Pharmacy Prior Authorization Criteria

Somatuline Depot (lanreotide)

Indications for Prior Authorization

Somatuline Depot (lanreotide)

• For diagnosis of 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.

• For diagnosis of 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.

• For diagnosis of Carcinoid Syndrome
  Indicated for the treatment of adults with carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analog rescue therapy.

Lanreotide Injection

• For diagnosis of 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.

• For diagnosis of 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.

• For diagnosis of Carcinoid Syndrome [3]
  Indicated for the treatment of adults with carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analog rescue therapy.

Criteria

Brand Somatuline Depot, Generic lanreotide

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Acromegaly

• Diagnosis of acromegaly
AND
• One of the following:
• Inadequate response to one of the following:
• Surgery
• Radiotherapy
OR
• Not a candidate for one of the following:
• Surgery
• Radiotherapy
AND
• Prescribed by or in consultation with an endocrinologist
AND
• Trial and intolerance to generic lanreotide (Applies to Brand Somatuline Depot 120 mg only)

Brand Somatuline Depot, Generic lanreotide

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
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
AND
• Trial and intolerance to generic lanreotide (Applies to Brand Somatuline Depot 120 mg only)

Brand Somatuline Depot 120mg/0.5mL, Generic lanreotide 120mg/0.5ml

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
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
• Trial and intolerance to generic lanreotide (Applies to Brand Somatuline Depot 120 mg only)

Brand Somatuline Depot 120mg/0.5mL, Generic lanreotide 120mg/0.5ml

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NET)

• Patient does not show evidence of progressive disease while on therapy
AND
• Trial and intolerance to generic lanreotide (Applies to Brand Somatuline Depot 120 mg only)

Brand Somatuline Depot 120mg/0.5mL, Generic lanreotide 120mg/0.5ml [off-label]

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
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 one of the following:
• Endocrinologist
• Oncologist
AND
• Trial and intolerance to generic lanreotide (Applies to Brand Somatuline Depot 120 mg only)

Brand Somatuline Depot 120mg/0.5mL, Generic lanreotide 120mg/0.5ml [off-label]

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Carcinoid Syndrome

• Patient demonstrates positive clinical response to therapy
AND
• Trial and intolerance to generic lanreotide (Applies to Brand Somatuline Depot 120 mg only)

P & T Revisions

2025-02-05, 2024-10-18, 2024-07-02, 2023-12-20, 2023-10-20, 2023-10-19, 2022-10-20, 2022-07-27, 2022-07-22, 2022-03-02, 2021-09-27, 2021-05-26, 2021-05-25, 2020-09-30, 2019-10-04

References

1. Somatuline Depot Prescribing Information. Ipsen Biopharmaceuticals, Inc. Cambridge, MA. July 2024.
2. Lanreotide Injection Prescribing Information. Cipla USA Inc. Warren, NJ. July 2024.

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Revision History

• 2025-02-05: Addition of T/F requirement
• 2024-10-18: 2024 annual review: removed prescriber requirement for GEP-NET indication. Background updates.
• 2024-07-02: Product name update and removal of NF criteria
• 2023-12-20: Program update to standard reauthorization language. No changes to clinical intent.
• 2023-10-20: Program update to standard reauthorization language. No changes to clinical intent.
• 2023-10-19: Annual review: no criteria changes.
• 2022-10-20: Annual review: no criteria changes.
• 2022-07-27: Addition of NF criteria and t/f criteria
• 2022-07-22: Addition of NF criteria
• 2022-03-02: Added new Lanreotide product to the program. Added specialist requirement for acromegaly and carcinoid syndrome.
• 2021-09-27: Annual Review
• 2021-05-26: Addition of EHB formulary to guideline, no changes to criteria
• 2021-05-25: Addition of EHB formulary to guideline, no changes to criteria
• 2020-09-30: Annual Review: removed drug name from reauth
• 2019-10-04: 2019 Annual Review, no changes to criteria.

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