CurrentmhnPolicy CP.PMN.71

Clinical Policy: Linaclotide (Linzess)

This policy defines medical necessity criteria, prior authorization and continued therapy requirements for linaclotide (Linzess) for IBS-C, chronic idiopathic constipation (CIC) in adults, and functional constipation (FC) in pediatric patients, for Medicaid line of business.

Policy Summary

Payermhn

PolicyLinaclotide (Linzess) coverage

Policy CodePolicy CP.PMN.71

Change TypeNo material changes

Effective DateNov 1, 2015

Next Review DateJul 14, 2025

Key ActionSubmit documentation showing the member meets the applicable approval criteria, including age and prior therapy trials.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3FDA-approved indications listed

12 monthsApproval duration (initial/continued)

Age-specificDistinct maximum doses

RT4New pediatric indication

NCApplicable state

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

Covered when ALL of the following are met

IBS-C initial criteria: 1. Diagnosis of IBS-C; 2. Age ≥ 18 years; 3. Failure of one bulk forming laxative (e.g., psyllium, methylcellulose, calcium polycarbophil), unless clinically significant adverse effects or contraindication; 4. Failure of generic lubiprostone, unless contraindicated or clinically significant adverse effects; 5. Dose does not exceed both: a) 290 mcg per day; b) 1 capsule per day.

Approval duration: 12 months

Initial Approval — Chronic Idiopathic Constipation (CIC)

Covered when ALL of the following are met

CIC initial criteria: 1. Diagnosis of CIC; 2. Age ≥ 18 years; 3. Failure of one bulk forming laxative (e.g., psyllium, methylcellulose, calcium polycarbophil), unless clinically significant adverse effects or contraindication; 4. Failure of one stimulant laxative (e.g., bisacodyl, senna), unless clinically significant adverse effects or contraindication; 5. Failure of polyethylene glycol (MiraLax) at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects; 6. Failure of generic lubiprostone, unless contraindicated or clinically significant adverse effects; 7. Dose does not exceed both: a) 145 mcg per day; b) 1 capsule per day.

Approval duration: 12 months

Initial Approval — Functional Constipation (FC) in Pediatrics

Covered when ALL of the following are met

FC pediatric initial criteria: 1. Diagnosis of FC; 2. Age 6 to 17 years; 3. Failure of one bulk forming laxative (e.g., psyllium, methylcellulose, calcium polycarbophil), unless clinically significant adverse effects or contraindication; 4. Failure of polyethylene glycol (MiraLax) at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects; 5. Failure of at least ONE of: a) stimulant laxative (e.g., bisacodyl, senna); b) osmotic laxative (e.g., lactulose, magnesium hydroxide); c) lubricant laxative (e.g., mineral oil); unless clinically significant adverse effects or contraindication; 6. Dose does not exceed 72 mcg (1 capsule) 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 Centene benefit or previously met initial approval criteria; b) currently receiving medication and enrolled in a state/product with continuity of care regulations; 2. Member is responding positively to therapy; 3. If request is for dose increase, new dose does not exceed indication-specific maximums: IBS-C 290 mcg/day (1 capsule/day); CIC 145 mcg/day (1 capsule/day); FC 72 mcg/day (1 capsule/day).

Approval duration: 12 months

Other diagnoses/indications

Other uses guidance: If this drug has had a label change within the last 6 months that is not yet reflected in this policy, refer to: a) CP.PMN.255 for drugs on the formulary/PDL (Medicaid) or b) CP.PMN.16 for drugs not on the formulary/PDL. If the requested use is not listed under the policy's exclusions and the label-change criterion does not apply, refer to off-label use policy CP.PMN.53.

Non‑FDA approved indications that are not specifically addressed by this policy are excluded from coverage unless there is sufficient documentation of efficacy and safety in accordance with the Medicaid off‑label use policy CP.PMN.53 or the member's evidence of coverage documents demonstrating a covered benefit for the requested use.

Linaclotide is contraindicated in patients younger than 2 years of age and in patients with known or suspected mechanical gastrointestinal obstruction; these contraindications must be observed when evaluating requests for coverage.

For Medicaid members, any applicable state Medicaid coverage provisions take precedence when they conflict with the provisions of this clinical policy; providers should consult the state Medicaid manual for specific state-level coverage requirements.

