ModifiedmhnPolicy CP.PHAR.391

Clinical Policy: Lanreotide (Somatuline Depot and Unbranded)

Defines medical necessity and prior authorization criteria for lanreotide (Somatuline Depot and unbranded) for acromegaly, carcinoid syndrome, and neuroendocrine tumors for members of Centene-affiliated health plans.

Policy Summary

Payermhn

PolicyClinical Policy: Lanreotide (Somatuline Depot and Unbranded)

Policy CodePolicy CP.PHAR.391

Change TypeStep therapy/redirection and guideline alignment

Effective Date08.14.18

Next Review Date

Key ActionPrior authorization required; member must try and fail generic octreotide acetate LAR (or Sandostatin LAR Depot if octreotide unavailable) before lanreotide unless an exception or state-specific bypass applies.

SourceLink

POLICY UPDATE CHANGES

Added redirection (step therapy) to octreotide acetate LAR (generic Sandostatin LAR Depot) for all indications and a member requirement to use generic lanreotide if available for Somatuline Depot requests.

Added Appendix E listing states with regulations against redirections in certain oncology settings (updated to include MS and IN).

For acromegaly, revised initial diagnostic criterion GH threshold formatting to '1 µg/L' as per practice guidelines.

Added HCPCS code J3490 and removed inactive HCPCS C9399.

120 mgmax dose q4w

≥18min age

12 moMedicaid/HIM approval

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6 moCommercial approval

Octreotide LARpreferred alternative

Coverage and Medical Necessity Criteria

Initial and Maintenance Therapy

Covered when ALL of the following are met (examples from dosing and general information):

Acromegaly initial therapy: Initial dosing: 90 mg SC every 4 weeks for 3 months; dose adjustments guided by reduction in serum GH or IGF‑I and clinical symptomsGH/IGF‑I monitoring

GH threshold guidance updated to 1 µg/L per professional society guidance

GEP‑NETs and carcinoid syndrome: Standard dosing: 120 mg SC every 4 weeks; do not administer an additional dose if treating both GEP‑NET and carcinoid syndrome; maximum routine dose 120 mg every 4 weeksmax 120 mg/4 weeks

SSTR positivity required for insulinoma and some lung NETs per NCCN

Non‑FDA approved indications not specifically listed in this policy are not authorized for coverage unless the provider submits sufficient clinical documentation demonstrating efficacy and safety consistent with the applicable off‑label use policies for the member's line of business (see CP.CPA.09 for commercial, HIM.PA.154 for marketplace, and CP.PMN.53 for Medicaid).

Lanreotide is contraindicated in patients with a known hypersensitivity to lanreotide. No boxed warnings are reported for lanreotide in this policy.

When used for insulinoma, lanreotide should be considered only if the tumor demonstrates somatostatin receptor (SSTR) expression; absence of SSTR expression renders lanreotide therapy inappropriate per the referenced guidance.

Initial Therapy Criteria and Dosing

Initial Therapy - top-level

Covered when ALL of the following are met:

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Initial dosing

Criteria for Continued Therapy

Continuation Criteria

Continued therapy general: Member currently receiving medication via Centene benefit or has previously met initial criteria; for carcinoid/NETs must have received medication for at least 30 days>=30 days for carcinoid/NETs

Generic lanreotide preferred for Somatuline Depot requests unless contraindicated

Maintenance / Continuation

Acromegaly maintenance: Maintenance 90–120 mg SC every 4 weeks; adjust based on GH/IGF‑I and symptomsmaintain within 120 mg/4 weeks

Discontinue for clinically significant progression in nonfunctional tumors; may continue for functional tumors

Provider Requirements, Documentation, and Step Therapy

Prior Authorization

Prior Authorization and Redirection Rules

Prior authorization is required. Requests for Somatuline Depot (lanreotide) or unbranded lanreotide may be redirected to octreotide acetate LAR (generic Sandostatin LAR Depot). If generic octreotide acetate LAR is unavailable due to shortage, requests may be redirected to brand Sandostatin LAR Depot. Members prescribed Somatuline Depot must use generic lanreotide if available unless contraindicated or a clinically significant adverse effect occurs.

Redirection to generic octreotide acetate LAR (Sandostatin LAR Depot) is implemented for all indications per policy update.
If generic octreotide acetate LAR is unavailable due to shortage, redirection to brand Sandostatin LAR Depot may occur.
Provider should document contraindications or clinically significant adverse effects to the redirected agent to avoid redirection.

