CurrentmhnPolicy CP.PMN.142

Lubiprostone (Amitiza) prior authorization and coverage criteria

Defines medical necessity, prior authorization, step therapy, dosing limits, and renewal criteria for lubiprostone (Amitiza) for chronic idiopathic constipation, IBS-C in adults, and opioid-induced constipation in adults under the payer's lines of business.

Policy Summary

Payermhn

PolicyLubiprostone (Amitiza) prior authorization and coverage criteria

Policy CodePolicy CP.PMN.142

Change TypeNo material change

Effective DateDec 1, 2014

Next Review Date

Key ActionSubmit prior authorization with documentation showing the member meets the diagnosis-specific criteria and required prior laxative therapy failures where applicable.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3FDA-approved indications covered

12 moApproval duration (initial)

48 mcg/dayMax dose (CIC/OIC)

16 mcg/dayMax dose (IBS-C)

≥18Minimum age

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Coverage and Medical Necessity Criteria

Initial Approval — Chronic Idiopathic Constipation (CIC)

Covered when ALL of the following are met:

CIC initial criteria: 1. Diagnosis of chronic idiopathic constipation (CIC); 2. Age ≥ 18 years; 3. Failure of one bulk-forming laxative (e.g., psyllium, methylcellulose, calcium polycarbophil) unless contraindicated or clinically significant adverse effects; 4. Failure of one stimulant laxative (e.g., bisacodyl, senna) unless contraindicated or clinically significant adverse effects; 5. Failure of polyethylene glycol (MiraLax) at up to maximally indicated doses unless contraindicated or clinically significant adverse effects; 6. Member must use generic lubiprostone unless contraindicated or clinically significant adverse effects; 7. Dose does not exceed both of the following: (a) 48 mcg per day; and (b) 2 capsules per day.

Approval duration: 12 months

Initial Approval — Irritable Bowel Syndrome with Constipation (IBS-C)

Covered when ALL of the following are met:

IBS-C initial criteria: 1. Diagnosis of irritable bowel syndrome with constipation (IBS-C); 2. Age ≥ 18 years; 3. Failure of one bulk-forming laxative (e.g., psyllium, methylcellulose, calcium polycarbophil) unless contraindicated or clinically significant adverse effects; 4. Member must use generic lubiprostone unless contraindicated or clinically significant adverse effects; 5. Dose does not exceed both of the following: (a) 16 mcg per day; and (b) 2 capsules per day.

Initial Approval — Opioid-Induced Constipation (OIC)

Covered when ALL of the following are met:

OIC initial criteria: 1. Diagnosis of opioid-induced constipation (OIC); 2. Age ≥ 18 years; 3. Member has been taking opioid(s) for ≥ 4 weeks for chronic pain not caused by active cancer; 4. Failure of one agent from each of the following classes while on opioid therapy, unless contraindicated or clinically significant adverse effects: (a) stimulant laxative (e.g., bisacodyl, senna); (b) osmotic laxative (e.g., lactulose, polyethylene glycol); (c) stool softener (e.g., docusate); 5. Member has used one of the aforementioned agents in the past 30 days unless contraindicated; 6. Member must use generic lubiprostone unless contraindicated or clinically significant adverse effects; 7. Dose does not exceed both of the following: (a) 48 mcg per day; and (b) 2 capsules per day.

Approval duration: 12 months

Continued Therapy — All Indications

Covered when ALL of the following are met:

Continued therapy criteria: 1. Member meets one of the following: (a) currently receiving medication via the Centene benefit or previously met initial approval criteria; or (b) currently receiving medication and enrolled in a state/product with continuity of care regulations; 2. For OIC, member continues to receive opioid therapy; 3. Member is responding positively to therapy; 4. Member must use generic lubiprostone unless contraindicated or clinically significant adverse effects; 5. If request is for a dose increase, the new dose does not exceed indication-specific maximums: (a) For IBS-C: 16 mcg per day and 2 capsules per day; (b) For CIC or OIC: 48 mcg per day and 2 capsules per day.

