ModifiedCignaPolicy IP0489

Octreotide Long-Acting Products

Defines prior authorization, coverage criteria, dosing, and prescriber requirements for long-acting octreotide (including Sandostatin LAR and generic octreotide IM depot) for Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyOctreotide Long-Acting Products (Somatostatin analogs — Sandostatin LAR and generic octreotide IM depot)

Policy CodePolicy IP0489

Change TypeTitle update, added generic product, added/removed indications, updated preferencing/step therapy

Effective DateJul 15, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of specialist involvement and, when required, evidence of prior trial of Somatuline Depot or that the patient was already started on Sandostatin LAR.

SourceLink

POLICY UPDATE CHANGES

Policy name changed from Somatostatin Analogs - Sandostatin LAR Depot to Somatostatin Analogs - Octreotide Long-Acting Products and the generic octreotide intramuscular injection was added.

Removed individual and family plans preferred product requirements and updated preferred product requirement table to require step through Somatuline Depot for certain indications.

Added numerous non‑FDA supportive indications and associated criteria including NETs, meningioma, pheochromocytoma/paraganglioma, thymoma/thymic carcinoma, enterocutaneous and pancreatic fistulas, and Merkel cell carcinoma.

Removed criteria for gastroesophageal variceal hemorrhage, secretory diarrhea in AIDS, perioperative pancreatic resection management, and TSH‑secreting pituitary adenoma.

Removed criteria for gastroesophageal variceal hemorrhage, acute; diarrhea associated with chemotherapy or radiation; enterocutaneous fistula; perioperative management for pancreatic resection; TSH-secreting pituitary adenoma; secretory diarrhea in AIDS.

Removed 'Individual has previously started on or is currently receiving Sandostatin LAR Depot' from preferencing table.

Added step through Somatuline Depot for Individual and Family Plan for Sandostatin LAR Depot.

Preferred product requirement table updated to specify for Sandostatin LAR Depot that for acromegaly documentation the patient has tried Somatuline Depot is required; for NETs and pheochromocytoma/paraganglioma either prior trial of Somatuline Depot or already started on Sandostatin LAR qualifies.

Removed 'Preferred product criteria is met for the product as listed in the below table' language for enterocutaneous fistulas, meningioma, pancreatic fistulas, thymoma/thymic carcinoma.

Diarrhea associated with chemotherapy was added under 'Other Uses with Supportive Evidence' with a note providing examples of Grade 3 or Grade 4 diarrhea.

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J2353Considered HCPCS

1 yearTypical approval

Up to 40 mgMax dose

Prior authGating

>=9Added/revised indications

Coverage Criteria and Indications

inv-01: Initial Therapy - Acromegaly

Acromegaly — Approve for 1 year if ALL of the following are met

Acromegaly criteria: A) Patient meets ONE of the following: (i) inadequate response to surgery and/or radiotherapy; OR (ii) not an appropriate candidate for surgery and/or radiotherapy; OR (iii) experiencing negative effects due to tumor size (e.g., optic nerve compression); AND 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; AND C) The medication is prescribed by or in consultation with an endocrinologist; AND D) Preferred product criteria is met for the product as listed in the below table.

Dosing: Approve up to 40 mg administered intramuscularly no more frequently than once every 4 weeks.

inv-02: Initial Therapy - Neuroendocrine Tumors

Neuroendocrine Tumors (NETs) — Approve for 1 year if ALL of the following are met

NET criteria: A) The medication is prescribed by or in consultation with an oncologist, endocrinologist, or gastroenterologist; AND B) Preferred product criteria is met for the product as listed in the below table.

Dosing: Approve up to 30 mg administered intramuscularly no more frequently than once every 4 weeks.

inv-03: Other Uses with Supportive Evidence

Other supportive evidence indications — specific approval durations and criteria

Diarrhea associated with chemotherapy: A) Patient has Grade 3 or Grade 4 diarrhea (examples: >6 bowel movements above baseline per day, colitis symptoms, interference with activities of daily living, hemodynamic instability, hospitalization, serious complications such as ischemic bowel, perforation, toxic mega-colon); AND B) Patient has tried at least one antimotility medication (e.g., loperamide or diphenoxylate); AND C) The medication is prescribed by or in consultation with an oncologist or gastroenterologist.

