WHA
 

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
  • Both of the following: [B]
    • Patient has recurrent symptoms of abdominal pain, occurring, on average, at least 1 day per week, over the past 3 months
      • AND
    • Abdominal pain is associated with TWO of the following:
      • Defecation
      • A change in stool pattern or frequency
      • A change in stool form or appearance
    AND
  • Patient is 18 years of age or older [A]
    • AND
  • Used as an adjunct to lifestyle modifications (e.g., increase intake of fibers and fluids, increase physical activity)
    • AND
  • Trial and failure (minimum 30-day supply), contraindication, or intolerance to ONE the following:
    • generic lactulose
    • generic polyethylene glycol
    AND
  • Trial and failure (minimum 30-day supply), 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)

  • Submission of medical records (e.g., chart notes) confirming diagnosis of irritable bowel syndrome with constipation (IBS-C)
    • AND
  • Submission of medical records (e.g., chart nots) confirming both of the following: [B]
    • Patient has recurrent symptoms of abdominal pain, occurring, on average, at least 1 day per week, over the past 3 months
      • AND
    • Abdominal pain is associated with TWO of the following:
      • Defecation
      • A change in stool pattern or frequency
      • A change in stool form or appearance
    AND
  • Patient is 18 years of age or older [A]
    • 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)

  • Guideline ID
    GL-556288

  • Formulary
    premium

  • Effective date
    Jun 1, 2026

  • P&T approval date
    May 19, 2022

P & T Revisions

2026-03-31, 2025-12-18, 2024-09-04, 2024-03-25, 2023-10-03, 2023-03-12, 2022-08-02, 2022-05-20

  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%20with%20constipation&source=search_result&selectedTitle=1~150&usage_type=default&display_rank=1. Accessed March 23, 2026.
  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.
  4. Lacy, B., Pimentel, M., Brenner, D., et al. ACG Clinical Guideline: Management of Irritable Bowel Syndrome. Available at: https://journals.lww.com/ajg/fulltext/2021/01000/acg_clinical_guideline__management_of_irritable.11.aspx. Accessed March 23, 2026.
  5. Rome IV Criteria for Irritable Bowel Syndrome. Available at: https://theromefoundation.org/rome-iv/rome-iv-criteria/. Accessed March 23, 2026.
  1. Per prescribing label, the safety and effectiveness of Ibsrela has not been established in pediatric patients less than 18 years of age [1]
  2. Rome IV diagnostic criteria for irritable bowel syndrome [4-5]
  • 2026-03-31: 2026 Annual Review
  • 2025-12-18: no criteria changes, added IL statute operational note
  • 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