CurrentNeighborhood Health Plan of Rhode IslandPolicy UM ONC_1042

Somatostatin Analogs

Defines accepted indications, continuation and exclusion criteria, required supporting evidence sources, coding and approval authority for somatostatin analog medications (Sandostatin/Sandostatin LAR/octreotide and Somatuline Depot/lanreotide) for oncology uses. Applies to medication requests processed by Evolent/Neighborhood Health Plan utilzation management.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySomatostatin Analogs

Policy CodePolicy UM ONC_1042

Change TypeNo material changes

Effective DateJan 31, 2025

Next Review Date

Key ActionEvolent processes all medication requests; requests must be supported by FDA labeling, CMS compendia, NCCN, ASCO, or acceptable peer‑reviewed literature and documentation (including Octreoscan when required) to be approvable.

POLICY UPDATE CHANGES

No material changes

3Covered Indications (listed)

3Dose Exclusion Limits

5Evidence Sources Required (types)

Coverage Summary

Coverage stance: covered_with_criteria — Somatostatin analogs (octreotide, lanreotide) are covered for specified oncology indications when criteria are met. Evolent (Utilization Management) processes all medication requests and medications not authorized by Evolent may be deemed not approvable and not reimbursable. Unsupported requests may be denied.

Initial & Continuation Therapy Criteria

General Continuation Exemption

Continuation requests for a previously authorized, otherwise not-approvable medication may be exempt when ALL of the following are met:

No progression: The member has not experienced disease progression on the requested medication
Prior use within last year: The requested medication was used within the last year without a lapse of more than 30 days of having an active authorization
No additional medications: Additional medication(s) are not being added to the continuation request

Meningiomas

Somatostatin analog (octreotide LAR/IVISQ or lanreotide) may be used when ALL of the following are met:

Recurrent/progressive: Recurrent or progressive meningioma
Radiation/surgery not feasible: Radiation and/or surgery are not feasible
SSTR-positive imaging: Tumor/disease is positive on an Octreoscan (or similar imaging confirming somatostatin receptor positivity)

Neuroendocrine Tumors (NETs)

Somatostatin analog (octreotide LAR/IVISQ or lanreotide) may be used in members with metastatic/unresectable NETs when ANY of the following apply (use as single agent or in combination):

Carcinoid syndrome symptom control: Used as symptom control in members with carcinoid syndrome or symptoms suggestive of carcinoid syndrome (e.g., diarrhea, flushing)
Metastatic/unresectable NET origin: Used in members with metastatic/unresectable neuroendocrine tumors originating in the gastrointestinal tract, pancreas, lung, adrenal glands, or other organs (except small cell lung cancer)

Thymomas and Thymic Carcinomas

Somatostatin analog (octreotide LAR/IVISQ or lanreotide) may be used when ALL of the following are met:

Unresectable/metastatic thymic disease: Member has unresectable or metastatic thymoma or thymic carcinoma
SSTR-positive imaging: Tumor/disease is positive on an Octreoscan (or similar imaging confirming that the tumor is somatostatin receptor positive)
Use for locally advanced/metastatic disease: Medication is being used for locally advanced/metastatic disease with or without prednisone

Evidence Requirements and Investigational Exclusions

Evidence Requirements

Use of drug must be supported by ONE of the following sources:

FDA labeling: FDA approved product labeling
CMS compendia: CMS-approved compendia
NCCN: National Comprehensive Cancer Network (NCCN)
ASCO: American Society of Clinical Oncology (ASCO) clinical guidelines
Peer-reviewed literature per CMS manual: Peer-reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 requirements

Investigational / Insufficient Evidence Exclusion

Use is considered investigational / not acceptable when the off-label indication lacks sufficient evidence as defined by ANY of the following deficiencies:

Inadequate patient representation: Clinical characteristics of the patient and the cancer are not adequately represented in the published evidence
Inadequate representation of concurrent therapies: The administered concurrent oncologic therapies are not adequately represented in the published evidence
Outcomes not clinically meaningful: Reported study outcomes do not represent clinically meaningful outcomes (ASCO guidance example: HR >= 0.80 or OS/PFS benefit < 3 months)
Inappropriate experimental design: Experimental design is inappropriate to address the investigative question

