Subject: Somavert 2097-A SGM P2022
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
Somavert is indicated for the treatment of acromegaly in
patients who have had an inadequate response to surgery or
radiation therapy, or for whom these therapies are not
appropriate.
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. For initial approval: Laboratory report indicating high
pretreatment insulin-like growth factor-1 (IGF-1) level and
chart notes indicating an inadequate or partial response to
surgery or radiotherapy or a clinical reason for not having
surgery or radiotherapy
B. For continuation: Laboratory report indicating normal
current IGF-1 levels or chart notes indicating that the
member’s IGF-1 level has decreased or normalized since
initiation of therapy
III. CRITERIA FOR INITIAL APPROVAL
Authorization of 12 months may be granted for the treatment
of acromegaly when all of the following criteria are met:
A. Member has a high pretreatment IGF-1 level for age and/or
gender based on the laboratory reference range.
B. Member had an inadequate or partial response to surgery
or radiotherapy OR there is a clinical reason why the
member has not had surgery or radiotherapy.
IV. CONTINUATION OF THERAPY
Authorization of 12 months may be granted for continuation of
therapy for acromegaly when the member’s IGF-1 level has
decreased or normalized since initiation of therapy.
Place of Service:
Outpatient
The above policy is based on the following references:
- Somavert [package insert]. New York, NY: Pharmacia & Upjohn Company LLC; August 2021.
- Katznelson L, Laws ER, Melmed S, et al. Acromegaly: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2014; 99:3933-3951.
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 26, 2022