Step Therapy

Step Therapy with Octreotide LAR

Step therapy requires failure of generic octreotide acetate LAR (generic Sandostatin LAR Depot) before approval of Somatuline Depot or unbranded lanreotide, unless octreotide acetate LAR is unavailable due to shortage. If unable to use generic octreotide acetate LAR due to shortage, trial of brand Sandostatin LAR Depot is required. For Illinois (HIM) requests, the step therapy requirement does not apply as of 1/1/2026 per IL HB 5395. Prior authorization may be required for octreotide acetate LAR and Sandostatin LAR Depot.

Step Therapy and Redirection Rules

Requirement	Details
Step therapy requirement	Member must try and fail preferred octreotide products before approval of lanreotide unless an exemption applies (failure of: generic octreotide acetate LAR [generic Sandostatin LAR Depot]; if octreotide unavailable due to shortage, Sandostatin LAR Depot). Exceptions include documented clinical adverse effects or contraindications and state-specific oncology step therapy prohibitions (see Appendix E). For Illinois HIM requests the step therapy requirement does not apply per IL HB 5395.
Product preference for Somatuline Depot	For Somatuline Depot requests, member must use generic lanreotide if available unless contraindicated or clinically significant adverse effects are experienced.
Dose limit related to step therapy	Dose requested must not exceed 120 mg every 4 weeks unless supported by practice guidelines or peer-reviewed literature for off‑label uses where applicable.

Redirection Rule	Action / Details
Redirect to octreotide acetate LAR	Requests may be redirected (step therapy) to octreotide acetate LAR (generic Sandostatin LAR Depot) prior to approval of lanreotide; if octreotide acetate LAR is unavailable due to shortage, redirection may be to brand Sandostatin LAR Depot.
Bypass / exemption conditions	Bypass of redirection is allowed for documented contraindication or clinically significant adverse effects to octreotide, during drug shortage when octreotide is unavailable, or when state regulations prohibit redirections in certain oncology settings (see Appendix E for listed states).
Documentation requirement	Providers must submit documentation supporting trial/failure or intolerance of the redirected agent or documentation supporting an applicable exemption (e.g., state oncology protection, shortage), otherwise request may be denied or redirected per policy.

Billing and Coding

HCPCS CodesHCPCS

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

Unclassified / miscellaneous HCPCSHCPCS

J3490

Unclassified drugs

Diagnostic threshold — Acromegaly

GH diagnostic threshold (acromegaly)1 µg/L

Quantity Limits and Product Information

Lanreotide (Somatuline Depot) — dosing & quantity limits

Maximum routine dose (every 4 weeks)120 mg

Available prefilled strengths60 mg, 90 mg, 120 mg syringes

Typical initial acromegaly dose90 mg SC every 4 weeks for 3 months

Quantity-limit / monthLimit: 120 mg per 4 weeks (per month)

Site of Care and Administration

Billing Rule

Office administration: prefilled single‑dose SC syringes

Somatuline Depot is supplied as single‑dose, prefilled subcutaneous syringes (60 mg, 90 mg, 120 mg); for office administration note the product is prefilled and intended for single‑dose SC use.

Available strengths: 60 mg/0.2 mL, 90 mg/0.3 mL, 120 mg/0.5 mL.
Site of care guidance is limited to noting prefilled single‑dose SC administration.

Abbreviations and Definitions

Abbreviations

SSTRsomatostatin receptor

GEPgastroenteropancreatic

IGF-Iinsulin-like growth factor I

NETneuroendocrine tumor

GEP — definition

GEPgastroenteropancreatic

ContextUsed in FDA indication: GEP‑NETs (gastroenteropancreatic neuroendocrine tumors)

Background and Clinical Context

Lanreotide is a long‑acting somatostatin analog used for chronic management of endocrine and neuroendocrine conditions. It is indicated for control of acromegaly in adults not adequately controlled by, or unsuitable for, surgery or radiotherapy and is used to reduce IGF‑I and serum GH concentrations and to improve tumor mass control. Lanreotide is also used for adults with unresectable or metastatic gastroenteropancreatic neuroendocrine tumors (GEP‑NETs) to improve progression‑free survival and for adults with carcinoid syndrome to reduce need for short‑acting rescue therapy.

Treatment requires specialist involvement (endocrinologist for acromegaly; oncologist for carcinoid syndrome and NETs), adherence to dosing limits (typically not exceeding 120 mg every 4 weeks for NETs/carcinoid and initial acromegaly dosing of 90 mg SC every 4 weeks for 3 months with maintenance adjustments), and appropriate documentation of biochemical response (GH/IGF‑I) and tumor characteristics. For certain tumor types (for example, insulinoma and some lung NETs), demonstration of SSTR positivity is required before lanreotide is considered.

