Subject: lanreotide injection-Somatuline Depot 2092-A SGM P2023

Drug

SOMATULINE DEPOT  (lanreotide acetate injection)

LANREOTIDE INJECTION  (lanreotide acetate injection)

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.

 

Place of Service:

Outpatient

The above policy is based on the following 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.

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.

May 15, 2023