Constipation Agents
Preferred agents: linaclotide (LINZESS), naloxegol (MOVANTIK), naldemedine (SYMPROIC)
Non-Preferred Agents (step therapy): lubiprostone (AMITIZA), tenapanor (IBSRELA), prucalopride (MOTEGRITY), methylnaltrexone bromide tablets (RELISTOR), methylnaltrexone bromide subcutaneous injection (RELISTOR), plecanatide (TRULANCE), tegaserod (ZELNORM)
Indication for Prior Authorization:
- Amitiza; lubiprostone authorized brand alternative (ABA)
- Chronic Idiopathic Constipation (CIC) - Indicated for the treatment of CIC in adults.
- Opioid-Induced Constipation (OIC) - 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. Limitations of Use: Effectiveness of Amitiza in the treatment of OIC in patients taking diphenylheptane opioids (e.g., methadone) has not been established.
- Irritable Bowel Syndrome with Constipation (IBS-C) - Indicated for the treatment of IBS-C in women at least 18 years old.
- Ibsrela
- IBS-C - Indicated for the treatment of IBS-C.
- Linzess
- IBS-C - Indicated in adults for the treatment of IBS-C.
- CIC - Indicated in adults for the treatment of CIC.
- Motegrity
- CIC - Indicated for the treatment of CIC in adults.
- Movantik
- OIC (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 Injection
- OIC (advanced illness or pain caused by active cancer) - 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.
- OIC (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 Tablet
- OIC (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
- OIC (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
- CIC - Indicated in adults for the treatment of CIC.
- IBS-C - Indicated in adults for the treatment of IBS-C.
- Zelnorm
- IBS-C - Indicated for the treatment of adult women less than 65 years of age with IBS-C. Limitation of Use: The safety and effectiveness of Zelnorm in men with IBS-C have not been established.
Coverage Criteria:
Request for Motegrity, Trulance or Zelnorm:
- Dose for an appropriate indication does not exceed the maximum approved by the FDA
- Motegrity - up to 2 mg once daily for CIC.
- Trulance - 3 mg once daily for CIC and IBS-C.
- Zelnorm - 6 mg twice daily for IBS-C (females less than 65 years of age only); AND
- Patient is 18 years of age or older; AND
- Patient has experienced an inadequate response, contraindication, or intolerable side effect to Linzess.
Request for Relistor tablet or Relistor injection:
- Dose for an appropriate indication does not exceed the maximum approved by FDA
- Relistor tablet - up to 450 mg once daily for OIC (non-cancer pain).
- Relistor injection - up to 12 mg once daily for OIC (non-cancer pain or advanced illness); AND
- Patient is 18 years of age or older; AND
- Patient has experienced an inadequate response, contraindication, or intolerable side effect to Symproic or Movantik.
Request for lubiprostone ABA or Amitiza:
- Dose for an appropriate indication does not exceed the maximum approved by the FDA
- lubiprostone (Amitiza) - up to 24 mcg twice daily for CIC and OIC.
- lubiprostone (Amitiza) - 8 mcg twice daily for IBS-C (females only); AND
- Patient is 18 years of age or older; AND
- Patient has experienced an inadequate response, contraindication, or intolerable side effect to Linzess, Symproic, or Movantik.
Request for Ibsrela:
- Dose for an appropriate indication does not exceed the maximum approved by the FDA
- Ibsrela - up to 50 mg twice daily for IBS-C; AND
- Patient is 18 years of age or older; AND
- Patient has experienced an inadequate response, contraindication, or intolerable side effect to Linzess; AND
- Patient has experienced an inadequate response, contraindication, or intolerable side effect to one of the following:
o Trulance
o Lubiprostone ABA 8 mcg twice daily (females only)
o Amitiza 8 mcg twice daily (females only)
Reauthorization Criteria:
Request for continuation of treatment:
- Dose does not exceed FDA label maximum for an appropriate indication; AND
- Patient has experienced a positive clinical response to therapy.
Coverage Duration:
- Initial: 12/31/2099
- Reauthorization: 12/31/2099
Authorization is not covered for the following:
The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.
