CurrentNeighborhood Health Plan of Rhode IslandPolicy UM ONC_1042

Somatostatin Analogs (octreotide, lanreotide)

Defines utilization management coverage criteria, continuation rules, approved oncologic indications (meningiomas, neuroendocrine tumors, thymomas/thymic carcinomas), exclusions (dose limits, investigational/off-label without sufficient evidence), coding and approval authority for somatostatin analog medications.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySomatostatin Analogs (octreotide, lanreotide)

Policy CodePolicy UM ONC_1042

Change TypeNo material changes

Effective DateJan 31, 2025

Next Review Date

Key ActionRequests must be supported by FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature per CMS Medicare Benefit Policy Manual Chapter 15.

POLICY UPDATE CHANGES

No material changes

3Primary Covered Indications

3Single-dose Limits Specified

7HCPCS/J Codes Listed

Coverage Summary & Indications

Meningiomas - Coverage Criteria

Covered when ALL of the following are met:

ALL of the following

Member has recurrent or progressive meningioma
Surgery and/or radiation are not feasible or have been exhausted
Tumor is somatostatin receptor positive on Octreoscan or equivalent imaging
Requested agent is Sandostatin (octreotide LAR depot/IV/SQ) or Somatuline Depot (lanreotide)

Neuroendocrine Tumors (NETs) - Coverage Criteria

Covered when ANY of the following branches are met:

ANY of the following

Symptom control
- Member has metastatic or unresectable neuroendocrine tumor (gastrointestinal, pancreatic, lung, adrenal, or other sites — excluding small cell lung cancer)
- Symptoms of carcinoid syndrome or symptoms suggestive of carcinoid syndrome (e.g., diarrhea, flushing) are present
- Requested agent is Sandostatin (octreotide LAR depot/IV/SQ) or Somatuline Depot (lanreotide), as single agent or in combination
Tumor control
- Member has metastatic or unresectable neuroendocrine tumor (gastrointestinal, pancreatic, lung, adrenal, or other sites — excluding small cell lung cancer)
- Therapy is intended for tumor/disease control
- Requested agent is Sandostatin (octreotide LAR depot/IV/SQ) or Somatuline Depot (lanreotide), as single agent or in combination

Thymomas and Thymic Carcinomas - Coverage Criteria

Covered when ALL of the following are met:

ALL of the following

Member has unresectable or metastatic thymoma or thymic carcinoma
Tumor is somatostatin receptor positive on Octreoscan or equivalent imaging
Requested agent is Sandostatin (octreotide LAR depot/IV/SQ) or Somatuline Depot (lanreotide) for locally advanced/metastatic disease; may be used with or without prednisone

Continuation Exceptions

Continuation requests are exempt from initial-therapy coverage requirements when ALL of the following are met:

ALL of the following

Member has not experienced disease progression while on the requested medication
Requested medication was used within the last year with no lapse of more than 30 days from an active authorization
No additional medications are being added to the continuation request

Continuation Therapy & Exclusions

Exclusion Criteria (Not Approvable)

Not approvable when ANY of the following apply:

ANY of the following

Dosing exceeds single dose limit of 60 mg Sandostatin LAR Depot (octreotide)<= 60 mg (Sandostatin LAR)
Dosing exceeds single dose limit of 500 mcg of Sandostatin IV/SQ (octreotide)<= 500 mcg (Sandostatin IV/SQ)
Dosing exceeds single dose limit Somatuline Depot (lanreotide) 120 mg<= 120 mg (Somatuline Depot)
Investigational / insufficient evidence
- Investigational use of somatostatin analogs with an off-label indication that is not sufficient in evidence or not generally accepted by the medical community
- Insufficient evidence defined by lack of CMS-recognized compendia or acceptable peer-reviewed literature, with considerations including representation of patient/cancer characteristics, regimen representation, clinically meaningful outcomes (e.g., HR <0.80 and OS/PFS benefit >= 3 months per ASCO guidance), study design appropriateness, limitations of case reports/abstracts, and strengths/limitations of non-randomized trials

