CurrentCignaPolicy IP0455

Tenapanor (Ibsrela) for Irritable Bowel Syndrome with Constipation (IBS‑C) — Coverage Criteria

Defines medical necessity criteria for coverage of tenapanor (Ibsrela) for adults with irritable bowel syndrome with constipation (IBS‑C) under Cigna-administered plans; includes initial, reauthorization, and coverage limitations.

Policy Summary

PayerCigna

PolicyTenapanor (Ibsrela) for IBS‑C — Coverage Criteria

Policy CodePolicy IP0455

Change TypeNo material change

Effective DateFeb 1, 2024

Next Review DateFeb 1, 2025

Key ActionObtain prior authorization and document age, IBS‑C diagnosis, and required prior-agent treatment or contraindications per plan group.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+minimum age for coverage

up to 12 moauthorization duration

linaclotide + plecanatideEmployer Group prior agents

linaclotideIndividual & Family prior agent

Coverage Criteria for tenapanor (Ibsrela)

Policy Summary

PayerCigna

PolicyTenapanor (Ibsrela) for IBS‑C — Coverage Criteria

Policy CodePolicy IP0455

Change TypeNo material change

Effective DateFeb 1, 2024

Next Review DateFeb 1, 2025

Key ActionObtain prior authorization and document age, IBS‑C diagnosis, and required prior-agent treatment or contraindications per plan group.

SourceLink

On This Page

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Employer Group Initial Criteria: 1. Age 18 years or older18 years

Employer Group Initial Criteria: 2. Documented diagnosis of irritable bowel syndrome with constipation (IBS-C)

Employer Group Initial Criteria: 3. Documentation of failure, contraindication, or intolerance to BOTH linaclotide (Linzess) AND plecanatide (Trulance)failure/intolerance/contraindication to both agents

Employer Group requires both agents failed or not tolerated.

Individual & Family Plan Initial Therapy

Individual and Family Plan coverage — Ibsrela is considered medically necessary when ALL of the following are met:

Individual & Family Initial Criteria: 1. Age 18 years or older18 years

Individual & Family Initial Criteria: 2. Documented diagnosis of irritable bowel syndrome with constipation (IBS-C)

Individual & Family Initial Criteria: 3. Documentation of failure, contraindication, or intolerance to linaclotide (Linzess)failure/intolerance/contraindication to linaclotide

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Coverage is contingent on meeting the plan's medical necessity criteria for tenapanor (Ibsrela); claims for tenapanor may be denied if authorization is not obtained or criteria are not met.

Step Therapy

Step Therapy / Prior Agent Requirements

For coverage under Employer Group and Individual & Family plans, documentation must show failure, contraindication, or intolerance to required prior agents before tenapanor is authorized. Employer Group requires failure, contraindication, or intolerance to BOTH linaclotide (Linzess) AND plecanatide (Trulance). Individual & Family plans require failure, contraindication, or intolerance to linaclotide (Linzess).

Employer Group: linaclotide (Linzess) AND plecanatide (Trulance) — documented failure, contraindication, or intolerance required
Individual & Family Plan: linaclotide (Linzess) — documented failure, contraindication, or intolerance required

Documentation Required

Required Documentation for Continuation

For reauthorization/continuation of tenapanor (Ibsrela), submit documentation that the member meets the original medical necessity criteria and that there has been a beneficial clinical response to therapy.

Documentation of initial diagnostic and prior therapy history supporting original approval
Objective or clinical evidence of beneficial response since initiation of tenapanor

Denial Risk

Non‑Covered Uses / Denial Risk

Uses of tenapanor (Ibsrela) outside the specified indication (irritable bowel syndrome with constipation meeting the plan criteria) are not covered and are considered not medically necessary; such requests are at high risk for denial.

Any use not meeting the documented IBS‑C indication and required prior-agent/authorization criteria
Requests lacking required prior-agent failure/contraindication/intolerance documentation or lacking evidence of benefit for continuation

Definitions

Ibsrela (tenapanor) — key drug definition and indication

Drug name (generic)tenapanor

Brand nameIbsrela

Mechanism of actionSodium/hydrogen exchanger 3 (NHE3) inhibitor

Indication (per policy)Treatment of irritable bowel syndrome with constipation (IBS‑C) in adults

Policy effective date2024-02-01

IBS‑C — definition of the condition required for coverage

Condition nameIrritable bowel syndrome with constipation (IBS‑C)

Required population for coverageAdults (age 18 years or older)

Role in this policyDiagnosed condition required for medical necessity of tenapanor (Ibsrela)

Related agents referencedlinaclotide (Linzess), plecanatide (Trulance)

OpenPayer

Tenapanor (Ibsrela) for Irritable Bowel Syndrome with Constipation (IBS‑C) — Coverage Criteria

Coverage Criteria for tenapanor (Ibsrela)

Provider Actions and Requirements

Background

Definitions