Subject: Somatuline Depot 2092-A SGM P2021

Drug

SOMATULINE DEPOT ®  (lanreotide)

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.

      A.  FDA-Approved Indications
           1.  Somatuline Depot is indicated for the long-term treatment of acromegalic patients who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy is not an
                option.
           2.  Somatuline Depot is indicated for the treatment of patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to
                improve progression-free survival.
           3.  Somatuline Depot is indicated for the treatment of adults with carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analog rescue therapy.  

 
      B.  Compendial Uses
           Neuroendocrine tumors (NETs):
           1.  Tumors of the gastrointestinal (GI) tract, lung, and thymus (carcinoid tumors)
           2.  Tumors of the pancreas
           3.  Pheochromocytoma and paraganglioma
           4.  Zollinger-Ellison syndrome

      All other indications are considered experimental/investigational and are not medically necessary.

II.   DOCUMENTATION 

      Submission of the following information is necessary to initiate the prior authorization review for acromegaly:
      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
 
      A.  Acromegaly
           Authorization of 12 months may be granted for the treatment of acromegaly when all of the following criteria are met:
           1.  Member has a high pretreatment IGF-1 level for age and/or gender based on the laboratory reference range.
           2.  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.

      B.  Neuroendocrine tumors (NETs)
           1.  Tumors of the gastrointestinal (GI) tract (carcinoid tumor)
                Authorization of 12 months may be granted for treatment of locoregional advanced or metastatic NETs of the GI tract or unresected primary gastrinoma.
           2.  Tumors of the thymus (carcinoid tumor)
                Authorization of 12 months may be granted for treatment unresectable or metastatic of NETs of the thymus.
           3.  Tumors of the lung (carcinoid tumor)
                Authorization of 12 months may be granted for treatment of unresectable or metastatic NETs of the lung.
           4.  Tumors of the pancreas
                Authorization of 12 months may be granted for treatment of NETs of the pancreas. 
           5.  Gastroenteropancreatic neuroendocrine tumors (GEP-NETs)
                Authorization of 12 months may be granted for treatment of unresectable, well- or moderately-differentiated, locally advanced or metastatic GEP-NETs. 

      C.  Carcinoid syndrome
           Authorization of 12 months may be granted for treatment of carcinoid syndrome when it is used in any of the following clinical settings:
           1.  As a single agent
           2.  In combination with telotristat for persistent diarrhea due to poorly controlled carcinoid syndrome
           3.  In combination with other systemic therapy options for persistent symptoms such as flushing or diarrhea, or for progressive disease

      D.  Pheochromocytoma and paraganglioma
           Authorization of 12 months may be granted for treatment of locally unresectable or metastatic pheochromocytoma and paraganglioma. 

      E.  Zollinger-Ellison syndrome
           Authorization of 12 months may be granted for treatment of Zollinger-Ellison syndrome.

IV.  CONTINUATION OF THERAPY  

      A.  Acromegaly
           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.

      B.  Carcinoid syndrome and Zolinger-Ellison syndrome
           Authorization of 12 months may be granted for continued treatment in members requesting reauthorization when the member is experiencing clinical benefit as evidenced by improvement or stabilization in clinical
           signs and symptoms since starting therapy. 

      C.  All other indications 
           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:

1. Somatuline Depot [package insert]. Basking Ridge, NJ: Ipsen Biopharmaceuticals, Inc.; June 2019.
2. National Comprehensive Cancer Network Drugs and Biologics Compendium. Available at: http://www.nccn.org. Accessed November 16, 2020.
3. Katznelson L, Laws ER, Melmed S, et al. Acromegaly: an endocrine society clinical practice guideline. J Clin Endocrinol Metab. 2014;99:3933-3951.
4. 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.
5. The NCCN Clinical Practice Guidelines in Oncology^® Neuroendocrine and Adrenal Tumors (Version 1.2019). © 2019 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed January 13, 2020.
6. Caplin ME, Pavel M, Cwikla JB, et al. Lanreotide in metastatic enteropancreatic neuroendocrine tumors. N Engl J Med. 2014;371:224-233.

 

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.

January 01, 2021