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Somatostatin Analogs

Brand Selection for Medically Necessary Indications for Commercial Medical Plans

Acromegaly Indications Only

As defined in Aetna commercial policies, health care services are not medically necessary when they are more costly than alternative services that are at least as likely to produce equivalent therapeutic or diagnostic results. Lanreotide acetate, Sandostatin LAR, Signifor LAR, and Somavert are more costly to Aetna than other somatostatin analogs for the treatment of acromegaly. Therefore, Aetna considers Lanreotide acetate, Sandostatin LAR, Signifor LAR, and Somavert to be medically necessary only for members who have a contraindication, intolerance or ineffective response to one of the available equivalent alternative somatostatin analogs for the treatment of acromegaly: octreotide acetate, Somatuline Depot.

Policy

Scope of Policy

This Clinical Policy Bulletin addresses somatostatin analogs for commercial medical plans. For Medicare criteria, see Medicare Part B Criteria.

Note: Requires Precertification:

Precertification of octreotide acetate (Sandostatin, Sandostatin LAR Depot), lanreotide (Somatuline or generic), pasireotide diaspartate (Signifor), and pasireotide pamoate (Signifor LAR) is required of all Aetna participating providers and members in applicable plan designs. For precertification of these products, call (866) 752-7021 or fax (888) 267-3277. For Statement of Medical Necessity (SMN) precertification forms, see Specialty Pharmacy Precertification.

Note: Site of Care Utilization Management Policy applies to octreotide acetate (Sandostatin LAR Depot) and lanreotide (Somatuline Depot, Lanreotide Injection). For information on site of service for these medications, see Utilization Management Policy on Site of Care for Specialty Drug Infusions.

Octreotide Acetate Injection (Sandostatin, Sandostatin LAR Depot, Generic Formulation)

Criteria for Initial Approval

Aetna considers octreotide acetate injection (Sandostatin, Sandostatin LAR Depot, or generic formulation) medically necessary for members with any of the following indications:

• Acromegaly - for treatment of acromegaly when both of the following criteria are met:
  • Member has a high pretreatment insulin-like growth factor-1 (IGF-1) level for age and/or gender based on the laboratory reference range; and
  • Member had an inadequate or partial response to surgery or radiotherapy or there is a clinical reason why the member has not had surgery or radiotherapy;
• Acquired immune deficiency syndrome (AIDS)-associated diarrhea-treatment of AIDS-associated severe secretory diarrhea when anti-microbial (e.g., ciprofloxacin or metronidazole) or anti-motility agents(e.g., loperamide or diphenoxylate and atropine) have become ineffective;
• Carcinoid syndrome treatment;
• Cancer-related diarrhea-for treatment when the member has Grade 3 or greater diarrhea according to National Cancer Institute(NCI) Common Terminology Criteria for Adverse Events (CTCAE);Footnote1*;
• Congenital hyperinsulinism (CHI)/persistent hyperinsulinemic hypoglycemia of infancy (octreotide and Sandostatin only)-treatment of CHI and persistent hyperinsulinemic hypoglycemia in an infant;
• Enterocutaneous fistulae-management of volume depletion from enterocutaneous fistulae;
• Gastroesophageal varices-treatment of acute bleeding of gastroesophageal varices associated with cirrhosis;
• Inoperable bowel obstruction in cancer-management of gastrointestinal (GI) symptoms (e.g., nausea, pain, vomiting) of inoperable bowel obstruction in members with cancer;
• Meningiomas - for treatment when used in combination with everolimus for surgically inaccessible recurrent or progressive disease;
• Neuroendocrine tumors(NETs)-for any of the following:
  • Treatment of NETs of the gastrointestinal (GI) tract, lung, and thymus (carcinoid tumors);
  • Treatment of NETs of the pancreas (islet cell tumors), including gastrinomas, glucagonomas, and insulinomas;
  • Treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs);
• Pancreatic fistulas-prevention and treatment of pancreatic fistulas following pancreatic surgery;
• Pheochromocytoma and paraganglioma treatment;
• Pituitary adenomas treatment;
• Short-bowel syndrome-treatment of short bowel syndrome when the daily intravenous fluid requirement is greater than 3 liters;
• Thymomas and thymic carcinomas treatment;
• Vasoactive intestinal peptide tumors (VIPomas)-for management of symptoms related to hormone hypersecretion of VIPomas;
• Zollinger-Ellison syndrome treatment.

