Octreotide Acetate (Bynfezia Pen, Mycapssa, Sandostatin, Sandostatin LAR Depot)

Octreotide Acetate (Bynfezia Pen™, Mycapssa®, Sandostatin®, Sandostatin® LAR Depot)

• Bynfezia Pen: Self-Administration - injectable
• Mycapssa: Self-Administration - oral
• Sandostatin/Octreotide: Self-Administration - injectable; Medical Administration - injectable
• Sandostatin LAR Depot: Medical Administration - injectable

Indications for Prior Authorization:

Sandostatin/Octreotide:

• Acromegaly: Indicated to reduce blood levels of growth hormone and IGF-1 (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. In patients with acromegaly, Sandostatin reduces growth hormone to within normal ranges in 50% of patients and reduces IGF-I (somatomedin C) to within normal ranges in 50%-60% of patients. Since the effects of pituitary irradiation may not become maximal for several years, adjunctive therapy with Sandostatin to reduce blood levels of growth hormone and IGF-I (somatomedin C) offers potential benefit before the effects of irradiation are manifested. Improvement in clinical signs and symptoms, or reduction in tumor size or rate of growth, were not shown in clinical trials performed with Sandostatin; these trials were not optimally designed to detect such effects.
• Carcinoid Tumors, for Symptomatic Treatment of Diarrhea or Flushing: Indicated for the symptomatic treatment of patients with metastatic carcinoid tumors where it suppresses or inhibits the severe diarrhea and flushing episodes associated with the disease. Sandostatin studies were not designed to show an effect on the size, rate of growth or development of metastases.
• Vasoactive Intestinal Peptide Tumors (VIPomas), for Symptomatic Treatment of Diarrhea: Indicated for the treatment of the profuse watery diarrhea associated with VIP-secreting tumors. Sandostatin studies were not designed to show an effect on the size, rate of growth or development of metastases.

Sandostatin LAR Depot:

• General: Indicated in patients in whom initial treatment with Sandostatin Injection has been shown to be effective and tolerated.
• Acromegaly: Indicated for long-term maintenance therapy in 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 GH and IGF-1 levels to normal.
• Carcinoid Tumors, for Symptomatic Treatment of Diarrhea or Flushing: Indicated for long-term treatment of the severe diarrhea and flushing episodes associated with metastatic carcinoid tumors. Limitation of Use: The effect of Sandostatin LAR on tumor size, rate of growth and development of metastases, has not been determined.
• Vasoactive Intestinal Peptide Tumors (VIPomas), for Symptomatic Treatment of Diarrhea: Indicated for long-term treatment of the profuse watery diarrhea associated with VIP-secreting tumors. Limitation of Use: The effect of Sandostatin LAR on tumor size, rate of growth and development of metastases, has not been determined.

Bynfezia:

• Acromegaly: Indicated for reduction of growth hormone (GH) and insulin-like growth factor 1 (IGF-1) [somatomedin C] in adult patients with acromegaly who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. Limitation of Use: In patients with acromegaly, the effect of Bynfezia Pen on improvement in clinical signs and symptoms, reduction in tumor size and rate of growth, has not been determined.
• Carcinoid Tumors, for Symptomatic Treatment of Diarrhea or Flushing: Indicated for treatment of severe diarrhea/flushing episodes associated with metastatic carcinoid tumors in adult patients. Limitation of Use: In patients with carcinoid syndrome, the effect of Bynfezia Pen on size, rate of growth and development of metastases, has not been determined. 
• Vasoactive Intestinal Peptide Tumors (VIPomas), for Symptomatic Treatment of Diarrhea: Indicated for treatment of profuse watery diarrhea associated with vasoactive intestinal peptide tumors (VIPomas) in adult patients. Limitation of Use: In patients with VIPomas, the effect of Bynfezia Pen on size, rate of growth and development of metastases, has not been determined.

Mycapssa:

• Acromegaly: Indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide.

