CurrentEmblemHealthPolicy UM ONC_1042

Somatostatin Analogs (octreotide, lanreotide)

Defines accepted indications, continuation and exclusion criteria, and coding for somatostatin analog drugs (Sandostatin/Sandostatin LAR/octreotide and Somatuline Depot/lanreotide) for oncology utilization management affecting network ordering providers and members whose coverage is managed by Evolent/EmblemHealth.

Policy Summary

PayerEmblemHealth

PolicySomatostatin Analogs (octreotide, lanreotide)

Policy CodePolicy UM ONC_1042

Change TypeNo material change

Effective DateJan 31, 2025

Next Review DateJan 8, 2025

Key ActionObtain prior authorization for requests; continuation requests may be exempt if continuation criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3Primary tumor groups with coverage language

60 mgSandostatin LAR single-dose max

120 mgSomatuline Depot single-dose max

J2353, J2354, J1930Representative HCPCS codes

FDA/Compendia/NCCN/ASCOAccepted evidence sources required

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Coverage Criteria for Somatostatin Analogs

inv-01: Meningiomas

Covered when ALL of the following are met for meningiomas:

Meningioma coverage: Sandostatin (octreotide) or Somatuline (lanreotide) may be used for recurrent or progressive disease when radiation and/or surgery are not feasible AND the tumor is positive on an Octreoscan (or similar imaging confirming somatostatin receptor positivity).

inv-02: Neuroendocrine tumors (NETs)

Covered when ANY of the following indications are met for NETs:

NET indications: Sandostatin (octreotide) or Somatuline (lanreotide) is being used in members with metastatic/unresectable neuroendocrine tumors originating in the gastrointestinal tract, pancreas, lung, adrenal glands, or other organs (excluding small cell lung cancer) as a single agent or in combination with other therapies for: (a) symptom control of carcinoid syndrome (e.g., diarrhea, flushing) AND/OR (b) tumor/disease control.

inv-03: Thymomas and thymic carcinomas

Covered when ALL of the following are met for thymomas/thymic carcinomas:

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

inv-04: Continuation requests exemption

Continuation (renewal) criteria:

Continuation exemption criteria: Continuation requests may be exempt from re-review if: (1) the member has not experienced disease progression on the requested medication; AND (2) the requested medication was used within the last year without a lapse of more than 30 days of having an active authorization; AND (3) additional medication(s) are not being added to the continuation request.

Requests for somatostatin analogs will be excluded when the proposed use is investigational for off‑label indications that lack sufficient supporting evidence or are not generally accepted by the medical community. The policy defines insufficient evidence as situations where published data do not adequately represent the patient/cancer characteristics, the therapy regimen, or clinically meaningful outcomes (for example, ASCO‑recommended effect sizes such as hazard ratios <0.80 or survival benefits of at least 3 months), or where study design, sample size, or publication type (e.g., single case reports or abstracts without full peer‑reviewed articles) do not provide robust support.

Off‑label uses of somatostatin analogs that are not supported by FDA labeling, CMS‑recognized compendia, NCCN/ASCO guidelines, or acceptable peer‑reviewed literature will be considered investigational and may be deemed not medically necessary. The policy requires that the requested indication be backed by one of those accepted sources; failure to provide such supporting documentation may result in denial. Examples of insufficient evidence include reliance on anecdotal case reports or meeting abstracts without full peer‑reviewed publication, or studies that do not adequately represent the patient population, regimen, or clinically meaningful outcomes as described in the exclusion criteria.

Initial Therapy Criteria

inv-16: Initial therapy

Initial therapy coverage logic

Initial indicated uses: Initial requests for octreotide or lanreotide are covered when the specific indication criteria are documented: for meningiomas, recurrent/progressive disease where surgery/radiation are not feasible and tumor is Octreoscan-positive; for NETs, metastatic/unresectable NETs for symptom control (carcinoid syndrome) and/or tumor control; for thymoma/thymic carcinoma, unresectable/metastatic disease that is Octreoscan-positive and treatment is for locally advanced/metastatic disease (with or without prednisone). Documentation of indication and receptor positivity where required is expected.

Continuation (Renewal) Criteria

inv-17: Continuation therapy

Continuation (renewal) exemption

Continuation exemption: Continuation (renewal) requests may be exempt from re-review when all of the following are met: member has not experienced disease progression on the requested medication; medication was used within the last year without a lapse of more than 30 days of active authorization; and no additional medications are being added to the continuation request.

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for requests; continuation requests may be exempt if criteria are met.

Prior authorization required for all new requests.
Continuation (renewal) requests may be exempt when continuation criteria are satisfied.

Note

Continuation Exemption Criteria

Continuation (renewal) requests have conditional exemptions when all listed conditions are met.

Member has not experienced disease progression on the requested medication.
Requested medication was used within the last year without a lapse of more than 30 days of having an active authorization.
No additional medication(s) are being added to the continuation request.

Billing and Coding

HCPCS / Misc billing codes listedHCPCS

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 — Somatostatin analogs

Sandostatin LAR Depot (octreotide)Single-dose maximum: <= 60 mg

Sandostatin IV/SQ (octreotide)Single-dose maximum: <= 500 mcg

Somatuline Depot (lanreotide)Single-dose maximum: <= 120 mg

Quantity and Dose Limits

Sandostatin LAR Depot (octreotide) — single-dose limit

DrugSandostatin LAR Depot (octreotide)

Quantity limit<= 60 mg per single dose

NotesDosing above this single-dose limit is listed in Exclusion Criteria and will be excluded (denied).

Sandostatin IV/SQ (octreotide) — single-dose limit

DrugSandostatin IV/SQ (octreotide)

Quantity limit<= 500 mcg per single dose

NotesDosing above this single-dose limit is listed in Exclusion Criteria and will be excluded (denied).

Step Therapy

Step	Requirement / Notes
No formal multi-step agent sequence required	Continuation (renewal) requests may be exempt from re‑review when all of the following are met: (1) no 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.

Definitions

Somatostatin receptor positivity (Octreoscan+)

DefinitionPositive Octreoscan (or similar imaging) indicating tumor expresses somatostatin receptors

TermSomatostatin receptor positive

Use in criteriaRequired for meningioma and thymoma/thymic carcinoma coverage to confirm receptor positivity

Background

Somatostatin analogs (octreotide and lanreotide) are used in oncology to control symptoms of carcinoid syndrome (for example, diarrhea and flushing) and for antiproliferative tumor control in neuroendocrine and other somatostatin receptor–positive tumors. Treatment decisions must be supported by accepted evidence sources — FDA product labeling, CMS‑recognized compendia, NCCN/ASCO clinical guidelines, or peer‑reviewed literature — as required by this policy.

Site of Care / Administration

Note

Administration guidance — infusion center

Refer to the FDA label/package insert for medication-specific administration guidance for somatostatin analogs; no alternate site-of-care restrictions are specified.

Site listed in policy: infusion center — follow FDA label/package insert for administration details.