Use of linaclotide for non‑FDA approved indications that are not addressed in this policy is generally not authorized unless the request is supported by adequate clinical documentation per the Medicaid off‑label use policy CP.PMN.53 or by evidence of coverage demonstrating the request is a covered benefit.

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization required — documentation that the member meets applicable initial approval criteria for the requested indication. Provider must submit documentation (office chart notes, lab results, or other clinical information) supporting that member has met all approval criteria.

Applies to all indications listed in this policy; approval durations vary by indication (see criteria).
Prior authorization requests may be denied if required documentation is not provided.

Step Therapy

Therapeutic Trials (Step Therapy)

Therapeutic trials required — Step therapy: trial and failure (or intolerance/contraindication) of specified laxatives and generic lubiprostone where required prior to approval.

IBS‑C: failure of one bulk-forming laxative and failure of generic lubiprostone unless contraindicated or adverse effects.
Chronic idiopathic constipation / other indications: failure of stimulant laxative and polyethylene glycol and failure of generic lubiprostone where specified.
Functional constipation (pediatric): failure of one bulk-forming laxative, polyethylene glycol, and at least one additional laxative class as listed.
Dose limits in criteria must be met.

Note

Historical Step‑Therapy Note

Historical step‑therapy note — per June SDC and prior clinical guidance, the policy was updated to add a requirement for use of generic lubiprostone prior to approval (historical context).

Change recorded during policy updates: requirement for generic lubiprostone added and applied to applicable lines of business (HIM line addition/retirement notes in policy history).

Documentation Required

Supporting Documentation Required

Supporting documentation required — provider must submit documentation (office notes, labs, other clinical information) supporting that member meets criteria.

Include diagnosis, prior therapies tried (drug names, doses, dates), reasons for discontinuation (adverse effects or lack of efficacy), and member age.
Documentation should demonstrate trials of required laxatives and generic lubiprostone when applicable.

Denial Risk

Non‑FDA Approved Indications

Non‑FDA approved indications — requests for non‑FDA uses not addressed may be denied without sufficient documentation per off‑label use policy.

Coverage for off‑label uses requires sufficient documentation of efficacy and safety per CP.PMN.53 (Medicaid) or the member's evidence of coverage.
If non‑covered by this policy, prior authorization may be denied.

Note

Provider Responsibility and Coverage Limits

Provider responsibility and coverage limits — providers expected to exercise professional medical judgment; coverage subject to member's evidence of coverage and all plan terms, conditions, exclusions, and limitations.

This clinical policy is a guide to medical necessity and does not guarantee payment.
Approval durations (typically 12 months) and dose limits in the criteria must be adhered to.
Denials may occur based on benefit limitations in the member's coverage documents.

Definitions and Indication Labels

CIC — Definition and policy context

TermChronic idiopathic constipation

AbbreviationCIC

Context in policyListed as an FDA‑approved indication for linaclotide in adults with specific prior‑therapy requirements and a 145 mcg/day max dose.

FC — Definition and policy context

TermFunctional constipation

AbbreviationFC

Age group (policy)Pediatric patients aged 6 to 17 years for the FC indication.

IBS-C — Definition and policy context

TermIrritable bowel syndrome with constipation

AbbreviationIBS-C

Age group (policy)Adults age ≥ 18 years for the IBS‑C indication with a 290 mcg/day maximum dose.

Chronic Idiopathic Constipation (alternate phrasing)

Preferred phrasingChronic Idiopathic Constipation

Use in policyAppears in appendices and references supporting the CIC indication and clinical guidance.

Synonym/NoteAlso abbreviated as CIC in the policy appendices.

Functional pediatric constipation — new indication (RT4)

Term addedFunctional pediatric constipation

Policy noteRT4: new indication added for functional pediatric constipation; included age 6–17 and 72 mcg/day dosing.

Contraindication reminderContraindications updated per product information; avoid use in patients < 2 years due to boxed warning for dehydration.

OpenPayer

Clinical Policy: Linaclotide (Linzess)

Coverage Criteria for Linaclotide (Linzess)

Dosing and Maximum Daily Dose by Indication

Provider Requirements and Prior Authorization

Background on Linaclotide

Definitions and Indication Labels