Subject: Zorbtive 2244-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 short bowel syndrome in adult patients receiving
specialized nutritional support.
All other indications are considered experimental/investigational
and not medically necessary.
II. CRITERIA FOR INITIAL APPROVAL
Short bowel syndrome (SBS)1
Authorization of a total duration of 4 weeks may be granted for
treatment of SBS in members who are dependent on parenteral
nutrition support.
III. CONTINUATION OF THERAPY
All members (including new members) requesting authorization
for continuation of therapy must meet all initial authorization
criteria.
Place of Service:
Outpatient
The above policy is based on the following references:
- Zorbtive [package insert]. Rockland, MA: EMD Serono, Inc.; September 2019.
- 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