Additional Information:
- Linzess and Trulance carries a risk of serious dehydration in pediatric patients. The safety and effectiveness of Linzess and Trulance has not been established in patients less than 18 years.
- Maintenance laxative therapy should be discontinued prior to initiating Relistor; may reintroduce laxatives as needed if suboptimal response to Relistor after 3 days.
- Use of Relistor injections beyond 4 months has not been studied. Discontinue methylnaltrexone if opioids are discontinued.
- Alteration in analgesic dosing regimen prior to initiating Movantik is not required.
- Zelnorm should be discontinued in patients with an inadequate response after 4 to 6 weeks of treatment.
Policy Updates:
- 10/19/2021 –Prior authorization policies for agents used to treat CIC, IBS-C, and OIC are combined into step therapy policy; Removed prior authorization from Linzess , Movantik, and Symproic; removed requirements for fiber therapy, osmotic agents, or laxative agents; added step therapy with Linzess, Symproic, or Movantik for coverage of lubiprostone ABA/Amitiza; added step therapy Linzess for coverage of Trulance/Motegrity; added step therapy with Movantik or Symproic for coverage of Relistor tabs or Relistor injection.
- 08/16/2022 – Ibsrela: New policy approved by P&T.
References:
- Relistor Prescribing Information. Salix Pharmaceuticals. Bridgewater, NJ. April 2020.
- 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.
- Movantik Prescribing Information. AstraZeneca Pharmaceuticals LP. Wilmington, DE. April 2020.
- Symproic Prescribing Information. Shionogi Inc. Florham Park, NJ. May 2020.
- Linzess Prescribing Information. Allergan USA, Inc. Madison, NJ. September 2020.
- Trulance Prescribing Information. Salix Pharmaceuticals Inc. Bridgewater, NJ. February 2021.
- Amitiza Prescribing Information. Takeda Pharmaceuticals America, Inc. Deerfield, IL. November 2020.
- 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.
- Ibsrela prescribing information. Ardelyx, Inc. Waltham, MA. May 2021.
- 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%20bowe%20syndrome%20with%20constipation&source=search_result&selectedTitle=1~150&usage_type=default&display_rank=1#H23037175. Accessed April 3, 2022.
- Furnari, M., de Bortoli, N., et al. Optimal Management of Constipation Associated with Irritable Bowel Syndrome. Ther Clin Risk Manag. 2015;11:691-703. Available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4425337/. Accessed April 3, 2022.
- Lacy, Brian E. PhD, MD, FACG1; Pimentel, Mark MD, FACG2; Brenner, Darren M. MD, FACG3; Chey, William D. MD, FACG4; Keefer, Laurie A. PhD5; Long, Millie D. MDMPH, FACG (GRADE Methodologist)6; Moshiree, Baha MD, MSc, FACG7 ACG Clinical Guideline: Management of Irritable Bowel Syndrome, The American Journal of Gastroenterology: January 2021 - Volume 116 - Issue 1 - p 17-44 doi: 10.14309/ajg.0000000000001036
- Chang, L., Sultan, S., Lembo, A., Verne, G.N., Smalley, W., Heidelbaugh, J.J., AGA Clinical Practice Guideline on the Pharmacological Management of Irritable Bowel Syndrome With Constipation, Volume 163, Issue 1, P118-136, July 01, 2022., https://doi.org/10.1053/j.gastro.2022.04.016
- Black, C. J., Burr, N. E., Quigley, E., Moayyedi, P., Houghton, L. A., & Ford, A. C. (2018). Efficacy of Secretagogues in Patients With Irritable Bowel Syndrome With Constipation: Systematic Review and Network Meta-analysis. Gastroenterology, 155(6), 1753–1763. https://doi.org/10.1053/j.gastro.2018.08.021
- Shah, E. D., Lacy, B. E., Chey, W. D., Chang, L., & Brenner, D. M. (2021). Tegaserod for Irritable Bowel Syndrome With Constipation in Women Younger Than 65 Years Without Cardiovascular Disease: Pooled Analyses of 4 Controlled Trials. The American journal of gastroenterology, 116(8), 1601–1611. https://doi.org/10.14309/ajg.0000000000001313
Last review date: August 16, 2022