CurrentCignaPolicy N/A

Somatostatin Analogs - Octreotide Immediate-Release Products Preferred Specialty Management Policy

Defines Cigna's preferred specialty management program for immediate‑release octreotide acetate injections (Bynfezia Pen, Sandostatin, and generic octreotide) and the exception criteria for non‑preferred products; applies to Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicySomatostatin Analogs - Octreotide Immediate-Release Products Preferred Specialty Management Policy

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateMay 7, 2025

Key ActionTrial a Preferred Product (generic octreotide) prior to approval of a Non‑Preferred Product unless exception criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2Preferred products listed

2Non-preferred products named

1 yearApproval duration

No criteria changesHistory

Coverage Criteria for Immediate‑Release Octreotide

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Non-Preferred Product Exception Criteria

Approvals for non-preferred immediate‑release octreotide products are granted only when ALL listed conditions are met.

Bynfezia Pen exception: Approve for 1 year if ALL of the following are met: (A) patient meets the standard Somatostatin Analogs - Octreotide Immediate‑Release Products Prior Authorization Policy criteria; AND (B) patient has tried generic octreotide acetate immediate‑release injection.1 year approval

If A is met but B is not, approve generic octreotide acetate immediate‑release injection instead.

Sandostatin exception: Approve for 1 year if ALL of the following are met: (A) patient meets the standard Somatostatin Analogs - Octreotide Immediate‑Release Products Prior Authorization Policy criteria; AND (B) patient has tried generic octreotide acetate immediate‑release injection.1 year approval

If A is met but B is not, approve generic octreotide acetate immediate‑release injection instead.

Any exception not meeting the stated Non‑Preferred Product Exception Criteria is considered not medically necessary. The program is designed to encourage use of Preferred Products and directs patients to meet the standard Somatostatin Analogs - Octreotide Immediate‑Release Products Prior Authorization Policy criteria and to try a Preferred Product before a Non‑Preferred Product will be approved; exceptions are only granted when the specific non‑preferred product exception criteria are satisfied.

Requests for non‑preferred products that do not meet the specified exception criteria are considered not medically necessary. For all medications (Preferred and Non‑Preferred), patients must meet the standard Somatostatin Analogs - Octreotide Immediate‑Release Products Prior Authorization Policy criteria and generally must trial a Preferred Product (generic octreotide) before a Non‑Preferred Product will be approved; only when the listed exception criteria are met will a non‑preferred product be authorized.

Provider Actions, Prior Authorization, and Administration

Billing Rule

Coding and claims

Claims submitted without covered diagnosis or procedure codes referenced in the applicable coverage policy will be denied as not covered. When billing, providers must use the most appropriate codes as of the date of service. Reimbursement is not allowed for services billed for conditions or diagnoses that are not covered under this coverage policy.

Use most appropriate CPT/HCPCS/ICD-10 codes as of the submission date
Claims missing covered diagnosis/procedure codes will be denied
Verify member's benefit plan for any plan-specific exclusions

Documentation Required

Product handling and administration

Proper training documentation for patient or caregiver self-administration is expected at the time of dispensing or prior to authorization when applicable. Follow storage and handling instructions for each product to ensure potency and patient safety.

Bynfezia Pen: Store refrigerated (36° to 46° F) prior to first use; after first use store at room temperature (68° to 77° F) with excursions 59° to 86° F; discard 28 days after first use
Sandostatin and Octreotide immediate‑release injection: For prolonged storage refrigerate (36° to 46° F); stable 14 days at room temperature (70° to 86° F) if protected from light; discard any unused portion after administration (multi‑use vial guidance: discard 14 days after first use where specified)
Document patient/caregiver training for self-administration in the medical record

Step Therapy

Preferred-first step requirement

Step therapy requires trying a Preferred Product prior to approval of a Non‑Preferred Product. If the patient meets the standard Somatostatin Analogs - Octreotide Immediate‑Release Products prior authorization criteria but has not tried a Preferred Product, approval for a Preferred Product will be authorized.

Preferred product(s): octreotide acetate immediate‑release injection (generic/formulary preferred)
Non‑Preferred examples: Bynfezia Pen, Sandostatin — exceptions require meeting exception criteria
Requests for non‑preferred products reviewed under exception criteria; approvals are for the duration noted in the policy

Prior Authorization

Prior authorization requirement

All medications (preferred and non‑preferred) require meeting the standard Somatostatin Analogs - Octreotide Immediate‑Release Products prior authorization policy criteria. Providers must follow the prior authorization process when requesting these agents; failure to meet PA or provide required documentation may result in denial.

Prior authorization required for all listed products (preferred and non‑preferred)
Non‑preferred product approvals require meeting exception criteria (see policy)
Approvals are typically authorized for 1 year when exception criteria are met

Initial Therapy Requirements

Initial Therapy Criteria

Preferred‑first initial therapy requirement; exception pathway to request a non‑preferred product when criteria are met.

Preferred-first: Patient should try one Preferred Product prior to approval of a Non‑Preferred Product; if standard prior authorization criteria are met but no Preferred Product trial has occurred, approval will be for a Preferred Product.

Preferred Products include generic octreotide acetate immediate‑release injection (listed as Preferred).

Step Therapy Requirements

Step	Requirement	Notes / Exceptions
1	Trial of a Preferred Product (generic octreotide acetate immediate‑release injection) is required prior to approval of a Non‑Preferred Product.	If standard Somatostatin Analogs - Octreotide Immediate‑Release Products prior authorization criteria are met but no Preferred Product trial has occurred, approval will be authorized for a Preferred Product.
Exception pathway	Non‑Preferred products (Bynfezia Pen or Sandostatin) may be approved for 1 year if BOTH: (A) patient meets the standard prior authorization criteria; AND (B) patient has tried generic octreotide acetate immediate‑release injection.	If criterion A is met but criterion B is not, approve generic octreotide acetate immediate‑release injection instead.

Definitions

Octreotide acetate immediate-release injection — Somatostatin analog

Drug classSomatostatin analog (octreotide acetate immediate‑release injection)

Primary indicationsAcromegaly: reduce growth hormone and IGF‑1 in adults with inadequate response to or unable to undergo surgery, pituitary irradiation, or bromocriptine at maximally tolerated doses.

Additional indicationsCarcinoid tumors: control severe diarrhea and flushing associated with metastatic carcinoid tumors.

Additional indicationsVasoactive intestinal peptide (VIP) tumors: manage profuse watery diarrhea associated with VIP‑secreting tumors.

Formulations notedAvailable as Bynfezia Pen (2.8 mL prefilled pen, 2,500 mcg/mL), Sandostatin (multiple ampule strengths), and generic octreotide immediate‑release injection.

Background

Octreotide acetate immediate‑release injections are somatostatin analogs indicated to reduce growth hormone and insulin‑like growth factor‑1 in acromegaly when other treatments are inadequate, and to manage severe diarrhea and flushing associated with metastatic carcinoid tumors and profuse watery diarrhea from VIPomas. Product formulations, available dose strengths, administration routes (subcutaneous or intravenous), and storage/handling instructions vary by manufacturer; specific product information should be followed for dosing, refrigeration or room‑temperature storage, and discard intervals.

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