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MA PPO Host - Medical Policy Bulletin

Octreotide Acetate (Sandostatin® LAR Depot)
MA08.065i

Policy

The Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition.

MEDICALLY NECESSARY

Octreotide acetate (Sandostatin LAR Depot) is considered medically necessary and, therefore, covered for the long-term treatment of any of the following conditions in individuals who have already started therapy with octreotide acetate (Sandostatin) immediate-release formulation, when the corresponding Dosing and Frequency Requirements are met:​

  • Acromegaly
    • For the management of individuals who had inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy was not an option
    • Dosage and frequency up to 40 mg every 4 weeks
  • Metastatic Carcinoid Tumors
    • For the management of severe diarrhea and flushing episodes associated with metastatic carcinoid tumors
    • Dosage and frequency up to 30 mg every 4 weeks
  • ​​Neuroendocrine and Adrenal Tumors (See corresponding Dosing and Frequency Requirements, listed after each condition)
    • Neuroendocrine Tumors of the GI Tract ​(well-differentiated Grade 1/2), Lung, and Thymus
      • ​As primary treatment for symptom and/or tumor control for ​unresected primary gastrinoma ​
      • For symptom control in individuals with carcinoid syndrome:
        • as a single agent
        • in combination with telotristat (Xermelo) for persistent diarrhea due to poorly controlled carcinoid syndrome
        • in combination with other systemic therapies (based on disease site) with or without telotristat (Xermelo) for persistent symptoms such as flushing or diarrhea due to poorly controlled carcinoid syndrome

      • For symptom and/or tumor control of recurrent, locoregional advanced disease, and/or distant metastases* of the gastrointestinal tract 

        • ​​​as a single agent if unresectable and a low tumor burden
        • as a single agent for disease progression (if not already receiving) following resection of primary metastases
        • as a single agent for disease progression (if not already receiving) following observation unresectable low tumor burden
        • ​​​as a single agent following resection of primary tumor if unresectable and locally symptomatic from primary tumor
        • as a single agent or in combination with alternative front-line therapy if clinically significant tumor burden
        • as a single agent as subsequent therapy at above label dosing after clinical, symptomatic, or radiographic progression (if SSTR-positive) on standard doses ​ 
      • For symptom and/or tumor control of recurrent and/or locoregional unresectable bronchopulmonary/thymic disease* if somatostatin receptor positive and/or hormonal symptoms 
        • ​​as primary therapy
        • as subsequent therapy (as alternate primary therapy) if progression on primary therapy​​
      • For symptom and/or tumor control of recurrent and/or distant metastatic bronchopulmonary/thymic disease* if somatostatin receptor positive and/or hormonal symptoms (preferred if clinically significant tumor burden and low grade (typical carcinoid), evidence of disease progression, intermediate grade (atypical carcinoid histology), or symptomatic.
        • as primary therapy
        • as subsequent therapy (as alternate primary therapy) if progression on primary therapy if clinically significant tumor burden and low grade (typical carcinoid), evidence of disease progression, intermediate grade (atypical carcinoid histology), or symptomatic
        • ​​at above label dosing if clinically significant tumor burden and low grade (typical carcinoid); evidence of disease progression, intermediate grade (atypical carcinoid histology); or symptomatic after clinical, symptomatic, or radiographic progression (if SSTR-positive and/or hormonal symptoms) on standard doses​
      • For symptom and/or tumor control of multiple lung nodules or tumorlets and evidence of diffuse idiopathic pulmonary neuroendocrine cell hyperplasia (DIPNECH) chronic cough/dyspnea is not responsive to inhalers as primary therapy ​​​​
      • Dosage and frequency up to 30 mg every four weeks until disease progression or unacceptable toxicity
    • ​​Neuroendocrine Tumors of the Pancreas (Islet Cell Tumors) ​(well-differentiated Grade 1/2)​
      • For the management of symptoms  and /or tumor control of locoregional disease
        • for gastrinoma (usually duodenal or head of pancreas)
        • insulinoma only if tumor expresses somatostatin receptors 
        • ​for glucagonoma (usually tail)
        • for VIPoma
      • For symptom and/or tumor control as subsequent therapy at above label dosing after clinical, symptomatic or radiographic progression on standard doses (if SSTR-positive) 
      • ​​​For NCCN-Preferred for symptoms  and /or tumor control in individuals** with recurrent or locoregional advanced disease and/or distant metastatic disease* if somatostatin receptor (SSTR​) -positive
        • as a single agent for asymptomatic, low tumor burden, and stable disease
        • as a single agent for symptomatic, clinically significant tumor burden, or clinically significant progression (if disease progression and not already receiving)
        • in combination with alternative front-line therapy for symptomatic, clinically significant tumor burden, or clinically significant progression
        • Dosage and frequency up to 30 mg every four weeks until disease progression or unacceptable toxicity​​
    • ​Pheochromocytoma/Paraganglioma
      • As primary treatment of either of the following:
        • hormone excess and symptom control of locally unresectable disease or distant metastases (if SSTR-positive) of secreting tumors
        • Dosage and frequency up to 30 mg every four weeks
    • ​​​​Neuroendocrine Tumors: well-differentiated Grade 3, as treatment of symptoms and /or tumor (if SSTR-positive and/or hormonal symptoms) for unresectable locally advanced/metastatic disease with favorable biology (e.g. relatively low Ki-67 [<55%], positive SSTR-based PET imaging)
      • Dosage and frequency up to 30 mg every four weeks until disease progression or unacceptable toxicity
  • Thymomas and Thymic Carcinomas
    • ​Preoperative systemic therapy if octreotide scan or dotatate PET/CT positive with or without prednisone for individuals who cannot tolerate first-line combination regimens for thymoma for surgically resectable disease if R0 resection is considered uncertain​
    • Postoperative treatment if octreotide scan or dotatate PET/CT positive with or without prednisone for individuals who cannot tolerate first-line combination regimens for thymoma after R2 resection​
    • ​First-line therapy if octreotide scan or dotatate PET/CT positive with or without prednisone for individuals who cannot tolerate first-line combination regimens for:
      • ​potentially resectable locally advanced disease
      • potentially resectable solitary metastasis or ipsilateral pleural metastasis
      • following surgery for solitary metastasis or ipsilateral pleural metastasis
      • medically inoperable/unresectable solitary metastasis or ipsilateral pleural metastasis​
      • extrathoracic metastatic disease​
    • Second-line therapy if octreotide scan or dotatate PET/CT positive with or without prednisone for:
      • unresectable locally advanced disease
      • solitary metastasis or ipsilateral pleural metastasis​
      • extrathoracic metastatic disease
    • Dosage and frequency up to 30 mg every four weeks until disease progression or unacceptable toxicity​
    • Central Nervous System Cancers: Meningiomas
      • in combination with everolimus for surgically inaccessible recurrent or progressive disease when radiation is not possible
      • ​Dosage and frequency up to​ 30 mg every 4 weeks until disease progression or unacceptable toxicity​​

