CurrentCignaPolicy IP0455

tenapanor (Ibsrela) for IBS-C — Coverage Criteria

Cigna coverage policy for medical necessity review of tenapanor (Ibsrela) tablets for treatment of irritable bowel syndrome with constipation (IBS-C) in adults; applies to Cigna-administered health benefit plans and affected lines of business.

Policy Summary

PayerCigna

Policytenapanor (Ibsrela) for IBS-C — Coverage Criteria

Policy CodePolicy IP0455

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization and document age, IBS‑C diagnosis, prior therapy history, and beneficial response for reauthorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Age ≥ 18minimum patient age for coverage

Up to 12 monthsinitial and reauthorization approval duration

Failure to 1–2 agentsprevious therapy required prior to coverage (varies by line of business)

Adults with IBS-Cindication covered when criteria met

Coverage Criteria

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Initial therapy (by line of business)

Covered when ALL of the following are met.

Main criteria: 1. Patient is age 18 years or older.Age ≥ 18

See plan-specific prior therapy requirements below.

Main criteria: 2. Documented diagnosis of irritable bowel syndrome with constipation (IBS-C).

Diagnosis must be documented in the medical record.

Prior therapy requirements (plan-specific)

Employer Group plans: Documentation of failure, contraindication, or intolerance to BOTH linaclotide (Linzess) AND plecanatide (Trulance).
Both agents required for Employer Group.
Individual and Family plans: Documentation of failure, contraindication, or intolerance to linaclotide (Linzess).
Single-agent requirement for Individual and Family plans.

Overall: All of the above criteria must be met for initial coverage of tenapanor (Ibsrela).

Per plan-specific step therapy requirements.

Reauthorization

Continuation therapy — reauthorization is allowed when ALL of the following are met.

Reauthorization: All initial medical necessity criteria are met AND there is documentation of beneficial response to tenapanor (Ibsrela).

Documentation of clinical benefit must be provided; authorization duration may be granted for up to 12 months when criteria are met.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for tenapanor (Ibsrela). Initial and reauthorization approvals may be granted for up to 12 months.

Initial and reauthorization approval duration: up to 12 months
PA required prior to initiation

Step Therapy

Step Therapy Requirements

Members must have documented failure, contraindication, or intolerance to required prior therapies before tenapanor will be approved.

Required step therapy: documentation of failure, contraindication, or intolerance to BOTH linaclotide (Linzess) and plecanatide (Trulance) for Employer Group plans
For Individual and Family plans: documentation of failure, contraindication, or intolerance to linaclotide (Linzess)

Documentation Required

Documentation Requirements

Provide complete patient-level documentation with the prior authorization request. Include age, diagnosis, prior therapy history (including trials of linaclotide and/or plecanatide as applicable), and documentation of beneficial response for reauthorization requests.

Patient age (must be 18 years or older)
Documented diagnosis of irritable bowel syndrome with constipation (IBS-C)
Detailed prior therapy history showing failure, contraindication, or intolerance to required agents
For reauthorization: documentation of beneficial response to tenapanor

Denial Risk

Non‑covered Uses / Denial Risk

Use outside the specified medically necessary indications is not covered and may be denied.

Any use not meeting the listed medical necessity criteria is considered not medically necessary and is not covered

Definitions

Irritable bowel syndrome with constipation (IBS-C) — definition and relation to indication

DefinitionIrritable bowel syndrome with constipation (IBS-C) is a subtype of irritable bowel syndrome characterized by predominant constipation; tenapanor (Ibsrela) is indicated for treatment of IBS-C in adults.

Age populationIndication and policy apply to adults (Age ≥ 18).

Drug class relationIbsrela (tenapanor) is a sodium/hydrogen exchanger 3 (NHE3) inhibitor used for IBS-C.

Place among bowel agentsTenapanor is listed alongside other bowel agents (e.g., linaclotide, plecanatide, lubiprostone) as therapies indicated for IBS-C in adults.

Scope of coveragePolicy covers tenapanor for IBS-C in adults when medical necessity criteria are met (see coverage criteria).