Notification



Notification Issue Date:



Medicare Advantage Policy

Title:Octreotide Acetate (Sandostatin® LAR Depot)
Policy #:MA08.065e

This policy is applicable to the Company’s Medicare Advantage products only. Policies that are applicable to the Company’s commercial products are accessible via a separate commercial policy database.


The Company makes decisions on coverage based on the Centers for Medicare and Medicaid Services (CMS) regulations and guidance, benefit plan documents and contracts, and the member’s medical history and condition. If CMS does not have a position addressing a service, the Company makes decisions based on Company Policy Bulletins. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable. Although the Medicare Advantage Policy Bulletin is consistent with Medicare’s regulations and guidance, the Company’s payment methodology may differ from Medicare.

When services can be administered in various settings, 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. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.


This Policy Bulletin document describes the status of CMS coverage, medical terminology, and/or benefit plan documents and contracts at the time the document was developed. This Policy Bulletin will be reviewed regularly and be updated as Medicare changes their regulations and guidance, scientific and medical literature becomes available, and/or the benefit plan documents and/or contracts are changed.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's Evidence of Coverage.

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 any of the following conditions are present and 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
  • Central Nervous System (CNS) Cancers
    • Meningiomas
      • For the management of surgically inaccessible recurrent or progressive meningiomas when radiation is not possible, if octreotide scan positive
      • Dosage and frequency up to 40 mg every 4 weeks until disease progression or unacceptable toxicity
  • 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 Tumors (See corresponding Dosing and Frequency Requirements, listed after each condition)
    • Neuroendocrine Tumors of the GI Tract, Lung, and Thymus
      • As symptom control in individuals with carcinoid syndrome:
        • as a single agent
        • in combination with telotristat for persistent diarrhea due to poorly controlled carcinoid syndrome
        • in combination with other systemic therapies for persistent symptoms such as flushing or diarrhea, or for progressive disease
      • As primary treatment for unresected primary gastrinoma
      • Management of distant metastatic bronchopulmonary/thymic disease* if somatostatin receptor positive and/or hormonal symptoms if clinically significant tumor burden and low grade (typical) histology, evidence of progression, or intermediate grade (atypical histology)
        • as primary therapy
        • consider as subsequent therapy if progression on first-line therapy
      • Management of locoregional advanced disease of the gastrointestinal tract and/or distant metastases*
        • if asymptomatic and a low tumor burden
        • with a clinically significant tumor burden
        • for disease progression if not already receiving
      • Management of locoregional unresectable bronchopulmonary/thymic disease* if somatostatin receptor positive and/or hormonal symptoms
        • as primary therapy in individuals with low grade (typical) histology
        • as subsequent therapy if progression on first-line therapy
      • Management of distant metastatic bronchopulmonary/thymic disease if somatostatin receptor positive and/or
        • hormonal symptoms if asymptomatic, low tumor burden and low grade (typical) histology
        • chronic cough/dyspnea if multiple lung nodules or tumorlets and evidence of diffuse idiopathic pulmonary neuroendocrine cell hyperplasia (DIPNECH)
      • Dosage and frequency up to 30 mg every 4 weeks until disease progression or unacceptable toxicity
    • Neuroendocrine Tumors of the Pancreas (Islet Cell Tumors)
      • For the management of symptoms related to hormone hypersecretion of locoregional disease
        • for gastrinoma (usually duodenal or head of pancreas)
        • for glucagonoma (usually tail)
        • for VIPoma
      • For tumor control in individuals** with locoregional advanced disease and/or distant metastatic disease*
        • for asymptomatic, low tumor burden and stable disease
        • for symptomatic, clinically significant tumor burden, or clinically significant progression (if disease progression and not already receiving)
      • Dosage and frequency up to 30 mg every 4 weeks until disease progression or unacceptable toxicity
    • Neuroendocrine Tumors: Pheochromocytoma/Paraganglioma
      • For the treatment of locally unresectable disease or distant metastases if somatostatin receptor positive imaging and symptomatic
      • Dosage and frequency up to 30 mg every 4 weeks
  • Thymomas and Thymic Carcinomas
    • As second-line therapy with or without prednisone for:
      • unresectable disease following first-line chemotherapy for potentially resectable locally advanced disease, solitary metastasis, or ipsilateral pleural metastasis
      • extrathoracic metastatic disease
    • Dosage and frequency up to 30 mg every 4 weeks until disease progression or unacceptable toxicity for a maximum of 12 cycles
  • 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 4 weeks

*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.
Policy Guidelines

There is no Medicare coverage determination addressing this drug; 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, seratonin, 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 that 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 acetate (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 2019. Octreotide acetate. [LexiDrug Web site]. updated 11/27/2017. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed October 23, 2019.

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.

Chamberlain MC, Glantz MJ, Fadul CE. Recurrent meningioma: salvage therapy with long-acting somatostatin analogue. Neurology. 2007;69(10):969-73.

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]. 06/22/2019. Available at: https://www.clinicalkey.com/pharmacology/ [via subscription only]. Accessed October 23, 2019.

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]. 10/21/19. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed October 23, 2019.

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.

Medscape Reference: Drugs, Diseases, and Procedures. octreotide. Sandostatin LAR. 2019. Available at: http://reference.medscape.com/drug/sandostatin-lar-octreotide-342836#10 . Accessed October 23, 2019.

Melmed S, Katznelson L. Treatment of acromegaly. 08/20/2019. Available at: http://www.uptodate.com/contents/treatment-of-acromegaly [via subscription only]. Accessed October 23, 2019.

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 09/06/19. Available at: http://www.micromedexsolutions.com/micromedex2/librarian [via subscription only]. Accessed October 23, 2019.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology - Central nervous system cancers. V3.2019. 10/18/19. [NCCN Web site]. Available at: https://www.nccn.org/professionals/physician_gls/pdf/cns.pdf [via free subscription]. Accessed October 23, 2019.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology - Neuroendocrine Tumors and Adrenal Tumors. V1.2019. 03/05/19. [NCCN Web site]. Available at: https://www.nccn.org/professionals/physician_gls/pdf/neuroendocrine.pdf [via free subscription]. Accessed October 23, 2019.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology - Thymomas and Thymic Carcinomas.V2.2019. 03/11/19. [NCCN Web site]. Available at: https://www.nccn.org/professionals/physician_gls/pdf/thymic.pdf [via free subscription]. Accessed October 23, 2019.

National Comprehensive Cancer Network (NCCN). NCCN Drugs & Biologics Compendium. Octreotide acetate (LAR). [NCCN Web site]. 2019. Available at: https://www.nccn.org/professionals/drug_compendium/content/ [via subscription only]. Accessed October 23, 2019.

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. 07/09/2019. Available at: http://www.uptodate.com/contents/treatment-of-the-carcinoid-syndrome [via subscription only]. Accessed October 23, 2019.

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 04/11/2019. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/. Accessed October 23, 2019.


Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


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

Coding and Billing Requirements


Cross References

Attachment A: Octreotide Acetate (Sandostatin® LAR Depot)
Description: ICD 10 codes and narratives






Policy History

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 to 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.

New policy MA08.065
01/01/2015This is a new policy.




Version Effective Date: 12/30/2019
Version Issued Date: 12/30/2019
Version Reissued Date: N/A