    • Vasoactive Intestinal Peptide (VIP)-secreting Tumors
      • For the management of profuse watery diarrhea associated with VIP-secreting tumors
      • Dosage and frequency up to 30 mg every four weeks
    Per NCCN : 
    *If disease progression, treatment with octreotide LAR should be continued in individuals with functional tumors and may be used in combination with any of the systemic therapy options.
    **For individuals with insulinoma, octreotide should be used only if somatostatin scintigraphy is positive.​​

    EXPERIMENTAL/INVESTIGATIONAL

    All other uses for octreotide acetate (Sandostatin LAR Depot), including dosage and frequency up to the covered amount specified, are considered experimental/investigational and, therefore, not covered unless the indication is supported as an accepted off-label use, as defined in the Company medical policy on off-label coverage for prescription drugs and biologics.

    DOSING AND FREQUENCY REQUIREMENTS

    The Company reserves the right to modify the Dosing and Frequency Requirements listed in this policy to ensure consistency with the most recently published recommendations for the use of octreotide acetate (Sandostatin LAR Depot). Changes to these guidelines are based on a consensus of information obtained from resources such as, but not limited to: the US Food and Drug Administration (FDA), Company-recognized authoritative pharmacology compendia, or published peer-reviewed clinical research. The professional provider must supply supporting documentation (i.e., published peer-reviewed literature) in order to request coverage for an amount of octreotide acetate (Sandostatin LAR Depot) outside of the Dosing and Frequency Requirements listed in this policy. For a list of Company-recognized pharmacology compendia, view the Company's policy on off-label coverage for prescription drugs and biologics.

