CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Gattex (teduglutide) for short bowel syndrome

Policy governs Medicaid coverage criteria, quantity limits, and authorization periods for Gattex (teduglutide) for treatment of short bowel syndrome (SBS) in patients aged ≥1 year, including initial and reauthorization criteria and dosing limits.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyGattex (teduglutide) for short bowel syndrome

Policy CodePolicy N/A

Change TypeRevision (non-material)

Effective DateFeb 1, 2022

Next Review Date

Key ActionProviders must submit prior authorization with documentation of age, SBS diagnosis, prescribing clinician or GI consult, parenteral dependence per age group, dosing (≤0.05 mg/kg/day), and IBD/fistula remission when applicable.

POLICY UPDATE CHANGES

Policy effective date 02/01/2022 with reviews noted 5/2023, 5/2024, 7/2025; Gattex package insert reference updated Sept 2024.

6 monthsAuthorization duration

1 kit/30dQuantity limit

>=1 yrMinimum age covered

0.05 mg/kgMaximum daily dose

Coverage Summary

Policy governs Medicaid coverage for Gattex (teduglutide) for treatment of short bowel syndrome (SBS) in patients aged ≥ 1 year. Coverage is covered with criteria and authorizations may be granted for 6 months for initial and continued therapy when specified clinical criteria are met. Policy effective date 02/01/2022; reviews noted 5/2023, 5/2024, 7/2025.

Thresholds

Minimum age>= 1 year

Adult parenteral dependence duration>= 12 months and IV nutrition/fluids at least 3 times/week

Pediatric parenteral dependence proportionIV nutrition/fluids account for >= 30% of caloric and/or fluid/electrolyte needs

Dose limit<= 0.05 mg/kg/day once daily

IBD/fistula remissionClinical remission >= 12 weeks

Reauthorization response>= 20% decrease in parenteral support requirement from baseline OR complete wean off while on therapy

Initial Therapy Criteria (Initial Authorization)

Covered Indication — Short Bowel Syndrome (SBS) Initial Authorization

Authorization of 6 months may be granted for treatment of SBS when ALL of the following are met:

ALL of the following

Age: Member is >= 1 year of age>= 1 year
Diagnosis: Documentation that the member has a diagnosis of short bowel syndrome (SBS)
Prescribing clinician: Medication is prescribed by or in consultation with a gastroenterologist
One of the parenteral dependence criteria
- Adult dependence: Members >= 18 years of age who have been dependent on parenteral nutrition and/or intravenous fluids for at least 12 months and receive intravenous nutrition/fluids at least 3 times a week>= 12 months and >= 3 times/week
- Pediatric dependence: Pediatric members < 18 years of age who are receiving intravenous nutrition/fluids to account for at least 30% of caloric and/or fluid/electrolyte needs>= 30% of needs
Dose limit: Dose does not exceed 0.05 mg/kg/day once a day<= 0.05 mg/kg/day once daily
IBD/fistula remission: If member has inflammatory bowel disease (IBD) and/or fistulas, documentation that they are in clinical remission for at least 12 weeks>= 12 weeks

Continuation Therapy Criteria (Reauthorization / Continued Treatment)

Reauthorization / Continued Treatment

Authorization of 6 months may be granted for continued treatment when ALL of the following are met:

Reauthorization criteria

Prior dependence documented: Documentation showing the member was previously dependent on parenteral nutrition and/or intravenous fluids
Includes documentation of duration and frequency for initial dependence
Response on therapy
- Wean off parenteral support: Documentation the member has been able to wean off the requirement for parenteral support while on the requested drug
- Reduction in parenteral support: Documentation the member remains dependent on parenteral nutrition and/or intravenous fluids and whose requirement for parenteral support has decreased by at least 20% from baseline while on therapy with the requested drug>= 20% decrease from baseline

Not Covered / Experimental Uses

Not Covered / Experimental

All other indications are considered experimental/investigational and not medically necessary:

Not covered uses: Any indication for Gattex other than SBS as specified (including non-FDA-approved uses and compendial uses not meeting criteria)

Background: Use is limited to the FDA-approved SBS indication — treatment of adults and pediatric patients ≥ 1 year with SBS dependent on parenteral support. The policy requires documentation of parenteral dependence and that the medication be prescribed by or in consultation with a gastroenterologist; other indications are considered experimental/investigational and not medically necessary.

Provider Actions / Requirements

Prior Authorization

Prior authorization required for initial and continued therapy

Authorization of up to 6 months may be granted for initial and continued therapy when the following documented clinical criteria are met: member is ≥ 1 year of age; diagnosis of short bowel syndrome (SBS); medication prescribed by or in consultation with a gastroenterologist; parenteral dependence details per age group (adults: dependent on parenteral nutrition and/or IV fluids ≥ 12 months and receive IV nutrition/fluids at least 3 times/week; pediatrics: IV nutrition/fluids account for ≥ 30% of caloric and/or fluid/electrolyte needs); dose does not exceed 0.05 mg/kg/day once daily; and if the member has inflammatory bowel disease and/or fistulas, documentation of clinical remission for at least 12 weeks.

Documentation Required

Document parenteral nutrition dependence and response

For initial requests, document the duration and frequency of parenteral nutrition and/or intravenous fluid support (per age-specific dependence criteria). For reauthorization, document that the member was previously dependent and either has weaned off parenteral support while on therapy or has had a ≥ 20% reduction in parenteral support requirement from baseline.

Billing Rule

Quantity limit billing

Quantity limit: 1 Gattex kit every 30 days (5 mg kit), equivalent to 0.04 per day.

Gattex Kit (5 mg): limit 1 kit every 30 days (0.04 per day)

Background & Definitions

FDA-approved indication: Gattex is indicated for the treatment of adult and pediatric patients 1 year of age and older with short bowel syndrome (SBS) who are dependent on parenteral support. The policy restricts use to that FDA-approved indication and requires documentation of parenteral dependence and clinician oversight (prescribed by or in consultation with a gastroenterologist); all other indications are considered experimental/investigational and not medically necessary.

Parenteral support / dependence: Use of parenteral nutrition and/or intravenous fluids as specified — adults: dependent for ≥ 12 months and receiving IV nutrition/fluids at least 3 times per week; pediatric members: receiving IV nutrition/fluids that account for at least 30% of caloric and/or fluid/electrolyte needs.

Revision History

2022-02-01policy_effective_date

Policy became effective on 02/01/2022.

2023-05-01periodic_review

Periodic review conducted; no material clinical policy changes noted.

2024-05-01periodic_review

Periodic review conducted; no material clinical policy changes noted.

2024-09-01reference_update

Gattex (teduglutide) package insert reference updated (September 2024).

2025-07-01periodic_reviewLatest

Periodic review conducted; no material clinical policy changes noted.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyGattex (teduglutide) for short bowel syndrome

Policy CodePolicy N/A

Change TypeRevision (non-material)

Effective DateFeb 1, 2022

Next Review Date

On This Page

OpenPayer

Gattex (teduglutide) for short bowel syndrome

Coverage Summary

Initial Therapy Criteria (Initial Authorization)

Continuation Therapy Criteria (Reauthorization / Continued Treatment)

Not Covered / Experimental Uses

Applicable Codes & Quantity Limits

Provider Actions / Requirements

Clinical Evidence & References

Background & Definitions

Revision History