CurrentNeighborhood Health Plan of Rhode IslandPolicy UM ONC_1042

Somatostatin Analogs (octreotide, lanreotide) coverage criteria

Defines accepted indications, continuation and exclusion criteria, and coding for somatostatin analogs (Sandostatin/Sandostatin LAR/octreotide and Somatuline Depot/lanreotide) for oncology medication management and utilization review affecting providers submitting authorization requests.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySomatostatin Analogs (octreotide, lanreotide) coverage criteria

Policy CodePolicy UM ONC_1042

Change TypeNo material change

Effective DateJan 31, 2025

Next Review DateJan 8, 2025

Key ActionSubmit prior authorization with supporting evidence from FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3major covered clinical categories

3primary labeled drug products

3single-dose maximums called out

8codes listed

Coverage Criteria for Somatostatin Analogs

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Meningiomas

Covered when ALL of the following are met (Meningiomas):

Meningiomas coverage: Use of Sandostatin (octreotide LAR Depot/IV/SQ) or Somatuline Depot (lanreotide) for recurrent or progressive meningioma is covered when radiation and/or surgery are not feasible AND the tumor is positive on Octreoscan or similar somatostatin receptor imaging.

Neuroendocrine Tumors (NETs)

Covered when ANY of the following apply (Neuroendocrine tumors - NETs):

NETs symptom control: Use of Sandostatin (octreotide LAR Depot/IV/SQ) or Somatuline Depot (lanreotide) as symptom control for carcinoid syndrome (e.g., diarrhea, flushing).

May be used as single agent or in combination for metastatic/unresectable NETs originating in the gastrointestinal tract, pancreas, lung, adrenal glands, or other organs (excluding small cell lung cancer).

NETs tumor control: Use of Sandostatin (octreotide LAR Depot/IV/SQ) or Somatuline Depot (lanreotide) for tumor/disease control in metastatic/unresectable neuroendocrine tumors.

Can be used as single agent or in combination.

Thymomas and Thymic Carcinomas

Covered when ALL of the following are met (Thymomas/Thymic carcinomas):

Thymoma/thymic carcinoma coverage: Member has unresectable/metastatic thymoma or thymic carcinoma AND tumor is positive on Octreoscan or similar somatostatin receptor imaging AND Sandostatin (octreotide LAR Depot/IV/SQ) or Somatuline Depot (lanreotide) is being used for locally advanced/metastatic disease with or without prednisone.

Requests for somatostatin analogs will be excluded when dosing exceeds established single‑dose maximums. Specifically, a single dose of Sandostatin LAR Depot (octreotide) greater than 60 mg, or Sandostatin IV/SQ (octreotide) greater than 500 mcg, or Somatuline Depot (lanreotide) greater than 120 mg will not be covered. These single‑dose limits are enforced as exclusion criteria and will be grounds for denial if exceeded.

Use of somatostatin analogs for investigational or off‑label indications that lack adequate evidence or broad professional acceptance is considered excluded. Adequate evidence is defined as support from CMS‑recognized compendia or acceptable peer‑reviewed literature; uses supported only by case reports or abstracts without full peer‑reviewed articles are not sufficient. The policy details specific evidence considerations, including whether the patient population and regimen are represented in the literature, whether outcomes are clinically meaningful (for example, ASCO‑recommended thresholds such as a hazard ratio <0.80 or survival benefits of at least 3 months), and whether study design is appropriate to answer the clinical question. Nonrandomized trials with substantial subject numbers may provide supportive evidence, but isolated case reports or meeting abstracts without full publication do not meet the standard for coverage.

Initial Therapy Coverage Criteria

Initial therapy

Initial therapy coverage criteria vary by indication; approval is linked to the clinical scenario and required imaging/evidence.

Initial - meningioma: Recurrent or progressive meningioma when radiation and/or surgery are not feasible AND tumor positive on Octreoscan or similar somatostatin receptor imaging.

Initial - NETs: Metastatic or unresectable neuroendocrine tumors originating in GI tract, pancreas, lung, adrenal glands, or other organs (excluding small cell lung cancer) when used for carcinoid symptom control (e.g., diarrhea, flushing) and/or for tumor/disease control; may be used as single agent or in combination.

Initial - thymoma: Unresectable or metastatic thymoma or thymic carcinoma AND tumor positive on Octreoscan or similar somatostatin receptor imaging; use may be with or without prednisone.

Continuation Therapy and Renewal Criteria

Continuation therapy

Continuation request exemption criteria

Continuation exemption: Continuation requests are exempt from policy review when: 1) the member has not experienced disease progression on the requested medication; 2) the medication was used within the last year without a lapse of more than 30 days of active authorization; and 3) no additional medications are being added to the continuation request.

