CurrentCignaPolicy IP0323

Lanreotide Products

Coverage policy for lanreotide injection products (Somatuline Depot and Cipla lanreotide) for Cigna-administered health benefit plans, describing indications, medical necessity criteria, dosing, and product-specific step/step-through rules.

Policy Summary

PayerCigna

PolicyLanreotide Products

Policy CodePolicy IP0323

Change TypeMaterial revision (clinical/operational updates)

Effective DateApr 15, 2025

Next Review DateFeb 15, 2025

Key ActionObtain prior authorization with required documentation—include baseline IGF-1 for acromegaly and demonstrate prior trial of Somatuline Depot or lanreotide acetate for step-through cases when applicable.

SourceLink

POLICY UPDATE CHANGES

Removed documentation option of growth hormone suppression testing for acromegaly.

Updated preferred product step-through language to require Somatuline Depot or lanreotide acetate (Cipla J1930/NDC 69097-0906-67) before coverage of Cipla J1932 product for certain plans.

Removed TSH-secreting pituitary adenoma from the policy.

Added oncology FDA-approved indications: carcinoid syndrome and gastrointestinal/lung/thymus/pancreatic NETs with corresponding criteria and dosing.

Added supportive-evidence indication for pheochromocytoma and paraganglioma.

120 mgmaximum dose per administration

1 yearinitial approval duration

J1930, J1932applicable HCPCS codes

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Coverage Criteria

Initial Therapy — Acromegaly

Covered when ALL of the following are met for Acromegaly (approve for 1 year):

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). B) Patient has a pre-treatment (baseline) insulin-like growth factor‑1 (IGF‑1) level above the upper limit of normal for age and gender for the reporting laboratory. C) The medication is prescribed by or in consultation with an endocrinologist. D) Preferred product criteria is met for the product(s) as listed in the below table(s).

Dosing: approve up to 120 mg administered subcutaneously no more frequently than once every 4 weeks; approval duration 1 year.

Initial Therapy — Carcinoid Syndrome

Covered when ALL of the following are met for Carcinoid Syndrome (approve for 1 year):

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

Dosing: approve up to 120 mg administered subcutaneously no more frequently than once every 4 weeks; approval duration 1 year.

Initial Therapy — Neuroendocrine Tumors (NETs)

Covered when ALL of the following are met for Gastrointestinal/Lung/Thymus/Pancreatic NETs (approve for 1 year):

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

Dosing: approve up to 120 mg administered subcutaneously no more frequently than once every 4 weeks; approval duration 1 year.

Initial Therapy — Pheochromocytoma and Paraganglioma (supportive evidence)

Covered when ALL of the following are met for Pheochromocytoma and Paraganglioma (approve for 1 year):

Pheochromocytoma/paraganglioma criteria: A) The medication is prescribed by or in consultation with an endocrinologist, oncologist, or neurologist. B) Preferred product criteria is met for the product(s) as listed in the below table(s).

Dosing: approve up to 120 mg administered subcutaneously no more frequently than once every 4 weeks; approval duration 1 year.

Any other use of lanreotide injection products not explicitly described in this policy is considered experimental, investigational, or unproven.

Uses not included in the indications and criteria outlined in this policy are considered not medically necessary or experimental. The policy will be updated as new published data become available.

Coding and Billing

Covered HCPCS CodesHCPCSCovered

J1930	Injection, lanreotide, 1 mg.
J1932	Injection, lanreotide, (Cipla), 1 mg

inv-08: Maximum dose frequency

Maximum dose and frequency120 mg administered subcutaneously no more frequently than once every 4 weeks.

Approval duration when criteria metApprove for 1 year for covered indications (acromegaly, carcinoid syndrome, NETs).

Applies toAll lanreotide products referenced in this policy (e.g., Somatuline Depot and Cipla lanreotide).

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for lanreotide products. Approvals are criteria-based and limited to the FDA-approved and evidence-supported indications listed in the policy. Dosing limits apply (approve up to 120 mg subcutaneously no more frequently than once every 4 weeks).

Prior authorization required for listed indications.
Dose limit: up to 120 mg subcutaneously every 4 weeks.

