CurrentAvMedPolicy N/A

Gattex (teduglutide) prior authorization for short bowel syndrome

Defines prior-authorization, clinical criteria, exclusions, and renewal requirements for coverage of Gattex (teduglutide) for members treated for short bowel syndrome who receive parenteral nutrition/IV fluids. Affects prescribers, specialty pharmacy (PropriumRx), and AvMed members.

Policy Summary

PayerAvMed

PolicyGattex (teduglutide) prior authorization for short bowel syndrome

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit a prescriber-signed prior authorization form with required documentation (PN/IV history, BMI, labs, colonoscopy/imaging) faxed to AvMed.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsinitial authorization length

6 monthsfirst renewal interval

6 monthssecond renewal interval

0.05 mg/kgrecommended dosing

50% reduction if CrCl<50renal impairment dosing

Coverage Criteria for Gattex (teduglutide)

Policy Summary

PayerAvMed

PolicyGattex (teduglutide) prior authorization for short bowel syndrome

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit a prescriber-signed prior authorization form with required documentation (PN/IV history, BMI, labs, colonoscopy/imaging) faxed to AvMed.

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Initial Therapy

Covered when ALL of the following are met

Initial Approval Criteria: Member has been dependent on parenteral nutrition/intravenous fluids (PN/IV) >3 times per week for >12 continuous months with failed previous trials of weaning (attach supportive documentation); current PN/IV frequency and baseline volume documented; member's BMI provided; diagnosis of short bowel syndrome OR short bowel syndrome due to Crohn's disease with documentation of clinical remission; colonoscopy or alternate imaging with removal of polyps (if necessary) within 6 months prior to initiation of therapy; dosing within recommended limits (maximum adult 0.05 mg/kg once daily; pediatric ≥10 kg 0.05 mg/kg once daily).

Initial approval length 6 months

Exclusions

Not covered / Exclusions

Exclusions: Age <1 year OR weight ≤10 kg; diagnosis of active cancer within the last 5 years; BMI <15 kg/m2; receipt of human growth hormone within the last 6 months; four or more SBS-related hospital admissions within the last 12 months; active intestinal obstruction.

These conditions exclude coverage

Coverage is excluded when any of the following apply: age <1 year or weight ≤10 kg, active cancer within the last 5 years, BMI <15 kg/m2, receipt of human growth hormone (e.g., Zorbtive) within the last 6 months, four or more SBS-related hospital admissions in the prior 12 months, or an active intestinal obstruction.

At each renewal the member must demonstrate clinical benefit in PN/IV use. Specifically, failure to show the required reduction in PN/IV or any worsening/increase in PN/IV use will result in denial: for the first continuation at 6 months the member must have achieved at least a 20% reduction from baseline in PN/IV; for the second and ongoing continuations the member must have achieved at least a 20% reduction from the last baseline or show stabilization (no increase) in PN/IV use. If renewal documentation indicates the member’s PN/IV use has increased or the required reduction/stabilization is not met, the request will be denied as not medically necessary.

Initial Therapy Requirements

Initial Therapy

Initial approval criteria and dosing

Eligibility: PN/IV dependency >3 times per week for >12 continuous months with failed weaning attempts; documented baseline PN/IV frequency and volume and current frequency; documented BMI; diagnosis of SBS (or SBS due to Crohn's disease with documentation of clinical remission); colonoscopy or alternate imaging with removal of polyps within 6 months prior to initiation; prescriber-signed prior authorization form and supportive documentation submitted.

Initial approval 6 months

Dosing: Recommended dosing: maximum adult 0.05 mg/kg once daily; pediatric patients ≥10 kg: 0.05 mg/kg once daily; reduce dose by 50% if CrCl <50 mL/min. (Final dose per day and SrCr/renal info to be provided on form; max 3.8 mg per vial.)

Follow dosing and renal adjustment guidance

Step	Requirement	Notes
Documented prior failed weaning attempts from PN/IV
Use of samples to initiate therapy does not satisfy the step edit; prior trials of weaning must be documented on the prior authorization form and supported with clinical records
Initial approval requires completion of all clinical criteria on the PA form; supportive documentation (frequency and baseline volume of PN/IV, BMI, colonoscopy/imaging) must be attached to avoid denial

Continuation and Renewal Requirements

First Continuation of Therapy

First continuation — all lines must be completed

First Continuation Criteria: At 6 months: documentation of at least 20% reduction from baseline in PN/IV; current PN/IV frequency and volume documented; member's BMI provided; member does not have any FDA-labeled contraindications to therapy; labs submitted every 6 months and colonoscopy one year after initiation of therapy (supportive documentation attached).20% reduction

Approval interval 6 months

Second and Ongoing Continuation

Second continuation — all lines must be completed

Second Continuation and Ongoing Criteria: At 1 year and beyond: documentation of at least 20% reduction from last PN/IV baseline OR stabilization (no increase) in PN/IV use; current PN/IV frequency and volume documented; member's BMI provided; member does not have any FDA-labeled contraindications to therapy; labs submitted every 6 months; colonoscopy one year after initiation and then every 5 years thereafter (supportive documentation attached).20% reduction or stabilization

