Last Review Date: 08/08/2023

Date of Origin: 06/21/2011

Dates Reviewed: 09/2011, 12/2011, 03/2012, 06/2012, 09/2012, 12/2012, 03/2013, 06/2013, 09/2013, 12/2013, 03/2014, 06/2014, 09/2014, 01/2015, 03/2015, 05/2015, 08/2015, 11/2015, 02/2016, 05/2016, 08/2016, 11/2016, 02/2017, 05/2017, 08/2017, 11/2017, 02/2018, 05/2018, 04/2019, 04/2020, 05/2020, 04/2021, 04/2022, 04/2023, 08/2023

1. Length of Authorization

Coverage is provided for 6 months and may be renewed.

2. Dosing Limits

A. Quantity Limit (max daily dose) [NDC Unit]:

• Sandostatin LAR Depot 10 mg single-use kit: 1 per 28 days
• Sandostatin LAR Depot 20 mg single-use kit: 2 per 28 days
• Sandostatin LAR Depot 30 mg single-use kit: 1 per 28 days

B. Max Units (per dose and over time) [HCPCS Unit]:

• Acromegaly: 40 billable units every 28 days
• Carcinoid Tumors, Neuroendocrine Tumors, and VIPomas: 30 billable units every 28 days
• Thymomas: 20 billable units every 14 days

3. Initial Approval Criteria ^1,12,13

Coverage is provided in the following conditions:

• Patient is at least 18 years of age; AND

Carcinoid Tumors/Neuroendocrine Tumors (e.g., Gastrointestinal Tract, Lung, Thymus, Pancreas, Adrenal) † ^1,4,6,9

• Patient has severe diarrhea/flushing episodes (carcinoid syndrome) † Ф; OR
• Used as primary treatment for symptom and/or tumor control of unresected primary gastrinoma; OR
• Used for symptom and/or tumor control of bronchopulmonary or thymic disease; AND
  • Used for somatostatin receptor positive disease and/or hormonal symptoms; AND
  • Used in one of the following treatment settings:
    • Used as primary therapy; OR
    • Used as subsequent therapy (as alternate primary therapy) if progression on primary therapy; OR
    • Patient has disease progression with functional tumors and will be continuing treatment with octreotide LAR; AND
  • Patient has one of the following:
    • Recurrent and/or locoregional unresectable disease; OR
    • Recurrent and/or distant metastatic disease; AND
      • Patient is asymptomatic with low tumor burden and low grade (typical) histology (**Note: Only applies to use as primary therapy); OR
      • Patient has clinically significant tumor burden and low grade (typical carcinoid) histology; OR
      • Patient has evidence of disease progression; OR
      • Patient has intermediate grade (atypical carcinoid) histology; OR
      • Patient has symptomatic disease; OR
• Used for symptom and/or tumor control of multiple lung nodules or tumorlets and evidence of diffuse idiopathic pulmonary neuroendocrine cell hyperplasia (DIPNECH); AND
  • Used as primary therapy for somatostatin receptor positive disease and/or chronic cough/dyspnea that is not responsive to inhalers; OR
• Used for symptom and/or tumor control of recurrent, locoregional advanced and/or distant metastatic disease of the gastrointestinal tract; AND
  • Used as single agent if patient is asymptomatic with a low tumor burden; OR
  • Used as a single agent or in combination with alternative front-line therapy if patient has a clinically significant tumor burden; OR
  • Used as a single agent for disease progression if not already receiving octreotide LAR; OR
  • Patient has disease progression with functional tumors and will be continuing treatment with octreotide LAR; OR
• Used for symptom and/or tumor control of somatostatin-receptor positive neuroendocrine tumors of the pancreas (well differentiated grade 1/2); AND
  • Patient has locoregional gastrinoma, insulinoma, glucagonoma, or VIPoma (**Note: Somatostatin-receptor positive disease ONLY applies to insulinoma); OR
  • Patient has recurrent or locoregional advanced and/or distant metastatic disease; AND
    • Used as a single agent if patient is asymptomatic with a low tumor burden and stable disease; OR
    • Patient is symptomatic; OR
    • Patient has a clinically significant tumor burden; OR
    • Patient has clinically significant progression and is not already receiving octreotide LAR; OR
    • Patient has disease progression with functional tumors and will be continuing treatment with octreotide LAR; OR
• Patient has pheochromocytoma or paraganglioma; AND
  • Used as primary treatment for secreting tumors for symptom and/or tumor control; AND
  • Patient has locally unresectable or distant metastatic disease; OR
• Patient has well-differentiated grade 3 neuroendocrine tumors; AND
  • Used for treatment of symptoms and/or tumor control for somatostatin receptor positive disease and/or hormonal symptoms; AND
  • Patient has unresectable locally advanced or metastatic disease with favorable biology (e.g., relatively low Ki-67 [<55%], positive SSTR-based PET imaging)

