CurrentCareSourcePolicy N/A

PHARMACY POLICY STATEMENT Akansas PASSE

Pharmacy benefit policy describing prior authorization criteria, age/weight limits, diagnosis requirements, dosing, initial and reauthorization durations, and exclusions for Gattex (teduglutide) for members with short bowel syndrome dependent on parenteral support.

Policy Summary

PayerCareSource

PolicyPHARMACY POLICY STATEMENT Akansas PASSE

Policy CodePolicy N/A

Change TypeRevision (01/05/2022)

Effective DateJan 5, 2022

Next Review Date

Key ActionSubmit prior authorization with clinical documentation showing diagnosis of short bowel syndrome dependent on parenteral support and include member weight and required colonoscopy documentation for adults.

SourceLink

POLICY UPDATE CHANGES

New policy for Gattex created 06/29/2020; revised 01/05/2022 to include baseline weekly volume of parenteral support reference.

1Covered Indications (SBS with parenteral support)

6 moInitial approval duration

12 moReauthorization duration

Coverage Summary

Coverage stance: covered_with_criteria under the pharmacy benefit for Gattex (teduglutide) for treatment of short bowel syndrome (SBS) when the member is dependent on parenteral support and all prior authorization criteria are met. Scope summary: Pharmacy benefit policy requiring prior authorization and clinical documentation of SBS dependent on parenteral support, with age/weight limits (member must be ≥ 1 year of age and weigh ≥ 10 kg (22 pounds)), documented diagnosis of SBS with dependence on parenteral support, dose calculated using documented weight at 0.05 mg/kg once daily, initial approval for 6 months and reauthorization for 12 months. Exclusions: treatment of diseases not listed in the policy (not medically necessary).

Initial Therapy Criteria

Initial Authorization / Medically Necessary

Covered when ALL of the following are met:

ALL of the following

Member is 1 year of age or older>= 1 year
Must weigh at least 10 kg (22 pounds)
Member has a diagnosis of short bowel syndrome and is dependent on parenteral support
Members 18 years old or older must have a colonoscopy within the past 6 monthswithin 6 months
Member does not have colorectal cancer
Weight must be included in chart notes
Required for dosing calculation

Dosing / Quantity Limit

Dosage allowed:

ALL of the following

Dose: 0.05 mg/kg once daily0.05 mg/kg once daily
Dose must be calculated using documented weight

Authorization Duration

ALL of the following

If initial criteria met, approve medication for 6 months6 months

Provider Actions & Billing

Prior Authorization

Prior authorization required

Prior authorization is required (non-preferred product) under the pharmacy benefit for Gattex; submit clinical documentation showing diagnosis of short bowel syndrome dependent on parenteral support and other criteria.

Diagnosis of short bowel syndrome dependent on parenteral support
Member is ≥ 1 year of age and weighs ≥ 10 kg (22 pounds)
Members ≥ 18 years must have a colonoscopy within the past 6 months
Member does not have colorectal cancer
If initial criteria met, approve for 6 months

Documentation Required

Weight documentation

Provider must include member weight in chart notes to calculate dose (0.05 mg/kg once daily).

Weight required for dose calculation (0.05 mg/kg once daily)

Documentation Required

Colonoscopy documentation for adults

Members 18 years or older must have a colonoscopy within the past 6 months documented in the chart.

Adults (>=18 years): colonoscopy within past 6 months required

Billing Rule

Use valid NDC code

Claims must use a valid NDC code for billing under the pharmacy benefit.

Claims must use a valid NDC for pharmacy benefit billing; NDC requirement group exists in code_groups (no codes listed in brief)

Clinical Evidence

Reduces parenteral supportKey RCT: Teduglutide reduces need for parenteral support (Gastroenterology 2012)

Background/evidence summary: Clinical trials and guideline references support that teduglutide reduces the need for parenteral support in patients with short bowel syndrome. Key randomized controlled trial evidence includes Jeppesen et al., which reported that teduglutide reduces need for parenteral support among patients with SBS (Gastroenterology 2012). The policy references this RCT alongside other adult and pediatric studies and guidelines supporting reduced parenteral dependence with teduglutide.

Background & Definitions

Background: Gattex (teduglutide) is indicated for treatment of adults and pediatric patients with short bowel syndrome who are dependent on parenteral support. This pharmacy policy establishes prior authorization requirements under the pharmacy benefit; providers must submit clinical documentation demonstrating diagnosis of SBS with dependence on parenteral support and meet age, weight, dosing, and documentation requirements to qualify for coverage.

Parenteral support: Intravenous fluids and/or parenteral nutrition support required due to intestinal failure from short bowel syndrome.

Revision History

2020-06-29creation

New policy for Gattex created 06/29/2020; revised 01/05/2022 to include baseline weekly volume of parenteral support reference.

2022-01-05revisionLatest

New policy for Gattex created 06/29/2020; revised 01/05/2022 to include baseline weekly volume of parenteral support reference.

Policy Summary

PayerCareSource

PolicyPHARMACY POLICY STATEMENT Akansas PASSE

Policy CodePolicy N/A

Change TypeRevision (01/05/2022)

Effective DateJan 5, 2022

Next Review Date

SourceLink

On This Page

OpenPayer

PHARMACY POLICY STATEMENT Akansas PASSE

Coverage Summary

Initial Therapy Criteria

Continuation (Reauthorization) Criteria

Unproven / Exclusions

Provider Actions & Billing

Applicable Codes

Clinical Evidence

Background & Definitions

Revision History