ModifiedCignaPolicy IP0489

Somatostatin Analogs - Octreotide Long-Acting Products

Defines prior authorization, coverage criteria, and approved indications for octreotide long-acting intramuscular injection (e.g., Sandostatin LAR and generics) for Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicySomatostatin Analogs - Octreotide Long-Acting Products

Policy CodePolicy IP0489

Change TypeMaterial updates: renaming, broadened product scope, added/removed indications, preferred product table revised

Effective DateApr 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization and document trial of a listed alternative long-acting somatostatin analog or prior start as required by the preferred product criteria.

SourceLink

POLICY UPDATE CHANGES

Policy name changed from 'Somatostatin Analogs - Sandostatin LAR Depot (for Non-Oncology Uses)' to 'Somatostatin Analogs - Octreotide Long-Acting Products' and the generic octreotide intramuscular injection was added where relevant.

Preferred product requirement table updated to require trial of specific alternatives (octreotide ER injectable suspension, Somatuline Depot, or lanreotide) for acromegaly, NETs, and pheochromocytoma/paraganglioma.

Removed criteria for gastroesophageal variceal hemorrhage, chemotherapy/radiation-associated diarrhea, enterocutaneous fistula, perioperative pancreatic resection management, TSH-secreting pituitary adenoma, and AIDS-related secretory diarrhea.

Added indications and dosing criteria for neuroendocrine tumors, meningioma, pheochromocytoma/paraganglioma, thymoma/thymic carcinoma, pancreatic fistulas, and enterocutaneous fistulas.

Removed 'Individual and Family Plans preferred' status and adjusted preferred product criteria across plan types.

Prior Authorization

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria and Indications

inv-01: Acromegaly (FDA) — Approve for 1 year if ALL are met

Approve for 1 year if ALL are met:

Acromegaly criteria: A) Patient meets ONE of: (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) pre-treatment (baseline) IGF-1 level above the upper limit of normal for age and gender for the reporting laboratory; AND C) medication prescribed by or in consultation with an endocrinologist; AND D) preferred product criteria is met for the product as listed in the policy's preferred product table.

Dosing: approve up to 40 mg IM no more frequently than once every 4 weeks; approval duration: 1 year.

inv-02: Neuroendocrine Tumors (gastrointestinal tract, lung, thymus, pancreas) (FDA) — Approve for 1 year if ALL are met

Approve for 1 year if ALL are met:

Neuroendocrine tumors (NETs) criteria: A) 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 policy's preferred product table.

Dosing: approve up to 30 mg IM no more frequently than once every 4 weeks; approval duration: 1 year.

inv-03: Other supported uses (chemotherapy diarrhea, enterocutaneous fistulas, meningioma) — authorization rules

Other uses with supportive evidence — authorization rules:

Diarrhea associated with chemotherapy: A) Patient has Grade 3 or Grade 4 diarrhea (examples include >6 bowel movements above baseline/day, colitis symptoms, hemodynamic instability, hospitalization, or life‑threatening colitis-related conditions); AND B) patient has tried at least one antimotility medication (e.g., loperamide, diphenoxylate); AND C) medication is prescribed by or in consultation with an oncologist or gastroenterologist; AND D) preferred product criteria is met for the product as listed in the policy's preferred product table.

Dosing: approve up to 40 mg IM every 4 weeks; approval duration: 3 months.

Enterocutaneous fistulas: A) Preferred product criteria is met for the product as listed in the policy's preferred product table.

Dosing: approve up to 40 mg IM every 4 weeks; approval duration: 3 months.

Meningioma: A) Medication is prescribed by or in consultation with an oncologist, radiologist, or neurosurgeon; AND B) preferred product criteria is met for the product as listed in the policy's preferred product table.

inv-04: Merkel cell carcinoma, pancreatic fistula, pheochromocytoma/paraganglioma — additional supportive indications and authorization rules

Additional supportive indications — authorization rules:

Merkel cell carcinoma: A) Patient ≥ 18 years of age; AND B) regional or distant metastatic disease; AND C) patient meets ONE of: (i) contraindication to checkpoint immunotherapy; OR (ii) progressed on checkpoint immunotherapy; AND D) medication is prescribed by or in consultation with an oncologist; AND E) preferred product criteria is met for the product as listed in the policy's preferred product table.

