Lanreotide (Somatuline® Depot; Lanreotide*)
Requires Step Therapy See “Step Therapy Requirements for Provider Administered Specialty Medications” Document at: https://www.bcbst.com/docs/providers/Comm_BC_PAD_Step_Therapy_Guide.pdf
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
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 NETs of the GI tract.
2. Tumors of the thymus (carcinoid tumor)
Authorization of 12 months may be granted for treatment of NETs of the thymus.
3. Tumors of the lung (carcinoid tumor)
Authorization of 12 months may be granted for treatment of 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 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 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.
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.
ADDITIONAL INFORMATION
For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).
REFERENCES
1. Somatuline Depot [package insert]. Cambridge, MA: Ipsen Biopharmaceuticals, Inc.; June 2019.
2. The NCCN Drugs & Biologics Compendium® © 2022 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed November 8, 2022.
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 1.2022). © 2022 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed November 8, 2022.
6. Caplin ME, Pavel M, Cwikla JB, et al. Lanreotide in metastatic enteropancreatic neuroendocrine tumors. N Engl J Med. 2014;371:224-233.
7. Lanreotide Injection [package insert]. Warren, NJ: Cipla USA, Inc.; December 2021.
ORIGINAL EFFECTIVE DATE: 4/1/2020
MOST RECENT REVIEW DATE: 1/1/2024
ID_CHS
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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