Policy Revision History

2026-03-31Appendix E update

Added Indiana (IN) to Appendix E list of states with regulations prohibiting redirection/step therapy in certain oncology settings.

2025-12-04Redirection/Step therapy addedLatest

Per December SDC, redirection to octreotide acetate LAR (generic Sandostatin LAR Depot) was added for all indications; also added redirection to brand Sandostatin LAR Depot if generic octreotide is unavailable due to shortage, and requirement that members use generic lanreotide if available for Somatuline Depot requests.

2024-07-20Diagnostic criterion formatting revised

Policy Summary

Payermhn

PolicyClinical Policy: Lanreotide (Somatuline Depot and Unbranded)

Policy CodePolicy CP.PHAR.391

Change TypeStep therapy/redirection and guideline alignment

Effective Date08.14.18

Next Review Date

SourceLink

On This Page

Acromegaly initial: 90 mg SC every 4 weeks for 3 monthsGH/IGF‑I monitoring

Adjust to 90–120 mg for maintenance

GEP‑NETs / carcinoid syndrome initial: 120 mg SC every 4 weeks; if treating both GEP‑NET and carcinoid syndrome do not administer an additional dosemax 120 mg/4 weeks

Acromegaly: failure of both (a) generic octreotide acetate LAR and (b) Sandostatin LAR Depot (if generic unavailable) required unless contraindicated or adverse effects.
Carcinoid syndrome and NETs: failure of generic octreotide acetate LAR (and Sandostatin LAR Depot if generic unavailable) required unless clinically contraindicated; or meet state-specific exception (see Appendix E).
Dose limits remain per indication (generally ≤ 120 mg every 4 weeks unless supported by guidelines).

Prior Authorization

State-Specific Redirection Prohibitions

Some states prohibit redirection or step therapy for advanced/metastatic cancer or specific oncology settings. If the request is for treatment-associated cancer in a covered state and the state law prohibits step therapy/redirection, the step therapy requirement may be bypassed. Refer to Appendix E for state-specific prohibitions and notes and document the cancer stage and indication.

Appendix E lists states where step therapy/redirection is prohibited in certain oncology settings (examples: FL, GA, IA, IN, LA, MS, NV, OH, OK, PA, TN, TX).
When a prohibition applies (e.g., stage 4 metastatic cancer), do not require prior trial of octreotide acetate LAR for that oncology indication; include documentation of stage and treatment intent.

Documentation Required

Supportive and SSTR/Hormonal Documentation Required

Supporting clinical documentation must be submitted with the request. Failure to provide required information may result in delay or denial.

Include office notes, relevant lab results (e.g., pre-treatment IGF‑I, GH with oral glucose tolerance test for acromegaly), tumor imaging or pathology reports (for NETs), and prior therapy documentation showing trials of octreotide acetate LAR and/or Sandostatin LAR Depot when applicable.
For insulinoma or other NETs where lanreotide efficacy depends on somatostatin receptor status, submit SSTR imaging or pathology confirming SSTR-positivity or documentation of hormonal symptoms as required by indication.
Document consultation with appropriate specialist (endocrinologist for acromegaly; oncologist for carcinoid syndrome or NETs) and rationale if skipping step therapy (e.g., contraindication, adverse effects, shortage, or applicable state law).

Denial Risk

Documentation Submission and Denial Risk

Failure to submit required documentation (office notes, labs, imaging, prior trial records) may result in denial or delay of the authorization request. Providers should proactively include evidence of SSTR status, hormonal symptomatology, prior octreotide trials, and any state law applicability to expedite review.

For acromegaly: include pre-treatment IGF‑I and/or GH levels (OGTT) and imaging or operative reports supporting prior surgery/irradiation status.
For NETs: include SSTR PET imaging or pathology confirming SSTR positivity when applicable, or documentation of hormonal symptoms for thymic/lung/grade 3 NETs per criteria.
If claiming a state-level prohibition to step therapy/redirection, indicate the state and provide documentation of the cancer stage and relevant clinical details.

IGF‑I — definition

IGF‑Iinsulin-like growth factor

Clinical useMeasured for acromegaly diagnosis and monitoring (pre-treatment IGF‑I above lab‑specific ULN supportive of diagnosis)

SSTR — definition

SSTRsomatostatin receptor

Clinical relevanceSSTR positivity required for insulinoma and some lung NETs per NCCN guidance

Revised acromegaly GH diagnostic threshold formatting to '1 µg/L' to align with PS/ES practice guidelines and Acromegaly Consensus Group guidance.