    Accurate member information is necessary for the Company to approve the requested dose and frequency of this drug. If the member’s dose, frequency, or regimen changes (based on factors such as changes in member weight or incomplete therapeutic response), the provider must submit those changes to the Company for a new approval based on those changes as part of the precertification process. The Company reserves the right to conduct post-payment review and audit procedures for any claims submitted for octreotide acetate (Sandostatin LAR Depot).

    REQUIRED DOCUMENTATION

    The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

    The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the drug.

    When coverage of octreotide acetate (Sandostatin LAR Depot) is requested outside of the Dosing and Frequency Requirements listed in this policy, the prescribing professional provider must supply documentation (i.e., published peer-reviewed literature) to the Company that supports this request.

    Guidelines

    There is no Medicare coverage determination addressing octreotide acetate (Sandostatin LAR Depot)​; therefore, the Company policy is applicable.

    BENEFIT APPLICATION

    Subject to the terms and conditions of the applicable Evidence of Coverage, octreotide acetate (Sandostatin LAR Depot) is covered under the medical benefits of the Company’s Medicare Advantage products when the medical necessity criteria and Dosing and Frequency Requirements listed in this medical policy are met.

    Certain drugs are available through either the member's medical benefit (Part B benefit) or pharmacy benefit (Part D benefit), depending on how the drug is prescribed, dispensed, or administered. This medical policy only addresses instances when octreotide acetate (Sandostatin LAR Depot) is covered under a member's medical benefit (Part B benefit). It does not address instances when octreotide acetate (Sandostatin LAR Depot) is covered under a member’s pharmacy benefit (Part D benefit).

    DRUG ADMINISTRATION

    Octreotide acetate (Sandostatin LAR Depot) is administered only intramuscularly.

    US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

    Octreotide acetate (Sandostatin LAR Depot) was approved by the FDA on November 25, 1998 for:
    • Long-term maintenance therapy in individuals with acromegaly who have had an inadequate response to surgery and/or radiotherapy, for whom surgery and/or radiotherapy is not an option, and in whom initial treatment with Sandostatin injection has been shown to be effective and tolerated
    • Long-term treatment of the severe diarrhea and flushing episodes associated with metastatic carcinoid tumors in individuals in whom initial treatment with Sandostatin injection has been shown to be effective and tolerated
    • Long-term treatment of the profuse watery diarrhea associated with VIP-secreting tumors in individuals in whom initial treatment with Sandostatin injection has been shown to be effective and tolerated
    The safety and efficacy of octreotide acetate (Sandostatin LAR Depot) in the pediatric population have not been demonstrated.

    Description

    Somatostatin is a naturally occurring hormone that has many biological actions because its receptors are found throughout the body. Some actions of somatostatin include inhibiting the secretion of growth hormones (GH), vasoactive intestinal peptide (VIP), gastrin, secretin, motilin, serotonin, pancreatic polypeptide, and insulin. Because somatostatin has a short half-life and targets many different hormones, somatostatin analogs were created, including octreotide acetate (Sandostatin, Sandostatin LAR Depot). Somatostatin analogs have a much longer half-life, so they can be dosed less often, and have greater inhibitory selectivity of GH secretion over insulin secretion.

    Octreotide acetate (Sandostatin) is a fast-acting formulation with a short half-life, so it needs to be administered two to four times a day subcutaneously. In contrast, the long-acting formulation, octreotide acetate (Sandostatin LAR Depot), is administered every four weeks, but it takes 10 to 14 days for the levels of the drug to achieve therapeutic levels in the body because it is not a fast-acting formulation. Hence, it is recommended that individuals with chronic conditions who require octreotide acetate initially receive octreotide acetate (Sandostatin), followed by octreotide acetate (Sandostatin LAR Depot) for continued therapy.

    Because somatostatin receptors have been found throughout the whole gastrointestinal tract, octreotide acetate (Sandostatin LAR Depot) aids in the long-term treatment of flushing and severe diarrhea associated with metastatic carcinoid tumors, as well as diarrhea associated with vasoactive intestinal peptide secreting tumors (VIPomas). These conditions cause the secretion of excessive amounts of vasoactive substances, such as histamine, bradykinin, serotonin, and prostaglandins. Octreotide acetate (Sandostatin LAR Depot) works by blocking the release of serotonin and many of these other active peptides, as well as suppressing the secretion of gastrin, glucagon, and secretin.

