Last Review Date: 04/04/2024

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, 04/2024

1. Length of Authorization

Oncology: Coverage is provided for 6 months and may be renewed at 6 month intervals.

Non-oncology: Coverage is provided for 6 months and may be renewed annually.

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: 2 per 28 days

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

• Carcinoid Tumors and Acromegaly: 40 billable units every 28 days
• Neuroendocrine Tumors: 60 billable units every 28 days
• CNS Cancers 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 (SSTR) 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
    • Used at above label dosing after disease progression on standard doses (**Note: Only applies to recurrent and/or metastatic disease); 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 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 if chronic cough/dyspnea is not responsive to inhalers or conventional treatment; 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 for unresectable disease with a low tumor burden; OR
      • Used as a single agent or in combination with alternative front-line therapy if unresectable and patient has a clinically significant tumor burden; OR
      • Used as a single agent for disease progression if not already receiving octreotide LAR; OR
      • Used as a single agent following resection of primary tumor if unresectable and locally symptomatic from primary tumor; OR
      • Used as a single agent as subsequent therapy at above label dosing after clinical, symptomatic, or radiographic progression on standard doses if SSTR-positive; 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
        • Used as subsequent therapy at above label dosing after clinical, symptomatic or radiographic progression on standard doses; 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%], slow growing, 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’s diagnosis is confirmed by one of the following:
  • Unequivocally elevated (age-adjusted) serum insulin-like growth factor-1 (IGF-1)
  • Equivocally elevated serum IGF-1 AND inadequate suppression of growth hormone (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
• Baseline growth hormone (GH) and IGF-1 blood levels have been obtained (renewal will require reporting of current levels)

Thymomas ‡ ^4,8

• Used with or without prednisone therapy; AND
• Patient has a positive octreotide scan or is dotatate PET/CT positive; AND
  • Used for patients who are unable to tolerate first-line combination regimens; AND
    • Used as first-line therapy for recurrent, advanced, or metastatic disease OR
    • Used as preoperative systemic therapy for surgically resectable disease if R0 resection is considered uncertain; OR
    • Used as postoperative treatment after R2 resection; OR
  • Used as second-line therapy for unresectable locally advanced or metastatic disease

CNS Cancers – Meningiomas ‡ ^4,13

• Used in combination with everolimus; AND
• Patient has surgically inaccessible recurrent or progressive disease; AND
• Treatment with radiation is not possible

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

4. Renewal Criteria ^1,4-9,12

Coverage can be renewed based on the following criteria:

• Patient continues to meet the 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

5. Dosage/Administration ^1,7,13-15

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; July 2023. Accessed March 2024.
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, 2024. 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 2024.
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 1.2024.  National Comprehensive Cancer Network, 2024. 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 2024.
9. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium^®) Neuroendocrine and Adrenal Tumors. Version 1.2023.  National Comprehensive Cancer Network, 2024. 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 2024.
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. Chan JA, Kulke M, Clancy TE (Feb 2024). Systemic therapy of metastatic well-differentiated pancreatic neuroendocrine tumors . In Goldberg, RM, Shah, S (Eds.). UpToDate. Accessed March 19, 2024. Available from: https://www.uptodate.com/contents/metastatic-well-differentiated-pancreatic-neuroendocrine-tumors-systemic-therapy-options-to-control-tumor-growth-and-symptoms-of-hormone-hypersecretion.
12. Melmed S, Katznelson L (Apr 2023). Treatment of acromegaly. In Snyder PJ, Martin KA (Eds.) UpToDate. Accessed March 08, 2024. Available from: https://www.uptodate.com/contents/treatment-of-acromegaly
13. Graillon T, Sanson M, Campello C, et al. Everolimus and Octreotide for Patients with Recurrent Meningioma: Results from the Phase II CEVOREM Trial. Clin Cancer Res. 2020 Feb 1;26(3):552-557. doi: 10.1158/1078-0432.CCR-19-2109. Epub 2020 Jan 22. PMID: 31969329.
14. Broder MS, Beenhouwer D, Strosberg JR, et al. Gastrointestinal neuroendocrine tumors treated with high dose octreotide-LAR: a systematic literature review. World J Gastroenterol. 2015 Feb 14;21(6):1945-55. doi: 10.3748/wjg.v21.i6.1945. PMID: 25684964; PMCID: PMC4323475.
15. Strosberg J, Weber J, Feldman M, et al. Above-Label Doses of Octreotide-LAR in Patients With Metastatic Small Intestinal Carcinoid Tumors. Gastrointest Cancer Res. 2013 May;6(3):81-5. PMID: 23936548; PMCID: PMC3737510.
16. 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 08/23/2023 with effective date 10/01/2023. Accessed March 2024.

Appendix 1 – Covered Diagnosis Codes

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

The preceding information is intended for non-Medicare coverage determinations. 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 Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.