Coverage Criteria:

For diagnosis of acromegaly:

For Sandostatin/Octretotide, Sandostatin LAR or Bynfezia:

• Dose does not exceed:
  • Bynfezia: initiate at 50 mcg three times a day (some patients may require up to 500 mcg three times a day), 
  • Sandostatin/Octreotide: initiate at 50 mcg three times a day (some patients may require up to 500 mcg three times a day),
  • Sandostatin LAR: 20 mg IM intragluteally at 4-week intervals for 3 months (after 3 months dosage may be adjusted based on growth hormone and IGF-1 levels. Dosages higher than 40 mg are not recommended), AND
• Prescribed by or in consultation with an endocrinologist, AND
• Patient is 18 years of age or older, AND
• Diagnosis of acromegaly confirmed by chart notes, AND
• One of the following:
  • Inadequate response to surgery OR pituitary irradiation
  • Not a candidate for surgical resection or pituitary irradiation, AND
• One of the following:
  • For Sandostatin LAR only: Patient has received short-acting generic octreotide for at least two weeks and responded to and tolerated therapy
  • For brand Sandostatin and Bynfezia only: Trial and failure, or intolerance to generic octreotide

For Mycapssa:

• Dose does not exceed initial dosing of 20 mg twice daily (maximum is 40 mg twice daily), AND
• Prescribed by or in consultation with an endocrinologist, AND
• Patient is 18 years of age or older, AND
• Diagnosis of acromegaly confirmed by chart notes, AND
• One of the following:
  • Inadequate response to surgery OR pituitary irradiation
  • Not a candidate for surgical resection or pituitary irradiation, AND
• Patient has responded to and tolerated treatment with generic octreotide or lanreotide.

For diagnosis of Carcinoid Tumors, for Symptomatic Treatment of Diarrhea or Flushing:

For Sandostatin/Octreotide, Sandostatin LAR or Bynfezia:

• Dose does not exceed 
  • Bynfezia: initiate at 100-600 mcg/day in 2-4 divided doses,
  • Sandostatin/Octretotide: initiate at 100-600 mcg/day in 2-4 divided doses,
  • Sandostatin LAR: 20 mg IM intragluteally at 4-week intervals for 2 months (after 2 months dosage may be adjusted based on symptoms.  Dosages higher than 30 mg are not recommended), AND
• Prescribed by or in consultation with an oncologist, AND
• Diagnosis of metastatic carcinoid tumor requiring symptomatic treatment of severe diarrhea or flushing episodes confirmed by chart notes, AND
• Patient is 18 years of age or older, AND
• One of the following:
  • For Sandostatin LAR only: Patient has received short-acting generic octreotide for at least two weeks and responded to and tolerated therapy
  • For brand Sandostatin and Bynfezia only: Trial and failure, or intolerance to generic octreotide

For diagnosis of Vasoactive Intestinal Peptide Tumors, for Symptomatic Treatment of Diarrhea:

For Sandostatin/Octreotide, Sandostatin LAR or Bynfezia:

• Dose does not exceed: 
  • Bynfezia: initiate at 200-300 mcg/day in 2-4 divided doses (range, 150 to 750 mcg),
  • Sandostatin/Octretotide: initiate at 200-300 mcg/day in 2-4 divided doses (range, 150 to 750 mcg),
  • Sandostatin LAR: 20 mg IM intragluteally at 4-week intervals for 2 months (after 2 months dosage may be adjusted based on symptoms.  Dosages higher than 30 mg are not recommended), AND
• Prescribed by or in consultation with an oncologist, AND
• Diagnosis of vasoactive intestinal peptide tumor requiring treatment of profuse watery diarrhea confirmed by chart notes, AND
• Patient is 18 years of age or older, AND
• One of the following:
  • For Sandostatin LAR only: Patient has had a trial of short-acting generic octreotide and responded to and tolerated therapy
  • For brand Sandostatin and Bynfezia only: Trial and failure, or intolerance to generic octreotide

