ModifiedAmeriHealth Caritas VIP CarePolicy MA08.090h

Lanreotide (Somatuline Depot)

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This policy governs medical-benefit coverage and medical necessity criteria for deep subcutaneous lanreotide injections for Medicare Advantage members. Coverage applies when the member's Evidence of Coverage permits the benefit and the policy's condition-specific criteria are met.

Policy Summary

PayerAmeriHealth Caritas VIP Care

PolicyLanreotide (Somatuline Depot)

Policy CodePolicy MA08.090h

Change TypeModified

Effective DateDec 15, 2025

Next Review DateN/A

Key ActionDocument the diagnosis, disease extent and grade, treatment history, symptoms, tumor status, and required receptor status.

SourceLink

POLICY UPDATE CHANGES

Coverage positions for pheochromocytoma/paraganglioma and neuroendocrine tumors of the gastrointestinal tract, lung, thymus, and pancreas were updated in accordance with NCCN guidance.

All ICD-10-CM codes were removed from the policy because they are informational.

OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

ModifiedAmeriHealth Caritas VIP CarePolicy MA08.090h

Lanreotide (Somatuline Depot)

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Sign up for amerihealth_caritas_vip_care Policy MA08.090h alerts

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Policy Summary

PayerAmeriHealth Caritas VIP Care

PolicyLanreotide (Somatuline Depot)

Policy CodePolicy MA08.090h

Change TypeModified

Effective DateDec 15, 2025

Next Review DateN/A

Key ActionDocument the diagnosis, disease extent and grade, treatment history, symptoms, tumor status, and required receptor status.

SourceLink

POLICY UPDATE CHANGES

Coverage positions for pheochromocytoma/paraganglioma and neuroendocrine tumors of the gastrointestinal tract, lung, thymus, and pancreas were updated in accordance with NCCN guidance.

All ICD-10-CM codes were removed from the policy because they are informational.

NCCNCoverage updates based on

2FDA-approved indications

2HCPCS codes listed

Not coveredOther uses

Covered Indications and Limitations

Acromegaly

Covered when the individual has acromegaly and meets the applicable treatment-history or treatment-ineligibility requirement.

Prior or unavailable local therapy
- The individual has had an inadequate response to surgery and/or radiotherapy.
- Surgery and/or radiotherapy is not an option.

Gastroenteropancreatic neuroendocrine tumors

Covered for treatment of the following unresectable gastroenteropancreatic neuroendocrine tumor population to improve progression-free survival.

GEP-NET treatment

Disease characteristics: The tumor is unresectable, well- or moderately differentiated, and locally advanced or metastatic.

Gastrointestinal, lung, thymic, and carcinoid tumors

Covered for symptom and/or tumor control when one of the following gastrointestinal, lung, thymic, or carcinoid tumor scenarios applies.

GI, lung, thymic, or carcinoid indications

GI tract carcinoid disease: Recurrent, locoregionally advanced and/or distantly metastatic gastrointestinal tract disease, with treatment as a single agent or in combination as specified by disease burden, progression, resection status, symptoms, or NCCN-preferred therapy.
Recurrent or unresectable lung/thymic disease: Recurrent and/or locoregionally unresectable or distant metastatic lung/thymic disease that is somatostatin receptor positive and/or associated with hormonal symptoms, treated as first-line or subsequent therapy as specified.
DIPNECH symptom control: Multiple lung nodules or tumorlets with diffuse idiopathic pulmonary neuroendocrine cell hyperplasia and chronic cough or dyspnea not responsive to inhalers or conventional treatment; lanreotide is used as first-line therapy.

Well-differentiated grade 3 neuroendocrine tumors

Covered for treatment and/or tumor control of the following well-differentiated grade 3 neuroendocrine tumors.

Well-differentiated grade 3 neuroendocrine tumor

Receptor or hormonal status
- The tumor is somatostatin receptor positive.
- The tumor is associated with hormonal symptoms.
Favorable biology
- The tumor has relatively low Ki-67 (less than 55%).
- The disease is slow growing.

Pheochromocytoma, paraganglioma, and pancreatic tumors

Covered when one of the following pheochromocytoma, paraganglioma, or pancreatic neuroendocrine tumor indications applies.