Coding and Single-dose Limits

Coding for somatostatin analogsHCPCS

J2353	Injection, octreotide, depot form for intramuscular injection, 1 mg.
J2354	Injection, octreotide, non-depot form for subcutaneous or intravenous injection, 25 mcg.
J3490	octreotide acetate.
J8499	octreotide, oral.
J1930	Injection, lanreotide, 1 mg.
J1932	Injection, lanreotide, (cipla), 1 mg.
J3490	lanreotide.
C9399	lanreotide

Single-dose maximums

Octreotide LAR Depot (Sandostatin LAR)60 mg single dose

Octreotide (Sandostatin IV/SQ)500 mcg single dose

Lanreotide (Somatuline Depot)120 mg single dose

Quantity and Dose Limitations

octreotide (Sandostatin LAR Depot, Sandostatin IV/SQ)

Quantity limit referenceSee single-dose maximums (Octreotide LAR 60 mg; Octreotide IV/SQ 500 mcg)

Clinical rationaleRequests exceeding single-dose limits are listed in exclusion criteria and may be denied.

Applies toSandostatin LAR Depot and Sandostatin IV/SQ (octreotide formulations)

lanreotide (Somatuline Depot)

Quantity limit referenceSee single-dose maximums (Somatuline Depot 120 mg)

Clinical rationaleRequests exceeding single-dose limits are listed in exclusion criteria and may be denied.

Applies toSomatuline Depot (lanreotide)

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior Authorization Required: Prior authorization is required for Somatostatin analogs. Continuation requests for a medication that would otherwise not meet this policy may be exempt when continuity criteria are met.

Continuation exemption criteria: member has not experienced disease progression on the requested medication
Requested medication used within the last year without a lapse of >30 days of active authorization
No additional medications are being added to the continuation request

Documentation Required

Required Supporting Evidence

Required supporting evidence must be provided with requests. Support may include FDA-approved product labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or peer‑reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 standards.

Denial Risk

Denial Triggers

Denial Triggers / Documentation Risks: Requests will be denied if dosing exceeds single‑dose limits or for investigational/off‑label uses lacking sufficient accepted evidence per policy. Insufficient evidence includes reliance on case reports, abstracts without full peer‑reviewed articles, or studies that do not adequately represent the patient population, regimen, or clinically meaningful outcomes (e.g., ASCO benchmarks).

Single‑dose limits: >60 mg Sandostatin LAR Depot (octreotide) or >500 mcg Sandostatin IV/SQ (octreotide)
Single‑dose limit: >120 mg Somatuline Depot (lanreotide)
Off‑label/investigational uses lacking support from CMS compendia, NCCN/ASCO, FDA labeling, or acceptable peer‑reviewed literature may be denied

Definitions and Imaging Requirements

Octreoscan/similar imaging positive

DefinitionImaging demonstrating that the tumor is somatostatin receptor positive (e.g., Octreoscan or similar)

Required indicationsRequired for use of somatostatin analogs in meningiomas

Required indicationsRequired for use of somatostatin analogs in thymomas and thymic carcinomas

Step Therapy and Evidence Requirements

Requirement	Acceptable sources
Coverage support requirement	FDA approved product labeling
Coverage support requirement	CMS-recognized compendia
Coverage support requirement	National Comprehensive Cancer Network (NCCN) clinical guidelines
Coverage support requirement	American Society of Clinical Oncology (ASCO) clinical guidelines
Coverage support requirement	Acceptable peer‑reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 requirements

Administration Site and Infusion Center Guidance

Note

Refer to FDA label/package insert for infusion center administration and site‑of‑care

For administration details, infusion site considerations, and other medication‑specific handling, refer to the FDA label/package insert for the product being administered.

Consult the FDA label/package insert for administration specifics and site‑of‑care considerations when delivering therapy in an infusion center.

Clinical Background

Somatostatin analogs, including octreotide and lanreotide, are therapies used both for symptom control and for tumor control in tumors that express somatostatin receptors. They are commonly used to manage carcinoid syndrome manifestations such as diarrhea and flushing and to provide disease control in metastatic or unresectable neuroendocrine tumors. Selected patients with somatostatin‑receptor positive meningiomas or unresectable/metastatic thymomas/thymic carcinomas may also be treated with these agents when surgery or radiation is not feasible; for some indications coverage is linked to demonstration of receptor positivity on imaging such as Octreoscan or similar studies. Approval and continued use should be supported by FDA labeling, recognized compendia, or acceptable peer‑reviewed literature.