Approval interval 6 months

Continuation Therapy

Continuation therapy requirements and intervals

First continuation: At 6 months from initiation: submit documentation of >=20% reduction in PN/IV from baseline OR as required; current PN/IV frequency and volume, BMI, labs, and absence of FDA-labeled contraindications must be provided.20% reduction

Approval 6 months

Second continuation and ongoing: At 1 year and beyond (and for ongoing renewals >1.5 years): documentation of >=20% reduction from last baseline or stabilization (no increase) in PN/IV use; current PN/IV frequency and volume; BMI; labs every 6 months; colonoscopy schedule per protocol (1 year after initiation then every 5 years). If PN/IV use has increased from the last baseline, renewal will be denied.20% reduction or stabilized use

Approval 6 months

Provider Actions, Documentation & Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required. The prescribing physician must sign and clearly print their name on the prior authorization request (preprinted stamps are not valid). Fax the completed, legible form to 1-305-671-0200. Incomplete, incorrect, or illegible requests (including missing phone/fax numbers) may delay processing or result in denial.

Fax: 1-305-671-0200
Prescriber signature required (no preprinted stamps)

Step Therapy

Step Edit Requirement

Use of free samples to initiate therapy does not satisfy step-edit or prior authorization requirements. Prior trials of weaning from parenteral nutrition/IV support must be documented. Supporting documentation (chart notes, pharmacy claims) will be reviewed.

Samples do not satisfy step edit/PA
Document prior weaning trials (attach supportive documentation)

Documentation Required

Required Documentation

Attach complete baseline and follow-up documentation with all requests. For initial and continuation approvals provide frequency and volume of PN/IV use, baseline and follow-up PN/IV volumes (L/week or per infusion), frequency/week, BMI, relevant labs (including serum creatinine), colonoscopy or alternate imaging dates/results, and chart notes demonstrating diagnosis and prior therapies. Labs are required every 6 months; colonoscopy within 6 months prior to initiation and at specified intervals thereafter; supportive documentation must be attached.

Baseline PN/IV frequency & volume (L/week or per infusion)
Follow-up PN/IV frequency & volume at 6 months and annually
BMI at baseline and follow-up
Serum creatinine and other labs every 6 months
Colonoscopy/alternate imaging within 6 months prior to initiation; then at 1 year and every 5 years thereafter (as specified)
Documentation of diagnosis (short bowel syndrome) and Crohn's disease remission when applicable

Note

Incomplete Request Risk

Incomplete, incorrect, or illegible requests — including missing supporting documentation, unclear dosing, or absent signature — may delay review or result in denial. Ensure all fields (drug form/strength, dosing schedule, length of therapy, diagnosis/ICD code, weight, date, final dose, SrCr when applicable) are completed.

Complete all drug and patient fields on the form
Include SrCr for renal dosing considerations (reduce dose by 50% if CrCl <50 mL/min)
Attach all required supporting labs and imaging

Denial Risk

Failure to Meet Continuation Criteria

Continuation approvals require demonstration of at least a 20% reduction from baseline (first continuation) or from the last baseline (second continuation) in PN/IV use, or stabilization (no increase) for long-term continuation (>1.5 years). Failure to meet these criteria (including lack of documented 20% reduction or lack of stabilization) will risk denial.

First continuation: ≥20% reduction from baseline in PN/IV required
Second continuation: ≥20% reduction from last baseline required
Long-term continuation (>1.5 years): stabilization (no increase) required — NO = denial

Coding, Age/Weight Thresholds, and Definitions

Age / weight thresholds

Age exclusionMembers younger than 1 year are excluded from coverage.

Weight exclusionMembers weighing ≤10 kg are excluded from coverage.

Pediatric dosing thresholdPediatric dosing applies for patients ≥10 kg (0.05 mg/kg once daily).

Short bowel syndrome — summary definition

Definition summaryShort bowel syndrome (SBS) — clinical diagnosis required for Gattex coverage; member must have SBS or SBS due to Crohn's disease (with documented clinical remission).

Supporting requirementDocumentation must include diagnosis of SBS and colonoscopy or alternate imaging (with polyp removal if necessary) within 6 months prior to initiation.

Relation to PN/IVSBS patients eligible for treatment are those who require parenteral nutrition/IV support as specified in authorization criteria.

PN/IV dependence — definition

Dependence definitionPN/IV dependence is defined as use of parenteral nutrition/intravenous fluids >3 times per week for >12 continuous months.

Failed weaningDependence requires documentation of failed previous trials of weaning from PN/IV (attach supportive documentation).

Documentation elementsRequests must include frequency of current PN/IV use and baseline volume (L/week or per infusion) and BMI to support dependence claim.

OpenPayer