CurrentNeighborhood Health Plan of Rhode IslandPolicy UM ONC_1042

Somatostatin Analogs (octreotide, lanreotide)

Defines utilization management coverage criteria for somatostatin analogs (Sandostatin/Sandostatin LAR/octreotide and Somatuline Depot/lanreotide) including accepted oncology indications, continuation rules, exclusions, dosing limits, and applicable J-codes for billing. Applies to medication request reviews processed by Evolent/Neighborhood Health Plan of Rhode Island effective for the plan.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySomatostatin Analogs (octreotide, lanreotide)

Policy CodePolicy UM ONC_1042

Change TypeClarified dates / administrative

Effective DateJan 31, 2025

Next Review Date

Key ActionEvolent (UM) must process all medication requests; requests must be supported by FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or peer-reviewed literature meeting CMS Chapter 15 requirements.

POLICY UPDATE CHANGES

Committee review and approval dates listed through 01/08/25; approval date January 08, 2025 and effective date January 31, 2025.

3Covered Indications (Meningioma, NETs, Thymoma/Thymic carcinoma)

3Single-dose limits listed

5Evidence sources cited

Coverage Summary

Policy UM ONC_1042 defines accepted oncologic indications for somatostatin analogs (octreotide and lanreotide), including FDA-approved uses and select off-label indications supported by recognized compendia or peer-reviewed literature. Evolent/Utilization Management (UM) is responsible for processing all medication requests and making authorization decisions; medications not authorized by Evolent may be deemed not reimbursable. Continuation rules apply for previously authorized therapy: continuation requests for a not-approvable medication are exempt provided the member has not experienced disease progression on the medication, the medication was used within the last year with no lapse greater than 30 days in active authorization, and no additional medications are being added to the continuation request. Policy number: UM ONC_1042. Effective date: 2025-01-31. Last review / approval date: 2025-01-08.

Initial Therapy Criteria

Covered when ALL of the following are met:

ALL of the following

Sandostatin (octreotide LAR Depot/IVISQ) or Somatuline Depot (lanreotide) is being used in members with metastatic/unresectable neuroendocrine tumors originating in the gastrointestinal tract/pancreas/lung/adrenal glands/other organs (except small cell lung cancer) as a single agent or in combination with other therapies.
Indication
- As symptom control in members with carcinoid syndrome or symptoms suggestive of carcinoid syndrome, e.g., diarrhea, flushing.
- For tumor/disease control.

ALL of the following

Sandostatin (octreotide LAR Depot/IVISQ) or Somatuline Depot (lanreotide) may be used for recurrent or progressive meningioma disease when radiation and/or surgery are not feasible.
The tumor/disease is positive on an Octreoscan (or similar imaging confirming that the tumor is somatostatin receptor positive).

Continuation Therapy Criteria

Continuation from prior authorization

Continuation requests for a not-approvable medication shall be exempt provided:

ALL of the following

The member has not experienced disease progression on the requested medication
The requested medication was used within the last year without a lapse of more than 30 days of having an active authorization
Additional medication(s) are not being added to the continuation request

Continuation request exemption: Continuation of not-approvable medication allowed if no disease progression, used within last year with <=30-day authorization lapse, and no additional medications added.

Definition provided in policy definitions.

Exclusions / Not Approvable Criteria

Exclusion / Not approvable criteria

The following are exclusionary — requests meeting any of these are not approvable:

ANY of the following

Dosing exceedance: Dosing exceeds single dose limit of 60 mg for Sandostatin LAR Depot (octreotide) or 500 mcg for Sandostatin IVISQ (octreotide)<= 60 mg (Sandostatin LAR); <= 500 mcg (Sandostatin IVISQ)
Dosing exceedance: Dosing exceeds single dose limit of Somatuline Depot (lanreotide) 120 mg<= 120 mg (Somatuline Depot)
Investigational / insufficient evidence: Off-label indication where evidence is not sufficient or not generally accepted by the medical community
Investigational / insufficient evidence
- Clinical characteristics of the patient and cancer are not adequately represented in published evidence
- Administered chemotherapy/biologic/immune/targeted/other oncologic therapy regimen is not adequately represented in published evidence
- Reported study outcomes do not represent clinically meaningful outcomes (ASCO definition e.g., HR < 0.80 or survival benefit for OS/PFS < 3 months)
- Experimental design is inappropriate to address the investigative question
- Non-randomized trials without significant subject numbers may not be adequate (though may be supportive in some cases)
- Case reports are uncontrolled/anecdotal and do not provide adequate supportive evidence