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider supplies sufficient documentation of efficacy and safety in accordance with applicable off‑label use policies: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid, or unless coverage is supported by the applicable evidence of coverage documents.

Coverage determinations under this clinical policy are guides to medical necessity and do not guarantee payment. All coverage decisions and the administration of benefits remain subject to the specific terms, conditions, exclusions, and limitations of the member's coverage documents (for example, evidence of coverage, certificate of coverage, policy or contract), as well as applicable state and federal requirements and Health Plan administrative policies and procedures.

Dosage Limits and Coding

Maximum daily dose

Maximum daily dose — CIC and OIC48 mcg per day (24 mcg PO twice daily); do not exceed 2 capsules/day

Maximum daily dose — IBS-C16 mcg per day (8 mcg PO twice daily); do not exceed 2 capsules/day

Capsule strengths referencedAvailable strengths referenced as 8 mcg and 24 mcg capsules

Prior Authorization, Step Therapy, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. For Opioid-Induced Constipation (OIC) indications, initial approval duration was updated from 6 to 12 months during the 4Q 2025 annual review; continued therapy criteria for OIC now require that the member continues to receive opioid therapy. Providers must request prior authorization and include all required supporting documentation to demonstrate that the member meets diagnosis-specific criteria and prior laxative therapy failures as specified in the approval criteria.

4Q2025 update: OIC initial approval duration changed to 12 months; continued therapy requires ongoing opioid use (see annual review notes).
Prior authorization required for CIC, IBS‑C, and OIC per criteria.

Step Therapy

Step Therapy Requirements

Step therapy requirements apply per indication. Providers must document failures of the specified laxative classes and use of generic lubiprostone where required, unless contraindicated or if clinically significant adverse effects are experienced.

CIC: failure of one bulk-forming laxative, one stimulant laxative, and polyethylene glycol (MiraLAX) at maximally indicated doses; trial of generic lubiprostone required unless contraindicated.

Key Terms and Indications

CIC — Definition and requirements

TermChronic idiopathic constipation (CIC)

DefinitionDiagnosis of CIC as required for coverage; policy references CIC abbreviation in Appendix A and therapeutic alternatives in Appendix B

Age requirementAge ≥ 18 years for initial approval

IBS-C — Definition and references

TermIrritable bowel syndrome with constipation (IBS-C)

DefinitionDiagnosis of IBS-C as required for coverage; referenced guideline citations for IBS management are included (AGA, ACG).

Age requirement

Drug Background and Clinical Context

Lubiprostone is a chloride channel activator that increases intestinal fluid secretion to facilitate transit and bowel movements. It is indicated for adult patients with chronic idiopathic constipation (CIC), for adult women with irritable bowel syndrome with constipation (IBS‑C), and for adults with opioid‑induced constipation (OIC) associated with chronic non‑cancer pain. Available capsule strengths include 8 mcg and 24 mcg, and dosing varies by indication with maximum daily doses specified per indication.

Policy Review and Revision History

2014-12-01policy effective

Policy originally effective date recorded for lubiprostone clinical coverage criteria.

2022-07-26annual review

4Q 2022 annual review: no significant clinical changes; references reviewed and template updates applied.

2023-07-05annual review

4Q 2023 annual review: no significant clinical changes; references reviewed and updated.

Policy Summary

Payermhn

PolicyLubiprostone (Amitiza) prior authorization and coverage criteria

Policy CodePolicy CP.PMN.142

Change TypeNo material change

Effective DateDec 1, 2014

Next Review Date

Key ActionSubmit prior authorization with documentation showing the member meets the diagnosis-specific criteria and required prior laxative therapy failures where applicable.

SourceLink

On This Page

IBS‑C: failure of one bulk-forming laxative; trial of generic lubiprostone required unless contraindicated.

OIC: failure of one agent from each class while on opioid therapy — stimulant laxative, osmotic laxative, and stool softener; member must have used one of these agents in the past 30 days; trial of generic lubiprostone required unless contraindicated.