Reauthorization Criteria:

For diagnosis of acromegaly:

For Sandostatin/Octreotide, Sandostatin LAR, Bynfezia or Mycapssa:

• Dose does not exceed: 
  • Bynfezia: 500 mcg three times a day, 
  • Sandostatin/Octreotide: 500 mcg three times a day,
  • Sandostatin LAR: 40 mg IM intragluteally at 4-week intervals
  • Mycapssa: 40 mg twice daily, AND
• Documentation of positive clinical response to therapy (e.g., reduction or normalization of IGF-1/GH level for same age and sex, reduction in tumor size)

For diagnosis of Carcinoid Tumors, for Symptomatic Treatment of Diarrhea or Flushing:

For Sandostatin/Octreotide, Sandostatin LAR or Bynfezia:

• Dose does not exceed:
  • Bynfezia: 1500 mcg daily in 2 to 4 divided doses
  • Sandostatin/Octreotide: 1500 mcg daily in 2 to 4 divided doses,
  • Sandostatin LAR: 30 mg IM intragluteally at 4-week intervals, AND
• Documentation of an improvement in the number of diarrhea or flushing episodes

For diagnosis of Vasoactive Intestinal Peptide Tumors, for Symptomatic Treatment of Diarrhea:

For Sandostatin/Octretotide, Sandostatin LAR or Bynfezia:

• Dose does not exceed:
  • Bynfezia: 750 mcg daily in 2 to 4 divided doses,
  • Sandostatin/Octreotide: 750 mcg daily in 2 to 4 divided doses,
  • Sandostatin LAR: 30 mg IM intragluteally at 4-week intervals, AND
• Documentation of an improvement in the number of diarrhea episodes

Coverage Duration:

• Initial: 1 year
• Reauthorization: 1 year

Authorization is not covered for the following:

The following conditions, and other uses of this drug for indications not listed in this policy, do not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics Committee:

• Cardiomyopathy
• Diarrhea-Graft vs. Host Disease
• Gastrointestinal Fistula
• Grave’s Disease
• Hypercalcemia
• Mccune-Albright Syndrome
• Mesenteric Angina
• Microsporidiosis
• Migraine Headache
• Neonatal Hypoglycemia
• Non-malignant intestinal obstruction
• Pancreatic Pseudocyst
• Peptic Ulcer Disease
• Postprandial Hypoglycemia
• Postprandial Hypotension
• Prolactinoma
• Quinine-Induced Hyperinsulinemia
• Retinal Edema
• Scintigraphy
• Scleroderma
• Tall Stature

Additional Information:

• Sandostatin LAR Depot should be administered by a trained healthcare provider. 
• Sandostatin LAR dosing:
  • Acromegaly:
    • Patients not currently receiving octreotide acetate should begin therapy with Sandostatin Injection given subcutaneously in an initial dose of 50 mcg three times daily which may be titrated. 
    • Patients currently receiving Sandostatin Injection can be switched directly to Sandostatin LAR DEPOT in a dose of 20 mg given IM intragluteally at 4-week intervals for 3 months. After 3 months, dosage may be adjusted as follows: 
      • GH ≤ 2.5 ng/mL, IGF-1 normal, and clinical symptoms controlled: maintain Sandostatin LAR DEPOT dosage at 20 mg every 4 weeks
      • GH > 2.5 ng/mL, IGF-1 elevated, and/or clinical symptoms uncontrolled, increase Sandostatin LAR DEPOT dosage to 30 mg every 4 weeks
      • GH ≤ 1 ng/mL, IGF-1 normal, and clinical symptoms controlled, reduce Sandostatin LAR DEPOT dosage to 10 mg every 4 weeks
      • If GH, IGF-1, or symptoms are not adequately controlled at a dose of 30 mg, the dose may be increased to 40 mg every 4 weeks. Doses higher than 40 mg are not recommended.
  • Carcinoid Tumors and VIPomas
    • Patients not currently receiving octreotide acetate should begin therapy with Sandostatin Injection given subcutaneously. The suggested daily dosage for carcinoid tumors during the first 2 weeks of therapy ranges from 100 to 600 mcg/day in 2 to 4 divided doses (mean daily dosage is 300 mcg). Some patients may require doses up to 1,500 mcg/day. The suggested daily dosage for VIPomas is 200 to 300 mcg in 2 to 4 divided doses (range, 150 to 750 mcg); dosage may be adjusted on an individual basis to control symptoms but usually doses above 450 mcg/day are not required.
    • Patients currently receiving Sandostatin Injection can be switched to Sandostatin LAR DEPOT in a dosage of 20 mg given IM intragluteally at 4-week intervals for 2 months.  Because of the need for serum octreotide to reach therapeutically effective levels following initial injection of SANDOSTATIN LAR DEPOT, carcinoid tumor and VIPoma patients should continue to receive Sandostatin Injection subcutaneously for at least 2 weeks in the same dosage they were taking before the switch. Failure to continue subcutaneous injections for this period may result in exacerbation of symptoms (some patients may require 3 or 4 weeks of such therapy).
    • Dosages higher than 30 mg are not recommended.
    • Despite good overall control of symptoms, patients with carcinoid tumors and VIPomas often experience periodic exacerbation of symptoms (regardless of whether they are being maintained on Sandostatin Injection or SANDOSTATIN LAR DEPOT). During these periods, they may be given Sandostatin Injection subcutaneously for a few days at the dosage they were receiving prior to switching to SANDOSTATIN LAR DEPOT. When symptoms are again controlled, the Sandostatin Injection subcutaneous can be discontinued.
• Off label indications include:
  • Control of diarrhea secondary to AIDS-associated enteropathy
  • The treatment of dumping syndrome
  • The treatment of short bowel syndrome
  • The treatment of enterocutaneous fistula
  • Reducing output from a pancreatic fistula
  • The treatment of variceal bleeding or nonvariceal upper GI bleeding
  • The treatment of hyperthyroidism secondary to thyrotropinoma
  • The treatment of hypoglycemia in patients with hyperinsulinism, including patients with benign or malignant insulinoma
  • The treatment of neurogenic orthostatic hypotension
  • The treatment of hepatorenal syndrome in combination with midodrine and albumin
  • The treatment of acute cluster headache
  • The treatment of sulfonylurea overdose
  • The treatment of hypothalamic obesity as a result of cranial injury
  • The treatment of secondary hypoglycemia due to congenital hyperinsulinemia (e.g., hyperinsulinemic hypoglycemia)
  • The treatment of chylothorax

Policy Updates:

• 12/02/2013 – New policy approved by P&T.
• 03/07/2022 – Sandostatin/Octretotide and Sandostatin LAR criteria updated.  Criteria created for Bynfezia and Mycapssa.

References:

1. Bynfezia prescribing information. Sun Pharmaceutical Industries Ltd. Gujarat, India. April 2020. 
2. Katznelson L, Atkinson JLD, Cook DM, et al. American association of clinical endocrinologists medical guidelines for clinical practice for the diagnosis and treatment of acromegaly – 2011 update. Endocr Pract. 2011;17(4):1-44.
3. Katznelson L, Laws ER Jr, Melmed S, et al. Acromegaly: an endocrine society clinical practice guideline. J Clin Endocrinol Metab. 2014;99(11):3933-3951. doi:10.1210/jc.2014-2700.
4. Mycapssa prescribing information. MW Encap Ltd. Scotland, UK. June 2020.
5. Sandostatin prescribing information. Novartis Pharmaceuticals Corporation. East Hanover, NJ. April 2019. 
6. Sandostatin LAR prescribing information. Novartis Pharmaceuticals Corporation. East Hanover, NJ. April 2019. 
7. Octreotide prescribing information. Fresenius Kabi USA, LLC. Lake Zurich, IL. May 2014.