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Somatuline Depot - OpenPayer

v1.0.10

OpenPayerPolicy UpdatesEndocrinologySomatuline Depot

CurrentCommunity-CarePolicy N/A

Somatuline Depot

Defines medical necessity criteria, initial and continuation approval rules, dosing, quantity limits, authorization periods, applicable HCPCS code(s), and acromegaly dose-adjustment guidance for lanreotide depot (Somatuline) for acromegaly, gastroenteropancreatic neuroendocrine tumors (GEP-NETs), and carcinoid syndrome.

Policy Summary

PayerCommunity-Care

PolicySomatuline Depot

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionPrescriber must meet specialty requirements and document diagnosis and prior trial of octreotide LAR (or contraindication/intolerance) where required; authorization will be for specified quantities and durations.

SourceLink

POLICY UPDATE CHANGES

No material change to clinical or coverage policy

3Covered Indications

1Primary HCPCS code listed

1Prefilled syringe per 4 weeks (quantity limit)

Coverage Summary & Determination

Coverage for Somatuline Depot (lanreotide) is covered with criteria for acromegaly, gastroenteropancreatic neuroendocrine tumors (GEP-NETs), and carcinoid syndrome. Dosing and continuation decisions are guided by biochemical markers (GH/IGF-1), symptom control, and disease status. Authorization includes specified dosing schedules and quantity limits and requires documentation of specialty prescribing and prior trial of octreotide LAR when indicated.

I. Coverage Determination Criteria for Approval - Acromegaly

Covered when ALL of the following are met:

ALL of the following

Prescribed by, or in consultation with, an endocrinologist
Diagnosis of acromegaly
Surgery was ineffective or contraindicated
Trial of octreotide LAR (Sandostatin LAR Depot) was ineffective, contraindicated, or not tolerated

II. Coverage Determination Criteria for Initial Approval - Neuroendocrine tumors (GEP-NETs and NCCN-supported indications)

Covered when ALL of the following are met:

ALL of the following

Prescribed by, or in consultation with, an oncologist
ALL of the following
- ONE of
- ALL of the following
  - Is unresectable
  - Is well- or moderately-differentiated
  - Disease is one of
    Locally advanced
    Metastatic
- Any indication supported by a recommendation from the National Comprehensive Cancer Network (NCCN) of category 1, 2A, or 2B (diagnosis provided)
  NCCN category 1, 2A or 2B with diagnosis provided
Trial of octreotide LAR (Sandostatin LAR Depot) was ineffective, contraindicated, or not tolerated

II. Coverage Determination Criteria for Initial Approval - Carcinoid syndrome

Covered when ALL of the following are met:

ALL of the following

Prescribed by, or in consultation with, an oncologist, endocrinologist, or gastroenterologist
Diagnosis of carcinoid syndrome
Patient is experiencing one of the following
- Flushing
- Diarrhea
Trial of octreotide LAR (Sandostatin LAR Depot) was ineffective, contraindicated, or not tolerated

Continuation Therapy Criteria

III. Coverage Determination Criteria for Continuation of Therapy - Neuroendocrine tumors

Covered when ALL of the following are met:

ALL of the following

Member is being monitored
Member has not experienced disease progression
Member is appropriate to continue therapy with lanreotide depot (Somatuline)

III. Coverage Determination Criteria for Continuation of Therapy - Carcinoid syndrome

Covered when ALL of the following are met:

ALL of the following

Diagnosis of carcinoid syndrome
Decrease in severity of and occurrence of flushing and diarrhea
Member is being monitored and is appropriate to continue therapy with lanreotide depot (Somatuline)

Dosing & Thresholds

Acromegaly - initial dosing period90 mg every 4 weeks for 3 months

Acromegaly - maintenance adjustment rulesIf IGF-1 ≤1 and symptoms controlled → lanreotide 60 mg every 4 weeks; If IGF-1 ≥1 to ≤2.5 and symptoms controlled → maintain 90 mg every 4 weeks; If IGF-1 >2.5 and symptoms uncontrolled → lanreotide 120 mg every 4 weeks

GEP-NETs dosing120 mg every 4 weeks

Carcinoid syndrome dosing120 mg every 4 weeks

Prior Authorization, Documentation & Billing

Prior Authorization

Prior authorization required per coverage criteria

Prescriber must meet the specialty requirements in the coverage criteria and document the diagnosis. Prior authorization requires documentation of a prior trial of octreotide LAR (Sandostatin LAR Depot) that was ineffective, contraindicated, or not tolerated, unless otherwise specified. Include documentation of contraindication or intolerance when applicable.

J1930

Documentation Required

Specialist consultation documentation

Document specialty consultation per indication: for acromegaly, prescribed by or in consultation with an endocrinologist; for neuroendocrine tumors and carcinoid syndrome, prescribed by or in consultation with appropriate specialists (oncologist, endocrinologist, or gastroenterologist).

Billing Rule

Quantity limits

If approved, authorization is for up to 1 prefilled syringe every 4 weeks for the listed indications. Providers must bill using the applicable HCPCS code and adhere to the one-syringe-per-4-weeks frequency.

J1930 — up to 1 prefilled syringe every 4 weeks

Documentation Required

Continuation monitoring

For continuation of therapy, document ongoing monitoring and disease status: for neuroendocrine tumors, documentation that the member is being monitored and has not experienced disease progression; for carcinoid syndrome, documentation of decreased severity and occurrence of flushing and diarrhea and that the member is being monitored and appropriate to continue therapy.

Applicable Codes

Applicable HCPCSHCPCS

J1930

Clinical Background & Definitions

Somatuline Depot (lanreotide) is a long-acting somatostatin analog used to treat acromegaly, gastroenteropancreatic neuroendocrine tumors (GEP-NETs), and carcinoid syndrome. Recommended dosing in the policy: acromegaly initial: 90 mg every 4 weeks for 3 months with maintenance adjusted based on GH and/or IGF-1 levels (see dose-adjustment appendix); and GEP-NETs and carcinoid syndrome: 120 mg every 4 weeks. Continuation and monitoring decisions are driven by biochemical markers (GH/IGF-1), symptom control (for example reduction in flushing and diarrhea in carcinoid syndrome), and evidence of disease status or progression.

Octreotide LAR (Sandostatin LAR Depot): an alternative long-acting somatostatin analog; a prior trial of octreotide LAR is required for approval unless it was ineffective, contraindicated, or not tolerated.

NCCN categories: Category 1 = high-level evidence with uniform NCCN consensus; Category 2A = lower-level evidence with uniform NCCN consensus; Category 2B = lower-level evidence with NCCN consensus. A supporting NCCN recommendation must include the diagnosis.

Clinical Evidence

Placeholder: Populate pivotal trial, clinical trial, or guideline citations and summaries here if available in the source documentation. If no such evidence entries are present in the source, omit evidence population.

Revision History

2024-10-01ReviewLatest

Policy last reviewed

Policy Summary

PayerCommunity-Care

PolicySomatuline Depot

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionPrescriber must meet specialty requirements and document diagnosis and prior trial of octreotide LAR (or contraindication/intolerance) where required; authorization will be for specified quantities and durations.

SourceLink

On This Page

Coverage Summary & Determination Continuation Therapy Criteria Prior Authorization, Documentation & Billing Applicable Codes Clinical Background & Definitions Clinical Evidence Revision History