CurrentEmblemHealthPolicy MG.MM.PH.165

Somatuline Depot (lanreotide) and lanreotide Injection

Policy governs medical necessity and coverage criteria for Somatuline Depot (lanreotide) and lanreotide injection for adults, including indications, dosing limits, prior authorization and renewal requirements for EmblemHealth members.

Policy Summary

PayerEmblemHealth

PolicySomatuline Depot (lanreotide) and lanreotide Injection

Policy CodePolicy MG.MM.PH.165

Change TypeStep therapy addedacromegaly combination use clarified

Effective DateN/A

Next Review DateFeb 14, 2025

Key ActionSubmit clinical evidence showing the member meets criteria when requesting prior authorization.

SourceLink

POLICY UPDATE CHANGES

All indications except Carcinoid syndrome are required to step through generic lanreotide.

Acromegaly initial criteria now specify Somatuline will not be used in combination with oral octreotide.

12 monthsLength of authorization

120Max billable units/28d

>=18Min age for initial approval

J1930, J1932Applicable HCPCS

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Initial Therapy

Covered when ALL general conditions are met AND criteria for one diagnosis branch (A, B, or C) are satisfied

General initial requirements

Diagnosis branch: Select one diagnosis branch: A. Acromegaly OR B. Carcinoid Syndrome OR C. Neuroendocrine tumor
Meet all required subcriteria for the selected branch

A. Acromegaly requirements: i. Diagnosis confirmed by elevated (age-adjusted) or equivocal serum IGF-1; AND ii. Inadequate suppression of GH after a glucose load; AND iii. Prior treatment/assessment of inadequate response to surgery and/or radiotherapy OR surgery and/or radiotherapy is not an option; AND iv. Baseline GH and IGF-I blood levels (renewal will require reporting of current levels); AND v. Tumor visualized on imaging (MRI or CT); AND vi. Will not be used in combination with oral octreotide; AND vii. Patient has tried and failed, or has a contraindication to, generic lanreotide

All subcriteria i-vii must be met for acromegaly

B. Carcinoid Syndrome requirements: i. To reduce the frequency of short-acting somatostatin analog rescue therapy; OR ii. Treatment and/or control of symptoms

Either i or ii suffices for Carcinoid syndrome

C. Neuroendocrine tumor requirements: Pathway 1 (GEP-NET non-functioning): i.a Disease is unresectable, locally advanced or metastatic; AND i.b Disease is a non-functioning tumor without hormone-related symptoms; AND i.c Disease is well or moderately differentiated; OR Pathway 2 (tumor-specific/symptom control): ii.a Treatment of unresectable primary gastrinoma; OR ii.b Treatment of symptoms related to hormone hypersecretion and/or Carcinoid syndrome; OR ii.c Tumor control in individuals with unresectable and/or metastatic disease; AND iii. Patient has tried and failed, or has a contraindication to, generic lanreotide

Either the GEP-NET non-functioning pathway (i.a-i.c) OR one of the tumor-specific options (ii.a-ii.c) plus the step-through requirement iii must be met

Continuation/Renewal Therapy

Renewal covered when ALL of the following are met

Renewal requirements: 1. Patient continues to meet INITIAL APPROVAL CRITERIA; 2. Absence of unacceptable toxicity including gallstones, cardiovascular abnormalities (bradycardia, sinus bradycardia, and hypertension), uncontrolled blood glucose abnormalities (hyperglycemia or hypoglycemia) or thyroid disorders (hypothyroidism); 3. Improved disease response in the above indications

All three conditions required for renewal

For acromegaly approvals, Somatuline Depot (lanreotide) must not be used in combination with oral octreotide. This prohibition is an explicit coverage requirement; requests indicating concurrent use with oral octreotide for acromegaly do not meet the policy’s diagnosis-specific initial criteria and will be considered non-compliant with coverage conditions.

For most indications covered by this policy (including acromegaly and neuroendocrine tumors), the patient must have tried and failed, or have a documented contraindication to, generic lanreotide prior to approval of Somatuline Depot. Failure to document a prior trial of generic lanreotide (or a medical contraindication) for non-Carcinoid indications constitutes a lack of required step therapy and means the request does not meet the policy’s criteria for medical necessity.

Coding and Billing Information

Applicable Procedure CodesHCPCSCovered

J1930	Injection, somatuline depot, 1 mg, 1 billable unit = 1 mg (Somatuline Depot)
J1932	Injection, lanreotide, (cipla), 1 mg

Applicable NDCsNDC

15054-1120-xx	Somatuline Depot single use subcutaneous solution
15054-1090-xx	Somatuline Depot 90 mg/0.3 mL prefilled syringe
15054-1060-xx	Somatuline Depot 60 mg/0.2 mL prefilled syringe
69097-0870-67	Lanreotide Acetate 120mg/0.5mL Solution
69097-0890-xx	Lanreotide Depot 90 mg/0.3 mL prefilled syringe
69097-0880-xx	Lanreotide Depot 60 mg/0.2 mL prefilled syringe

ICD-10 Diagnoses (selected examples)ICD-10

E22.0	Acromegaly and pituitary gigantism
E34.0	Carcinoid syndrome
C7A	Malignant neuroendocrine tumors
D35.2	Benign neoplasm of pituitary gland

inv-08: Max billable units per 28 days

Maximum billable units120 billable units per 28 days

Prior Authorization, Documentation, and Step Therapy

Prior Authorization

Prior Authorization Required

Prior authorization is required for Somatuline Depot/lanreotide. Initial approval requires the patient to be >= 18 years of age and to have not used a long-acting octreotide or lanreotide product within the last 4 weeks. The treating clinician must submit documentation demonstrating the patient meets the applicable medical necessity criteria (diagnosis-specific criteria such as acromegaly or neuroendocrine tumor) for preauthorization review.

Initial approval age requirement: >= 18 years
No long-acting octreotide/lanreotide within prior 4 weeks
Diagnosis-specific medical necessity criteria must be met

Step Therapy

Generic lanreotide Step Requirement

For all indications except Carcinoid syndrome, members must trial generic lanreotide (e.g., biosimilar/generic formulations) and demonstrate inadequate response or intolerance before Somatuline Depot (brand) will be authorized.

Step therapy requirement applies to all indications except Carcinoid syndrome
Documentation of trial and failure or contraindication to generic lanreotide is required

Documentation Required

Documentation Submission Required

The treating physician or primary care provider must submit clinical evidence to EmblemHealth to support the preauthorization request. Without submission of the required clinical documentation (diagnostic test results, prior treatments, rationale for contraindications or intolerance, current labs/imaging as indicated), EmblemHealth may be unable to complete review and the request may be denied.

Submit baseline and current lab/imaging results when requested (e.g., GH and IGF-1 levels for acromegaly)
Provide documentation of prior therapies tried and reasons for discontinuation (including trial of generic lanreotide when applicable)
Lack of submitted clinical evidence may prevent review and result in denial

OpenPayer

Somatuline Depot (lanreotide) and lanreotide Injection

Coverage Criteria for Somatuline Depot (lanreotide)

Coding and Billing Information

Prior Authorization, Documentation, and Step Therapy

Background

Definitions