Aetna considers octreotide experimental, investigational, or unproven for all other indications.

Continuation of Therapy

Aetna considers continuation of octreotide acetate injection therapy medically necessary for the following:

• Acromegaly-when the member's IGF-1 level has decreased or normalized since initiation of therapy; or
• NETs, Carcinoid syndrome, VIPomas, pheochromocytoma/paraganglioma, thymomas/thymic carcinomas, AIDS-associated diarrhea, bowel obstruction, cancer-related diarrhea, Zollinger-Ellison syndrome, and meningiomas - when the member is experiencing clinical benefit as evidenced by improvement or stabilization in clinical signs and symptoms since initiation of therapy; or
• All other indications- all members (including new members) must meet all initial authorization criteria.

Lanreotide Acetate Injection (Somatuline Depot, Lanreotide Injection)

Criteria for Initial Approval

Aetna considers lanreotide acetate injection (Somatuline Depot or Lanreotide Injection) medically necessary for the treatment of any of the following indications:

• Acromegaly - for the treatment of acromegaly when both of the following criteria are met:
  • Member has a high pretreatment insulin-like growth factor-1 (IGF-1) level for age and/or gender based on the laboratory reference range;and
  • Member had an inadequate or partial response to surgery or radiotherapy or there is a clinical reason why the member has not had surgery or radiotherapy;
• Carcinoid syndrome treatment;
• Neuroendocrine tumors (NETs)-considered medically necessary for any of the following:
  • Treatment of NETs of the gastrointestinal (GI) tract, lung and thymus (carcinoid tumors); or
  • Treatment of NETs of the pancreas (islet cell tumors), including gastrinomas, glucagonomas, insulinomas, and VIPomas; or
  • Treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs);
• Pheochromocytoma and paraganglioma treatment;
• Zollinger-Ellison syndrome treatment.

Aetna considers lanreotide acetate injection experimental, investigational, or unproven for all other indications.

Continuation of Therapy

Aetna considers continuation of lanreotide acetate injection (Somatuline Depot or Lanreotide Injection) therapy medically necessary for the following:

• Acromegaly-continuation of therapy for acromegaly when the member’s IGF-1 level has decreased or normalized since initiation of therapy;
• Carcinoid syndrome, NETs,pheochromocytoma/paraganglioma, and Zollinger-Ellison syndrome-when the member is experiencing clinical benefit as evidenced by improvement or stabilization in clinical signs and symptoms since starting therapy.

Pasireotide Diaspartate (Signifor)

Criteria for Initial Approval

Aetna considers pasireotide diaspartate solution for subcutaneous injection(Signifor) medically necessary for treatment of Cushing's disease in members who either have had surgery that was not curative or for members who are not candidates for surgery.

Aetna considers pasireotide diaspartate experimental, investigational, or unproven for all other indications.

Continuation of Therapy

Aetna considers continuation of pasireotide diaspartate (Signifor) therapy medically necessary for members with Cushing's disease who meet one of the following criteria:

• Lower cortisol levels since the start of therapy per one of the following tests:
  • Urinary free cortisol (UFC); or
  • Late-night salivary cortisol (LNSC); or
  • 1 mg overnight dexamethasone suppression test (DST); or
  • Longer, low dose DST (2 mg per day for 48 hours); or
• Improvement in signs or symptoms of the disease.

