Subject: Gattex 1838-A SGM P2022

Drug

GATTEX  (teduglutide)

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
            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.

             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 (greater than or equal to 18 years of
                       age): 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.  Pediatric members (less than 18 years of age): Chart
                       notes supporting the use of parenteral nutrition/IV
                       fluids to account 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 on parenteral nutrition
                     and have been weaned off parenteral nutrition/IV fluids
                     while on therapy with the requested drug: Chart notes
                     supporting 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 greater than or
                 equal to 18 years of age who have been dependent on
                 parenteral nutrition and/or intravenous (IV) fluids for at
                 least 12 months and receive 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 pediatric 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 continued
                 treatment in members requesting reauthorization when the
                 member remains 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 continued
                 treatment in members requesting reauthorization when the
                 member who was previously dependent on parenteral
                 nutrition and/or IV fluids has 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:

1. Gattex [package insert]. Lexington, MA: Shire-NPS Pharmaceuticals, Inc.; January 2021.
2. 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.
3. 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 Gastroenerol. 2016; 7(2):e142.

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.

December 11, 2022