Single-dose limits

Sandostatin LAR (octreotide) single-dose limit<= 60 mg

Sandostatin IV/SQ (octreotide) single-dose limit<= 500 mcg

Somatuline Depot (lanreotide) single-dose limit<= 120 mg

Applicable Codes

Drug HCPCS/J-codes (listed in policy)HCPCS

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

Prior Authorization, Documentation & Billing

Prior Authorization

Authorization required for somatostatin analogs

Evolent processes all medication requests; medications not authorized by Evolent may be deemed not approvable and not reimbursable. Requests must be supported by FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature per CMS Medicare Benefit Policy Manual Chapter 15.

J2353
J2354
J1930
J1932
C9399
J3490
J8499

Documentation Required

Octreoscan or similar imaging requirement for certain indications

For meningiomas and thymomas/thymic carcinomas, documentation of tumor somatostatin receptor positivity via Octreoscan or similar imaging must be provided.

Meningiomas
Thymomas / Thymic carcinomas

Denial Risk

Dose limit exceedance risk

Claims will be excluded/denied if single dose limits are exceeded for the specified somatostatin analog formulations.

J2353
J2354
J1930
J1932
C9399
Refer to thresholds: Sandostatin LAR ≤ 60 mg; Sandostatin IV/SQ ≤ 500 mcg; Somatuline Depot ≤ 120 mg

Evidence & Guideline Basis

Coverage requires support from recognized sources including FDA labeling, CMS‑recognized compendia, NCCN, ASCO, or acceptable peer‑reviewed literature per the CMS Medicare Benefit Policy Manual Chapter 15. The policy’s reference list cites a systematic review (Merola et al., Oncotarget) and a pivotal ECOG Phase II trial (Loehrer et al., J Clin Oncol 2004) among the evidentiary sources informing approved and select off‑label uses.

The policy also references ASCO’s guidance on clinically meaningful trial outcomes to define sufficient evidence (e.g., hazard ratios and minimum survival benefits) and relies on product prescribing information for Sandostatin/Sandostatin LAR and Somatuline in assessing labeled indications and dosing.

Policy Background & Definitions

The policy covers FDA‑approved and select off‑label oncologic uses of somatostatin analogs and delineates accepted indications: recurrent or progressive meningiomas when surgery/radiation are not feasible and tumor is somatostatin receptor positive; metastatic or unresectable neuroendocrine tumors (GI, pancreas, lung, adrenal, other non‑small cell sites) for symptom control (carcinoid syndrome) and/or tumor control; and unresectable/metastatic thymoma or thymic carcinoma with somatostatin receptor positivity (with or without prednisone).

Evolent is responsible for processing prior authorization requests and requires documentation (including Octreoscan or similar imaging for certain indications) and adherence to specified single‑dose limits: Sandostatin LAR ≤ 60 mg, Sandostatin IV/SQ ≤ 500 mcg, and Somatuline Depot ≤ 120 mg; requests not meeting these requirements or lacking sufficient supporting evidence may be denied.

Term	Definition
Continuation request exemption	Continuation allowed if no progression, used within last year without >30 day lapse, and no additional meds added.
Somatostatin receptor positive	Tumor positive on Octreoscan or similar imaging demonstrating somatostatin receptor expression.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySomatostatin Analogs (octreotide, lanreotide)

Policy CodePolicy UM ONC_1042

Change TypeNo material changes

Effective DateJan 31, 2025

Next Review Date

Key ActionRequests must be supported by FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature per CMS Medicare Benefit Policy Manual Chapter 15.

On This Page

OpenPayer

Somatostatin Analogs (octreotide, lanreotide)

Coverage Summary & Indications

Continuation Therapy & Exclusions

Applicable Codes

Prior Authorization, Documentation & Billing

Evidence & Guideline Basis

Policy Background & Definitions

Revision History