Approve for 3 months; Dosing: Approve up to 40 mg administered intramuscularly no more frequently than once every 4 weeks.

Enterocutaneous fistulas: Patient is being treated for an enterocutaneous fistula as documented and the medication is prescribed by or in consultation with an appropriate specialist.

Approve for 3 months; Dosing: Approve up to 40 mg administered intramuscularly no more frequently than once every 4 weeks.

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

Octreotide long-acting intramuscular injection (Sandostatin LAR Depot or generic octreotide IM depot) is covered only when the specific, indication‑based criteria in this policy are met. For each covered indication the policy specifies required prescriber specialty, prior treatments or trials when applicable, baseline testing where noted, dosing limits, and approval duration (for many indications approval is for 1 year).

When coverage is sought, dosage, frequency, duration, and site of care must be reasonable and clinically appropriate and supported by the applicable criteria and evidence; receipt of sample product does not satisfy criteria requirements. Octreotide intramuscular injection for any use not listed in the policy is considered not medically necessary and will be denied unless and until criteria are added or revised in the policy.

The policy’s annual review removed several previously listed indications from coverage criteria. Specifically, criteria for gastroesophageal variceal hemorrhage (acute), diarrhea associated with chemotherapy or radiation, enterocutaneous fistula, perioperative management for pancreatic resection (including fistula), TSH‑secreting pituitary adenoma, and secretory diarrhea in AIDS were removed during the review.

Selected revisions also modified preferencing language and step‑through requirements (for example, adding step‑through via Somatuline Depot for certain plan types) and updated the policy title to reflect inclusion of generic octreotide long‑acting products.

Unless an indication and the required criteria are explicitly listed in this policy, use of octreotide intramuscular injection is not medically necessary. The policy states plainly that octreotide intramuscular injection for any other use is considered not medically necessary, and criteria will be updated only if new published data support additional uses.

Initial Authorization Requirements

inv-20: Initial therapy — indication-specific initial authorization criteria, specialist involvement, preferred product where applicable

Initial authorization criteria are indication-specific and require specialist involvement, meeting of preferred product criteria where applicable, and baseline labs where specified.

Initial therapy per indication: See individual indication criteria (Acromegaly, NETs, other supportive indications) for required prescriber specialty, prior treatments, and baseline testing.

Dosing varies by indication (30 mg or 40 mg IM every 4 weeks as specified).

Prescriber and baseline testing: Medication must be prescribed by or in consultation with a specialist appropriate to the indication (e.g., endocrinologist for acromegaly; oncologist, endocrinologist, or gastroenterologist for NETs; oncologist/radiologist/neurosurgeon for meningioma). For acromegaly, a pre-treatment (baseline) IGF-1 level above the upper limit of normal for lab age/gender is required prior to initiation of any somatostatin analog.

Prior Authorization is required for octreotide intramuscular injection.

inv-21: Preferencing and prior trial — step/try requirements for certain plans and indications

Continuation Therapy and Renewal

inv-22: Continuation therapy — ongoing documentation and response requirements for renewals

Continuation approvals follow the initial approval duration and require ongoing documentation of specialist involvement and clinical response as implied by the original approval.

Continuation general: Approvals are provided for the duration noted at initial approval (e.g., 1 year) and continuation requires that the original criteria remain met and that therapy continues to be prescribed by or in consultation with the appropriate specialist.

Dosing intervals should not exceed once every 4 weeks as specified per indication.

Provider Requirements, Documentation, and Billing

Prior Authorization

Prior Authorization Required

Prior authorization is required for octreotide intramuscular injection. Approvals are issued for the durations specified in the policy indications (e.g., 1 year for most indications, 3 months for diarrhea associated with chemotherapy or enterocutaneous fistulas).

Prior authorization must document the approving duration per the indication.

Step Therapy

Preferred product / Step-through and Prior Trial Requirement

For plans/indications with a preferred product requirement, documentation must show a prior trial of Somatuline Depot (lanreotide) or documentation that the member was already started on Sandostatin LAR, as specified below. If preferencing applies and the required trial documentation is not provided, the request may be denied.

Acromegaly: documentation the patient has tried Somatuline Depot is required.
Neuroendocrine tumors: documentation the patient has tried a Somatuline Depot subcutaneous injection OR documentation the patient has already been started on Sandostatin LAR.

Step Therapy / Preferencing Requirements

Plan type / context	Step therapy requirement	Exceptions / satisfying documentation
Employer Plans (Sandostatin LAR Depot)
Patient must have tried Somatuline Depot (lanreotide) prior to coverage of Sandostatin LAR Depot for acromegaly; for neuroendocrine tumors and pheochromocytoma/paraganglioma, see options in next row.
Documentation that the patient previously tried Somatuline Depot satisfies the requirement; alternatively, for NETs and pheochromocytoma/paraganglioma, prior start on Sandostatin LAR also satisfies the requirement.

Plan type / context	Step therapy requirement	Exceptions / satisfying documentation
Individual and Family Plans / Specified plan types
Step-through via Somatuline Depot is required for Sandostatin LAR Depot for certain indications (NETs, pheochromocytoma/paraganglioma, and others as specified).
Exceptions: patient already started on therapy with Sandostatin LAR (documentation of prior start) satisfies the preferencing requirement; policy revisions note added/clarified exceptions and plan-specific application.

Billing and Codes

Considered Medically Necessary HCPCSHCPCSCovered

J2353

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

Dose and Quantity Limits

Octreotide long-acting IM depot — dosing and quantity limits

Typical per-dose limit30–40 mg per administration (no more frequently than once every 4 weeks)

Acromegaly dosingUp to 40 mg IM every 4 weeks

NETs dosingUp to 30 mg IM every 4 weeks

Other supportive indications dosingUp to 40 mg IM every 4 weeks (per indication-specific notes)

Authorization intervalApprovals typically issued for 1 year for many indications (shorter durations for some supportive uses)

Site of Care and Prescribing

Note

Prescribe by or in consultation with an appropriate specialist

Because specialized skills are required for evaluation and monitoring, the medication must be prescribed by or in consultation with a specialist appropriate to the condition being treated.

Site of care: office setting with appropriate specialist involvement.

Background

Octreotide is a somatostatin analog that inhibits release of several peptide hormones and is used to reduce hormone‑mediated symptoms and to inhibit growth or secretory activity of neuroendocrine tumors. In clinical practice long‑acting intramuscular depot formulations (e.g., Sandostatin LAR Depot or generic octreotide IM depot) are used for chronic management of conditions such as acromegaly and neuroendocrine tumors (NETs), and for selected supportive‑evidence indications where symptom control or reduction of secretions is the therapeutic goal.

The policy requires specialist involvement for initiation and monitoring (for example endocrinologist for acromegaly; oncologist, endocrinologist, or gastroenterologist for NETs), defines dosing limits by indication (commonly up to 30–40 mg IM no more frequently than once every 4 weeks), and ties prior authorization approvals to the documented indication‑specific criteria and prior‑trial/preferencing requirements where applicable.

Definitions and Indication Summaries

Acromegaly — definition and role of therapy

DefinitionAcromegaly: disorder characterized by excess growth hormone; treatment goal is to reduce GH and IGF‑1 to normal

When indicatedUsed when surgery and/or radiotherapy is inadequate or not an option, or when tumor size causes negative effects (e.g., optic nerve compression)

Prescriber requirementMedication must be prescribed by or in consultation with an endocrinologist

Typical authorizationApprove for 1 year if criteria met (baseline IGF‑1 above lab-specific upper limit of normal required)

Dosing noteDosing: up to 40 mg IM no more frequently than once every 4 weeks

Carcinoid syndrome / Neuroendocrine tumors — definition and context

Policy Summary

PayerCigna

PolicyOctreotide Long-Acting Products (Somatostatin analogs — Sandostatin LAR and generic octreotide IM depot)

Policy CodePolicy IP0489

Change TypeTitle update, added generic product, added/removed indications, updated preferencing/step therapy

Effective DateJul 15, 2025

Next Review DateN/A

SourceLink

On This Page

Approve for 1 year; Dosing: Approve up to 40 mg administered intramuscularly no more frequently than once every 4 weeks.

Merkel cell carcinoma: A) Patient is >=18 years; AND B) Regional or distant metastatic disease; AND C) Patient has contraindications to checkpoint immunotherapy OR progressed on checkpoint immunotherapy; AND D) Medication is prescribed by or in consultation with an oncologist.

Approve for 1 year; Dosing: Approve up to 30 mg administered intramuscularly no more frequently than once every 4 weeks.

Pancreatic fistulas: Patient is being treated for operative trauma, pancreatic resection, acute or chronic pancreatitis, or pancreatic infection as documented.

Approve for 2 months; Dosing: Approve up to 40 mg administered intramuscularly no more frequently than once every 4 weeks.

Pheochromocytoma and paraganglioma: A) Medication is prescribed by or in consultation with an endocrinologist, oncologist, or neurologist; AND B) Preferred product criteria is met.

Approve for 1 year; Dosing: Approve up to 40 mg administered intramuscularly no more frequently than once every 4 weeks.

Thymoma and thymic carcinoma: Medication is prescribed by or in consultation with an oncologist.

Approve for 1 year; Dosing: Approve up to 40 mg administered intramuscularly no more frequently than once every 4 weeks.

Preferencing/initial product requirements (per updated preferencing table) — documentation requirements differ by indication

Preferencing options for Sandostatin LAR: For acromegaly: documentation the patient has tried Somatuline Depot. For neuroendocrine tumors: either A) documentation the patient has tried Somatuline Depot OR B) patient has already been started on therapy with Sandostatin LAR. For pheochromocytoma/paraganglioma: either A) documentation the patient has tried Somatuline Depot OR B) patient has already been started on therapy with Sandostatin LAR.

Applies per updated preferred product requirement table; failure to document when required may result in non-preferred coverage or denial.

Pheochromocytoma/paraganglioma: documentation the patient has tried Somatuline Depot OR documentation the patient has already been started on Sandostatin LAR.

Certain indications (enterocutaneous fistula; meningioma; pancreatic fistula; thymoma/thymic carcinoma) are listed as covered without the trial requirement per the preferencing table language — confirm applicable plan-specific requirements.

Documentation Required

Preferencing Documentation Required

When preferencing applies, providers must submit supporting documentation of the prior product trial or evidence the patient was already started on Sandostatin LAR. Examples of acceptable documentation include medical records showing prior lanreotide administration, treatment start notes for Sandostatin LAR, or chart notes describing intolerance/contraindication to the preferred product when relevant.

Absence of required prior trial documentation when preferencing applies may result in denial.
Receipt of sample product does not satisfy trial/documentation requirements.

Documentation Required

Prescriber and Baseline Test Requirements

Prescriptions for octreotide intramuscular injection must be written by or in consultation with a specialist appropriate to the indication (e.g., endocrinologist for acromegaly; oncologist, endocrinologist, or gastroenterologist for neuroendocrine tumors). Baseline testing requirements apply where specified (for example, pre-treatment IGF-1 level above the upper limit of normal for acromegaly prior to initiation of any somatostatin analog).

Acromegaly: medication prescribed by or in consultation with an endocrinologist and baseline IGF-1 prior to initiation of somatostatin analog therapy.
NETs: medication prescribed by or in consultation with an oncologist, endocrinologist, or gastroenterologist.

Billing Rule

Coding and Submission Requirements

Claims must be submitted with the most appropriate and covered diagnosis and procedure codes for the service. Claims submitted without covered diagnosis/procedure codes or not submitted in accordance with the policy coding instructions will be denied.

Use the appropriate covered diagnosis/procedure codes in effect on the date of service.
Claims lacking covered codes under this Coverage Policy will be denied as not covered.

DefinitionCarcinoid syndrome/NETs: neuroendocrine tumors that can cause severe diarrhea and flushing associated with metastatic carcinoid tumors

Clinical role of octreotideSomatostatin analogs are used to control hormone‑mediated symptoms (diarrhea, flushing) and may help control tumor growth

Prescriber requirement and authorizationMedication must be prescribed by or in consultation with an oncologist, endocrinologist, or gastroenterologist; approve for 1 year when criteria met

DosingFor NETs: up to 30 mg IM no more frequently than once every 4 weeks

NETs specifics — sites and related tumor types

Anatomic sites includedNETs of the gastrointestinal tract, lung, thymus (carcinoid tumors), and pancreas

Representative tumor typesCarcinoid tumors, VIPomas, glucagonomas, gastrinomas, insulinomas

Approval durationApprove for 1 year if criteria met

PrescriberPrescribed by or in consultation with an oncologist, endocrinologist, or gastroenterologist

Dosing specificityDosing for NETs: up to 30 mg IM every 4 weeks