Pharmacy Prior Authorization Criteria

Constipation Agents

Indications for Prior Authorization

Amitiza (lubiprostone)

• For diagnosis of Chronic Idiopathic Constipation (CIC)
  Indicated for the treatment of CIC in adults.

• For diagnosis of Opioid-Induced Constipation in Adult Patients with Chronic Non-Cancer Pain
  Indicated for the treatment of opioid-induced constipation (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.

  Limitations of Use: Effectiveness of Amitiza in the treatment of opioid-induced constipation in patients taking diphenylheptane opioids (e.g., methadone) has not been established.

• For diagnosis of Irritable Bowel Syndrome with Constipation
  Indicated for the treatment of irritable bowel syndrome with constipation in women at least 18 years old.

Linzess (linaclotide)

• 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).

Movantik (naloxegol)

• 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.

Motegrity (prucalopride)

• For diagnosis of CIC
  Indicated for the treatment of CIC in adults.

Relistor (methylnaltrexone bromide) injection

• For diagnosis of Opioid-Induced Constipation (advanced illness or pain caused by active cancer) [1, 2]
  Indicated for the treatment of OIC in adult patients with advanced illness or pain caused by active cancer who require opioid dosage escalation for palliative care.

• 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.

Relistor (methylnaltrexone bromide) tablet

• 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.

Symproic (naldemedine)

• 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.

Trulance (plecanatide)

• For diagnosis of CIC
  Indicated in adults for the treatment of CIC.

• For diagnosis of IBS-C
  Indicated in adults for the treatment of IBS-C.

Criteria

Brand Amitiza

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]
• Lactulose
• Polyethylene glycol
AND
• Trial and failure (of a minimum 30 days supply), contraindication, or intolerance to one of the following preferred brands: [B]
• Linzess
• Movantik
• Symproic

Linzess, Movantik, Symproic

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]
• Lactulose
• Polyethylene glycol

Motegrity, Trulance

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]
• Lactulose
• Polyethylene glycol
AND
• Trial and failure (of a minimum 30 days supply), contraindication, or intolerance to Linzess
AND
• For Trulance, trial and failure (of a minimum 30 days supply), contraindication, or intolerance to generic lubiprostone

Relistor injection, Relistor tablet

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]
• Lactulose
• Polyethylene glycol
AND
• Trial and failure (of a minimum 30 days supply), contraindication, or intolerance to one of the following preferred brands: [B]
• Movantik
• Symproic
AND
• Trial and failure (of a minimum 30 days supply), contraindication, or intolerance to generic lubiprostone

P & T Revisions

2024-04-24, 2024-03-13, 2023-10-25, 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

References

1. Relistor Prescribing Information. Salix Pharmaceuticals. Bridgewater, NJ. April 2020.
2. Per clinical consult with gastroenterologist, February 19, 2019.
3. 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.
4. Movantik Prescribing Information. AstraZeneca Pharmaceuticals LP. Wilmington, DE. April 2020.
5. Symproic Prescribing Information. BioDelivery Sciences International Inc. Raleigh, NC. July 2021.
6. Linzess Prescribing Information. Allergan USA, Inc. Madison, NJ. June 2023.
7. Trulance Prescribing Information. Salix Pharmaceuticals Inc. Bridgewater, NJ. April 2021.
8. Amitiza Prescribing Information. Takeda Pharmaceuticals America, Inc. Deerfield, IL. November 2020.
9. Motegrity Prescribing Information. Takeda Pharmaceuticals America, Inc. Lexington, MA. November 2020.
10. 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.

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End Notes

1. Stimulant and osmotic laxatives should be tried/failed first before patients are placed on OIC agents (ie, Relistor and Movantik). [2, 3]
2. 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, and lower cost. 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, namely naldemedine and naloxegol. [2]

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Revision History

• 2024-04-24: Operational updates - added Amitiza GPI back to guideline, missing from Amitiza criteria bucket
• 2024-03-13: 2024 UM Annual Review. No criteria changes
• 2023-10-25: Added t/f/c/i to generic lubiprostone requirement for Relistor and Trulance
• 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.

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