Pasireotide Pamoate (Signifor LAR)

Criteria for Initial Approval

Aetna considers pasireotide pamoate for intramuscular injection (Signifor LAR)medically necessary for the following indications:

• Acromegaly - treatment when both of the following criteria are met:
  • Member has a high pretreatment insulin-like growth factor-1 (IGF-1) level for age and/or gender based on the laboratory reference range; and
  • Member had an inadequate or partial response to surgery or there is a clinical reason why the member has not had surgery;
• Cushing’s disease-for treatment when the member has had surgery that was not curative or the member is not a candidate for surgery.

Aetna considers pasireotide pamoate experimental, investigational, or unproven for all other indications.

Continuation of Therapy

Aetna considers continuation of pasireotide pamoate for intramuscular injection (Signifor LAR) therapy medically necessary for the following:

• Acromegaly-when the member’s IGF-1 level has decreased or normalized since initiation of therapy;
• Cushing disease-for members that meet one of the following criteria:
  • Lower cortisol levels since the start of therapy per one of the following tests:
    • Urinary free cortisol (UFC); or
    • Late-night salivary cortisol (LNSC); or
    • 1 mg overnight dexamethasone suppression test (DST); or
    • Longer, low dose DST (2 mg per day for 48 hours); or
  • Improvement in signs and symptoms of the disease.

Note:Octreotide, pasireotide and lanreotide are not covered for constitutional (idiopathic) tall stature because such use is not considered treatment of disease.

Footnote1*The NCI definitions for diarrhea are, using a grading system: Grade 1: mild diarrhea, 2-3 stools above normal per day; Grade 2: mild to moderate: 4 to 6 stools above normal per day; Grade 3:moderate severe to severe: 7 or more stools above normal;and Grade 4 is severe:life-threatening consequences; urgent intervention indicated.

Related Policies

Note: see Pharmacy Clinical Policy Bulletin (PCPB), octreotide products 1734-A SGM, for Mycapssa (octreotide delayed-release capsule) and Bynfezia Pen (octreotide acetate subcutaneous injection).

See also:

• CPB 0168 - Tumor Scintigraphy-for OctreoScan
• CPB 0170 - Growth Hormone (GH) and Growth Hormone Antagonists-for Somavert (pegvisomant).

Dosage and Administration

Lanreotide Acetate Injection

Lanreotide acetate is available as Somatuline Depot or Lanreotide Injection supplied in single-dose prefilled syringes of 60 mg/0.2 mL, 90 mg/0.3 mL, and 120 mg/0.5 mL. Both products are labeled to be administered via deep subcutaneous injection by a healthcare provider.

• Lanreotide Injection
  • Acromegaly: 90 mg every 4 weeks for 3 months. Adjust thereafter based on GH and/or IGF-1 levels. See full prescribing information for titration regimen;
  • GEP-NETs: 120 mg every 4 weeks.
• Somatuline Depot
  • Acromegaly: 90 mg every 4 weeks for 3 months. Adjust thereafter based on GH and/or IGF-1 levels. See full prescribing information for titration regimen;
  • GEP-NETs: 120 mg every 4 weeks;
  • Carcinoid Syndrome: 120 mg every 4 weeks. If individual is already being treated with Somatuline Depot for GEP-NET, do not administer an additional dose for carcinoid syndrome.

Source: Cipla USA, 2023; Ipsen Biopharmaceuticals, 2023

Octreotide Acetate Injection

Sandostatin and generic formulation

Octreotide acetate injection is available as Sandostatin and supplied in 1 mL ampules containing:

• 50 mcg/mL
• 100 mcg/mL
• 500 mcg/mL

Octreotide acetate injection is also available in generic formulation and supplied in a 1 mL single dose syringe as follows:

• 50 mcg/mL
• 100 mcg/mL
• 500 mcg/mL

The FDA-approved labeling includes the following dosage and administration recommendations:

Octreotide acetate injection may be administered subcutaneously or intravenously. Pain with subcutaneous administration may be reduced by using the smallest volume that will deliver the desired dose. Sandostatin Injection may be diluted in volumes of 50 mL to 200 mL and infused intravenously over 15 to 30 minutes or administered by intravenous (IV) push over 3 minutes. In emergency situations (e.g., carcinoid crisis), it may be give