Subject: lanreotide injection-Somatuline Depot 2092-A SGM P2022
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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. Well-differentiated grade 3 NETs with favorable
biology
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. 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 (islet cell tumors)
Authorization of 12 months may be granted for
treatment of NETs of the pancreas, including
gastrinomas, glucagonomas,
insulinomas, and VIPomas.
5. Well-differentiated grade 3 NETs with favorable biology
Authorization of 12 months may be granted for
treatment of well-differentiated grade 3 unresectable
locally advanced or metastatic NETs (not of
gastroenteropancreatic origin) with favorable biology
(e.g., relatively low Ki-67 [less than 55%],
somatostatin receptor [SSR] positive imaging)
6. 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 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.
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:
- Somatuline Depot [package insert]. Cambridge, MA: Ipsen Biopharmaceuticals, Inc.; June 2019.
- National Comprehensive Cancer Network Drugs and Biologics Compendium. Available at: http://www.nccn.org. Accessed November 3, 2021.
- 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 3.2021). © 2021 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed November 3, 2021.
- 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.; December 2021.
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
