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Sustol (granisetron extended-release)

Policy Number: PH-90283

Subcutaneous

Last Review Date: 07/01/2025

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, 07/2025

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.
  1. Length of Authorization
  • Initial: Prior authorization validity will be provided initially for 6 months.
  • Renewal: Prior authorization validity may NOT be renewed
  1. Dosing Limits

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

  • 100 billable units per 7 days
  1. 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

  • Patient has failed§ with palonosetron while receiving the current anticancer chemotherapy regimen; AND
  • Used in combination with dexamethasone; AND
  • Patient is receiving highly emetogenic anticancer chemotherapy (HEC)*; AND
  • Used in combination with either aprepitant (PO or IV), fosaprepitant, or rolapitant with or without olanzapine; OR
  • Patient is receiving moderately emetogenic anticancer chemotherapy (MEC)**; or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens; OR
  • Used in combination with olanzapine, neurokinin-1 receptor antagonist (NK-1 RA), and dexamethasone as a component of a 4-drug regimen if not previously given; AND
  • Patient experienced emesis during a previous cycle of anticancer chemotherapy with a 3-drug regimen (olanzapine or NK-1 RA-containing regimen); OR
  • Patient has additional risk factors for anticancer agent-induced nausea/vomiting ¥; AND
  • Sustol is NOT covered for any of the following:
  • Breakthrough emesis
  • Repeat dosing in multi-day emetogenic chemotherapy regimens

§ NOTE: Failure is defined as two or more documented episodes of vomiting attributed to the current chemotherapy regimen

*Highly emetogenic chemotherapy (HEC):

Highly Emetogenic Chemotherapy (HEC) 3

                                                           

Carboplatin AUC ≥4

Carmustine >250 mg/m2

Cisplatin

Cyclophosphamide >1500 mg/m2

Dacarbazine

Datopotamab deruxtecan-dlnk

Doxorubicin ≥60 mg/m2

Epirubicin >90 mg/m2

Fam-trastuzumab deruxtecan-nxki

Ifosfamide ≥2 g/m2 per dose

Mechlorethamine

Melphalan≥140 mg/m2  

Sacituzumab govitecan-hziy

Streptozocin

Zolbetuximab-clzb

The following can be considered HEC in certain patients 3

Dactinomycin

Daunorubicin

Doxorubicin <60 mg/m2

Epirubicin ≤90 mg/m2

Idarubicin

Ifosfamide <2 g/m2

 per dose

Irinotecan

Oxaliplatin

Trabectedin

The following regimens can be considered HEC 3

FOLFOX

FOLFIRI

FOLFIRINOX; FOLFOXIRI

AC (any anthracycline + cyclophosphamide)

**Moderately emetogenic chemotherapy (MEC):

Moderately Emetogenic Chemotherapy (MEC) 3

Aldesleukin >12–15 million IU/m2 or 600,000 IU/kg

Amifostine >300 mg/m2

Bendamustine

Busulfan

Carboplatin AUC <4

Carmustine ≤250 mg/m2

Clofarabine

Cyclophosphamide ≤1500 mg/m2

Cytarabine >200 mg/m2

Dinutuximab

Dual-drug liposomal

encapsulation of cytarabine and

daunorubicin

Irinotecan (liposomal)

Lurbinectedin

Melphalan <140 mg/m2

Methotrexate ≥250 mg/m2

Mirvetuximab soravtansine-gynx

Naxitamab-gqgk

Romidepsin

Temozolomide

¥ Patient risk factors for anticancer agent-induced nausea/vomiting 3
  • Younger age
  • Female sex
  • Previous history of anticancer agent-induced nausea and vomiting (chemotherapy-induced nausea and vomiting [CINV])
  • Little or no previous alcohol use
  • Prone to motion sickness
  • History of morning sickness during pregnancy
  • Anxiety/high pretreatment expectation of nausea
  • Partial or complete bowel obstruction
  • Vestibular dysfunction
  • Brain metastases
  • Electrolyte imbalance: hypercalcemia, hyperglycemia, or hyponatremia
  • Uremia
  • Concomitant drug treatments, including opioids
  • Gastroparesis: tumor or chemotherapy (e.g., vincristine) induced or other causes (e.g., diabetes)
  • Excessive secretions (e.g., seen in patients with head and neck cancers)
  • Malignant ascites
  • Psychophysiologic: Anxiety or anticipatory nausea/vomiting
  • Cannabinoid hyperemesis syndrome
  • Rapid opioid withdrawal
  • Pancreatitis
  • Dysmotility
  • Concomitant radiation therapy (RT), especially total body irradiation and RT directed at the abdomen or brain

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

  1. Renewal Criteria 1

Duration of authorization has not been exceeded (refer to section I).

  1. Dosage/Administration 1

Indication

Dose

Prevention of chemotherapy-induced nausea and vomiting (CINV)

10 mg, administered subcutaneously by a healthcare provider, on Day 1 of chemotherapy; not more frequently than once every 7 days.
  1. 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
  1. References
  1. Sustol [package insert].  San Diego, CA; Heron Therapeutics; May 2023. Accessed June 2025.
  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 2.2025. National Comprehensive Cancer Network, 2025. 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 June 2025.
  4. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for granisetron extended release subcutaneous system. National Comprehensive Cancer Network, 2025.  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. June 2025.
  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)

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

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

M (11)

NC, SC, WV, VA (excluding below)

Palmetto GBA

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