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Sustol® (granisetron extended-release) (Subcutaneous)

Policy Number: VP-0283

Last Review Date: 03/31/2023

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

FOR PEEHIP Members Only -Coverage excludes the provider-administered medication(s) outlined in this drug policy from being accessed through a specialty pharmacy. It must be obtained through buy and bill.

I. Length of Authorization

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

II. 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
  1. Max Units (per dose and over time) [HCPCS Unit]:
  • 100 billable units per 7 days

III. Initial Approval Criteria 1

For PEEHIP Members Only

Sustol (granisetron extended release) is non-covered, the preferred 5HT3 antagonists are palonosetron, ondansetron or granisetron IV.

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

  • 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):

Highly Emetogenic Chemotherapy (HEC)

Carboplatin

Carmustine

Cisplatin

Cyclophosphamide

Dacarbazine

Doxorubicin

Epirubicin

Fam-trastuzumab deruxtecan-nxki

Ifosfamide

Mechlorethamine

Melphalan ≥140 mg/m2

Sacituzumab govitecan-hziy

Streptozocin

The following can be considered HEC in certain patients

Dactinomycin

Daunorubicin

Idarubicin

Irinotecan

Methotrexate ≥250mg/m2

Oxaliplatin

Trabectedin

The following regimens can be considered HEC

FOLFOX

FOLFIRI

FOLFIRINOX; FOLFOXIRI

AC (any anthracycline + cyclophosphamide)

** Failure is defined as:

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

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

IV. Renewal Criteria 1

Coverage cannot be renewed.

V. Dosage/Administration 1

Indication

Dose

Prevention of chemotherapy-induced nausea and vomiting in adults

10 mg, administered subcutaneously by a healthcare provider, on Day 1 of chemotherapy; not more frequently than once every 7 days.

VI. 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

VII. References

  1. Sustol [package insert].  San Diego, CA; Heron Therapeutics; May 2017. Accessed March 2023.
  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 1.2023. 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 March 2023.
  4. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for granisetron extended release subcutaneous system. 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. March 2023.
  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

ICD-10

ICD-10 Description

R11.0

Nausea

R11.10

Vomiting, unspecified

R11.11

Vomiting without nausea

R11.12

Projectile vomiting

R11.2

Nausea with vomiting, unspecified

T45.1X5A

Adverse effect of antineoplastic and immunosuppressive drugs, initial encounter

T45.1X5D

Adverse effect of antineoplastic and immunosuppressive drugs, subsequent encounter

T45.1X5S

Adverse effect of antineoplastic and immunosuppressive drugs, sequela

T45.95XA

Adverse effect of unspecified primarily systemic and hematological agent, initial encounter

T45.95XD

Adverse effect of unspecified primarily systemic and hematological agent, subsequent encounter

T45.95XS

Adverse effect of unspecified primarily systemic and hematological agent, sequela

T50.905A

Adverse effect of unspecified drugs, medicaments and biological substances, initial encounter

T50.905D

Adverse effect of unspecified drugs, medicaments and biological substances, subsequent

T50.905S

Adverse effect of unspecified drugs, medicaments and biological substances, sequela

Z51.11

Encounter for antineoplastic chemotherapy

Z51.12

Encounter for antineoplastic immunotherapy

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 Article(s) 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): N/A

Medicare Part B Administrative Contractor (MAC) Jurisdictions

Jurisdiction

Applicable State/US Territory

Contractor

E (1)

CA, HI, NV, AS, GU, CNMI

Noridian Healthcare Solutions, LLC

F (2 & 3)

AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ

Noridian Healthcare Solutions, LLC

5

KS, NE, IA, MO

Wisconsin Physicians Service Insurance Corp (WPS)

6

MN, WI, IL

National Government Services, Inc. (NGS)

H (4 & 7)

LA, AR, MS, TX, OK, CO, NM

Novitas Solutions, Inc.

8

MI, IN

Wisconsin Physicians Service Insurance Corp (WPS)

N (9)

FL, PR, VI

First Coast Service Options, Inc.

J (10)

TN, GA, AL

Palmetto GBA, LLC

M (11)

NC, SC, WV, VA (excluding below)

Palmetto GBA, LLC

L (12)

DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA)

Novitas Solutions, Inc.

K (13 & 14)

NY, CT, MA, RI, VT, ME, NH

National Government Services, Inc. (NGS)

15

KY, OH

CGS Administrators, LLC