Jardiance
Overview
- Drug Brand Name: Jardiance
- Active moiety or active ingredient: empagliflozin
- Application Number: NDA204629
- Jardiance NDC 11s in the Cost Review Study Process - PDF - 88.24 KB
Jardiance Cost Review Study Process
Jardiance 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.
Relevant Information:
Comments received on Jardiance during the 60 day comment period - PDF - 844.12 KB
The request for information for Jardiance 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 Jardiance dossier was posted on June 18, 2025 and comments were accepted through July 3, 2025.
Dossier Information:
- June 18, 2025 Jardiance Dossier - PDF - 4.18 MB
- Exhibit 1: Jardiance Therapeutic Alternative Pricing_REDACTED - XLSX - 315.31 KB
- Exhibit 2: Jardiance Therapeutic Alternative Medical Claims Data Base (MCDB) Statistics - XLSX - 150.21 KB
- Exhibit 3
- Exhibit 3A: Jardiance Summary of Cost Effectiveness Analyses
- Exhibit 3B: Jardiance Summary of Comparative Effectiveness Research
- Exhibit 4
- Exhibit 5- Pricing History_REDACTED - PDF - 198.82 KB
The final Jardiance dossier was posted on July 18, 2025 for discussion at the July 28, 2025 Board Meeting.
Dossier Information:
- July 18, 2025 Jardiance Dossier- updated 7/23/2025 - PDF - 2.16 MB
- Exhibit 1 Pricing History REDACTED - PDF - 220.37 KB
- Exhibit 2 RFI Submissions (NON-PUBLIC--TRADE SECRET, CONFIDENTIAL, AND PROPRIETARY)
- Exhibit 3 Jardiance Therapeutic Alternative Pricing REDACTED - XLSX - 315.15 KB
- Exhibit 4 Jardiance Therapeutic Alternative Medical Claims Data Base (MCDB) Statistics - XLSX - 150.29 KB
- Exhibit 5
- Exhibit 6
At the July 28, 2025 PDAB meeting, the Board made a preliminary determination that the use of Jardiance: has created an affordability challenge for the State health care system; and the use creating the affordability challenge was consistent with the labeling approved by the FDA or standard medical practice.
The circumstances under which use of the drug has or will lead to an affordability challenge are:
- the percentage change in WAC over time is substantially larger than the percentage change in inflation (rate of increase in inflation) (closed session);
- at 90 percentile, patient out of pocket (OOP) cost in certain markets is disproportionate to the net cost paid by payors (closed session); and
- total gross spending for Jardiance for state and local governments exceeds 1.8% 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 Jardiance Cost Review Study Report on March 16, 2026 and requested public written comment. Comments were submitted in accordance with COMAR 14.01.01.05B(4) by close of business, March 30, 2026 to [email protected]
- Draft Jardiance Cost Review Study Report - PDF - 5.3 MB
- Appendix A Excel Exhibits:
- Written Comments Received - PDF - 499.42 KB
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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 September 3, 2025.
Read the archived informational hearing notice. - PDF - 116.66 KB
The Board discussed the Jardiance preliminary policy options at the November 17, 2025 PDAB meeting.
Relevant Materials:
Upper Payment Limit Policy Actions
Jardiance Upper Payment Limit Policy Actions
Staff posted a proposed revised version of the Jardiance: Calculations and Analyses Underpinning Potential UPL Values (Formerly: Jardiance UPL Amount and Methodology Documents) on March 30, 2026. Comments were submitted in accordance with COMAR 14.01.01.05B(4) by close of business, April 6, 2026 to [email protected]
A previous version: Jardiance UPL Amount and Methodology Documents, was posted on February 17, 2026 with comments being due March 4, 2026. The updated version provides a redline of the changes from the February 17, 2026 version to the March 30, 2026 version. All versions are posted below.
Relevant Materials:
- Jardiance: Calculations and Analyses Underpinning Potential Upper Payment Limit (UPL) Values- Clean Version 2.0 (March 30, 2026) - PDF - 184.69 KB
- Jardiance: Calculations and Analyses Underpinning Potential Upper Payment Limit (UPL) Values-Tracked Version 2.1 (March 30, 2026) - PDF - 111.03 KB
- Written Comments Received April 6, 2026 - PDF - 1.04 MB
- Jardiance UPL Amount and Methodology Documents (February 17, 2026 version) - PDF - 183.35 KB
- Written Comments Received March 4, 2026. - PDF - 1.15 MB
Jardiance: Calculation and Analysis Underpinning Potential UPL Values was also discussed at the April 13, 2026 Board Meeting.
The PDAB solicited comments on draft UPL regulations for Farxiga and Jardiance (Posted on March 16, 2026) under COMAR 14.0101.05B(4). Comments were accepted to [email protected] until Monday, March 30, 2026 on the draft regulations listed below:
- Draft COMAR 14.01.06- Implementation and Monitoring of Upper Payment Limits - PDF - 103.07 KB
- Draft COMAR 14.01.07- Upper Payment Limit - PDF - 161.92 KB
- Written Comments Received - PDF - 1.46 MB
The PDAB reviewed the following relevant information at the April 13, 2026 Board Meeting:
The Board approved to establish an Upper Payment Limit for Jardiance by adopting COMAR 14.01.07.01 as drafted and authorizing staff to submit it for review and publication in accordance with the Administrative Procedure Act at the April 13, 2026 Board meeting.
COMAR 14.01.07.01- Upper Payment Limit for Jardiance was revised and approved at the May 18, 2026 Board Meeting. Relevant information from that meeting:
- Recommended Revision to Board Adopted Proposed- COMAR 14.01.07.01
Non-Upper Payment Limit Policy Actions
Jardiance Non-Upper Payment Limit Policy Actions
The following Non-UPL policies were discussed at the April 13, 2026 Board meeting.
The Board Adopted a slate of NON-UPL policies for Jardiance to include: WAC Inflation Penalty, PBM Reimbursement- Delinking or Flat Fee, and Navigator Program at the April 13, 2026 Board Meeting.