Somatostatin Analogs – NC Standard

Restricted Product(s)

Restriction applies to brand and generic formulations

• Mycapssa® (octreotide) delayed-release capsules
• Sandostatin® (octreotide) 

FDA Approved Use

• Mycapssa
  • Long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide
• Sandostatin
  • Reduction in blood levels of growth hormone and IGF-I (somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. The goal is to achieve normalization of growth hormone and IGF-I (somatomedin C) levels. 
  • Symptomatic treatment of patients with metastatic carcinoid tumors where it suppresses or inhibits the severe diarrhea and flushing episodes associated with the disease. 
  • Treatment of the profuse watery diarrhea associated with VIP-secreting tumors

Criteria for approval of Restricted Product(s)

Initial Coverage Criteria

1. The patient has a diagnosis of Acromegaly; AND
   1. The use of the requested agent is for adjunctive therapy with irradiation to alleviate acromegaly symptoms; OR 
   2. The patient had an inadequate response to surgery or pituitary irradiation defined by ONE of the following documented parameters (medical record documentation required):
      1. Growth hormone level > 5 ng/mL; OR
      2. IGF-1 level > 1.9 U/mL for males or > 2.2 U/mL for females; OR
   3. Patient is not a candidate for surgical resection; AND
   4. The patient has tried and failed or has a contraindication to cabergoline; OR
2. The patient has a diagnosis of Carcinoid tumors, locally advanced/metastatic gastroenteropancreatic neuroendocrine tumor or poorly differentiated (high-grade)/large or small cell neuroendocrine tumor, pancreas islet cell neuroendocrine tumor, or vasoactive intestinal polypeptidoma; AND 
   1. ONE of the following:
      1. The patient will be using the medication for symptom control for carcinoid syndrome or hormone hypersecretion; OR
      2. The patient has had an inadequate response to or is not a candidate for surgical resection or radiation therapy; AND
3. If the requested agent is Mycapssa (octreotide DR capsules) or Brand Sandostatin, the patient has tried and failed or has a contraindication to generic octreotide injection; AND
4. If the requested agent is Mycapssa (octreotide DR capsules), the patient has been adequately controlled on and tolerated an octreotide or lanreotide injection; AND
5. The patient is being managed by or in consultation with a specialist in the area of the patient’s diagnosis (e.g., Endocrinologist, Gastroenterologist or Oncologist); AND
6. The prescribed dose and quantity are appropriate based on intended use and FDA labeling; AND
7. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Duration of Approval:  24 weeks (6 months) 

Continuation Coverage Criteria

1. The patient has been previously approved with Blue Cross and Blue Shield of North Carolina (Blue Cross NC) or would have met initial criteria for approval upon the start of therapy; AND
2. The patient has experienced clinical benefit since initiation of therapy as indicated by ONE of the following (medical record documentation required): 
   1. Growth hormone (GH) level < 5 ng/mL; OR
   2. IGF-1 level < 1.9 U/mL for a male or < 2.2 U/mL for a female: OR
   3. Clinical improvement in conditions related to the approved diagnosis:
      1. Reduction in tumor size; OR
      2. Decreased headaches; OR
      3. Improved cardiovascular symptoms; OR
      4. Improved respiratory symptom; OR
      5. Decreased severity and frequency of diarrhea and/or flushing symptoms; AND
3. If the requested agent is Mycapssa (octreotide DR capsules) or Brand Sandostatin, the patient has tried and failed or has a contraindication to generic octreotide injection; AND
4. If the requested agent is Mycapssa (octreotide DR capsules), the patient has been adequately controlled on and tolerated an octreotide or lanreotide injection; AND
5. The prescribed dose and quantity are appropriate based on intended use and FDA labeling; AND
6. The patient continues to be managed by or in consultation with a specialist in the area of the patient’s diagnosis (e.g., Endocrinologist, Gastroenterologist or Oncologist).
7. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Duration of Approval:  365 days (1 year)

Quantity Limitations

Quantity limitations apply to brand and associated generic products.

Quantity Limit Exception Criteria

1. The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90 day titration period); AND
2. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND
3. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR
4. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed).

Duration of Approval:  365 days (1 year)

References

All information referenced is from FDA package insert unless otherwise noted below.

1. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®¹) for Neuroendocrine Tumors V.1.2019. National Comprehensive Cancer Network, Inc. 2019. Accessed August 22, 2019
2. Katznelson L, Laws ER Jr, Melmed S, et al. Acromegaly: an endocrine society clinical practice guideline. J Clin Endocrinol Metab 2014; 99:3933.

Policy Implementation/Update Information

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q1 annually. 

September 2023: Criteria update: Removed Bynfezia from policy (no longer available).

July 2023: Criteria change:  Decreased the duration of approval for the continuation criteria to 365 days. Added duration of approval to quantity limit exception criteria. Added the patient is being managed by or in consultation with a specialist. Added the prescribed dose and quantity are appropriate based on intended use and FDA labeling.  Added the patient has experienced clinical benefit since initiation of therapy.

October 2020: Criteria change: Removed Sandostatin LAR and Somatuline Depot from policy (medical product). Added step through cabergoline for diagnosis of acromegaly. Added step through generic octreotide for Brand Sandostatin requests. Added quantity limits to Sandostatin and Bynfezia.

July 2020: Original utilization management criteria issued. Combined Bynfezia Pen™ - Sandostatin® & Somatuline® criteria. Retired both.