prescription drug products for cost review
The 60 day comment period was posted on May 23, 2024 and comments were accepted until July 22, 2024.
Relevant information:
Comments received on Jardiance during the 60 day comment period
The request for information for Jardiance was distributed/posted on 7/25/2024. For each prescription drug product under review, the Board may request the following information from: Manufacturer, Health Insurance Carrier, HMO, and MCO, Pharmacy Benefit Managers, and Wholesale Distributors.
Read the archived RFI notice
The draft Jardiance dossier was posted on 6/18/25 and comments were accepted through 7/3/2025.
Written Comments Received:
- June 18, 2025 Jardiance Dossier
- Exhibit 1: Jardiance Therapeutic Alternative Pricing_REDACTED
- Exhibit 2: Jardiance Therapeutic Alternative Medical Claims Data Base (MCDB) Statistics
- Exhibit 3
- Exhibit 3A: Jardiance Summary of Cost Effectiveness Analyses
- Exhibit 3B: Jardiance Summary of Comparative Effectiveness Research
- Exhibit 4
- Exhibit 4A: Written Comments (60-day COMAR 14.01.04.05C(2))
- Exhibit 4B: Written Comments (Request October 28, 2024)
- Exhibit 4C: Written Comments (Request January 27, 2025)
- Exhibit 5: Pricing History_REDACTED
The final Jardiance dossier was posted on 7/18/2025 for discussion at the 7/28/2025 Board Meeting.
Written Comments Received:
- July 18, 2025 Jardiance Dossier- updated 7/23/2025
- Exhibit 1: Pricing History_REDACTED
- Exhibit 2: RFI Submissions (NON-PUBLIC--TRADE SECRET, CONFIDENTIAL, AND PROPRIETARY)
- Exhibit 3: Jardiance Therapeutic Alternative Pricing_REDACTED
- Exhibit 4: Jardiance Therapeutic Alternative Medical Claims Data Base (MCDB) Statistics
- Exhibit 5
- Exhibit 5A: Jardiance Summary of Cost Effectiveness Analyses
- Exhibit 5B: Jardiance Summary of Comparative Effectiveness Research
- Exhibit 6
- Exhibit 6A: Written Comments (60-day COMAR 14.01.04.05C(2))
- Exhibit 6B: Written Comments (Request October 28, 2024)
- Exhibit 6C: Written Comments (Request January 27, 2025)
- Exhibit 6D: Written Comments (Request June 18, 2025)
The Board made a preliminary determination on 7/28/2025 and this preliminary determination included:
Board Preliminary Determination
Info goes here
Info goes here
Jardiance Policy Review Process
The Policy Review, Final Action, Upper Payment Limits Authority is guided by COMAR 14.01.05.
Jardiance Policy Review Process
An informational Hearing for Jardiance took place on December 16, 2026.
Read the archived informational hearing notice
The Board discussed the preliminary Policy options at the February 23, 2026 Board meeting.
Upper Payment Limit Policy Actions
Jardiance Upper Payment Limit Policy Actions
Farxiga: Calculations and Analyses Underpinning Potential UPL Values (Posted 4/22/2026)
Staff posted a proposed version of the Jardiance: Calculations and Analyses Underpinning Potential UPL Values. Written public comments are requested. Comments were submitted in accordance with COMAR 14.01.01.05B(4) by close of business, Friday, May 1, 2026 to [email protected]
Please reference “Jardiance: Calculations and Analyses” in the subject line.
Jardiance: Calculations and Analysis Underpinning Potential UPL Values
Written Comment Packet
The Board approved to establish an Upper Payment Limit for Jardiance 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
Jardiance Non-Upper Payment Limit Policy Actions
The following Non-UPL policies were discussed at the May 18, 2026 Board meeting.
- Jardiance - Non-UPL Policies- Presentation
- Non-UPL Policy- Plan Design and PBM Reform Study and Recommendations
- Non-UPL Policy- GLP-1 Study and Recommendations
- Non-UPL Policy- Bulk Purchasing/Subscription Model
- Non-UPL Policy- Patient Navigator Program
- Non-UPL Policy- State Participation in CMMI Models
The Board Adopted a slate of NON-UPL policies for Jardiance 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.