ModifiedAmeriHealth Caritas VIP CarePolicy MA08.065i

Octreotide Acetate (Sandostatin LAR Depot)

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Medical-benefit coverage and prior authorization for intramuscular octreotide acetate (Sandostatin LAR Depot) in Medicare Advantage members when specified medical-necessity and dosing requirements are met; Part D pharmacy-benefit coverage is excluded.

Policy Summary

PayerAmeriHealth Caritas VIP Care

PolicyOctreotide Acetate (Sandostatin LAR Depot)

Policy CodePolicy MA08.065i

Change TypeModified

Effective DateSep 18, 2026

Last ReviewDec 15, 2025

Next Review DateN/A

Key ActionObtain precertification for octreotide acetate under the medical benefit and provide the requested dose, frequency, regimen, and medical-necessity information.

SourceLink

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ModifiedAmeriHealth Caritas VIP CarePolicy MA08.065i

Octreotide Acetate (Sandostatin LAR Depot)

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Policy Summary

PayerAmeriHealth Caritas VIP Care

PolicyOctreotide Acetate (Sandostatin LAR Depot)

Policy CodePolicy MA08.065i

Change TypeModified

Effective DateSep 18, 2026

Last ReviewDec 15, 2025

Next Review DateN/A

Key ActionObtain precertification for octreotide acetate under the medical benefit and provide the requested dose, frequency, regimen, and medical-necessity information.

SourceLink

POLICY UPDATE CHANGES

The policy criteria were revised to add discontinuation guidance and address SSTR-negative use in pancreatic neuroendocrine tumors.

Coverage criteria were added for Merkel cell carcinoma.

The policy was updated because of extensive NCCN compendia revisions for neuroendocrine tumors and thymomas and thymic carcinomas.

Coverage criteria for meningiomas were removed, along with nine associated ICD-10 diagnosis codes.

Coverage positions were changed for adrenal gland tumors, other neuroendocrine tumors, and thymomas and thymic carcinomas in accordance with NCCN.

The policy added dosing and frequency program information and new NCCN criteria for neuroendocrine tumors of the gastrointestinal tract, lung, and thymus.

Several ICD-10 diagnosis narratives for malignant and benign carcinoid tumors of the foregut, midgut, and hindgut were revised from NOS wording to unspecified wording.

FDA-labeling updates changed the central nervous system cancer dosage to up to 40 mg every 4 weeks and revised criteria for neuroendocrine tumors and thymomas or thymic carcinomas.

Criteria were added for adrenal gland tumors, gastrointestinal, lung, and thymus neuroendocrine tumors, pancreatic islet cell tumors, and somatostatin-scintigraphy-positive poorly differentiated high-grade or large- or small-cell tumors.

The indication for symptom control of unresectable or metastatic hormone-secreting poorly differentiated high-grade or large- or small-cell tumors when combined with chemotherapy with or without radiation therapy was removed.

30 mgCommon maximum dose every 4 weeks for covered oncology and neuroendocrine indications

40 mgMaximum listed dose every 4 weeks for acromegaly

IM onlyPermitted administration route

Part BMedical-benefit coverage addressed by this policy

9Meningioma ICD-10 codes removed from coverage criteria

8Revision-history entries represented in this document window

Medical Necessity and Coverage Rules

Experimental/Investigational Uses

Uses not meeting the covered indications and requirements below are not covered unless supported as an accepted off-label use under the Company's medical policy on off-label coverage for prescription drugs and biologics.

Not covered as experimental/investigational

All other uses of octreotide acetate (Sandostatin LAR Depot), including uses with dosage and frequency up to the covered amount specified in this policy, are considered experimental/investigational.
An otherwise unsupported use may be covered only when the indication is supported as an accepted off-label use under the Company's medical policy on off-label coverage for prescription drugs and biologics.

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 in this policy are met. Certain drugs may be available through either the member's medical benefit (Part B) or pharmacy benefit (Part D), depending on how the drug is prescribed, dispensed, or administered. This policy addresses only instances in which octreotide acetate (Sandostatin LAR Depot) is covered under the member's medical benefit (Part B); it does not address instances covered under the pharmacy benefit (Part D).

Octreotide acetate (Sandostatin LAR Depot) is administered only by intramuscular injection.

Per NCCN, if clinically significant disease progression occurs, treatment with octreotide LAR should be discontinued for nonfunctional tumors and may be continued in patients with functional tumors. For individuals with insulinoma, octreotide should be used only if somatostatin scintigraphy is positive.

