SOMATULINE DEPOT (lanreotide acetate)

SOMATULINE DEPOT (lanreotide acetate)

Office-Administration – subcutaneous (SC) injection

Diagnosis considered for coverage:

• Acromegaly: Indicated for the long-term treatment of acromegalic patients who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy is not an option. The goal of treatment in acromegaly is to reduce growth hormone (GH) and insulin growth factor-1 (IGF-1) levels to normal.
• Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs): Indicated for the treatment of adult patients with unresectable, well or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival.
• Carcinoid Syndrome: Indicated for the treatment of adults with carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analog rescue therapy.
  • Off Label Use for Lanreotide

Coverage Criteria:

For diagnosis of acromegaly:

• Diagnosis of acromegaly, AND
• Prescribed by or in consultation with an endocrinologist, AND
• Trial and failure or intolerance to Somatuline Depot (Applies to Brand Lanreotide only), AND
• One of the following: 
  • Inadequate response to one of the following:
    • Surgery
    • Radiotherapy
  • Not a candidate for one of the following:
    • Surgery
    • Radiotherapy

For diagnosis of advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NET): 

• Diagnosis of gastroenteropancreatic neuroendocrine tumor (GEP-NET), AND
• Disease is one of the following: 
  • Unresectable, locally advanced 
  • Metastatic, AND
• Prescribed by or in consultation with an oncologist, AND
• Trial and failure or intolerance to Somatuline Depot (Applies to Brand Lanreotide only) 

For diagnosis of carcinoid syndrome:

• Diagnosis of carcinoid syndrome, AND
• Used to reduce the frequency of short-acting somatostatin analog rescue therapy, AND
• Prescribed by or in consultation with an endocrinologist or oncologist, AND
• Trial and failure or intolerance to Somatuline Depot (Applies to Brand Lanreotide only)

Reauthorization Criteria:

For diagnosis of acromegaly:

• Patient demonstrates positive clinical response to therapy, such as a reduction or normalization of IGF-1/GH level for same age and sex 

For diagnosis of GEP-NET:

• Patient does not show evidence of progressive disease while on therapy

For diagnosis of carcinoid syndrome: 

• Patient demonstrates positive clinical response to therapy

Coverage Duration: 

• Initial: 12 months
• Reauthorization: 12 months

Dosing: 

For diagnosis of acromegaly:

• 90 mg every 4 weeks for 3 months. Adjust thereafter based on GH and/or IGF-1 levels as follows:
  • GH greater than 1 ng/mL to less than or equal to 2.5 ng/mL, IGF-1 normal, and clinical symptoms controlled: maintain dosage at 90 mg every 4 weeks
  • GH greater than 2.5 ng/mL, IGF-1 elevated, and/or clinical symptoms uncontrolled: increase dosage to 120 mg every 4 weeks
  • GH less than or equal to 1 ng/mL, IGF-1 normal, and clinical symptoms controlled: reduce dosage to 60 mg every 4 weeks
• Patients who are controlled on 60 or 90 mg may be considered for an extended dosing interval of 120 mg every 6 or 8 weeks

For diagnosis of GEP-NET:

• 120 mg every 4 weeks 

For diagnosis of carcinoid syndrome: 

• 120 mg every 4 weeks

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information: 

• If patients are already being treated with Somatuline Depot for GEP-NET, do not administer an additional dose for carcinoid syndrome.

Policy Updates:

• 09/01/2024 – New policy for Somatuline approved by WHA P&T Committee (P&T, 08/20/2024) 

References:

1. Somatuline Depot Prescribing Information. Ipsen Biopharmaceuticals, Inc. Cambridge, MA. February 2023. 
2. Lanreotide Injection Prescribing Information. Cipla USA Inc. Warren, NJ. December 2021. 
3. Lanreotide Acetate. In: IBM Micromedex® DRUGDEX® (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at: https://www.micromedexsolutions.com/. Accessed September 12, 2023.