Diarrhea associated with Vasoactive Intestinal Peptide tumors (VIPomas) † Ф ¹

• Patient has profuse watery diarrhea

Acromegaly † Ф ^1,3,5,10

• Patient diagnosis confirmed by elevated (age-adjusted) or equivocal serum IGF-1 as well as inadequate suppression of GH after a glucose load; AND
• Patient has documented inadequate response to surgery and/or radiotherapy or it is not an option for the patient; AND
• Used as long-term maintenance therapy; AND
• Patient’s tumor has been visualized on imaging studies (i.e., MRI or CT-scan); AND
• Baseline growth hormone (GH) and IGF-1 blood levels (renewal will require reporting of current levels)

Thymomas ‡ ^4,8

• Used with or without prednisone therapy; AND
  • Used for patients who are unable to tolerate first-line combination regimens; AND
    • Used as first line therapy; OR
    • Used as postoperative treatment after R2 resection; OR
  • Used as second-line therapy for unresectable or metastatic disease

† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug

4. Renewal Criteria ^1,4-9

Coverage can be renewed based on the following criteria:

• Patient continues to meet indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. identified in section III; AND
• Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: cholelithiasis and complications of cholelithiasis (i.e. cholecystitis, cholangitis, pancreatitis), hyperglycemia, hypoglycemia, hypothyroidism, sinus bradycardia, cardiac arrhythmias, cardiac conduction abnormalities, depressed vitamin B₁₂ levels, etc.; AND
• Disease response with improvement in patient’s symptoms including reduction in symptomatic episodes (such as diarrhea, rapid gastric dumping, flushing, bleeding, etc.) and/or stabilization of glucose levels and/or decrease in size of tumor or tumor spread; AND
  • Acromegaly ONLY: Disease response as indicated by an improvement in signs and symptoms compared to baseline; AND
    • Reduction of growth hormone (GH) from pre-treatment baseline; OR
    • Age-adjusted normalization of serum IGF-1
  • Neuroendocrine tumors (gastrointestinal tract, bronchopulmonary, thymus, or pancreas) ONLY: Patient has had disease progression and therapy will be continued in patients with functional tumors.

5. Dosage/Administration ^1,7

6. Billing Code/Availability Information

HCPCS Code:

• J2353 – Injection, octreotide, depot form for intramuscular injection, 1 mg: 1 mg = 1 billable unit

NDC:

• Sandostatin LAR Depot 10 mg single-use kit: 00078-0811-XX
• Sandostatin LAR Depot 20 mg single-use kit: 00078-0818-XX
• Sandostatin LAR Depot 30 mg single-use kit: 00078-0825-XX