Billing and Diagnosis Codes

CPT Procedure Code Number(s)CPT

N/A

ICD-10 Procedure Code Number(s)ICD-10

N/A

ICD-10 Diagnosis Code Number(s)ICD-10

No codes listed

HCPCS Level II Code Number(s)HCPCSCovered

J2353

Injection, octreotide, depot form for intramuscular injection, 1 mg

Revenue Code Number(s)Revenue

No codes listed

ICD-10 codes removed from policyICD-10Not Covered

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

ICD-10 diagnosis narratives revisedICD-10

C7A.094	Malignant carcinoid tumor of the foregut, unspecified
C7A.095	Malignant carcinoid tumor of the midgut, unspecified
C7A.096	Malignant carcinoid tumor of the hindgut, unspecified
D3A.094	Benign carcinoid tumor of the foregut, unspecified
D3A.095	Benign carcinoid tumor of the midgut, unspecified
D3A.096	Benign carcinoid tumor of the hindgut, unspecified

ICD-10 codes added or removedICD-10

D3A.094	Code added to policy; description not stated in revision text
D3A.095	Code added to policy; description not stated in revision text
D3A.096	Code added to policy; description not stated in revision text
D3A.098	Code added to policy; description not stated in revision text
E24.8	Code added to policy; description not stated in revision text
C77.9	Code removed from policy; description not stated in revision text
E24.0	Code removed from policy; description not stated in revision text
E24.2	Code removed from policy; description not stated in revision text
E24.3	Code removed from policy; description not stated in revision text
R19.7	Code removed from policy; description not stated in revision text

Historical diagnosis codes addedmixed

255.0	ICD-9 code added to policy; description not stated in revision text
E24.0	ICD-10 code added to policy; description not stated in revision text
E24.2	ICD-10 code added to policy; description not stated in revision text
E24.3	ICD-10 code added to policy; description not stated in revision text

Authorization, Documentation, and Denial Risks

Prior Authorization

Medical-Benefit Precertification Required

Obtain precertification before administering octreotide acetate (Sandostatin LAR Depot) under the member’s medical benefit. Submit the requested dose, frequency, regimen, and medical-necessity information.

Applies to coverage under the medical benefit (Part B), not pharmacy-benefit (Part D) coverage.
Coverage is subject to the policy’s medical-necessity criteria and Dosing and Frequency Requirements.

Prior Authorization

New Approval for Regimen Changes

Obtain a new approval through the precertification process whenever the member’s dose, frequency, or regimen changes. Changes may include adjustments related to weight or incomplete therapeutic response.

Do not rely on the existing approval after a dose, frequency, or regimen change.

Clinical Background

Octreotide is a somatostatin analog that suppresses secretion of growth hormone and multiple vasoactive or gastrointestinal peptides. Immediate-release octreotide is short acting and administered subcutaneously multiple times daily, whereas Sandostatin LAR Depot is a long-acting formulation administered intramuscularly, generally every four weeks. The long-acting formulation requires approximately 10 to 14 days to reach therapeutic levels. FDA-approved uses include long-term treatment of acromegaly, severe diarrhea and flushing associated with metastatic carcinoid tumors, and profuse watery diarrhea associated with VIP-secreting tumors.

Policy Definitions

Somatostatin receptor positive

DefinitionSomatostatin receptor positive means that tumor receptor expression is identified on somatostatin receptor scintigraphy or somatostatin imaging.

Assessment methodReceptor status may be evaluated using somatostatin scintigraphy.

Assessment methodReceptor status may also be evaluated using somatostatin imaging.

Functional versus nonfunctional tumor

Functional tumorAfter clinically significant disease progression, octreotide LAR may be continued for a functional tumor.

Nonfunctional tumorAfter clinically significant disease progression, octreotide LAR should be discontinued for a nonfunctional tumor.

Initial Sandostatin LAR Depot Authorization

Initial LAR Depot Authorization

Initial Sandostatin LAR Depot therapy is covered when all of the following requirements are met.

Initial authorization: The member has already started therapy with immediate-release octreotide (Sandostatin); the requested condition meets one of the covered indication pathways; and the requested dose and frequency meet the applicable requirement.Acromegaly: up to 40 mg every 4 weeks; most other listed indications: up to 30 mg every 4 weeks.

Submit accurate member, dose, frequency, and regimen information through the precertification process. A dose, frequency, or regimen change requires new approval.

Long-Term and Continuation Therapy

Continuation or long-term treatment is covered when all applicable requirements remain satisfied.

Ongoing therapy: The member previously started immediate-release octreotide and is receiving Sandostatin LAR Depot for a covered indication; the disease-specific medical-necessity criteria continue to be met; the requested dose and frequency remain supported; and treatment has not been stopped for disease progression or unacceptable toxicity where discontinuation is required.Most oncology and neuroendocrine indications: up to 30 mg every 4 weeks; acromegaly: up to 40 mg every 4 weeks.

For clinically significant progression, discontinue octreotide LAR for nonfunctional tumors; it may be continued for functional tumors. For insulinoma, use octreotide only when somatostatin scintigraphy is positive. A change in dose, frequency, or regimen requires new precertification approval. Medical records demonstrating medical necessity must be available upon request.

Required Precursor Therapy

Step	Requirement	Rationale
1	Start immediate-release octreotide (Sandostatin) before beginning long-term treatment with Sandostatin LAR Depot.	Sandostatin LAR Depot takes 10 to 14 days to reach therapeutic levels; immediate-release octreotide is recommended first for individuals requiring chronic therapy.

Maximum Doses by Indication

Octreotide acetate for acromegaly

Drug and indicationOctreotide acetate (Sandostatin LAR Depot) for acromegaly.

Maximum doseUp to 40 mg.

FrequencyEvery 4 weeks.

Octreotide acetate for listed oncology and neuroendocrine indications

Drug and indicationsOctreotide acetate (Sandostatin LAR Depot) for Merkel cell carcinoma, carcinoid tumors, neuroendocrine tumors, pheochromocytoma/paraganglioma, well-differentiated Grade 3 neuroendocrine tumors, thymic tumors, meningioma, and VIP-secreting tumors.

Maximum doseUp to 30 mg.

Frequency

Administration Setting and Route

Billing Rule

Use the appropriate site of care

Administer octreotide acetate only intramuscularly and use the most appropriate and cost-effective setting consistent with the member’s medical needs, condition, and required monitoring.

Policy Summary

PayerAmeriHealth Caritas VIP Care

PolicyOctreotide Acetate (Sandostatin LAR Depot)

Policy CodePolicy MA08.065i

Change TypeModified

Effective DateSep 18, 2026

Last ReviewDec 15, 2025

Next Review DateN/A

Key ActionObtain precertification for octreotide acetate under the medical benefit and provide the requested dose, frequency, regimen, and medical-necessity information.

SourceLink

On This Page

Step Therapy

Immediate-Release Octreotide Is a Prerequisite

Initiate immediate-release octreotide (Sandostatin) before starting long-term octreotide acetate (Sandostatin LAR Depot) treatment. The immediate-release formulation provides initial therapy while the long-acting formulation reaches therapeutic levels.

Coverage for long-term treatment requires that therapy with the immediate-release formulation has already been started.

Documentation Required

Maintain Medical-Necessity Records

Maintain complete medical records demonstrating medical necessity and provide them to the Company when requested. Relevant records may come from professional providers, hospitals, nursing homes, home health agencies, therapy providers, and test reports.

Records must be available for Company review and audit, regardless of provider participation status.

Documentation Required

Support Out-of-Guideline Dosing

For a request outside the listed Dosing and Frequency Requirements, submit supporting published peer-reviewed literature to the Company. The literature must support the requested off-guideline amount or schedule.

The Company may modify dosing requirements based on FDA information, recognized pharmacology compendia, or peer-reviewed clinical research.
Consult the Company policy on off-label coverage for the list of recognized pharmacology compendia.

Prior Authorization

Submit Accurate Regimen Information

Submit accurate member information, including the requested dose, frequency, and regimen, during precertification and report any subsequent changes. Accurate information is required for approval and supports post-payment review and audit.

Report changes related to factors such as member weight or incomplete therapeutic response.
The Company may conduct post-payment reviews and audits of submitted claims.

Billing Rule

Submit the Appropriate Diagnosis Code

Report the most appropriate ICD-10 diagnosis code supporting the medically necessary criteria in the policy.

The diagnosis code must support the indication and medical necessity for the requested treatment.

Denial Risk

Uncovered or Unsupported Indication

All other uses of octreotide acetate (Sandostatin LAR Depot), including use within a covered dosage range, are experimental or investigational and are not covered unless the indication is supported as an accepted off-label use under the Company’s applicable policy.

Coverage may be denied for an indication that is not listed or otherwise supported as an accepted off-label use.

Denial Risk

Prerequisite, Dosing, or Approval Mismatch

Coverage may be denied when required immediate-release octreotide therapy has not been started, the requested dose or frequency does not meet policy requirements, or the required approval is absent or outdated.

Obtain approval for any dose, frequency, or regimen change before submitting claims for the changed treatment.
Requests outside listed dosing requirements require supporting peer-reviewed literature.

Denial Risk

Missing Records May Result in Denial

Failure to provide requested documentation may result in denial of the drug. Ensure that records supporting medical necessity and any required dosing justification are complete and available for Company review.

Requested records may include professional, facility, home-care, therapy, and test-report documentation.
The Company may review or audit services regardless of the provider’s participation status.

Clinical significanceThe continuation or discontinuation decision applies when clinically significant disease progression occurs.

Sandostatin LAR Depot

FormulationSandostatin LAR Depot is the long-acting formulation of octreotide acetate.

Administration routeThe formulation is administered intramuscularly.

Dosing intervalIt is generally administered every four weeks.