    Octreotide acetate (Sandostatin LAR Depot) has been successful at reducing the signs and symptoms of acromegaly, a rare condition characterized by abnormal enlargement of bones in the extremities and head, as well as thickening of soft tissues, such as the heart, lips, and tongue. Acromegaly occurs when the pituitary gland produces too much GH, which in turn causes excess secretion of insulin-like growth factor-1 (IGF-1). The long-term use of this medication suppresses the secretion of GH and IGF-1 in individuals who have had inadequate response to, or cannot be treated with, other therapies, including surgery or radiotherapy.

    Octreotide acetate (Sandostatin LAR Depot) is approved by the US Food and Drug Administration (FDA) for long-term treatment in individuals with acromegaly who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy is not an option; long-term treatment for individuals with severe diarrhea and flushing episodes associated with metastatic carcinoid tumors; and long-term treatment of profuse watery diarrhea associated with VIP-secreting tumors.

    CLINICAL STUDIES

    ACROMEGALY
    The efficacy of octreotide acetate (Sandostatin LAR Depot) was evaluated in 101 individuals with acromegaly who achieved growth hormone (GH) levels less than 5 ng/mL while on subcutaneous octreotide acetate (Sandostatin) injections in two clinical studies. Individuals were switched to 10 mg, 20 mg, 30 mg, or 40 mg of octreotide acetate (Sandostatin LAR Depot) once every 4 weeks for up to 27 to 28 injections. Of the 101 individuals, only 88 individuals received all of the 27 to 28 injections. A mean GH level of less than 5.0 ng/mL was observed in 83% of the individuals who completed all 27 or 28 injections. GH and insulin-like growth factor-1 (IGF-1) levels were at least as well controlled with octreotide acetate (Sandostatin LAR Depot) as they had been on octreotide acetate (Sandostatin) injections and retained the level of control for the duration of the clinical trials.

    The efficacy of octreotide acetate (Sandostatin LAR Depot) was evaluated in a third study of 151 individuals with acromegaly who achieved GH levels less than 10 ng/mL on octreotide acetate (Sandostatin) injections. Individuals were switched to 10 mg, 20 mg, or 30 mg of octreotide acetate (Sandostatin LAR Depot) once every 4 weeks for up to 12 injections. Only 122 individuals received all 12 injections; a mean GH level of less than 5.0 ng/mL was observed in 97% of the individuals. Growth hormone and IGF-1 levels were at least as well controlled with octreotide acetate (Sandostatin LAR Depot) as they had been on octreotide acetate (Sandostatin) injections and retained the level of control for the duration of the clinical trial.

    CARCINOID SYNDROME
    In a 6-month double-blind clinical study, the efficacy of octreotide acetate (Sandostatin LAR Depot) was evaluated in 93 individuals with malignant carcinoid syndrome who had previously been responsive to octreotide acetate (Sandostatin) injections. Sixty-seven individuals were randomized to receive 10 mg, 20 mg, or 30 mg of octreotide acet​ate (Sandostatin LAR Depot) every 28 days, and 26 individuals remained on octreotide acetate (Sandostatin) injections (100-300 mcg three times daily) unblinded. Over the 6-month period, approximately 50-70% of octreotide acetate (Sandostatin LAR Depot) group required octreotide acetate (Sandostatin) injections as supplemental therapy to control exacerbations of carcinoid symptoms, although steady-state serum octreotide acetate (Sandostatin LAR Depot) levels had been reached. The mean daily stool frequency was as well controlled on octreotide acetate (Sandostatin LAR Depot) as on octreotide acetate (Sandostatin) injections.

    Seventy-eight individuals with malignant carcinoid syndrome who participated in the 6-month study also participated in a 12-month extension study in which they received 12 injections of octreotide acetate (Sandostatin LAR Depot) at 4-week intervals. During the extension study, diarrhea and flushing were as well controlled as during the 6-month study.

    OFF-LABEL INDICATIONS

    There may be additional indications contained in the Policy section of this document due to evaluation of criteria highlighted in the Company’s off-label policy, and/or review of clinical guidelines issued by leading professional organizations and government entities.

    References

    American Hospital Formulary Service (AHFS). Drug Info 2024. Octreotide acetate. [LexiDrug Web site]. updated 03/11/2024. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed June 10, 2024. 

    Brunton LL, Lazo JS, Parker KL. Goodman & Gilman’s The Pharmacological Basis of Therapeutics. 11th ed. 2006;1496-98.

    Chadha MK, Lombardo J, Mashtare T, et al. High-dose octreotide acetate for management of gastroenteropancreatic neuroendocrine tumors. Anticancer Res. 2009;29(10):4127-30.

    Colao A, Faggiano A, Pivonello R. Somatostatin analogues: treatment of pituitary and neuroendocrine tumors. In: L. Martini, eds. Prog Brain Res. 2010;182:281-94.

    Colao A, Pivonello R, Auriemma RS, Galdiero M, Savastano S, Lombardi G. Beneficial effect of dose escalation of octreotide-LAR as first-line therapy in patients with acromegaly. Eur J Endocrinol. 2007;157(5):579-87.

    Dipiro JT, Talbert RL, Yee GC, et al. Pharmacotherapy: A Pathophysiologic Approach. 8th ed. 2011;626-27, 1349-50.

    Elsevier’s Clinical Pharmacology Compendium. Octreotide acetate. [ClinicalKey Web site]. 06/08/2024. Available at: https://www.clinicalkey.com/pharmacology/ [via subscription only]. Accessed June 10, 2024​. 

    Fleseriu M. Clinical efficacy and safety results for dose escalation of somatostatin receptor ligands in patients with acromegaly: a literature review. Pituitary. 2011;14(2):184-93.

    Freda PU, Katznelson L, van der Lely AJ, et al. Long-acting somatostatin analog therapy of acromegaly: a meta-analysis. J Clin Endocrinol Metab. 2005;90(8):4465-73.

    Giustina A, Bonadonna S, Bugari G, et al. High-dose intramuscular octreotide in patients with acromegaly inadequately controlled on conventional somatostatin analogue therapy: a randomised controlled trial. Eur J Endocrinol. 2009;161(2):331-8.

    Lexi-Drugs Compendium. Octreotide acetate. [Lexicomp Online Web site]. 06/05/2024. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed June 10, 2024. 

    Ludlam WH, Anthony L. Safety review: dose optimization of somatostatin analogs in patients with acromegaly and neuroendocrine tumors. Adv Ther. 2011;28(10):825-41.

    ​Melmed S, Katznelson L. Treatment of acromegaly. 12/03/2020. Available at: http://www.uptodate.com/contents/treatment-of-acromegaly [via subscription only]. Accessed June 10, 2024​.  

    Melmed S, Casanueva F, Cavagnini F, et al. Consensus statement: medical management of acromegaly. Eur J Endocrinol. 2005;153(6):737-40.

    Melmed S, Colao A, Barkan A, Acromegaly Consensus Group, et al. Guidelines for acromegaly management: an update. J Clin Endocrinol Metab. 2009;94(5):1509-17.

    Micromedex Healthcare Series. DrugDex®. Octreotide Acetate. [Micromedex® 2.0 Web site]. updated 06/03/2024. Available at: http://www.micromedexsolutions.com/micromedex2/librarian [via subscription only]. Accessed June 10, 2024. 

    National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology - Central Nervous System Cancers.V1.2024. 05/31/2024. [NCCN Web site]. Available at: https://www.nccn.org/professionals/physician_gls/pdf/thymic.pdf [via free subscription]. Accessed June 10, 2024. ​

    National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology - Neuroendocrine Tumors and Adrenal Tumors. V1.2023. 08/02/2023. [NCCN Web site]. Available at: https://www.nccn.org/professionals/physician_gls/pdf/neuroendocrine.pdf [via free subscription]. Accessed June 10, 2024. 

    National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology - Thymomas and Thymic Carcinomas.V1.2024. 11/21/2024. [NCCN Web site]. Available at: https://www.nccn.org/professionals/physician_gls/pdf/thymic.pdf [via free subscription]. Accessed June 10, 2024. 

    National Comprehensive Cancer Network (NCCN). NCCN Drugs & Biologics Compendium. Octreotide acetate (LAR). [NCCN Web site]. 2024. Available at: https://www.nccn.org/professionals/drug_compendium/content/ [via subscription only]. Accessed June 10, 2024. 

    Oberg K, Kvols L, Caplin M, et al. Consensus report on the use of somatostatin analogs for the management of neuroendocrine tumors of the gastroenteropancreatic system. Ann Oncol. 2004;15(6):966-73. Review.