Dosing: approve up to 30 mg IM every 4 weeks; approval duration: 1 year.

Pancreatic fistulas: A) Patient is being treated for operative trauma, pancreatic resection, acute or chronic pancreatitis, or pancreatic infection; AND B) preferred product criteria is met for the product as listed in the policy's preferred product table.

Dosing: approve up to 40 mg IM every 4 weeks; approval duration: 2 months.

Pheochromocytoma and paraganglioma: A) Medication is prescribed by or in consultation with an endocrinologist, oncologist, or neurologist; AND B) preferred product criteria is met for the product as listed in the policy's preferred product table.

inv-05: Small bowel bleeds / Thymoma and thymic carcinoma — other supported uses continued

Other supported uses continued — authorization rules:

Small bowel bleeds/angiodysplasia related bleeding: A) Patient has chronic, recurrent gastrointestinal bleeds lasting ≥ 3 months; AND B) medication is prescribed by or in consultation with a gastroenterologist; AND C) preferred product criteria is met for the product as listed in the policy's preferred product table.

Dosing: approve up to 40 mg IM every 4 weeks; approval duration: 6 months.

Thymoma and thymic carcinoma: A) Medication is prescribed by or in consultation with an oncologist; AND B) preferred product criteria is met for the product as listed in the policy's preferred product table.

Dosing: approve up to 40 mg IM every 4 weeks; approval duration: 1 year.

inv-06: Covered Indications and General Criteria — Covered when indication-specific criteria and preferred product requirements are met

Covered when indication-specific criteria and preferred product requirements are met:

Covered indications: Coverage applies for indicated conditions including acromegaly; neuroendocrine tumors (GI tract, lung, thymus, pancreas including VIPomas, glucagonomas, gastrinomas, insulinomas); pheochromocytoma and paraganglioma; meningioma; thymoma and thymic carcinoma; pancreatic fistulas; enterocutaneous fistulas; and other uses with supportive evidence (e.g., Merkel cell carcinoma, chemotherapy‑associated diarrhea, small bowel bleeds/angiodysplasia related bleeding).

See indication-specific sections for required prescriber specialty, required baseline testing (e.g., IGF-1 for acromegaly), dosing limits, and approval durations.

inv-07: Preferred Product / Step Therapy Criteria — Preferred product / step therapy condition for approval

ONE of the following must be met for approval (preferred product / step therapy logic):

Preferred product trial logic: 1) Acromegaly: documentation the patient has tried one of octreotide ER injectable suspension, Somatuline Depot, or lanreotide subcutaneous injection; OR 2) Neuroendocrine tumors: documentation the patient has tried one of octreotide ER injectable suspension, Somatuline Depot subcutaneous injection, or lanreotide subcutaneous injection; OR documentation that the patient has already been started on therapy with octreotide ER injectable suspension or Sandostatin LAR Depot; OR 3) Pheochromocytoma/paraganglioma: documentation the patient has tried one of the listed alternatives OR documentation that the patient has already been started on Sandostatin LAR or octreotide ER injectable suspension.

Policy lists specific product exceptions and a preferred Cipla lanreotide NDC (J1930, NDC 69097-0906-67) where applicable; employer-plan specific variations may apply (see employer plan table).

Octreotide intramuscular injection for any use not specifically listed in this policy is considered not medically necessary. Requests for indications outside those enumerated under Covered Indications and Other Uses with Supportive Evidence should be denied unless future policy updates explicitly add the indication.

Receipt of a manufacturer or clinic sample of octreotide does not satisfy prior authorization or coverage criteria and cannot be used to justify approval. Documentation of an actual prescription, dosing, and required supporting clinical information must be provided to meet coverage requirements.

During the most recent annual review, several previously listed indications were removed from the policy. Removed criteria include: gastroesophageal variceal hemorrhage (acute), diarrhea associated with chemotherapy or radiation, enterocutaneous fistula (previously removed then later re-added where noted), perioperative management for pancreatic resection (including fistula), TSH-secreting pituitary adenoma, and AIDS-related secretory diarrhea. These removals reflect the policy update and should not be considered covered indications unless subsequently reinstated.