Dose Exclusions

Applications are excluded when any of the following single-dose limits are exceeded:

Sandostatin LAR limit: Dosing exceeds single dose limit of 60 mg for Sandostatin LAR Depot (octreotide)<= 60 mg
Sandostatin IVISQ limit: Dosing exceeds single dose limit of 500 mcg for Sandostatin IVISQ (octreotide)<= 500 mcg
Somatuline Depot limit: Dosing exceeds single dose limit of 120 mg for Somatuline Depot (lanreotide)<= 120 mg

Referenced guidelines/compendia: FDA labeling; CMS-approved compendia; National Comprehensive Cancer Network (NCCN) guidelines and Drugs & Biologics Compendium; American Society of Clinical Oncology (ASCO) clinical guidance; peer-reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 requirements.

Key literature citations: Oncotarget systematic review (Merola et al.); ECOG Phase II trial (Loehrer et al.); Sandostatin and Sandostatin LAR prescribing information; Clinical Pharmacology (Elsevier) 2025; Micromedex Healthcare Series 2025; NCCN 2025.

Provider Actions & Prior Authorization

Prior Authorization

Authorization required for medication requests

Evolent processes all medication requests for somatostatin analogs. Medications not authorized by Evolent may be deemed not approvable and not reimbursable. Requests must be supported by ONE accepted evidence source: FDA product labeling, CMS‑recognized compendia, NCCN, ASCO clinical guidelines, or peer‑reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 requirements.

J2353
J2354
J1930
J1932
J3490
J8499
C9399

Documentation Required

Evidence and imaging documentation

For meningiomas and thymic tumors, clinical documentation must include Octreoscan (or similar somatostatin receptor imaging) demonstrating tumor positivity. Documentation must also support that radiation and/or surgery are not feasible or that the tumor is unresectable/inoperable where required; for thymomas/thymic carcinomas, documentation should reflect locally advanced/metastatic disease and whether prednisone is being used.

Denial Risk

Denial risk for investigational/insufficient evidence uses

Requests for off‑label or investigational uses that lack sufficient supporting evidence may be excluded or denied. Sufficient evidence must be supported by CMS compendia, NCCN, ASCO, FDA labeling, or acceptable peer‑reviewed literature; uses are considered investigational when evidence is deficient per any listed criteria (e.g., inadequate representation of patient/cancer characteristics, inappropriate experimental design, non‑randomized small trials, case reports, abstracts without full articles, or outcomes not clinically meaningful per ASCO thresholds).

Billing Rule

Dose limits enforced

Claims exceeding the single‑dose limits specified in policy will be excluded.

Sandostatin LAR (octreotide depot) single dose limit: 60 mg — affected codes: J2353
Sandostatin IVISQ (octreotide) single dose limit: 500 mcg — affected codes: J2354
Somatuline Depot (lanreotide) single dose limit: 120 mg — affected codes: J1930, J1932, C9399

Background

Background: This policy defines accepted oncology indications for somatostatin analogs including FDA-approved indications and off-label uses supported by recognized compendia (CMS, NCCN) or acceptable peer-reviewed literature. Indications specifically addressed include use for neuroendocrine tumors (metastatic/unresectable, symptom control for carcinoid syndrome), recurrent/progressive meningioma when surgery/radiation are not feasible with somatostatin receptor–positive imaging, and unresectable/metastatic thymoma/thymic carcinoma with somatostatin receptor–positive imaging.

Utilization management responsibility: Evolent is responsible for processing all medication requests from network ordering providers; medications not authorized by Evolent may be deemed not approvable and not reimbursable. Requests must be supported by one of the accepted evidence sources (FDA labeling, CMS compendia, NCCN, ASCO, or acceptable peer-reviewed literature).

Scope summary (concise): Applies to payer coverage determinations for somatostatin analogs (Sandostatin/Sandostatin LAR/octreotide and Somatuline Depot/lanreotide) processed by Evolent/Neighborhood Health Plan utilization management and defines continuation, exclusion and dosing limits enforced during authorization (e.g., single-dose limits).