CurrentCignaPolicy IP0288

Gastroenterology - Gattex

This Cigna coverage policy governs prior authorization and medical necessity criteria for Gattex (teduglutide) used to treat short bowel syndrome in patients aged ≥1 year who are dependent on parenteral support; it affects providers requesting prescription benefit coverage under Cigna-administered plans.

Policy Summary

PayerCigna

PolicyGastroenterology - Gattex

Policy CodePolicy IP0288

Change TypeMaterial changes to initial and continuation criteriaadministrative title update

Effective DateThe policy effective date is in force until updated or retired.

Next Review Date

Key ActionObtain prior authorization and document age, parenteral nutrition dependence or prescriber statement about inability to receive adequate TPN; approvals are time-limited (6 months initial, 1 year continuation).

SourceLink

POLICY UPDATE CHANGES

Updated coverage policy title from 'Teduglutide' to 'Gastroenterology - Gattex'.

Initial therapy criteria add: prescriber may state patient is unable to receive adequate total parenteral nutrition (TPN) required for caloric needs.

Continuation therapy criteria add: patient must have already received at least 6 months of Gattex; patients with <6 months continuous therapy should be considered under Initial Therapy.

≥1 yrMin age

≥3PN days/week (initial)

20%Efficacy threshold

6 moInitial approval duration

1 yrContinuation approval

Coverage Criteria for Gattex (teduglutide)

FDA-Approved Indication: Short Bowel Syndrome

Gattex is considered medically necessary when treating Short Bowel Syndrome and the patient meets ONE of the following (A or B):

FDA-Approved Indication: Patient meets ONE of the following: A) Initial Therapy OR B) Currently Receiving Gattex

A) Initial Therapy

A.i Age: Patient is ≥ 1 year of age
A.ii Parenteral support requirement
- A.ii.a: Patient is currently receiving parenteral nutrition on 3 or more days per week

Policy Summary

PayerCigna

PolicyGastroenterology - Gattex

Policy CodePolicy IP0288

Change TypeMaterial changes to initial and continuation criteriaadministrative title update

Effective DateThe policy effective date is in force until updated or retired.

Next Review Date

SourceLink

On This Page

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Coding and Key Criteria Values

Covered Codesmixed

No codes listed

Parenteral nutrition days per week — initial therapy threshold

Initial therapy PN frequencyPatient is receiving parenteral nutrition on 3 or more days per week (>= 3 days/week).

Alternate to PN frequencyPrescriber may state patient is unable to receive adequate total parenteral nutrition (TPN) required for caloric needs (alternative to meeting >=3 days/week).

Approval duration for initial therapyApprove for 6 months when initial therapy criteria are met.

Efficacy reduction threshold for continuation

Required efficacy for continuationPatient has experienced at least a 20% decrease from baseline in the weekly volume of parenteral nutrition (>= 20% reduction).

Who documents responseDecrease must be documented according to the prescriber.

Associated approval durationWhen continuation criteria met, approve for 1 year for patients currently receiving Gattex who meet response and prior therapy duration requirements.

Minimum age

Minimum patient agePatient must be at least 1 year of age (>= 1 year).

Age contextThis age requirement aligns with the FDA indication for Gattex in short bowel syndrome.

Applies to both initial and continuation therapyThe >=1 year age requirement is part of the FDA‑approved indication used in coverage criteria.

Prior Authorization, Documentation, and Denials

Prior Authorization

Prior Authorization Required

Prior Authorization is recommended for Gattex. Approvals are time-limited: initial therapy approvals are for 6 months; approvals for patients already receiving Gattex are for 1 year. In cases where the approval is authorized in months, 1 month = 30 days. Gattex must be prescribed by or in consultation with a gastroenterologist due to the specialized evaluation and monitoring required.

Initial therapy: approve for 6 months when ALL initial criteria are met
Continuation (currently receiving Gattex): approve for 1 year when ALL continuation criteria are met
1 month = 30 days for authorization period calculation
Prescriber requirement: prescribed by or in consultation with a gastroenterologist

Step Therapy

No step therapy requirements are specified for Gattex in this policy.

Documentation Required

Documentation Requirements

Prior authorization is recommended and documentation should support that the patient meets the applicable FDA‑approved indication criteria. The medication must be prescribed by or in consultation with a gastroenterologist. For initial therapy, documentation should support age ≥ 1 year and parenteral nutrition dependence or inability to receive adequate TPN. For continuation therapy, documentation should confirm at least 6 months prior Gattex use and at least a 20% decrease from baseline in weekly parenteral nutrition volume as reported by the prescriber.

Recommended: submit prior authorization with clinical documentation addressing all applicable criteria
Initial therapy documentation: age, PN requirements (3+ days/week) or inability to receive adequate TPN, prescriber specialty/consultation
Continuation therapy documentation: ≥6 months prior Gattex use, documented ≥20% decrease from baseline in weekly PN volume, prescriber specialty/consultation

Denial Risk

Denial Triggers

Claims submitted without covered diagnosis/procedure codes or that do not meet the Coverage Policy criteria will be denied as not covered.

Denial trigger: missing or non-covered diagnosis/procedure codes
Denial trigger: failure to meet policy coverage criteria (including prescriber specialty, duration, or clinical response requirements)

Key Definitions and Safety Programs

Definition of Short Bowel Syndrome

DefinitionShort Bowel Syndrome: a condition leading to dependence on parenteral support due to insufficient intestinal length or function.

Indication contextGattex is indicated for treatment of short bowel syndrome in patients >= 1 year of age who are dependent on parenteral support.

Coverage implicationPolicy approvals for Gattex require that the patient meet the short bowel syndrome indication as defined in the policy.

REMS — serious risks

REMS presenceGattex was approved with a Risk Evaluation and Mitigation Strategy (REMS) program to inform providers and patients about serious risks.

Key risks included in REMSPossible acceleration of neoplastic growth and enhancement of colon polyp growth.

Other serious risksGastrointestinal (intestinal) obstruction and biliary and pancreatic disorders are highlighted in REMS communications.

OpenPayer

Gastroenterology - Gattex

Coverage Criteria for Gattex (teduglutide)

Coding and Key Criteria Values

Prior Authorization, Documentation, and Denials

Background on Gattex (teduglutide)

Key Definitions and Safety Programs