Subject: Specialty Quantity Limit lanreotide injection-Somatuline Depot 1710-H P2024
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SOMATULINE DEPOT
(lanreotide acetate injection)
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LANREOTIDE INJECTION
(lanreotide acetate injection)
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Policy:
I. PROGRAM DESCRIPTION
The standard limit is designed to allow a quantity sufficient for the most common uses of the medication. If the member’s plan allows a quantity limit exception review for the requested medication, coverage of an additional quantity may be provided up to the exception limit with prior authorization.
II. COVERED QUANTITIES
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Medication
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Standard Limit
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Exception Limit*
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FDA-recommended dosing
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Somatuline (lanreotide) Depot Inj 60 mg/0.2 mL
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60 mg per 28 days
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Not Applicable
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Acromegaly:
• Recommended starting dose is 90 mg every 4 weeks for 3
months. Adjust thereafter based on GH, IGF-1 levels,
and/or clinical symptoms.
• Dose range is 60 mg to 120 mg every 4 weeks.
• Moderate and severe renal and hepatic impairment: Initial
dose is 60 mg every 4 weeks for 3 months. Adjust
thereafter based on GH, IGF-1 levels, and/or clinical
symptoms.
Gastroenteropancreatic neuroendocrine tumors (GEP-NETs)
and carcinoid syndrome:
• Recommended dose is 120 mg every 4 weeks.
Neuroendocrine tumors of the gastrointestinal tract, lung,
thymus, and pancreas
• Above label dosing after clinical, symptomatic or
radiographic progression on standard somatostatin analog
(SSA) doses: up to 120 mg every 14 days.
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Somatuline (lanreotide) Depot Inj 90 mg/0.3 mL
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90 mg per 28 days
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180 mg per 28 days
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Somatuline (lanreotide) Depot Inj 120 mg/0.5 mL
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120 mg per 28 days
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240 mg per 28 days
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Lanreotide Injection 60 mg/0.2 mL
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60 mg per 28 days
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Not Applicable
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Lanreotide Injection 90 mg/0.3 mL
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90 mg per 28 days
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180 mg per 28 days
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Lanreotide Injection 120 mg/0.5 mL
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120 mg per 28 days
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240 mg per 28 days
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* Coverage up to the exception limits may be provided with prior authorization via the Specialty Post Limit Quantity Exception Criteria for approval.
Place of Service:
Outpatient
The above policy is based on the following references:
- Somatuline Depot [package insert]. Cambridge, MA: Ipsen Biopharmaceuticals, Inc.; February 2023.
- Lanreotide Injection [package insert]. Warren, NJ: Cipla USA, Inc.; September 2023
- National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Neuroendocrine and Adrenal Tumors. Version 1.2023. https://www.nccn.org/professionals/physician_gls/pdf/neuroendocrine. pdf. Accessed November 13, 2023.
Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
April 17, 2024
