Pharmacy Prior Authorization Criteria

5-Aminosalicylates - PA, ST

Indications for Prior Authorization

Asacol HD (mesalamine delayed-release)

• For diagnosis of Ulcerative colitis
  Indicated for the treatment of moderately active ulcerative colitis in adults. Limitations of Use: Safety and effectiveness of Asacol HD beyond 6 weeks have not been established.

Delzicol (mesalamine delayed-release)

• For diagnosis of Treatment of mildly-moderately active ulcerative colitis
  Indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older.

• For diagnosis of Maintenance of remission of ulcerative colitis
  Indicated for the maintenance of remission of ulcerative colitis in adults.

Lialda (mesalamine 1.2g) delayed-release tablet

• For diagnosis of Treatment of mildly-moderately active ulcerative colitis
  Indicated for the induction of remission in adult patients with mildly to moderately active ulcerative colitis. Indicated for the treatment of mildly to moderately active ulcerative colitis in pediatric patients weighing at least 24 kg.

• For diagnosis of Maintenance of remission of ulcerative colitis
  Indicated for the maintenance of remission in adult patients with ulcerative colitis.

Apriso (mesalamine extended-release) capsules

• For diagnosis of Maintenance of remission of ulcerative colitis
  Indicated for the maintenance of remission in adult patients with ulcerative colitis.

Pentasa

• For diagnosis of Ulcerative colitis
  Indicated for the induction of remission and for the treatment of adult patients with mildly to moderately active ulcerative colitis.

Criteria

Asacol HD, 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 [5]

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
• 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
• Justification provided for why the generic is expected to provide benefit when brand Apriso has not been shown to be effective

P & T Revisions

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

References

1. Apriso Prescribing Information. Salix Pharmaceuticals, Inc. Bridgewater, NJ. October 2023.
2. Asacol HD Prescribing Information. Allergan USA, Inc. Madison, NJ. November 2022.
3. Delzicol Prescribing Information. Allergan USA, Inc. Irvine, CA. October 2023.
4. Lialda Prescribing Information. Shire US Inc. Lexington, MA. October 2023.
5. Rubin DT, Ananthakrishnan AN, Siegel CA, et al. ACG Clinical Guideline: Ulcerative Colitis in Adults. Am J Gastroenterol, 2019;114:384–413.
6. Mesalamine delayed-release Prescribing Information. Zydus Pharmaceuticals, Inc. Pennington, NJ. October 2023.
7. Pentasa Prescribing Information. Takeda Pharmaceuticals America, Inc. Lexington, MA. October 2023.

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Revision History

• 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.

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