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Last Review Date: 04/04/2024

Date of Origin: 08/30/2016

Dates Reviewed: 08/2016, 11/2016, 02/2017, 05/2017, 08/2017, 11/2017, 02/2018, 04/2018, 04/2019, 4/2020, 04/2021, 04/2022, 04/2023, 04/2024

1. Length of Authorization

Coverage will be provided for 6 months and may NOT be renewed.

2. Dosing Limits

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

•  Sustol Extended-Release Injection 10 mg/0.4 mL single-dose pre-filled syringe: 1 syringe per 7 day supply

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

• 100 billable units per 7 days

3. Initial Approval Criteria ¹

Coverage is provided in the following conditions:

• Patient must be at least 18 years of age; AND

Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) † ‡ ^1,3-6

• Patient meets one of the following criteria:
  • Used in combination with dexamethasone; AND

• Patient is receiving highly emetogenic anticancer chemotherapy (HEC)*; OR
• Patient is receiving moderately emetogenic chemotherapy (MEC) *** or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens; OR
  • Patient experienced emesis during a previous cycle of anticancer chemotherapy with a 3-drug regimen (olanzapine or NK-1 receptor antagonist-containing regimen); AND
• Used in combination with olanzapine, neurokinin-1 receptor antagonist, and dexamethasone as a component of a 4-drug regimen if not previously given; AND

• Sustol is NOT covered for any of the following:

• Breakthrough emesis
• Repeat dosing in multi-day emetogenic chemotherapy regimens

*Highly emetogenic chemotherapy (HEC):

***Moderately emetogenic chemotherapy (MEC):

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

4. Renewal Criteria ¹

Coverage cannot be renewed.

5. Dosage/Administration ¹

6. Billing Code/Availability Information

HCPCS code:

• J1627 – Injection, granisetron, extended-release, 0.1 mg; 1 billable unit = 0.1 mg

NDC:

• Sustol Extended-Release Injection 10 mg/0.4 mL single-dose pre-filled syringe: 47426-0101-xx

7. References

1. Sustol [package insert].  San Diego, CA; Heron Therapeutics; May 2023. Accessed March 2024.
2. Schnadig ID, Agajanian R, Dakhil C, et al. APF530 (granisetron injection extended-release) in a three-drug regimen for delayed CINV in highly emetogenic chemotherapy. Future Oncol. 2016;12:1469-1481
3. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium^®) Antiemesis. 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.
4. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for granisetron extended release subcutaneous system. 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. March 2024.
5. Roila F, Molassiotis A, Herrstedt J, et al. MASCC and ESMO Consensus Guidelines for the Prevention of Chemotherapy and Radiotherapy-Induced Nausea and Vomiting: ESMO Clinical Practice Guidelines. Ann Oncol (2016) 27 (suppl 5): v119-v133.
6. Hesketh PJ, Kris MG, Basch E, et al. Antiemetics: American Society of Clinical Oncology Guideline Update. J Clin Oncol. 2020 Aug 20;38(24):2782-2797. Doi: 10.1200/JCO.20.01296.

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.

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

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