Adrenal or pancreatic neuroendocrine tumor indications

Pheochromocytoma or paraganglioma: Secreting, locally unresectable disease or distant metastases requiring hormone-excess and symptom control; the disease is SSTR-positive when applicable.
Pancreatic well-differentiated grade 1/2 NET: Locoregional disease requiring symptom and/or tumor control with gastrinoma, insulinoma that expresses somatostatin receptors, glucagonoma, or VIPoma.
For insulinoma, SSTR-based imaging must be positive.
Advanced or metastatic pancreatic NET: Recurrent or locoregionally advanced and/or distant metastatic, SSTR-positive disease treated as an NCCN-preferred regimen, including single-agent use for asymptomatic low-burden stable disease, single-agent use for symptomatic or clinically significant disease or progression, or combination with alternative front-line therapy.

Experimental or investigational uses

Not covered as medically necessary under this policy unless the indication is supported as an accepted off-label use under the Company's policy on off-label coverage for prescription drugs and biologics.

Other uses: Any use of lanreotide not otherwise listed in the policy is considered experimental/investigational.

An accepted off-label use may qualify under the separate Company policy for off-label coverage of prescription drugs and biologics.

All other uses of lanreotide are considered experimental/investigational and are not covered under this policy unless the indication is supported as an accepted off-label use under the Company's policy for off-label coverage of prescription drugs and biologics.

For clinically significant disease progression, lanreotide should be discontinued for nonfunctional tumors. Treatment may be continued for functional tumors and may be combined with subsequent treatment options as described in the applicable NCCN guidance.

Initial Therapy

Initial therapy criteria

Initial therapy is covered when the individual has one of the following medically necessary conditions and meets the associated disease, receptor-status, treatment-history, symptom, tumor-burden, or progression requirements.

Covered initial indications

Acromegaly: There has been an inadequate response to surgery and/or radiotherapy, or surgery and/or radiotherapy is not an option.
GEP-NET: The disease is unresectable, well- or moderately differentiated, locally advanced or metastatic, and treatment is intended to improve progression-free survival.
Carcinoid or other GI/lung/thymic NET: The applicable recurrent, advanced, metastatic, symptomatic, receptor-positive, low-burden, clinically significant burden, progression, or first-line/subsequent therapy criterion is met.

Continuation and Subsequent Therapy

Continuation and subsequent therapy

Continuation or subsequent therapy is covered when the applicable disease remains within the policy criteria and the specified progression, symptom, receptor-status, or dosing conditions are met.

Continuation or subsequent therapy scenarios

GI tract progression: Use as a single agent after progression following specified resection or observation scenarios, or at above-label dosing after clinical, symptomatic, or radiographic progression when the disease is SSTR-positive.
Lung or thymic progression: Use as subsequent therapy or alternate first-line therapy after progression on first-line therapy when the stated receptor-status, grade, tumor-burden, progression, or symptom conditions are met.
Pancreatic NET progression: Use as subsequent therapy at above-label dosing after clinical, symptomatic, or radiographic progression on standard doses when the disease is SSTR-positive.

Billing and Clinical Coding

CPT Procedure Code Number(s)CPT

N/A

ICD-10 Procedure Code Number(s)ICD-10

N/A

ICD-10 Diagnosis Code Number(s)ICD-10

N/A

HCPCS Level II Code Number(s)HCPCS

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

Revenue Code Number(s)Revenue

N/A

Grade 3 neuroendocrine tumor Ki-67

Ki-67 threshold<55%

Clinical contextRelatively low Ki-67 is an example of favorable biology in well-differentiated grade 3 neuroendocrine tumors.

Treatment doseLanreotide is used at the standard dose for this indication.

Acromegaly study entry IGF-1

Study entry thresholdIGF-1 ≥1.3 times the upper limit of normal

Study duration48 weeks

Documentation and Coverage Responsibilities

Documentation Required

Medical Necessity Records

Maintain complete records demonstrating that lanreotide is medically necessary for the care provided. Records must be available to the Company upon request and may be reviewed or audited regardless of the provider's participation status.

Professional provider office records
Hospital, nursing home, and home health agency records
Therapy records and relevant test reports

Documentation Required

Condition-Specific Clinical Support

Submit condition-specific clinical documentation supporting the requested use of lanreotide, including the diagnosis, disease extent, grade or differentiation, treatment history, symptoms, and current tumor status.

Acromegaly: inadequate response to or inability to receive surgery and/or radiotherapy
Neuroendocrine or adrenal tumors: site, resectability, local or metastatic extent, grade/differentiation, biology, progression, and somatostatin receptor or hormonal status when applicable

Drug and Disease Context

Lanreotide is a long-acting somatostatin analogue administered by deep subcutaneous injection. It suppresses growth hormone and IGF-1 in acromegaly and provides antiproliferative and symptom-control effects in neuroendocrine tumors, including control of hormone-related symptoms such as flushing and diarrhea.

