Subject: Gattex 1838-A SGM P2023
Policy:
I. INDICATIONS
The indications below including FDA-approved indications and
compendial uses are considered a covered benefit provided that
all the approval criteria are met and the member has no
exclusions to the prescribed therapy.
FDA-Approved Indication
Treatment of adult and pediatric patients 1 year of age and
older with short bowel syndrome (SBS) who are dependent on
parenteral support.
All other indications are considered experimental/investigational
and not medically necessary.
II. DOCUMENTATION
Submission of the following information is necessary to initiate
the prior authorization review:
A. Initial requests
1. Adult members: Chart notes supporting the use of
parenteral nutrition/intravenous (IV) fluids at least 3
times a week for 12 months and current volume of
parenteral support in liters per week.2. Members less
than 18 years of age: Chart notes supporting the use of
parenteral nutrition/IV fluids accounting for at least 30%
of caloric and/or fluid/electrolyte needs.
B. Continuation requests
1. Members who remain dependent on parenteral
nutrition/IV fluids: Chart notes supporting the continued
use of parenteral nutrition/IV fluids and current volume of
parenteral support in liters per week.
2. Members who were previously dependent on parenteral
nutrition/IV fluids and have been weaned off parenteral
support while on therapy with the requested drug: Chart
notes supporting previous dependence on parenteral
nutrition/IV fluids and the volume of parenteral support
in liters per week required at baseline.
III. CRITERIA FOR INITIAL APPROVAL
Short bowel syndrome (SBS)
A. Authorization of 6 months may be granted for treatment of
short bowel syndrome in adult members who have been
dependent on parenteral nutrition and/or intravenous (IV)
fluids for at least 12 months and are receiving parenteral
nutrition and/or IV fluids at least 3 times a week.
B. Authorization of 6 months may be granted for treatment of
short bowel syndrome in members less than 18 years of age
who are receiving parenteral nutrition and/or IV fluids to
account for at least 30% of caloric and/or fluid/electrolyte
needs.
IV. CONTINUATION OF THERAPY
Short bowel syndrome (SBS)
A. Authorization of 6 months may be granted for members who
are using the requested medication for SBS and who remain
dependent on parenteral nutrition and/or intravenous (IV)
fluids and whose requirement for parenteral support has
decreased by at least 20% from baseline while on therapy
with the requested drug.
B. Authorization of 6 months may be granted for members who
are using the requested medication for SBS and who were
previously dependent on parenteral nutrition and/or IV fluids
and have been able to wean off the requirement for
parenteral support while on therapy with the requested drug.
V. DOSAGE AND ADMINISTRATION
Approvals may be subject to dosing limits in accordance with
FDA-approved labeling, accepted compendia, and/or evidence-
based practice guidelines.
Place of Service:
Outpatient
The above policy is based on the following references:
- Gattex [package insert]. Lexington, MA: Takeda Pharmaceuticals America, Inc.; October 2022.
- Jeppesen PB, Pertkiewicz M, Messing B, et al. Teduglutide reduces need for parenteral support among patients with short bowel syndrome with intestinal failure. Gastroenterology. 2012; 143(6):1473-1481.
- Schwartz LK, O’Keefe SJD, Fujioka K, et al. Long-term teduglutide for the treatment of patients with intestinal failure associated with short bowel syndrome. Clin Transl Gastroenterol. 2016; 7(2):e142.
- Iyer K, DiBaise JK, Rubio-Tapia A. AGA Clinical practice update on management of short bowel syndrome: Expert review. Clin Gastroenterol Hepatol. 2022; 20(10):2185-2194.
Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
June 11, 2023