Single-dose limits for somatostatin analogs are: Sandostatin LAR (octreotide) ≤ 60 mg per single dose, Sandostatin IVISQ (octreotide) ≤ 500 mcg per single dose, and Somatuline Depot (lanreotide) ≤ 120 mg per single dose. Requests that exceed these single-dose limits are exclusionary and can be denied.

Applicable Codes

Depot octreotide (J-code)HCPCSCovered

J2353

Injection, octreotide, depot form for intramuscular injection, mg

Non-depot octreotide (J-code)HCPCSCovered

J2354	Injection, octreotide, non-depot form for subcutaneous or intravenous injection, 25 mcg
J3490	Octreotide acetate

Lanreotide (J-codes / unlisted)HCPCSCovered

J1930	Injection, lanreotide, 1 mg
J1932	Injection, lanreotide, (cipla), 1 mg
C9399	Lanreotide (unclassified)
J3490	Lanreotide

Unclassified / miscellaneousHCPCS

J8499

Octreotide, oral

Provider Actions

Prior Authorization

Authorization required for medication requests

Evolent (UM) must process all medication requests; medications not authorized may be deemed not reimbursable. Requests must be supported by FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or peer-reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 requirements.

Documentation Required

Documentation of somatostatin receptor positivity

For meningiomas and thymic tumors, provide an Octreoscan or similar imaging study confirming that the tumor is somatostatin receptor positive.

Octreoscan (or similar) required

Denial Risk

Dosing exceedance denial risk

Claims or requests that exceed the policy's single-dose limits for specified products are exclusionary and may be denied.

J2353
J2354
J1930
J1932
Single-dose limits: Sandostatin LAR ≤ 60 mg; Sandostatin IVISQ ≤ 500 mcg; Somatuline Depot ≤ 120 mg

Clinical Evidence & References

Evidence requirements include support from FDA product labeling, CMS-recognized compendia, National Comprehensive Cancer Network (NCCN) or American Society of Clinical Oncology (ASCO) clinical guidelines, or peer-reviewed literature that meets the requirements of the CMS Medicare Benefit Policy Manual Chapter 15.

Selected references cited in the policy include: Oncotarget systematic review (Merola et al.), the ECOG Phase II trial of octreotide with/without prednisone in thymoma, Sandostatin (octreotide) and Sandostatin LAR prescribing information, Clinical Pharmacology (Elsevier) 2025, Micromedex Healthcare Series 2025, and NCCN 2025.

Background

This policy scope covers accepted oncologic indications for somatostatin analogs including FDA-approved and select off-label uses supported by recognized compendia or peer-reviewed literature. Accepted oncology indications specified include use for recurrent or progressive meningioma when radiation and/or surgery are not feasible and the tumor is somatostatin receptor positive; metastatic or unresectable neuroendocrine tumors (NETs) of the gastrointestinal tract, pancreas, lung, adrenal glands or other organs (except small cell lung cancer) for symptom control (e.g., carcinoid syndrome) or tumor/disease control; and unresectable/metastatic thymoma or thymic carcinoma when the tumor is somatostatin receptor positive. Evolent/UM is responsible for medication authorization decisions and must process all medication requests; requests must be supported by FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or peer-reviewed literature meeting CMS Chapter 15 requirements.

Definitions

OctreoscanImaging study confirming somatostatin receptor positivity of a tumor (or similar receptor imaging)

Continuation request exemptionContinuation of not-approvable medication allowed if: no disease progression on the medication; medication used within the last year with <=30-day authorization lapse; no additional medications added.