Subject: Somavert 2097-A SGM P2023

Drug

SOMAVERT  (pegvisomant)

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

          Acromegaly
          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:

1. Somavert [package insert]. New York, NY: Pharmacia & Upjohn Company LLC; August 2021.
2. Katznelson L, Laws ER, Melmed S, et al. Acromegaly: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2014; 99:3933-3951.
3. American Association of Clinical Endocrinologists Acromegaly Guidelines Task Force. Medical guidelines for clinical practice for the diagnosis and treatment of acromegaly – 2011 update. Endocr Pract. 2011;17(suppl 4):1-44.

 

 

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.

April 15, 2023