Subject: octreotide products 1734-A SGM P2022

Drug

SANDOSTATIN  (octreotide acetate injection)

BYNFEZIA PEN  (octreotide acetate injection)

MYCAPSSA  (octreotide delayed-release capsule)

SANDOSTATIN LAR DEPOT  (octreotide acetate for injectable suspension)

octreotide 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.  octreotide acetate/Sandostatin/Bynfezia Pen:
                     a.  Indicated to reduce blood levels of growth hormone
                          (GH) and insulin growth factor-1 (IGF-1;
                          somatomedin C) in acromegaly patients who have
                          had inadequate response to or cannot be treated with
                          surgical resection, pituitary irradiation, and
                          bromocriptine mesylate at maximally tolerated doses.
                     b.  Indicated for the symptomatic treatment of patients
                          with metastatic carcinoid tumors where it suppresses
                          or inhibits the severe diarrhea and flushing episodes
                          associated with the disease.
                     c.  Indicated for the treatment of the profuse watery
                         diarrhea associated with vasoactive intestinal peptide
                         (VIP)-secreting tumors.
                2.  Sandostatin LAR: Sandostatin LAR Depot is indicated in
                     patients who have responded to and tolerated
                     Sandostatin subcutaneous injection for:
                     a.  Long-term maintenance therapy in acromegalic
                          patients who have had an inadequate response to
                          surgery and/or radiotherapy, or for whom surgery
                          and/or radiotherapy is not an option.
                     b.  Long-term treatment of the severe diarrhea and
                          flushing episodes associated with metastatic carcinoid
                          tumors.
                     c.  Long-term treatment of the profuse watery diarrhea
                          associated with vasoactive intestinal peptide (VIP)-
                          secreting tumors.

                 3.  Mycapssa is indicated for long-term maintenance
                      treatment in acromegaly patients who have responded
                      to and tolerated treatment with octreotide or lanreotide.

           B.  Compendial Uses (applies to injectable products)
                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.   Thymomas and thymic carcinomas
                4.   Congenital hyperinsulinism (CHI)/persistent
                      hyperinsulinemic hypoglycemia of infancy (PHHI)
                      (octreotide and Sandostatin only)
                5.   Acquired immune deficiency syndrome (AIDS)-
                      associated diarrhea
                6.   Inoperable bowel obstruction
                7.   Chemotherapy- and radiation-induced diarrhea
                8.   Enterocutaneous fistula
                9.   Gastroesophageal varices
               10.  Pancreatic fistulas
               11.  Pituitary adenoma
               12.  Short bowel syndrome
               13.  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:
           A.  For acromegaly:
                1.  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.
                2.  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
            B.  Chemotherapy- and radiation-induced diarrhea: Chart notes
                 indicating grade 3 or 4 diarrhea with current chemotherapy
                 or radiation.

  
    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.
                 3.  For Mycapssa requests, member has previously
                      responded to and tolerated treatment with octreotide or
                      lanreotide.

           B.  Neuroendocrine tumors (NETs) (injectable products
                 only)
                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 of unresectable or metastatic 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, and insulinomas.
                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 with favorable
                     biology (e.g., relatively low Ki-67 [less than 55%],
                     somatostatin receptor [SSR] positive imaging)

           C.  Carcinoid syndrome (injectable products only)
                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.  Vasoactive intestinal peptide tumors (VIPomas)
                  (injectable products only)
                 Authorization of 12 months may be granted for
                 management of symptoms related to hormone
                 hypersecretion of VIPomas.

            E.  Pheochromocytoma and paraganglioma (injectable
                 products only) Authorization of 12 months may be
                 granted for treatment of locally unresectable or metastatic
                 pheochromocytoma and paraganglioma.

            F.  Thymomas and thymic carcinomas (injectable
                 products only)
                Authorization of 12 months may be granted for treatment of
                thymomas and thymic carcinomas when the requested drug
                is used with or without prednisone in any of the following
                clinical settings:
                1.  Postoperative treatment for patients who cannot tolerate
                     first-line combination regimens after resection.
                2.  First-line therapy for patients who cannot tolerate first-
                     line combination regimens.
                3.  Second-line therapy for unresectable or metastatic
                     disease.

           G.  Congenital hyperinsulinism (CHI)/persistent
                 hyperinsulinemic hypoglycemia of infancy (octreotide
                 and Sandostatin only)
                Authorization of 6 months may be granted for treatment of
                CHI and persistent hyperinsulinemic hypoglycemia in an
                infant.

           H.  AIDS-associated diarrhea (injectable products only)
                Authorization of 12 months may be granted for treatment of
                AIDS-associated severe secretory diarrhea when anti-
                microbial (e.g., ciprofloxacin or metronidazole) or anti-
                motility agents (e.g., loperamide or diphenoxylate and
                atropine) have become ineffective.

           I.  Inoperable bowel obstruction in terminal cancer
               (injectable products only)
               Authorization of 12 months may be granted for management
               of GI symptoms (e.g., nausea, pain, vomiting) of inoperable
               bowel obstruction in members with terminal cancer.

           J.  Chemotherapy- and radiation-induced diarrhea
                (injectable products only)
                Authorization of 12 months may be granted for treatment of
                chemotherapy- or radiation-induced diarrhea when all of the
                following criteria are met:
                1.  Member is receiving treatment with chemotherapy or
                     radiation.
                2.  Member has grade 3 or greater diarrhea according to
                     National Cancer Institute (NCI) Common Terminology
                     Criteria for Adverse Events (CTCAE).

           K.  Enterocutaneous fistula (injectable products only)
                Authorization of 12 months may be granted for
                management of volume depletion from enterocutaneous
                fistula.

           L.  Gastroesophageal varices (injectable products only)
                Authorization of 6 months may be granted for treatment of
                acute bleeding of gastroesophageal varices associated with
                cirrhosis.

          M.  Pancreatic fistulas (injectable products only)
                Authorization of 6 months may be granted for prevention
                and treatment of pancreatic fistulas following pancreatic
                surgery.

           N.  Pituitary adenoma (injectable products only)
                Authorization of 12 months may be granted for treatment of
                pituitary adenoma.

           O.  Short bowel syndrome (injectable products only)
                 Authorization of 12 months may be grated for treatment of
                 short bowel syndrome when the daily intravenous fluid
                 requirement is greater than 3 liters.

            P.  Zollinger-Ellison syndrome (injectable products only)
                 Authorization of 12 months may be grated 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, VIPomas, AIDS-associated
            diarrhea, bowel obstruction, chemotherapy/radiation-
            induced diarrhea, and Zollinger-Ellison syndrome
            (injectable products only)
            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 initiation of therapy.

       C.  All other indications
            All 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. Octreotide acetate [package insert]. Morgantown, WV: Mylan Institutional LLC; June 2021.
2. Sandostatin [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; May 2021.
3. Sandostatin LAR Depot [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; March 2021.
4. National Comprehensive Cancer Network Drugs and Biologics Compendium. Available at: http://www.nccn.org. Accessed November 2, 2021.
5. Katznelson L, Laws ER, Melmed S, et al. Acromegaly: an endocrine society clinical practice guideline. J Clin Endocrinol Metab. 2014;99:3933-3951.
6. 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.

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