CurrentCignaPolicy IP0489

Octreotide Long-Acting Products

Defines prior authorization, clinical coverage criteria, dosing limits, and preferred-product/step therapy requirements for octreotide long-acting intramuscular injection across FDA-approved indications and select supportive-evidence uses for Cigna-administered health plans.

Policy Summary

PayerCigna

PolicyOctreotide Long-Acting Products

Policy CodePolicy IP0489

Change TypeRevisions & Additions (2024-2025)

Effective DateJul 15, 2025

Next Review Date

Key ActionPrior Authorization must be obtained for octreotide intramuscular injection; approvals are time-limited per indication and the medication must be prescribed by or in consultation with an appropriate specialist.

POLICY UPDATE CHANGES

Removed criteria for multiple prior non-oncology indications and updated preferred product requirements and policy name to 'Somatostatin Analogs - Octreotide Long-Acting Products'.

Added diarrhea associated with chemotherapy, enterocutaneous fistulas, pancreatic fistulas, meningioma, pheochromocytoma/paraganglioma, thymoma/thymic carcinoma, and Merkel cell carcinoma as supportive-evidence uses with approval durations and dosing.

Updated Employer Plans preferred product requirement: step through Somatuline Depot for certain indications or documentation patient already started on Sandostatin LAR.

Removed 'Preferred product criteria is met for the product as listed in the below table' language from several supportive-evidence indication entries (enterocutaneous fistulas, meningioma, pancreatic fistulas, thymoma/thymic carcinoma).

9Covered Indications (FDA-approved + supportive)

Primary HCPCS code listed

4Typical approval durations (months/years)

Coverage Summary & Scope

This policy covers octreotide long‑acting intramuscular injection (somatostatin analog) for FDA‑approved indications including acromegaly, carcinoid and other neuroendocrine tumors (NETs), and VIPomas, and also incorporates guideline‑supported and literature‑supported uses (e.g., meningioma, thymoma/thymic carcinoma, Merkel cell carcinoma, enterocutaneous and pancreatic fistulas, and chemotherapy‑associated diarrhea). The policy follows FDA indications and NCCN/NANETS guideline recommendations where applicable.

The policy applies to Cigna‑administered health benefit plans and requires prior authorization and specialist prescribing or consultation for covered conditions. Coverage stance is covered_with_criteria — approvals are time‑limited and subject to indication‑specific criteria, dosing limits, and any employer‑plan preferred product/step‑through requirements.

Key thresholds: Acromegaly IGF‑1 — pre‑treatment (baseline) insulin‑like growth factor‑1 (IGF‑1) must be above the laboratory‑specific upper limit of normal for age and gender prior to initiating octreotide for acromegaly.

Diarrhea severity — chemotherapy‑associated diarrhea eligible for approval requires Grade 3 or Grade 4 severity (examples include: >6 bowel movements above baseline per day, interference with activities of daily living, hemodynamic instability, hospitalization, or other life‑threatening colitis‑related conditions).

Initial Therapy Criteria (Prior Authorization & FDA-Approved Indications)

Prior Authorization and Prescriber Requirement

Prior Authorization is required and medication must be prescribed by or in consultation with a specialist for the treated condition.

ALL of the following

Prior Authorization required for prescription benefit coverage of octreotide intramuscular injection
Medication is prescribed by or in consultation with a physician who specializes in the condition being treated

FDA-Approved Indication: Acromegaly

Approve for 1 year if ALL of the following (A, B, C and D) are met:

ALL of the following

A) ONE of
- Patient has had an inadequate response to surgery and/or radiotherapy
- Patient is NOT an appropriate candidate for surgery and/or radiotherapy
- Patient is experiencing negative effects due to tumor size (e.g., optic nerve compression)
B) Patient has (or had) a pre-treatment (baseline) insulin-like growth factor-1 (IGF-1) level above the upper limit of normal based on age and gender for the reporting laboratory
Pre-treatment refers to IGF-1 level prior to initiation of any somatostatin analog or related therapies

FDA-Approved Indication: Neuroendocrine Tumors (NETs) of GI tract, Lung, Thymus, Pancreas

Approve for 1 year if ALL of the following (A and B) are met:

ALL of the following

A): Medication is prescribed by or in consultation with an oncologist, endocrinologist, or gastroenterologist
B): Preferred product criteria is met for the product as listed in the preferred product / employer plan table

Other Uses with Supportive Evidence (Time‑limited Approvals)

Other Uses with Supportive Evidence: Diarrhea Associated with Chemotherapy

Approve for 3 months if ALL of the following (A, B, and C) are met:

ALL of the following

A): Patient has Grade 3 or Grade 4 diarrhea
Examples include >6 bowel movements above baseline per day, colitis symptoms, interference with ADLs, hemodynamic instability, hospitalization, serious complications (ischemic bowel, perforation, toxic megacolon), or other life-threatening colitis-related conditions
B): Patient has tried at least one antimotility medication
Examples include loperamide and diphenoxylate
C): Medication is prescribed by or in consultation with an oncologist or gastroenterologist

Not Medically Necessary / Exclusions

Not Medically Necessary

Octreotide intramuscular injection for any other use not specified above is considered not medically necessary.