Clinical Terms

GEP-NETs

Full termGastroenteropancreatic neuroendocrine tumors

ResectabilityUnresectable

Disease characteristicsWell- or moderately differentiated, locally advanced, or metastatic tumors.

Carcinoid tumors

Anatomical sitesNeuroendocrine tumors of the gastrointestinal tract, lung, or thymus.

Differentiation and gradeGenerally well-differentiated grade 1/2.

Alternative termThese tumors may be referred to as carcinoid tumors.

Administration Setting

Billing Rule

Administer in the office setting

Administer lanreotide by deep subcutaneous injection in the office setting.

Policy Summary

PayerAmeriHealth Caritas VIP Care

PolicyLanreotide (Somatuline Depot)

Policy CodePolicy MA08.090h

Change TypeModified

Effective DateDec 15, 2025

Next Review DateN/A

Key ActionDocument the diagnosis, disease extent and grade, treatment history, symptoms, tumor status, and required receptor status.

SourceLink

On This Page

Carcinoid syndrome: Symptom control of carcinoid syndrome as a single agent, with telotristat for persistent diarrhea, or with other systemic therapy with or without telotristat for persistent flushing or diarrhea due to poorly controlled syndrome.

SSTR-based PET imaging is positive.

Subsequent therapy at above-label dosing after progression on standard doses is covered when the disease is SSTR-positive.

DIPNECH: Chronic cough or dyspnea associated with DIPNECH is not responsive to inhalers or conventional treatment.

Well-differentiated grade 3 NET: Unresectable locally advanced or metastatic disease has favorable biology and is SSTR-positive and/or associated with hormonal symptoms.Ki-67 less than 55% is an example of relatively low Ki-67.

Standard dose is specified.

Pheochromocytoma/paraganglioma: The disease is secreting, locally unresectable or distantly metastatic, requires hormone-excess and symptom control, and is SSTR-positive when applicable.

Pancreatic NET: The applicable gastrinoma, SSTR-positive insulinoma, glucagonoma, VIPoma, or advanced/metastatic pancreatic NET criterion is met.

Initial study regimenFour deep subcutaneous injections at 4-week intervals during the fixed-dose phase.

Acromegaly study response GH

Reported GH endpoint 1GH ≤2.5 ng/mL, with normal IGF-1 levels

Reported GH endpoint 2GH <1 ng/mL, with normal IGF-1 levels

Endpoint assessmentBoth endpoints were reported at completion of the 48-week trial.

Document relevant symptoms or hormone excess, tumor burden, functional status, and carcinoid syndrome or other symptom-control needs

Document prior surgery, radiotherapy, observation, systemic therapy, treatment response or progression, and the requested treatment line

For pancreatic tumors, document the specific indication and somatostatin receptor status when required, including for insulinoma

Denial Risk

Unlisted or Unsupported Use

Uses outside the medically necessary criteria in this policy are considered experimental/investigational and are not covered unless the indication is supported as an accepted off-label use under the Company's policy for off-label coverage of prescription drugs and biologics.

Verify that the requested indication is supported by the applicable policy criteria or accepted off-label coverage requirements before treatment.

Denial Risk

Insufficient Documentation

Failure to produce requested medical records or supporting documentation may result in denial of the drug. Ensure all documentation supporting medical necessity is retained and supplied promptly during Company reviews or audits.

Documentation must be available upon Company request.
The Company may review or audit services regardless of provider participation status.

Billing Rule

Benefit or Contract Limitation

Coverage is subject to the member's Evidence of Coverage, benefit terms, contract limitations and exclusions, applicable Medicare requirements, and this medical policy. Verify that the benefit exists and that no contract exclusion applies before relying on the medical-necessity criteria; individual benefits may vary.

Lanreotide is covered under the medical benefit only when the applicable medical-necessity criteria are met.
The Company may determine reimbursement based on the most appropriate and cost-effective setting consistent with the member's medical needs.
When Medicare coverage criteria do not address a service, Company-developed criteria may apply.

DIPNECH

Full termDiffuse idiopathic pulmonary neuroendocrine cell hyperplasia

Associated lung findingsMultiple lung nodules or tumorlets.

Policy symptom contextChronic cough or dyspnea not responsive to inhalers or conventional treatment.

SSTR-positive

MeaningSomatostatin receptor positive

Policy abbreviationSSTR-positive

Imaging-related expressionFor insulinoma, SSTR-based imaging must be positive.

Acromegaly

CauseExcess growth hormone produced by the pituitary gland.

Laboratory findingElevated insulin-like growth factor-1 (IGF-1).

Physical changesEnlargement of bones and thickening or enlargement of soft tissues.