CurrentHealth NetPolicy CP PMN.71

Linaclotide (Linzess)

Policy governing medical necessity criteria, dosing limits, and coverage for linaclotide (Linzess) across indications (IBS-C, CIC, pediatric functional constipation) for Health Net / Centene affiliated plans (Medicaid line of business). Applies to providers requesting coverage for members.

Policy Summary

PayerHealth Net

PolicyLinaclotide (Linzess)

Policy CodePolicy CP PMN.71

Change TypeNo material changes

Effective DateNov 1, 2015

Next Review DateNov 24, 2024

Key ActionSubmit prior authorization with documentation showing failures of required laxatives and that dosing limits do not exceed indication-specific maximums.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3FDA-approved indications

3capsule strengths

12approval duration (months)

Yesboxed warning <2 yrs

AppliesMedicaid precedence

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Initial Approval — IBS‑C (adults)

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 clinically significant adverse effects or contraindications; 4) Failure of generic lubiprostone unless contraindicated or clinically significant adverse effects are experienced; 5) Dose does not exceed 290 mcg per day AND 1 capsule per day; Approval duration: 12 months

Initial Approval — Chronic Idiopathic Constipation (CIC, adults)

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 clinically significant adverse effects or contraindications; 4) Failure of one stimulant laxative (e.g., bisacodyl, senna) unless clinically significant adverse effects or contraindications; 5) Failure of generic lubiprostone unless contraindicated or clinically significant adverse effects are experienced; 6) Dose does not exceed 145 mcg per day AND 1 capsule per day; Approval duration: 12 months

Initial Approval — Functional Constipation (FC, pediatric 6–17 years)

Covered when ALL of the following are met

FC initial criteria: 1) Diagnosis of functional constipation (FC); 2) Age 6 to <18 years; 3) Failure of one bulk‑forming laxative (e.g., psyllium, methylcellulose, calcium polycarbophil) unless clinically significant adverse effects or contraindications; 4) Failure of polyethylene glycol (MiraLax) at maximally indicated doses unless clinically significant adverse effects or contraindications; 5) Failure of at least one of the following unless clinically significant adverse effects or contraindications: a) stimulant laxative (e.g., bisacodyl, senna), b) osmotic laxative (e.g., lactulose, magnesium hydroxide), or c) lubricant laxative (e.g., mineral oil); 6) Dose does not exceed 72 mcg (1 capsule) per day; Approval duration: 12 months

Continued Therapy

Covered when ALL of the following are met

Continued therapy criteria: 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) If request is for a dose increase, new dose does not exceed indication‑specific maximums: IBS‑C — 290 mcg/day and 1 capsule/day; CIC — 145 mcg/day and 1 capsule/day; FC (pediatric) — 72 mcg/day and 1 capsule/day; Approval duration: 12 months

Requests for non‑FDA approved indications that are not specifically addressed in this policy are excluded from coverage unless the provider supplies sufficient documentation of efficacy and safety in accordance with the Health Plan’s off‑label use policy CP PMN.53 (or applicable evidence of coverage documents).

This clinical policy is a coverage guideline and does not constitute medical advice, a treatment recommendation, or a guarantee of payment. Coverage decisions remain subject to the terms, conditions, exclusions, and limitations of the member’s evidence of coverage or contract, as well as applicable state and federal laws and Health Plan administrative policies. Providers are expected to exercise professional medical judgment and remain solely responsible for clinical care and treatment decisions.

Prior Authorization, Step Therapy, and Provider Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for linaclotide (Linzess). Initial and continued therapy approvals are contingent on meeting the diagnosis‑specific clinical criteria in this policy. Approval duration is up to 12 months when criteria are met. Requests that do not meet the criteria may be denied.

Policy effective date: 2015-11-01
Approval duration: 12 months

Documentation Required

Required Documentation

Providers must submit supporting clinical documentation with the prior authorization request. Acceptable documentation includes but is not limited to: office chart notes, relevant laboratory or diagnostic results, medication trial history (including dates, doses, and reasons for discontinuation), and other clinical information demonstrating medical necessity.

Include documentation of prior laxative trials and lubiprostone use where applicable
Provide member age and diagnosis details
Document contraindications or adverse effects if skipping step therapy

Step Therapy

Step Therapy Requirements

Step therapy requirements apply and must be documented. For most indications, members must have tried and had an inadequate response to or intolerance/contraindication to at least one bulk‑forming laxative (examples: psyllium/Metamucil, methylcellulose/Citrucel, calcium polycarbophil/FiberCon) prior to approval. For certain indications the policy also requires failure of a stimulant laxative and/or polyethylene glycol (PEG 3350) or trial of generic lubiprostone prior to linaclotide.

Document trials of bulk‑forming laxative (dose/duration) or rationale for avoidance
Where required, document trial/failure of stimulant laxative (e.g., bisacodyl, senna) or polyethylene glycol
Policy includes age‑specific requirements and demonstrated failure/intolerance before approval

Note

Preferred Agent / Step Considerations (historical)

Historically the policy was updated to add a requirement for use of generic lubiprostone prior to linaclotide where clinically appropriate. Prior authorization edits and preferred product considerations may have applied in the past; clinicians should follow current policy criteria and document use or contraindication of preferred agents.

Per policy history, addition of generic lubiprostone requirement (see policy criteria)
Prior edits related to preferred agents are historical; current determinations follow the clinical criteria herein

Definitions and Abbreviations

Definition — Chronic idiopathic constipation

TermChronic idiopathic constipation (CIC)

AbbreviationCIC

ContextListed as a distinct indication addressed by the policy for adult patients; see approval criteria for required prior laxative trials and maximum dose (145 mcg/day).

Definition — Irritable bowel syndrome with constipation

TermIrritable bowel syndrome with constipation (IBS-C)

AbbreviationIBS-C

ContextListed as an FDA-approved indication for adults; policy requires prior laxative trials and limits dose to 290 mcg/day (1 capsule/day).

Definition — Functional constipation

TermFunctional constipation (FC)

AbbreviationFC

ContextDefined as functional constipation and addressed as the pediatric indication (ages 6 to <18 years); policy requires prior laxative trials including polyethylene glycol and limits dose to 72 mcg/day (1 capsule/day).

Clinical conditions addressed by guideline literature and prescribing information

Clinical conditions referencedChronic idiopathic constipation (CIC) — guideline literature: AGA/ACG clinical practice guidelines cited in policy references.

Clinical conditions referencedFunctional constipation (FC) — pediatric guideline literature on pharmacological management cited in policy references.

Source of guidanceLinaclotide (Linzess) prescribing information and cited guideline literature are used to define indications and dosing in this policy.

OpenPayer

Linaclotide (Linzess)

Coverage Criteria for Linaclotide (Linzess)

Dosing Limits and Code-related Details

Prior Authorization, Step Therapy, and Provider Documentation

Background on Linaclotide

Definitions and Abbreviations