7. References

1. Sandostatin LAR [package insert]. East Hanover, NJ; Novartis Pharmaceuticals Corporation; March 2021. Accessed July 2023.
2. Giustina A, Chanson P, Kleinberg D, et al. Expert consensus document: A consensus on the medical treatment of acromegaly. Nat Rev Endocrinol. 2014 Apr; 10(4):243-8. doi: 10.1038/nrendo.2014.21. Epub 2014 Feb 25.
3. Katznelson L, Laws ER Jr, Melmed S, et al. Acromegaly: an endocrine society clinical practice guideline. J Clin Endocrinol Metab. 2014 Nov; 99(11):3933-51. doi: 10.1210/jc.2014-2700. Epub 2014 Oct 30.
4. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for Octreotide acetate (LAR). National Comprehensive Cancer Network, 2023. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed March 2023.
5. Lancranjan I, Atkinson AB & Sandostatin® LAR® Group#. Results of a European Multicentre Study with Sandostatin® LAR® in Acromegalic Patients. Pituitary 1, 105–114; Published: June 1999. https://doi.org/10.1023/A:1009980404404.
6. Rubin J, Ajani J, Schirmer W, et al. Octreotide Acetate Long-Acting Formulation Versus Open-Label Subcutaneous Octreotide Acetate in Malignant Carcinoid Syndrome. J Clin Oncol, 17 (2), 600-6; Feb 1999. PMID: 10080605. DOI: 10.1200/JCO.1999.17.2.600.
7. Longo F, De Filippis L, Zivi A, et al. Efficacy and Tolerability of Long-Acting Octreotide in the Treatment of Thymic Tumors: Results of a Pilot Trial. Am J Clin Oncol, 35 (2), 105-9; April 2012. PMID: 21325939. DOI: 10.1097/COC.0b013e318209a8f8.
8. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium^®) Thymomas and Thymic Carcinomas. Version 1.2023.  National Comprehensive Cancer Network, 2023. The NCCN Compendium^® is a derivative work of the NCCN Guidelines^®. NATIONAL COMPREHENSIVE CANCER NETWORK^®, NCCN^®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed July 2023.
9. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium^®) Neuroendocrine and Adrenal Tumors. Version 2.2022.  National Comprehensive Cancer Network, 2022. The NCCN Compendium^® is a derivative work of the NCCN Guidelines^®. NATIONAL COMPREHENSIVE CANCER NETWORK^®, NCCN^®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed July 2023.
10. Fleseriu M, Biller BMK, Freda PU, et al. A Pituitary Society update to acromegaly management guidelines. Pituitary. 2021 Feb;24(1):1-13. doi: 10.1007/s11102-020-01091-7.
11. Palmetto GBA. Local Coverage Article: Billing and Coding: Octreotide Acetate for Injectable Suspension (Sandostatin LAR® depot) (A56531). Centers for Medicare & Medicaid Services, Inc. Updated on 05/19/2022 with effective date 05/26/2022. Accessed March 2023.
12. Chan JA, Kulke M, Clancy TE (Nov 2022). Metastatic well-differentiated pancreatic neuroendocrine tumors: Systemic therapy options to control tumor growth and symptoms of hormone hypersecretion. In Goldberg, RM, Shah, S (Eds.). UpToDate. Accessed July 07, 2023. Available from: https://www.uptodate.com/contents/uremic- https://www.uptodate.com/contents/metastatic-well-differentiated-pancreatic-neuroendocrine-tumors-systemic-therapy-options-to-control-tumor-growth-and-symptoms-of-hormone-hypersecretion?search=octreotide%20acetate&source=search_result&selectedTitle=10~148&usage_type=default&display_rank=9
13. Melmed S, Katznelson L (Apr 2023). Treatment of acromegaly. In Snyder PJ, Martin KA (Eds.) UpToDate. Accessed July 07, 2023. Available from: https://www.uptodate.com/contents/treatment-of-acromegaly?search=Acromegaly&source=search_result&selectedTitle=3~88&usage_type=default&display_rank=3#H3315970343

Appendix 1 – Covered Diagnosis Codes

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) may exist and compliance with these policies is required where applicable. They can be found at: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications may be covered at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA):