Subject: lanreotide injection-Somatuline Depot 2092-A SGM P2024
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SOMATULINE DEPOT
(lanreotide acetate injection)
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LANREOTIDE INJECTION
(lanreotide acetate injection)
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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
a. Long-term treatment of acromegalic patients who have had an inadequate response
to or cannot be treated with surgery and/or radiotherapy.
b. Treatment of adult patients with unresectable, well- or moderately-differentiated,
locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-
NETs) to improve progression-free survival.
c. Treatment of adults with carcinoid syndrome; when used, it reduces the frequency of
short-acting somatostatin analog rescue therapy.
2. Lanreotide Injection
a. Long-term treatment of acromegalic patients who have had an inadequate response
to or cannot be treated with surgery and/or radiotherapy.
b. Treatment of adult patients with unresectable, well- or moderately-differentiated,
locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-
NETs) to improve progression-free survival.
B. Compendial Uses
1. Neuroendocrine tumors (NETs):
a. Tumors of the gastrointestinal (GI) tract, lung, and thymus (carcinoid tumors)
b. Tumors of the pancreas (islet cell tumors)
c. Gastroenteropancreatic neuroendocrine tumors (GEP-NETs)
2. Pheochromocytoma and paraganglioma
3. Zollinger-Ellison syndrome
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 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. Authorization of 12 months may be granted for treatment of NETs of the gastrointestinal
(GI) tract, lung and thymus (carcinoid tumors).
2. Authorization of 12 months may be granted for treatment of NETs of the pancreas (islet
cell tumors), including gastrinomas, glucagonomas, insulinomas, and VIPomas.
3. Authorization of 12 months may be granted for treatment of gastroenteropancreatic
neuroendocrine tumors (GEP-NETs).
C. Carcinoid syndrome
Authorization of 12 months may be granted for treatment of carcinoid syndrome.
D. Pheochromocytoma and paraganglioma
Authorization of 12 months may be granted for treatment of 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. NETs, Carcinoid syndrome, pheochromocytoma/paraganglioma, and Zollinger-
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.
Place of Service:
Outpatient
The above policy is based on the following references:
- Somatuline Depot [package insert]. Cambridge, MA: Ipsen Biopharmaceuticals, Inc.; February 2023.
- The NCCN Drugs & Biologics Compendium® © 2023 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed November 13, 2023.
- Katznelson L, Laws ER, Melmed S, et al. Acromegaly: an endocrine society clinical practice guideline. J Clin Endocrinol Metab. 2014;99:3933-3951.
- 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.
- The NCCN Clinical Practice Guidelines in Oncology® Neuroendocrine and Adrenal Tumors (Version 1.2023). © 2023 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed November 13, 2023.
- Caplin ME, Pavel M, Cwikla JB, et al. Lanreotide in metastatic enteropancreatic neuroendocrine tumors. N Engl J Med. 2014;371:224-233.
- Lanreotide Injection [package insert]. Warren, NJ: Cipla USA, Inc.; September 2023.
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 17, 2024