Step Therapy

Product Step Therapy and Exceptions

Employer and Individual/Family Plans: product-specific step therapy applies for the Cipla lanreotide J1932 product — members must have tried Somatuline Depot or lanreotide acetate (Cipla J1930 / NDC 69097-0906-67) prior to coverage of the J1932 product, unless there is an exception. Exceptions include documented inability to use the preferred medication due to a formulation difference in inactive ingredients that, per the prescriber, would cause a significant allergy or serious adverse reaction.

Employer Plans: step-through requires trial of Somatuline Depot or lanreotide acetate (Cipla J1930 or NDC 69097-0906-67) before J1932.

Initial Therapy — Authorization Requirements

Initial Therapy

Initial authorization requirements

Initial therapy nodes: See indication-specific coverage criteria for required elements. Prescriber specialty requirements apply per indication (e.g., endocrinologist for acromegaly; oncologist/endocrinologist/gastroenterologist for carcinoid syndrome and NETs; endocrinologist/oncologist/neurologist for pheochromocytoma/paraganglioma). For acromegaly, a pre-treatment (baseline) IGF‑1 above the upper limit of normal for the reporting laboratory is required. Preferred product criteria and any applicable step-through rules must be met.

Dosing limited to 120 mg administered subcutaneously no more frequently than once every 4 weeks; approvals issued for up to 1 year when criteria are met.

Continuation Therapy — Renewal Requirements

Continuation Therapy

Continuation/renewal approvals

Continuation therapy: Continuation typically follows the same requirements as the initial approval, including prescriber specialty and, for acromegaly, monitoring as clinically indicated. Dosing limit remains 120 mg administered subcutaneously no more frequently than once every 4 weeks.

Approvals for continuation are granted for up to 1 year when criteria continue to be met; clinical monitoring and documentation per prescriber discretion and plan terms.

Step Therapy and Product Sequencing

Plan Type	Step Therapy Requirement	Exception / Documentation Required
Employer Plans	Patient must have tried Somatuline Depot or lanreotide acetate (Cipla J1930/NDC 69097-0906-67) prior to coverage of Cipla lanreotide (J1932)	Documentation that the patient cannot continue the preferred medication due to a formulation difference in inactive ingredients (e.g., stabilizing agent, buffering agent, surfactant) that, per the prescriber, would cause a significant allergy or serious adverse reaction
Individual/Family Plans	Patient must have tried Somatuline Depot or lanreotide acetate (Cipla J1930/NDC 69097-0906-67) prior to coverage of Cipla lanreotide (J1932)	Documentation that the patient cannot continue the preferred medication due to a formulation difference in inactive ingredients (e.g., stabilizing agent, buffering agent, surfactant) that, per the prescriber, would cause a significant allergy or serious adverse reaction

Quantity Limits

inv-20: lanreotide (any product) — quantity limit 120 mg

Quantity limit per administration120 mg (per administration).

Frequency limitNo more frequently than once every 4 weeks (monthly).

Per periodLimit expressed as 120 mg per month when dosed every 4 weeks.

Site of Care

Note

Site‑of‑care must be clinically appropriate

Site of care (including office administration) should be reasonable and clinically appropriate and supported by evidence; the policy does not mandate a specific site‑of‑care restriction.

Background

Lanreotide is a long‑acting somatostatin analog indicated in this policy to: reduce growth hormone and IGF‑1 in acromegaly, control symptoms of carcinoid syndrome, and treat unresectable or metastatic well‑ or moderately‑differentiated gastroenteropancreatic and other neuroendocrine tumors (NETs). Dosing in the policy is limited to 120 mg administered subcutaneously no more frequently than once every 4 weeks.

Definitions

inv-16: Baseline IGF-1 level prior to initiation of any somatostatin analog therapy — define pre-treatment IGF-1

DefinitionPre-treatment (baseline) insulin-like growth factor-1 (IGF-1) level measured prior to initiation of any somatostatin analog therapy.

Context for acromegalyRequired to be above the upper limit of normal for age and gender for the reporting laboratory as part of acromegaly coverage criteria.

Examples of somatostatin analogs to consider when defining pre-treatmentIncludes agents such as Mycapssa (octreotide delayed‑release), octreotide injection products, Signifor LAR, Somatuline Depot (lanreotide), and others listed in the policy note.