Gattex - NC Standard

Restricted Product(s)

• Gattex® (teduglutide)

FDA Approved Use

• For the treatment of adults and pediatric patients 1 year of age and older with Short Bowel Syndrome (SBS) who are dependent on parenteral support.

Criteria for Approval of Restricted Product(s)

Initial Coverage Criteria

1. The patient has a diagnosis of short bowel syndrome (SBS); AND 
2. The patient is currently receiving parenteral nutrition (PN) / intravenous fluids (IV) for at least 3 days per week; AND 
3. The patient has had a colonoscopy with any polyps removed within the last 6 months; AND 
4. The dose is within the FDA-labeled dose of 0.05 mg/kg/day; AND 
5. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.
   
   Duration of Approval: 26 weeks

Continuation Coverage Criteria

1. The patient has been previously approved for Gattex (teduglutide) with Blue Cross and Blue Shield of North Carolina (Blue Cross NC) or would have met initial criteria for approval upon the start of therapy; AND 
2. The patient has had at least a 20% reduction from baseline in PN/IV fluids; AND 
3. The dose remains within the FDA-labeled dose of 0.05 mg/kg/day.
   
   Duration of Approval: 365 days (1 year)

References

All information referenced is from FDA package insert unless otherwise noted below.

Policy Implementation/Update Information

November 2022: Criteria update: Formatting changes and review.
July 2019: Criteria update: Reformatted criteria & added pediatric indication in top section
October 2018: Annual review; No change
April 2017: Original utilization management criteria issued.