    Rinke A, Müller HH, Schade-Brittinger C, et al; PROMID Study Group. Placebo-controlled, double-blind, prospective, randomized study on the effect of octreotide LAR in the control of tumor growth in patients with metastatic neuroendocrine midgut tumors: a report from the PROMID Study Group. J Clin Oncol. 2009;27(28):4656-63.

    Strosberg JR. Treatment of the carcinoid syndrome. 03/01/2020. Available at: http://www.uptodate.com/contents/treatment-of-the-carcinoid-syndrome [via subscription only]. Accessed June 10, 2024.  ​

    Tritos N. Advances in medical therapies for Cushing's syndrome. Discov Med. 2012;13(9):171-179.

    US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Octreotide (Sandostatin LAR® Depot) drug label and approval letter [FDA Web site]. updated 03/2021. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/. Accessed June 01, 2024​.​​

    Coding

    CPT Procedure Code Number(s)
    N/A
    ICD - 10 Procedure Code Number(s)
    N/A
    ICD - 10 Diagnosis Code Number(s)
    See Attachment A.
    HCPCS Level II Code Number(s)
    J2353 Injection, octreotide, depot form for intramuscular injection, 1 mg
    Revenue Code Number(s)
    N/A

    Policy History

    Revisions From MA08.065i:

    ​ 07/29/2024​

    ​​​This version of the policy will become effective​ 07/29/2024​​.
    ​
    This policy was updated to communicate the coverage position changes for neuroendocrine and adrenal tumors and thymomas and thymic carcinomas in accordance with the National Comprehensive Cancer Network (NCCN) compendium.

    The following ICD-10 codes have been added to ​​​Attachment A:

    • C74.01 Malignant neoplasm of cortex of right adrenal gland
    • C74.02 Malignant neoplasm of cortex of left adrenal gland       
    • D35.01 Benign neoplasm of right adrenal gland
    • D35.02 Benign neoplasm of left adrenal gland​


    Revisions From MA08.065h:

    01/01/2024

    Effective 01/01/2024 this policy applies to New Jersey Medicare Advantage (MA) lines of business.​​​

    08/28/2023This version of the policy will become effective​ 08/28/2023​
    This Policy was updated to communicate the coverage position changes for Neuroendocrine and Adrenal Tumors , Thymomas and Thymic Carcinomas and Central Nervous System Cancers​ in accordance with the National Comprehensive Cancer Network (NCCN).

    Following ICD-10 codes were added to the policy:

    C70.0 Malignant neoplasm of cerebral meninges
    C70.1 Malignant neoplasm of spinal meninges
    C70.9 Malignant neoplasm of meninges, unspecified
    C74.11 Malignant neoplasm of medulla of right adrenal gland
    C74.12 Malignant neoplasm of medulla of left adrenal gland
    C74.91 Malignant neoplasm of unspecified part of right adrenal gland
    C74.92 Malignant neoplasm of unspecified part of left adrenal gland
    C75.5 Malignant neoplasm: Aortic body and other paraganglia
    D32.0 Benign neoplasm of cerebral meninges
    D32.1 Benign neoplasm of spinal meninges
    D32.9 Benign neoplasm of meninges, unspecified​​

    Revisions From MA08.065g:
    ​05/04/2022

    		​This policy has been reissued in accordance with the Company's annual review process.
    10/25/2021
    		This version of the policy will become effective 10/25/2021​.​

    The policy has been updated due to extensive revisions in National Comprehensive Cancer Network (NCCN) compendia for Neuroendocrine Tumors and Thymomas and Thymic Carcinomas​.

    Revisions From MA08.065f:
    06/08/2020This version of the policy will become effective 06/08/2020.

    This policy was updated to remove the coverage criteria for meningiomas, per National Comprehensive Cancer Network (NCCN). The following ICD-10 Diagnoses were removed from Attachment A:

    C70.0 Malignant neoplasm of cerebral meninges
    C70.1 Malignant neoplasm of spinal meninges
    C70.9 Malignant neoplasm of meninges, unspecified
    D32.0 Benign neoplasm of cerebral meninges
    D32.1 Benign neoplasm of spinal meninges
    D32.9 Benign neoplasm of meninges, unspecified
    D42.0 Neoplasm of uncertain behavior of cerebral meninges
    D42.1 Neoplasm of uncertain behavior of spinal meninges
    D42.9 Neoplasm of uncertain behavior of meninges, unspecified

    Revisions From MA08.065e:
    12/30/2019This Policy was updated to communicate the coverage position changes for Adrenal Gland Tumors, other Neuroendocrine Tumors, and Thymomas and Thymic Carcinomas, in accordance with the National Comprehensive Cancer Network (NCCN).

