CurrentHealth NetPolicy CP. PHAR.114

Clinical Policy: Teduglutide (Gattex)

Medical necessity criteria and coverage guidance for teduglutide (Gattex) for members (adult and pediatric) with short bowel syndrome dependent on parenteral support across Commercial, HIM, and Medicaid lines of business.

Policy Summary

PayerHealth Net

PolicyTeduglutide (Gattex) for short bowel syndrome

Policy CodePolicy CP. PHAR.114

Change TypeAnnual reviews with clinical updates (weight threshold, step therapy removal, documentation added)

Effective Date05.01.13

Next Review Date

Key ActionSubmit prior authorization with documentation demonstrating diagnosis of SBS, current body weight (kg), prescriber specialty, and duration of parenteral support.

SourceLink

POLICY UPDATE CHANGES

Added minimum weight requirement based on prescribing information.

Removed required somatropin trial for adults per AGA guidelines.

Added documentation requirement of current body weight in kg.

0.05 mg/kg/dayMaximum daily dose

≥ 1 yearMinimum covered age

≥ 10 kgMinimum weight

≥ 12 monthsParenteral support prior to approval

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Approval duration (HIM/Medicaid)

Coverage Criteria for Teduglutide (Gattex)

Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Initial SBS criteria: 1. Diagnosis of short bowel syndrome (SBS); 2. Prescribed by or in consultation with a gastroenterologist; 3. Age >= 1 year; 4. Weight >= 10 kg; 5. Dependent on parenteral nutrition or other intravenous support for >= 12 months; 6. Documentation of member's current body weight (in kg); 7. Dose does not exceed 0.05 mg/kg per day.see individual nodes

Initial approval duration: HIM/Medicaid 12 months; Commercial 12 months or to member's renewal period, whichever is longer.

Continuation Therapy — Continued therapy is covered when ALL of the following are met

Continued therapy is covered when ALL of the following are met

Continued SBS criteria: 1. Member meets one of the following: (a) currently receiving medication via the benefit or previously met initial approval criteria; OR (b) currently receiving medication and enrolled in a state/product with continuity of care regulations; 2. Requirement for parenteral nutrition or other IV support has decreased since initiation of therapy; 3. Documentation of member's current body weight (in kg); 4. If request is for a dose increase, new dose does not exceed 0.05 mg/kg per day.see individual nodes

Continued approval duration: HIM/Medicaid 12 months; Commercial 12 months or to member's renewal period, whichever is longer.

Other Indications — For other diagnoses/indications

For other diagnoses/indications

Other indications: 1. If this drug has undergone a label change within the last 6 months that is not yet reflected in this policy, refer to the appropriate formulary/no-coverage or non-formulary policy for the relevant line of business (see listed policies); OR 2. If the requested use is not listed in section III (Diagnoses/Indications for which coverage is NOT authorized) and criterion 1 does not apply, refer to the off-label use policy for the relevant line of business.

References: CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16, CP.CPA.09, HIM.PA.154, CP.PMN.53.

Non-FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider submits sufficient documentation demonstrating efficacy and safety consistent with the applicable off-label use policy or evidence of coverage documents. Refer to the off-label use policies for the appropriate line of business: CP.CPA.09 (commercial), HIM.PA.154 (health insurance marketplace), or CP.PMN.53 (Medicaid).

Requests for non-FDA approved indications without adequate supporting documentation per the applicable off-label use policy are considered not authorized. Providers should follow the referenced off-label review requirements and submit clinical evidence as outlined in the off-label policy for the member's line of business.

Coding and Dose Limits

HCPCS Codes (referenced)HCPCS

J3490

Unclassified drugs

inv-07: Maximum daily dose — 0.05 mg/kg/day

Maximum daily dose0.05 mg/kg per day (0.05 mg/kg/day); dosed subcutaneously once daily

Dosing regimen referenceSBS dosing: 0.05 mg/kg SC QD

Dose limit for dose increase requestsAny requested dose increase must remain ≤ 0.05 mg/kg/day for continued therapy

inv-08: Minimum age — >= 1 year

Minimum covered age≥ 1 year

FDA indication ageIndicated for adult and pediatric patients 1 year of age and older with SBS dependent on parenteral support

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Member must meet the clinical criteria for Short Bowel Syndrome (SBS) including diagnosis of SBS, prescribed by or in consultation with a gastroenterologist, age ≥ 1 year, weight ≥ 10 kg, dependent on parenteral nutrition or other intravenous support for ≥ 12 months, documentation of current body weight (kg), and dose not to exceed 0.05 mg/kg per day. Providers should submit supporting clinical documentation (office chart notes, lab results, or other clinical information) with the prior authorization request.

