Pharmacy Prior Authorization Criteria

Constipation Agents

For diagnosis of Irritable Bowel Syndrome with Constipation (IBS-C)
Indicated in adults for the treatment of irritable bowel syndrome with constipation (IBS-C).
For diagnosis of CIC
Indicated in adults for the treatment of CIC.
For diagnosis of Functional Constipation (FC)
Indicated in pediatric patients 6 to 17 years of age for the treatment of functional constipation (FC).

For diagnosis of Opioid-Induced Constipation (chronic non-cancer pain, chronic pain related to prior cancer or its treatment)
Indicated for the treatment of OIC in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.

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 days supply), contraindication, or intolerance to one of the following generics: [A]

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 days supply), contraindication, or intolerance to one of the following generics: [A]

AND

Trial and failure (of a minimum 30 days supply), contraindication, or intolerance to Linzess

2025-03-25, 2023-10-23, 2023-07-26, 2023-07-26, 2023-03-23, 2023-01-21, 2022-03-09, 2021-09-30, 2021-05-05, 2021-03-02, 2020-03-09

Per clinical consult with gastroenterologist, February 19, 2019.
Crockett SD, Greer KB, Heidelbaugh JJ, et al. American Gastroenterological Association Institute Guideline on the Medical Management of Opioid-Induced Constipation. Gastroenterology. Gastroenterology. 2019;156:218-226.
Symproic Prescribing Information. BioDelivery Sciences International Inc. Raleigh, NC. July 2021.
Linzess Prescribing Information. Allergan USA, Inc. Madison, NJ. June 2023.
Motegrity Prescribing Information. Takeda Pharmaceuticals America, Inc. Lexington, MA. November 2020.
Ford AC, Moayyedi P, Chey WD, Harris LA, Lacy BE, Saito YA, Quigley EMM; ACG Task Force on Management of Irritable Bowel Syndrome. American College of Gastroenterology Monograph on Management of Irritable Bowel Syndrome. Am J Gastroenterol. 2018 Jun;113(Suppl 2):1-18.

The 2019 American Gastroenterological Association (AGA) Guideline for Opioid-Induced Constipation (OIC) recommends traditional laxative therapy as first-line agents given their established efficacy, safety, lower cost and availability. If an adequate trial of laxatives does not optimally control symptoms, the AGA recommends treatment with peripherally acting mu-opioid receptor antagonist (PAMORA) drugs with higher quality evidence of efficacy e.g. naldemedine [2]

2025-03-25: Removed target drugs: Amitza, Movantik, Relistor, Trulance. Added generic prucalopride as target drug. Background updates.
2023-10-23: Created EHB specific GL
2023-07-26: Added new indication for Linzess for functional constipation
2023-07-26: Removed generic lubiprostone as target from the ST
2023-03-23: 2023 UM Annual Review. No criteria changes. Added minimum 30 day trial duration to trial and failure requirements. Updated references.
2023-01-21: update guideline
2022-03-09: 2022 UM Annual Review.
2021-09-30: Attached EHB formulary to guideline, benefit coverage effective 1/1/2022. No changes to clinical criteria.
2021-05-05: 2021 UM Annual Review.
2021-03-02: Added new ABA for Amitiza to guideline. Named product "brand lubiprostone."
2020-03-09: 2020 UM Annual Review. No changes to criteria.