Dose limits per indication must be met.

Documentation Required

Required Supporting Documentation

Provider must submit documentation (such as office chart notes, lab results, medication history or other clinical information) supporting that the member has met all approval criteria. Documentation should clearly indicate prior medication trials, dates, doses, reasons for discontinuation (if applicable), current opioid use for OIC, and any contraindications or adverse effects to therapies tried.

Examples: office visit notes, medication administration records, pharmacy fill history, relevant laboratory results.
For OIC: documentation of opioid use ≥ 4 weeks for chronic pain (not due to active cancer) and recent use of a qualifying laxative agent within 30 days, unless contraindicated.

Documentation Required

Documentation Insufficiency

Lack of required or sufficient documentation may result in denial of the prior authorization or a request for additional information. Ensure submitted records clearly support each criterion; vague or missing evidence of prior laxative trials, opioid use, or contraindications can trigger administrative denials.

Incomplete medication histories, absent dates/doses, or missing clinical notes are common denial triggers.
If documentation is insufficient, the plan may request additional information or deny the request per administrative policy.

Denial Risk

Coverage and Administrative Limits May Trigger Denial

Coverage decisions remain subject to the member's plan terms, conditions, exclusions, and limitations. This policy is a guide to medical necessity and does not guarantee payment. Providers should verify benefits and applicable coverage rules prior to submission.

Denials may be issued based on plan exclusions, non‑covered indications, or other administrative limits.
This policy does not supersede evidence of coverage, certificate of coverage, or contract terms.

Step Therapy

Step Therapy Bypass for Illinois HIM

Step therapy bypass: For Illinois HIM requests, the step therapy requirements described in the criteria do not apply as of 1/1/2026 per IL HB 5395. Submit requests for Illinois HIM members with appropriate indication documentation; do not rely on step-failure documentation for bypassing required steps in that line of business.

IL HIM step therapy bypass effective 01/01/2026 per IL HB 5395.
Other lines of business remain subject to the standard step therapy requirements unless otherwise noted.

Note

Provider Responsibility

Providers are expected to exercise professional medical judgment in managing patient care. This policy is not intended to dictate clinical practice; providers remain solely responsible for medical advice and treatment decisions.

The policy provides coverage guidance but does not replace individualized clinical decision‑making.
Providers should document rationale when deviating from step therapy or when contraindications justify bypassing preferred therapies.

Age ≥ 18 years for initial approval

OIC — Definition and requirements

TermOpioid-induced constipation (OIC)

DefinitionDiagnosis of OIC required for coverage; policy requires opioid use ≥ 4 weeks for chronic pain (not caused by active cancer)

Age requirementAge ≥ 18 years for initial approval

OIC — Referenced guidelines and consensus documents

Primary guideline sources — OICAmerican Gastroenterological Association Institute Guidelines on the Medical Management of Opioid-Induced Constipation (Crockett et al., 2019)

Consensus recommendationsConsensus Recommendations on Initiating Prescription Therapies for Opioid-Induced Constipation (Argoff et al., 2015)

Reviews and clinical guidanceMultiple reviews and guidance articles on OIC pathophysiology and management (e.g., Nelson & Camilleri; Kumar et al.; Camilleri et al.) cited in policy

2024-07-12annual review

4Q 2024 annual review: no significant clinical changes; references reviewed and updated.

2025-10-01annual review/planned changeLatest

4Q 2025 annual review: for OIC, initial approval duration updated from 6 to 12 months; continued therapy criteria added that member continues opioid therapy; step therapy bypass added for IL HIM per IL HB 5395; references reviewed and updated.

This policy is developed as a clinical guide and does not constitute medical advice or dictate clinical practice. Providers remain responsible for exercising professional medical judgment and must submit necessary clinical documentation (such as office chart notes, laboratory results, or other information) to support that the member meets all applicable approval criteria. In cases where this policy conflicts with state Medicaid provisions, the state Medicaid manual and applicable law govern.