Affected indication: Short Bowel Syndrome (SBS)
Prescriber: gastroenterologist or in consultation with one
Age threshold: ≥ 1 year
Weight threshold: ≥ 10 kg
Parenteral nutrition/IV support requirement: ≥ 12 months
Dose limit: ≤ 0.05 mg/kg/day
Documentation: current body weight (kg) must be provided

Background

Teduglutide is a glucagon-like peptide-2 analog indicated for the treatment of adults and pediatric patients aged ≥ 1 year with short bowel syndrome (SBS) who are dependent on parenteral support. The product is administered subcutaneously at a dosing regimen of 0.05 mg/kg once daily, and is supplied as a single-use 5 mg vial.

Definitions

inv-16: Definition of Short Bowel Syndrome (SBS)

DefinitionShort bowel syndrome (SBS) is a condition characterized by insufficient functional small intestine length leading to dependence on parenteral nutrition or other intravenous support.

Indication relevanceTeduglutide (Gattex) is indicated for adults and pediatric patients ≥1 year with SBS who are dependent on parenteral support

Clinical consequenceSBS leads to need for parenteral nutrition/IV support; teduglutide dosing for SBS is 0.05 mg/kg SC once daily

Product availabilitySingle-use vial available: 5 mg

Policy Summary

PayerHealth Net

PolicyTeduglutide (Gattex) for short bowel syndrome

Policy CodePolicy CP. PHAR.114

Change TypeAnnual reviews with clinical updates (weight threshold, step therapy removal, documentation added)

Effective Date05.01.13

Next Review Date

Key ActionSubmit prior authorization with documentation demonstrating diagnosis of SBS, current body weight (kg), prescriber specialty, and duration of parenteral support.

SourceLink

On This Page

Age requirement applies to initial and continued approvalAge ≥1 year required for initial approval and referenced in continued therapy criteria

inv-09: Minimum weight — >= 10 kg

Minimum weight for coverage≥ 10 kg

Policy historyMinimum weight requirement added in 1Q 2022 annual review per prescribing information

Weight documentationDocumentation of member's current body weight (in kg) is required

inv-10: Parenteral support duration prior to approval — >= 12 months

Required duration of parenteral support prior to initial approvalDependent on parenteral nutrition or other intravenous support for ≥ 12 months

Applies to initial approvalDuration requirement is part of initial SBS approval criteria

Continued therapy considerationContinued therapy requires decreased need for parenteral support since initiation rather than meeting the prior-duration threshold

Documentation Required

Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that the member has met all approval criteria at the time of request. Required documentation specifically includes evidence of diagnosis, prescriber specialty/consult note, current body weight in kilograms, duration and dependence on parenteral nutrition or IV support, and dosing calculations when applicable.

Office chart notes supporting SBS diagnosis and treatment plan
Lab results or nutrition support records documenting parenteral dependence and duration
Documentation of current body weight in kg
Prescriber attestation or consultation note from a gastroenterologist
Medication dosing rationale and calculations if dose increase requested

Denial Risk

Triggers for Denial

Requests may be denied if the submitted documentation does not demonstrate that the member meets ALL approval criteria. Common triggers for denial include lack of documented SBS diagnosis, absence of gastroenterology prescriber or consultation, age or weight below policy thresholds, insufficient evidence of dependence on parenteral nutrition/IV support for ≥ 12 months, missing current body weight in kg, or dosing that exceeds 0.05 mg/kg per day.

No documentation of SBS diagnosis
No gastroenterologist prescriber or consultation note
Age < 1 year or weight < 10 kg
No evidence of ≥ 12 months dependence on parenteral nutrition/IV support
Missing documentation of current body weight (kg)
Requested dose exceeds 0.05 mg/kg/day
Request for non‑FDA approved indication without sufficient off‑label justification

Step Therapy

Step Therapy Exception

Step therapy exception: there is no required trial of somatropin for adults. The prior somatropin trial requirement for adults was removed per AGA guidelines; do not require somatropin trial documentation for adult members.

Somatropin trial is NOT required for adult members (per AGA guidelines, 1Q 2023 update)