Last Review Date: 04/03/2020

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

1. Length of Authorization

Coverage is provided for six months and may NOT be renewed.

2. Dosing Limits

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

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

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

• 100 billable units per 7 days

3. Initial Approval Criteria ^1,3,4,5,6

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) †

• Must be administered in combination with dexamethasone; AND
  • Patient is receiving highly emetogenic chemotherapy (HEC)*; OR
  • Patient is receiving moderately emetogenic chemotherapy (MEC); AND
• Sustol is NOT covered for:

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

*Highly emetogenic chemotherapy (HEC):

** Failure is defined as:

• Two or more documented episodes of vomiting attributed to the current chemotherapy regimen

† FDA-approved indication(s)

4. Renewal Criteria

Coverage cannot be renewed.

5. Dosage/Administration

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 2017. Accessed February 2020.
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 1.2020. National Comprehensive Cancer Network, 2020. 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 February 2020.
4. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for granisetron extended release subcutaneous system. National Comprehensive Cancer Network, 2019.  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. February 2020.
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 Clinical Practice Guideline Update. J Clin Oncol. 2017 Oct 1;35(28):3240-3261.

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) and Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. They can be found at: http://www.cms.gov/medicare-coverage-database/search/advanced-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): N/A