Use of octreotide intramuscular injection for indications that are not listed in this policy is considered not medically necessary. Providers should confirm that the patient’s diagnosis matches one of the covered or supportive indications and that all associated criteria are met prior to submitting a request for authorization.

Initial Therapy — Dosing and Authorization

inv-30: Initial therapy dosing — Initial therapy dosing and duration per indication

Initial therapy dosing and typical approval durations by indication:

Acromegaly initial dosing: Dosing: up to 40 mg IM administered no more frequently than once every 4 weeks.

Approve for 1 year when indication criteria are met; pre-treatment (baseline) IGF-1 required.

Neuroendocrine tumors initial dosing: Dosing: up to 30 mg IM administered no more frequently than once every 4 weeks.

Approve for 1 year when indication criteria are met; prescriber specialty required (oncology, endocrinology, or gastroenterology).

Other indications initial dosing: Dosing: for most other indicated uses (e.g., chemotherapy-associated diarrhea, enterocutaneous/pancreatic fistulas, meningioma, thymoma), dosing up to 40 mg IM no more frequently than once every 4 weeks.

Continuation of Therapy

inv-32: Continuation/start exceptions for Sandostatin LAR — Employer plan-specific continuation/start rules

Employer plan-specific continuation/start exceptions for Sandostatin LAR:

Employer plan continuation/start exceptions: Patient already started on Sandostatin LAR Depot may be eligible without trial of alternatives as specified in employer plan criteria (employer plan table lists Sandostatin LAR Depot pathways).

If requesting a Cipla lanreotide product, note the preferred product mapping (J1930, NDC 69097-0906-67) per employer plan guidance.

inv-33: Continuation of Therapy — Continuation/allowance when patient already started on therapy

Continuation/allowance when patient already started on indicated octreotide long-acting therapy:

Prior start allowance: If the patient has already been started on octreotide ER injectable suspension or Sandostatin LAR Depot, continuation is an accepted pathway to approval without additional step-through of alternatives, provided documentation shows therapy was initiated.

Step Therapy Requirements

Employer plan	Step requirement
Sandostatin LAR Depot (octreotide ER injectable suspension) - Employer Plans
ONE of the following must be met: (1) Acromegaly: patient has tried one of octreotide ER injectable suspension, Somatuline Depot, or lanreotide subcutaneous injection; (2) NETs: patient has tried one of octreotide ER injectable suspension, Somatuline Depot subcutaneous injection, or lanreotide subcutaneous injection OR patient has already been started on therapy with Sandostatin LAR Depot; (3) Pheochromocytoma/paraganglioma: patient has tried one of octreotide ER injectable suspension, Somatuline Depot, or lanreotide subcutaneous injection OR patient has already been started on Sandostatin LAR; (4) For other listed indications (diarrhea associated with chemotherapy; enterocutaneous fistula; meningioma; Merkel cell carcinoma; pancreatic fistula; small bowel bleeds), follow indication-specific criteria as noted.

Employer plan

Step requirement

Sandostatin LAR Depot (octreotide ER injectable suspension) - Employer Plans

ONE of the following must be met: (1) Acromegaly: patient has tried one of octreotide ER injectable suspension, Somatuline Depot, or lanreotide subcutaneous injection; (2) NETs: patient has tried one of octreotide ER injectable suspension, Somatuline Depot subcutaneous injection, or lanreotide subcutaneous injection OR patient has already been started on therapy with Sandostatin LAR Depot; (3) Pheochromocytoma/paraganglioma: patient has tried one of octreotide ER injectable suspension, Somatuline Depot, or lanreotide subcutaneous injection OR patient has already been started on Sandostatin LAR; (4) For other listed indications (diarrhea associated with chemotherapy; enterocutaneous fistula; meningioma; Merkel cell carcinoma; pancreatic fistula; small bowel bleeds), follow indication-specific criteria as noted.