    Revisions From MA08.065d:
    09/20/2017This version of the policy will become effective 09/20/2017.

    This policy has been updated to include information regarding the Company's Dosing and Frequency Program.

    This policy has been updated to be consistent with the US Food and Drug Administration (FDA) labeling and NCCN compendia.

    Policy criteria was updated to include new NCCN criteria for neuroendocrine tumors of the GI tract, lung, and thymus.

    Revisions From MA08.065c:
    10/01/2016The following ICD-10 narratives have been revised in this policy:

    C7A.094
    FROM: Malignant carcinoid tumor of the foregut NOS
    TO: Malignant carcinoid tumor of the foregut, unspecified

    C7A.095
    FROM: Malignant carcinoid tumor of the midgut NOS
    TO: Malignant carcinoid tumor of the midgut, unspecified

    C7A.096
    FROM: Malignant carcinoid tumor of the hindgut NOS
    TO: Malignant carcinoid tumor of the hindgut, unspecified

    D3A.094
    FROM: Benign carcinoid tumor of the foregut NOS
    TO: Benign carcinoid tumor of the foregut, unspecified

    D3A.095
    FROM: Benign carcinoid tumor of the midgut NOS
    TO: Benign carcinoid tumor of the midgut, unspecified

    D3A.096
    FROM: Benign carcinoid tumor of the hindgut NOS
    TO: Benign carcinoid tumor of the hindgut, unspecified

    Revisions From MA08.065b:
    05/04/2016This version of the policy will become effective 05/04/2016.

    This policy has been updated to be consistent with the US Food and Drug Administration (FDA) labeling:
    • The dosage and frequency for Central Nervous System Cancer was changed to up to 40 mg every 4 weeks.
    • The policy criteria for Neuroendocrine Tumors of the GI Tract, Lung, and Thymus was updated to include low or intermediate-grade neuroendocrine carcinoma.
    • The policy criteria for Thymomas and Thymic Carcinomas was updated to remove the requirement that treatment has to follow radiation therapy for locally advanced unresectable disease.
    The following ICD-10 codes were added to the policy: D3A.094, D3A.095, D3A.096, D3A.098, E24.8.

    The following ICD-10 codes were removed from the policy: C77.9, C77.9, E24.0, E24.2, E24.3, R19.7.

    Revisions From MA08.065a:
    02/25/2015This policy was updated to be consistent with US Food and Drug Administration (FDA) Labeling and Drug Compendia. The following criteria have been added to this policy:
    • Neuroendocrine Tumors
      • Adrenal Gland Tumors
        • For symptom control if somatostatin scintigraphy positive in persons with non-adrenocorticotropic hormone dependent Cushing's syndrome with tumors less than 4 cm, benign imaging characteristics, and abnormal contralateral gland and symmetric cortisol production
        • Dosage and frequency up to 30 mg every 4 weeks
      • Neuroendocrine Tumors of the GI tract, Lung, and Thymus
        • Treatment of underlying Zollinger-Ellison syndrome
      • Neuroendocrine Tumors of the Pancreas (Islet Cell Tumors)
        • For tumor control in patients with unresectable locoregional disease and/or metastatic disease and clinically significant tumor burden or clinically significant progression if not already given
      • Poorly Differentiated (High Grade)/Large or Small Cell
        • For symptom control if somatostatin scintigraphy positive
    The following indication was removed from the policy:
    • Poorly Differentiated (High Grade)/Large or Small Cell
      • As symptom control for unresectable locoregional and metastatic hormone-secreting tumors when used in combination with chemotherapy (using small cell lung cancer regimens) with or without radiation therapy
    The following ICD-9 code was added to the policy: 255.0.

    The following ICD-10 codes were added to the policy: E24.0, E24.2, E24.3.

    Revisions From ​MA08.065:
    01/01/2015This is a new policy.
    07/29/2024
    07/29/2024
    N/A
    MA08.065
    Medical Policy Bulletin
    Medicare Advantage
    {"532": {"Id":532,"MPAttachmentLetter":"A","Title":"ICD-10 codes and narratives","MPPolicyAttachmentInternalSourceId":8829,"PolicyAttachmentPageName":"f5d5581c-887d-4c50-b6ff-650297953731"},}
    No
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