WHA
 

5-Aminosalicylates - PA, ST

Indications for Prior Authorization

Apriso (mesalamine extended-release) capsules
  • For diagnosis of Ulcerative Colitis, maintenance
    Indicated for the maintenance of remission in adult patients with ulcerative colitis.

Delzicol (mesalamine delayed-release)
  • For diagnosis of Ulcerative Colitis, treatment
    Indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older.

  • For diagnosis of Ulcerative Colitis, maintenance
    Indicated for the maintenance of remission of ulcerative colitis in adults.

Lialda (mesalamine 1.2g) delayed-release tablet
  • For diagnosis of Ulcerative Colitis, induction and maintenance
    Indicated for the induction and maintenance of remission in adult patients with mildly to moderately active ulcerative colitis.

  • For diagnosis of Ulcerative Colitis, treatment
    Indicated for the treatment of mildly to moderately active ulcerative colitis in pediatric patients weighing at least 24 kg.

Pentasa (mesalamine extended-release) capsules
  • For diagnosis of Ulcerative Colitis, induction and treatment
    Indicated for the induction of remission and for the treatment of mildly to moderately active ulcerative colitis in adult patients.

Criteria

Delzicol, Brand Lialda

Step Therapy

Length of Approval: 12 Month(s)

  • Requested drug is being used for a Food and Drug Administration (FDA)-approved indication
    • AND
  • Trial and failure (of a minimum 30-day supply), age contraindication, or intolerance to Brand Apriso
Pentasa

Step Therapy

Length of Approval: 12 Month(s)

  • Requested drug is being used for a Food and Drug Administration (FDA)-approved indication
    • AND
  • Trial and failure (of a minimum 30-day supply), contraindication, or intolerance to both of the following:
    • Generic mesalamine (Delzicol, Asacol HD, Pentasa 500mg, Lialda)
    • Brand Apriso
Generic mesalamine ER capsules 0.375 gm (generic Apriso)

Prior Authorization

Length of Approval: 12 Month(s)

  • One of the following:
    • Requested drug is being used for a Food and Drug Administration (FDA)-approved indication
      • OR
    • If requested for an off-label indication, the off-label guideline approval criteria have been met
    AND
  • Both of the following:
    • Paid claims or submission of medical records (e.g., chart notes) confirming at least 6 months use of Brand Apriso within the previous 365 days
      • AND
    • Submission of medical records (e.g., chart notes) confirming Brand Apriso has not been effective AND valid clinical justification provided explaining how generic mesalamine ER capsule 0.375 gm is expected to provide benefit when Brand Apriso has not been shown to be effective despite having the same active ingredient

  • Guideline ID
    GL-548243

  • Formulary
    Premium

  • Effective date
    Jun 1, 2026

  • P&T approval date
    Jul 27, 2016

P & T Revisions

2026-03-13, 2025-12-18, 2025-03-24, 2024-03-14, 2023-10-23, 2023-09-05, 2023-03-07, 2022-03-09, 2021-11-16, 2021-03-17, 2020-09-08, 2020-03-12, 2020-01-13

  1. Apriso Prescribing Information. Salix Pharmaceuticals, Inc. Bridgewater, NJ. October 2023.
  2. Delzicol Prescribing Information. Allergan USA, Inc. Madison, NJ. October 2023.
  3. Lialda Prescribing Information. Shire US Inc. Lexington, MA. October 2023.
  4. Rubin DT, Ananthakrishnan AN, Siegel CA, et al. ACG Clinical Guideline: Ulcerative Colitis in Adults. Am J Gastroenterol, 2019;114:384–413.
  5. Pentasa Prescribing Information. Takeda Pharmaceuticals America, Inc. Cambridge, MA. July 2024.
  • 2026-03-13: Annual Review 2026 - Updated generic Apriso criteria to standard embedded ST verbiage through non-preferred product with same active ingredient. Background updates.
  • 2025-12-18: no criteria changes, added IL statute operational note
  • 2025-03-24: 2025 UM Annual Review. Removed Asacol HD from guideline as it is now obsolete (obsolete date 4/6/2025). Background updates
  • 2024-03-14: 2024 UM Annual Review. Updated generic mesalamine criteria to align with other BoG PA criteria. Required submission of medical records or paid claims for use of brand Apriso within previous 365 days and removed criteria requiring documentation that brand Apriso has not been effective. Background updates.
  • 2023-10-23: Removed PA on generic Lialda, added Pentasa 250mg tablets to guideline and updated ST requirements
  • 2023-09-05: Added criteria for brand Pentasa
  • 2023-03-07: 2023 UM Annual Review. Added minimum 30 day trial requirement for ST. Updated references
  • 2022-03-09: 2022 UM Annual Review.
  • 2021-11-16: Program update to include generic mesalamine criteria
  • 2021-03-17: 2021 UM Annual Review
  • 2020-09-08: Updated criteria to accommodate expanded pediatric indication for Lialda.
  • 2020-03-12: 2020 UM Annual Review. No changes to criteria.
  • 2020-01-13: Removed generic mesalamine as a target drug and trial/failure option per formulary strategy.