Use not listed in the policy's covered FDA-approved indications or supportive-evidence uses

Claims for uses not listed will be denied as not medically necessary

Dosing Limits and Frequency

Dosing Limits (General)

Approvals include the following maximum dosing and frequency per indication:

ANY of the following

Acromegaly: Approve up to 40 mg intramuscularly no more frequently than once every 4 weeks
NETs (GI, lung, thymus, pancreas): Approve up to 30 mg intramuscularly no more frequently than once every 4 weeks
Diarrhea associated with chemotherapy: Approve up to 40 mg intramuscularly no more frequently than once every 4 weeks
Enterocutaneous fistulas: Approve up to 40 mg intramuscularly no more frequently than once every 4 weeks

Applicable Codes

Covered HCPCS for octreotide LAR depotHCPCSCovered

J2353

Injection, octreotide, depot form for intramuscular injection, 1 mg

Provider Actions & Administrative Requirements

Prior Authorization

Prior Authorization required

Prior Authorization must be obtained for prescription benefit coverage of octreotide long-acting intramuscular injection. Approvals are time-limited per indication (examples in policy: 1 year for acromegaly and NETs, 3 months for chemotherapy-associated diarrhea, 2 months for pancreatic fistulas). Use HCPCS code J2353 for billing of octreotide LAR depot (1 mg units).

Documentation Required

Specialist prescribing or consultation required

The medication must be prescribed by or in consultation with a specialist appropriate to the condition being treated. Examples in the policy include: endocrinologist for acromegaly; oncologist, endocrinologist, or gastroenterologist for neuroendocrine tumors; oncologist or gastroenterologist for chemotherapy-associated diarrhea; oncologist, radiologist, or neurosurgeon for meningioma.

Clinical Evidence & Guidelines

Evidence and guidance cited include NCCN guideline recommendations for multiple tumor types (CNS/meningioma, neuroendocrine and adrenal tumors, thymomas/thymic carcinomas, Merkel cell carcinoma) supporting use of octreotide LAR.

The Sandostatin LAR prescribing information (Novartis, July 2023) is referenced for FDA indications and product information.

Supportive clinical evidence includes case series, trials, and reviews documenting benefit of octreotide for enterocutaneous and pancreatic fistulas and for chemotherapy‑associated diarrhea (e.g., Canadian Working Group consensus and multiple case series and retrospective studies).

Definitions

Pre‑treatment (baseline) IGF‑1: IGF‑1 measured prior to initiation of any somatostatin analog or related therapy; coverage for acromegaly requires the value to be above the lab‑specific upper limit of normal for the patient’s age and gender.

Checkpoint immunotherapy: Examples include Bavencio (avelumab), Keytruda (pembrolizumab), and Opdivo (nivolumab), which are referenced in criteria for Merkel cell carcinoma where octreotide is an option when there are contraindications to or progression on checkpoint immunotherapy.

Policy Revision History

8/15/2024revised

Removed criteria for several non-oncology indications and removed 'Individual has previously started on or is currently receiving Sandostatin LAR Depot' from preferencing table; updated policy title from Sandostatin LAR Depot to Somatostatin Analogs - Sandostatin LAR Depot; added enterocutaneous and pancreatic fistulas, NETs criteria/dosing, meningioma, pheochromocytoma/paraganglioma, and thymoma/thymic carcinoma.

10/15/2024revised

Selected revisions added criteria and dosing for NETs, meningioma, pheochromocytoma/paraganglioma, thymoma/thymic carcinoma and noted other content additions.

2/15/2025revised

Policy Summary

PayerCigna

PolicyOctreotide Long-Acting Products

Policy CodePolicy IP0489

Change TypeRevisions & Additions (2024-2025)

Effective DateJul 15, 2025

Next Review Date

On This Page

C) Medication is prescribed by or in consultation with an endocrinologist

D) Preferred product criteria is met for the product as listed in the preferred product / employer plan table

Other Uses with Supportive Evidence: Enterocutaneous Fistulas

Approve for 3 months when medically necessary:

Indication: Enterocutaneous fistulas

Listed as supportive-evidence use; no additional criteria specified in policy

Other Uses with Supportive Evidence: Meningioma

Approve for 1 year when medication is prescribed by or in consultation with specified specialists:

Medication is prescribed by or in consultation with an oncologist, radiologist, or neurosurgeon

Other Uses with Supportive Evidence: Merkel Cell Carcinoma

Approve for 1 year if ALL of the following (A, B, C, and D) are met:

ALL of the following

A): Patient is ≥ 18 years of age
B): Patient has regional or distant metastatic disease
C) ONE of
- Patient has contraindications to checkpoint immunotherapy
- Patient has progressed on checkpoint immunotherapy
D): Medication is prescribed by or in consultation with an oncologist
Checkpoint immunotherapy examples: Bavencio (avelumab), Keytruda (pembrolizumab), Opdivo (nivolumab)

Other Uses with Supportive Evidence: Pancreatic Fistulas

Approve for 2 months if treating operative trauma, pancreatic resection, acute or chronic pancreatitis, or pancreatic infection:

Indication: Pancreatic fistulas in the contexts listed (operative trauma, pancreatic resection, acute or chronic pancreatitis, or pancreatic infection)

Other Uses with Supportive Evidence: Pheochromocytoma and Paraganglioma

Approve for 1 year if ALL of the following (A and B) are met:

ALL of the following

A): Medication is prescribed by or in consultation with an endocrinologist, oncologist, or neurologist
B): Preferred product criteria is met for the product as listed in the preferred product / employer plan table
Preferred-product / step-through requirements vary by plan and indication (e.g., Somatuline Depot trial or documentation of prior Sandostatin LAR use for certain Employer Plans)

Other Uses with Supportive Evidence: Thymoma and Thymic Carcinoma

Approve for 1 year when prescribed by or in consultation with an oncologist:

Medication is prescribed by or in consultation with an oncologist

Meningioma: Approve up to 40 mg intramuscularly no more frequently than once every 4 weeks

Merkel cell carcinoma: Approve up to 30 mg intramuscularly no more frequently than once every 4 weeks

Pancreatic fistulas: Approve up to 40 mg intramuscularly no more frequently than once every 4 weeks

Pheochromocytoma and Paraganglioma: Approve up to 40 mg intramuscularly no more frequently than once every 4 weeks

Thymoma and Thymic Carcinoma: Approve up to 40 mg intramuscularly no more frequently than once every 4 weeks

Documentation Required

Acromegaly baseline IGF-1 documentation

For coverage of acromegaly, document a pre-treatment (baseline) IGF-1 level above the laboratory-specific upper limit of normal measured prior to initiation of any somatostatin analog or related therapy (the policy defines Pre-treatment as IGF-1 prior to starting any somatostatin analog or related therapies).

Step Therapy

Preferred product / step-through requirements

Employer-plan preferred-product requirements may require trial of Somatuline Depot (lanreotide) before approval of Sandostatin LAR for certain indications, or documentation that the patient has already started on Sandostatin LAR. Preferred-product criteria vary by plan and indication and must be met as listed in the employer-plan table.

Billing Rule

Dosing frequency limits

Do not administer more frequently than once every 4 weeks. Indication-specific maximum doses in the policy include examples such as: Acromegaly up to 40 mg every 4 weeks; NETs up to 30 mg every 4 weeks; chemotherapy-associated diarrhea up to 40 mg every 4 weeks; many other indications up to 40 mg every 4 weeks.

Denial Risk

Not medically necessary exclusions

Octreotide intramuscular injection submitted for uses not listed as covered FDA-approved indications or supportive-evidence uses in this policy will be denied as not medically necessary.

Documentation Required

Prior therapies for chemotherapy-associated diarrhea

For chemotherapy-associated diarrhea, document trial of at least one antimotility medication (policy examples: loperamide or diphenoxylate) prior to approval.

Policy name changed to 'Somatostatin Analogs - Octreotide Long-Acting Products' and generic octreotide intramuscular injection was added; Employer Plans preferred product table updated to require step through Somatuline Depot or documentation patient already started on Sandostatin LAR for certain indications.

4/01/2025revised

Removed Individual and Family Plans preferred product requirements (relaxing prior product-preference linkage for those plan types).

5/15/2025added

Added Merkel cell carcinoma and diarrhea associated with chemotherapy under 'Other Uses with Supportive Evidence'; updated Employer Plans preferred product table to include diarrhea associated with chemotherapy and Merkel cell carcinoma; added a note providing examples of Grade 3 or 4 diarrhea.

7/15/2025revisedLatest

Policy effective date 7/15/2025 reflecting multiple changes across 2024-2025: removed certain prior non-oncology indication criteria; added generic octreotide; updated preferred product/step-through requirements (Employer Plans require trial of Somatuline Depot or documentation patient already started on Sandostatin LAR for specified indications); removed 'Preferred product criteria is met for the product as listed in the below table' language from several supportive-evidence indication entries; and added specific approval durations and dosing limits for newly listed supportive-evidence uses (diarrhea associated with chemotherapy, enterocutaneous and pancreatic fistulas, meningioma, pheochromocytoma/paraganglioma, thymoma/thymic carcinoma, Merkel cell carcinoma).