Step requirement	Accepted alternatives (trial required before Sandostatin LAR)
Step therapy requires documentation of trial (or documentation of prior start) before approval of Sandostatin LAR Depot for specified indications
Octreotide ER injectable suspension; Somatuline Depot (lanreotide); lanreotide subcutaneous injection — patient must have tried ONE of these alternatives (or show documentation they were already started on octreotide ER injectable suspension or Sandostatin LAR). Note: If requesting a Cipla lanreotide product, preferred product mapping is J1930, NDC 69097-0906-67.

Billing Codes and Preferred Product Identifiers

Considered Medically Necessary HCPCSHCPCSCovered

J2353

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

Employer-plan preferred product mappingHCPCS | NDC

J1930

Reference to preferred product NDC mapping for Cipla lanreotide product (J1930, NDC 69097-0906-67) as noted in employer plans

Preferred product codes / referencesCPT

J1930

Cipla lanreotide product (preferred product billing code referenced)

Preferred NDCNDC

NDC 69097-0906-67

Preferred Cipla lanreotide NDC

Prescriber Requirements and Documentation

Prior Authorization

Prior Authorization Required

Prior Authorization is required for prescription benefit coverage of octreotide intramuscular injection. Approvals are provided for the durations noted in the policy when indication-specific criteria are met. Approval requires the medication to be prescribed by or in consultation with a physician who specializes in the condition being treated (e.g., endocrinologist for acromegaly; oncologist, endocrinologist, or gastroenterologist for neuroendocrine tumors).

Prior authorization required for octreotide intramuscular injection
Approvals provided for specified durations when indication-specific criteria are met
Prescription must be by or in consultation with an appropriate specialist

Note

Delegated Prior Authorization/Preferred Product Requirements

For certain indications and where Evernorth delegates to EviCore, prior authorization medical necessity criteria in the Oncology Medications (1403) policy may apply. Preferred product requirements in this policy (including oncology or oncology-related uses) remain applicable as noted.

Dosing Limits and Maximum Frequency

octreotide LAR (long-acting IM injection) — typical dose ranges (30-40 mg)

Typical dosing range30–40 mg administered intramuscularly no more frequently than once every 4 weeks (NETs dosing up to 30 mg; most other indications up to 40 mg)

Dose intervalNo more frequently than once every 4 weeks

NETs-specific maximumUp to 30 mg IM every 4 weeks for neuroendocrine tumors

Other-indications maximumUp to 40 mg IM every 4 weeks for acromegaly and most other supported indications

Quantity limit summaryPolicy lists a dose limit range of 30–40 mg per month depending on indication

Site of Care and Prescriber Specialty

Note

Specialist prescriber or consultation required

Because specialized skills are required for evaluation and monitoring, the prescriber must be a specialist or have consulted with a specialist for use of octreotide long-acting products.

Note

Infusion center: refer to full policy for site‑of‑care rules

No site-of-care restrictions for infusion center administration are specified in the provided policy excerpts; refer to the full policy for any site-specific rules.

Background and Definitions

Octreotide is a long-acting somatostatin analog formulated for intramuscular depot administration (e.g., Sandostatin LAR Depot and generic octreotide long-acting products). It is used to reduce hormone-related symptoms and may inhibit tumor growth in conditions such as acromegaly and various neuroendocrine tumors. The policy also acknowledges supportive evidence for non-oncology uses including severe chemotherapy-associated diarrhea, enterocutaneous and pancreatic fistulas, and bleeding from angiodysplasia or small bowel sources. For many indications the policy requires documentation of a trial of or prior start on specified alternative long-acting somatostatin analogs (for example, octreotide ER injectable suspension, Somatuline Depot, or lanreotide) before approving octreotide long-acting intramuscular products.

Octreotide LAR (long-acting release) — definition/key facts

Drug class / formulationOctreotide long-acting intramuscular injection — a somatostatin analog

Indicated uses (examples)Acromegaly; carcinoid tumors; vasoactive intestinal peptide (VIP) tumors; other NETs as specified in policy

Prior authorizationPrior Authorization required; approvals granted when indication-specific criteria and prescriber specialty requirements are met

Prescriber requirements

Policy Summary

PayerCigna

PolicySomatostatin Analogs - Octreotide Long-Acting Products

Policy CodePolicy IP0489

Change TypeMaterial updates: renaming, broadened product scope, added/removed indications, preferred product table revised

Effective DateApr 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization and document trial of a listed alternative long-acting somatostatin analog or prior start as required by the preferred product criteria.

SourceLink

On This Page

inv-31: Initial Therapy Criteria — Initial authorization requires meeting indication-specific criteria plus preferred product trial or documented prior start

Initial authorization requires meeting indication-specific criteria plus ONE of the preferred product requirements below:

Initial therapy criteria: For many indications, approval requires documentation of trial of one of the alternative long‑acting somatostatin analogs (octreotide ER injectable suspension, Somatuline Depot subcutaneous injection, or lanreotide subcutaneous injection) OR documentation that the patient is already receiving Sandostatin LAR Depot or octreotide ER injectable suspension.

See policy preferred product table for indication-specific acceptable alternatives and employer-plan exceptions; documentation of prior start must be provided to use the prior‑start pathway.

Prior Authorization

Employer Plan Product Trial Requirements

Employer plan members may be required to trial an alternative somatostatin analog before approval for Sandostatin LAR Depot (octreotide ER injectable suspension). For employer plans, criteria require documentation of trial of ONE of: octreotide ER injectable suspension, Somatuline Depot (lanreotide) subcutaneous injection, or lanreotide subcutaneous injection — depending on indication. Some employer-plan exceptions allow approval if the patient has already been started on Sandostatin LAR.

Employer plans: Sandostatin LAR Depot criteria = try ONE of octreotide ER injectable suspension, Somatuline Depot, or lanreotide subcutaneous injection
Employer plans may allow approval if patient was already started on Sandostatin LAR

Step Therapy

Step Therapy Requirement

Step therapy requirements apply where noted: prior trial (or documentation of prior start) of one of the specified alternatives is required before approval. Acceptable alternatives include octreotide ER injectable suspension, Somatuline Depot (lanreotide) subcutaneous injection, or lanreotide subcutaneous injection. Documentation that the patient has already been started on the requested product may satisfy the requirement where specifically allowed.

Step therapy requires trial OR documentation of prior start of octreotide ER injectable suspension, Somatuline Depot, or lanreotide subcutaneous injection
Documentation of prior start may be acceptable in lieu of trial when policy language allows

Documentation Required

Prior Authorization: Alternative Trial or Prior Start / Required Documentation

When requesting coverage based on an alternative trial or prior start, submit supporting documentation showing the trial of one of the listed alternatives OR documentation that the member was previously started on the requested product. Failure to provide required documentation of trial or prior start may result in denial.

Required supporting documentation: medical records or pharmacy records showing trial of one of the listed alternatives OR evidence of prior start on the requested therapy
Failure to document prior trial or prior start may lead to denial

Grade 3-4 diarrhea — definition/examples for chemotherapy-associated diarrhea

Definition/examplesGrade 3–4 chemotherapy-associated diarrhea includes >6 bowel movements above baseline per day; colitis symptoms; interference with activities of daily living; hemodynamic instability; hospitalization; serious complications (e.g., ischemic bowel, perforation, toxic megacolon); or other colitis-related life‑threatening conditions.

Prior therapy requirementPatient must have tried at least one antimotility medication (examples: loperamide, diphenoxylate) before octreotide for chemotherapy-associated diarrhea

Prescriber requirementMedication must be prescribed by or in consultation with an oncologist or gastroenterologist

Preferred alternative products — acceptable products for trial prior to approval

Accepted alternatives for trialOctreotide ER injectable suspension; Somatuline Depot (lanreotide) subcutaneous injection; lanreotide subcutaneous injection

Preferred Cipla lanreotide noteIf requesting a Cipla lanreotide product, preferred product billing mapping is J1930 with NDC 69097-0906-67 (policy note)

Prior-start exceptionApproval may be granted without trial of alternatives if the patient has already been started on octreotide ER injectable suspension or Sandostatin LAR Depot as documented

Indication scope for alternativesThese alternative products are required trial options for many indications including acromegaly, NETs, and pheochromocytoma/paraganglioma per the preferred product/step therapy criteria