Pharmacy Prior Authorization Criteria

Ibsrela (tenapanor) - PA, NF

Indications for Prior Authorization

Ibsrela (tenapanor)

• For diagnosis of Irritable Bowel Syndrome with Constipation
  Indicated for the treatment of irritable bowel syndrome with constipation (IBS-C) in adults.

Criteria

Ibsrela

Prior Authorization (Initial Authorization)

Length of Approval: 3 Month(s)

• Diagnosis of irritable bowel syndrome with constipation (IBS-C)
AND
• Used as an adjunct to lifestyle modifications (e.g., increase intake of fibers and fluids, increase physical activity)
AND
• Trial and failure, contraindication, or intolerance to ONE the following:
• generic lactulose
• generic polyethylene glycol
AND
• Trial and failure, contraindication, or intolerance to Linzess

Ibsrela

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient demonstrates positive clinical response to therapy as evidenced by ONE of the following:
• Improvement in constipation or stool frequency from baseline
• Decrease in abdominal pain or discomfort

Ibsrela

Non Formulary

Length of Approval: 3 Month(s)

• Diagnosis of irritable bowel syndrome with constipation (IBS-C)
AND
• Used as an adjunct to lifestyle modifications (e.g., increase intake of fibers and fluids, increase physical activity)
AND
• Submission of medical records (e.g. chart notes) or paid claims confirming trial and failure (minimum 30 days supply), contraindication, or intolerance to ONE the following:
• generic lactulose
• generic polyethylene glycol
AND
• Submission of medical records (e.g. chart notes) or paid claims confirming trial and failure (minimum 30 days supply), contraindication, or intolerance to both of the following:
• Linzess
• generic lubiprostone (Amitiza)

P & T Revisions

1970-01-01, 2024-09-04, 2024-03-25, 2023-10-03, 2023-03-12, 2022-08-02, 2022-05-20

References

1. Ibsrela prescribing information. Ardelyx, Inc. Waltham, MA. May 2021.
2. UpToDate. Wald, A. Treatment of Irritable Bowel Syndrome in Adults. Available at https://www.uptodate.com/contents/treatment-of-irritable-bowel-syndrome-in-adults?search=irritable%20bowel%20syndrome%20constipation&source=search_result&selectedTitle=1~150&usage_type=default&display_rank=1. Accessed March 11, 2023.
3. Chang, L., Sultan, S., et al. AGA Clinical Practice Guideline on the Pharmacological Management of Irritable Bowel Syndrome with Constipation. Gastroentrology. 2022;11:118-136.Available at https://www.gastrojournal.org/article/S0016-5085(22)00390-0/fulltext, Accessed March 11, 2023.

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Revision History

• 2024-09-04: update guideline
• 2024-03-25: 2024 Annual Review
• 2023-10-03: Program update to standard reauthorization language. No changes to clinical intent
• 2023-03-12: 2023 Annual Review
• 2022-08-02: Update Guideline
• 2022-05-20: New PA Criteria

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