CurrentCentenePolicy CP PMN.142

Lubiprostone (Amitiza) Coverage Policy

Defines Centene medical necessity criteria, prior authorization and continuation requirements for lubiprostone (Amitiza) for CIC, IBS-C, and OIC across applicable lines of business.

Policy Summary

PayerCentene

PolicyLubiprostone (Amitiza) Coverage Policy

Policy CodePolicy CP PMN.142

Change TypeNo material changes noted

Effective DateDec 1, 2014

Next Review Date

Key ActionObtain prior authorization with documentation of diagnosis-specific criteria and prior trials/failures of required laxative classes; require use of generic lubiprostone unless contraindicated.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsinitial approval CIC/IBS-C

6 monthsinitial approval OIC

48 mcg/daymax daily dose (CIC/OIC)

16 mcg/daydaily dose (IBS-C)

Commercial, HIM, Medicaidapplicable lines

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Initial Therapy — Chronic Idiopathic Constipation (CIC)

Covered when ALL of the following are met

CIC Initial: 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 (e.g., MiraLAX) at maximally indicated doses unless contraindicated or clinically significant adverse effects. 6. Member must use generic lubiprostone unless contraindicated or clinically significant adverse effects are experienced. 7. Dose does not exceed both: (a) 48 mcg per day and (b) 2 capsules per day.

Approval duration: 12 months

Continued Therapy

Covered when ALL of the following are met

Continued Therapy: 1. Member is currently receiving medication via the Centene benefit or has previously met initial approval criteria. 2. Member is responding positively to therapy. 3. Member must use generic lubiprostone unless contraindicated or clinically significant adverse effects are experienced. 4. If a dose increase is requested, the new dose must not exceed: (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.

Continuity of care provisions may apply per state/product.

Requests for use of lubiprostone (Amitiza) for non‑FDA approved indications that are not specifically addressed in this clinical policy are not authorized unless the request includes sufficient supporting documentation of efficacy and safety as required by the applicable off‑label use policies (see CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, and CP PMN.53 for Medicaid) or other evidence of coverage documents.

Lubiprostone is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction. Requests for therapy in these patients should be denied based on this contraindication unless clear clinical evidence demonstrates obstruction is absent and treatment is otherwise appropriate.

For members covered under Medicaid, state Medicaid coverage provisions take precedence over the provisions of this clinical policy where conflicts exist. Providers should consult the applicable state Medicaid manual for any state‑specific coverage rules that apply to lubiprostone.

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Requests must include documentation supporting the diagnosis and that the member meets all applicable approval criteria for the specific indication (CIC, IBS-C, or OIC), including age requirements and dosing not to exceed the policy limits.

Prior authorization must document diagnosis-specific criteria, prior trial(s)/failures, age, dosing, and use of generic lubiprostone unless contraindicated.
Approval durations: CIC — 12 months; IBS-C — 12 months; OIC — 6 months.

Note

Prior Authorization Note

Note: The policy requires use of generic lubiprostone when available unless there is documented contraindication or clinically significant adverse effects. Business-line applicability and references have been updated per SDC and clinical guidance (see revision history).

Requirement for use of generic lubiprostone added (March SDC).
Policy references and line-of-business applicability were updated in 2020–2022 reviews.

Denial Risk

Non-covered Indications

Requests for indications not authorized by FDA and not addressed in this policy are not covered unless sufficient documentation of efficacy and safety is provided per the applicable off-label use policies and evidence of coverage documents.

Non-FDA approved indications require documentation per off-label use policies: CP CPA.09 (commercial), HIM.PA.154 (health insurance marketplace), CP PMN.53 (Medicaid), or relevant evidence of coverage documents.

Denial Risk

No Specific Denial Triggers Listed

No specific denial triggers are listed in the policy text. However, lack of required documentation (diagnosis, prior trials/failures, age, dosing, or inability to justify use of branded product when generic is available) may result in denial under standard review.

Absence of documentation of required prior trials or contraindications to required agents may lead to non-authorization.
Use of branded lubiprostone without documented contraindication to generic formulation may affect coverage decisions.

Step Therapy

Step Therapy / Required Prior Agents

Step therapy / required prior agents: Prior authorization requires documented failure (or contraindication/intolerance) of specified laxative classes before approval depending on indication.

CIC: Failure of one bulk-forming laxative (e.g., psyllium, methylcellulose, calcium polycarbophil) AND failure of one stimulant laxative (e.g., bisacodyl, senna) AND failure of polyethylene glycol (MiraLax) at maximally indicated doses, unless contraindicated or adverse effects.
IBS-C: Failure of one bulk-forming laxative unless contraindicated or adverse effects.
OIC: Member must have been on opioids ≥ 4 weeks for chronic pain (non-cancer) and failed one agent from each class while on opioid therapy: stimulant laxative, osmotic laxative (e.g., lactulose or polyethylene glycol), and a stool softener (e.g., docusate). At least one of the aforementioned agents must have been used in the past 30 days unless contraindicated.

Billing Rule

Generic Product Requirement

Generic product requirement: Use of generic lubiprostone is required unless there is documented contraindication or clinically significant adverse effects to the generic formulation.

Added requirement for use of generic lubiprostone per March SDC and subsequent reviews.
If generic is contraindicated or not tolerated, documentation must be provided to justify use of branded product.

Condition Definitions and Guideline References

CIC — definition

TermChronic idiopathic constipation (CIC)

DefinitionChronic idiopathic constipation

Appendix referenceListed in Appendix A abbreviations as CIC

OIC — definition

TermOpioid‑induced constipation (OIC)

DefinitionOpioid-induced constipation

Appendix referenceListed in Appendix A abbreviations as OIC

IBS-C — definition

TermIrritable bowel syndrome with constipation (IBS-C)

DefinitionIrritable bowel syndrome with constipation

Appendix referenceListed in Appendix B/General Information as IBS-C abbreviation

Chronic idiopathic constipation (CIC) — guideline references

ASCRSClinical Practice Guideline for constipation (ASCRS) referenced via link to guideline document

AGAAmerican Gastroenterological Association medical position statement on constipation (Bharucha AE et al., Gastroenterol. 2013) and AGA-ACG pharmacological management guideline (Gastroenterology 2023)

ACGAmerican College of Gastroenterology monograph on management of IBS and CIC (Am J Gastroenterol. 2014) referenced

Irritable bowel syndrome with constipation (IBS-C) — guideline references

AGA (IBS pharmacologic)American Gastroenterological Association Institute guideline on pharmacological management of irritable bowel syndrome (Weinberg DS et al., Gastroenterology. 2014)

ACGACG clinical guideline: Management of irritable bowel syndrome (Lacy BE et al., Am J Gastroenterol. 2021)

AGA (IBS-C specific)AGA clinical practice guideline on pharmacological management of irritable bowel syndrome with constipation (Chang L et al., Gastroenterology. 2022)

Opioid‑induced constipation (OIC) — guideline references and consensus recommendations

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

AGA guidelinesAmerican Gastroenterological Association Institute Guidelines on the Medical Management of Opioid-Induced Constipation (Crockett SD et al.) referenced

Additional reviewsReviews and guidance on OIC pathophysiology and management (Nelson AD; Kumar L; Pergolizzi JV et al.) cited as supporting references

OpenPayer

Lubiprostone (Amitiza) Coverage Policy

Coverage Criteria for Lubiprostone (Amitiza)

Provider Requirements, Prior Authorization, and Documentation

Background on Lubiprostone

Condition Definitions and Guideline References