Sustol (granisetron extended-release) — Coverage Criteria
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Covers prior authorization, dosing, clinical criteria, and billing for Sustol (granisetron extended-release) when used for prevention of chemotherapy-induced nausea and vomiting (CINV) in Viva Health members.
No material clinical or coverage changes in this revision.
Coverage criteria
Initial Approval for Prevention of CINV
Covered when ALL of the following are met
Emetogenic regimen and additional antiemetics
- HEC regimen option: Member is receiving highly emetogenic anticancer chemotherapy (HEC) AND Sustol is used with aprepitant (PO or IV), fosaprepitant, or rolapitant (with or without olanzapine)
- MEC or AC regimen option: Member is receiving moderately emetogenic anticancer chemotherapy (MEC) OR an anthracycline plus cyclophosphamide (AC) regimen
- 4-drug regimen option: Sustol used in combination with olanzapine, an NK-1 receptor antagonist, and dexamethasone as part of a 4-drug regimen when that 4-drug regimen has not been previously given
Risk factors are enumerated in policy
Sustol is NOT covered for these uses
Sustol is not covered for management of breakthrough emesis. The policy explicitly excludes use of Sustol for breakthrough vomiting episodes that occur despite a scheduled antiemetic regimen.
Sustol is also not covered for repeat dosing in multi-day emetogenic chemotherapy regimens (more frequently than once every 7 days). Doses given more often than once every 7 days in the setting of multi-day chemotherapy are outside the coverage criteria and should not be authorized.
For Medicare Part B considerations the policy notes that the section is intended for non‑Medicare coverage determinations and directs users to CMS guidance. The document lists Medicare Part B Covered Diagnosis Codes: N/A for the non‑Medicare coverage determinations in this policy, and instructs reviewers to consult NCDs/LCDs/LCAs via the CMS coverage database where applicable.
Initial therapy dosing and administration
Initial Dosing
Dosing and administration for initial therapy
Corresponds to HCPCS J1627 where 1 unit = 0.1 mg
Renewal and continuation criteria
Renewal Criteria
Renewal rules
Refer to section I for length of authorization
Coding and billing
| J1627 | Injection, granisetron, extended-release, 0.1 mg; 1 billable unit = 0.1 mg |
| 47426-0101-xx | Sustol Extended-Release Injection 10 mg/0.4 mL single-dose pre-filled syringe: 47426-0101-xx |
| 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 |
| 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 |
Provider actions, prior authorization, and documentation
Prior authorization required; initial 180 days, not renewable
Prior authorization is required for Sustol. Initial authorization is valid for 6 months (180 days) and may NOT be renewed. Member must be at least 18 years of age and meet the policy’s clinical criteria for prevention of CINV, including prior palonosetron failure and required regimen-specific combination therapy.
- Initial PA duration: 6 months (180 days).
- Renewals: Not allowed (prior authorization may NOT be renewed).
- Age requirement: Member must be ≥18 years.
PA may be applied per NQTL considerations (indication, cost)
The policy’s NQTL checklist identifies 'Indication' and 'Cost of drug' as factors considered when applying prior authorization; providers should be aware that PA may be applied for these reasons.
- NQTL factors recorded: Indication = Yes (Consider for PA); Cost of drug = Yes (Consider for PA).
Must trial and fail palonosetron on current regimen before approval
Approval requires a documented trial and failure of palonosetron while the member is receiving the current anticancer chemotherapy regimen before Sustol will be approved for CINV prevention.
- Step requirement: Trial and documented failure of palonosetron while on the current anticancer regimen is required prior to approval.
No other explicit step therapy requirements stated
No additional or alternate step therapy requirements are specified in the policy beyond the palonosetron failure requirement.
Document palonosetron failure (two or more vomiting episodes)
Provide documentation showing failure with palonosetron as defined by the policy: two or more documented episodes of vomiting attributed to the current chemotherapy regimen while receiving the current anticancer regimen.
- Failure definition: two or more documented episodes of vomiting attributed to the current chemotherapy regimen.
- Documentation must tie episodes of vomiting to the current anticancer chemotherapy regimen.
Reference Sustol package insert and NCCN Compendium
Refer to the Sustol (granisetron extended-release) package insert and the NCCN Drugs & Biologics Compendium (Antiemesis) for clinical support and cited references when submitting PA requests.
- Reference: Sustol package insert (Heron Therapeutics, Feb 2026).
- Reference: NCCN Drugs & Biologics Compendium — Antiemesis (Version 1.2026).
Use listed ICD-10 codes (Appendix 1) to support indication
Support the clinical indication with one of the covered ICD-10 diagnosis codes listed in Appendix 1 (for example R11.0, R11.10, R11.11, R11.12, R11.2, T45.1X5A, Z51.11, Z51.12).
- Use an Appendix 1 ICD-10 code from the policy’s Covered Diagnosis Codes to support the PA request.
Do not request coverage for breakthrough emesis or repeat multi-day dosing
Sustol is not covered for breakthrough emesis or for repeat dosing in multi-day emetogenic chemotherapy regimens (i.e., more frequently than once every 7 days); do not request coverage for these situations.
- Exclusions: Breakthrough emesis.
- Exclusions: Repeat dosing in multi-day regimens more frequently than once every 7 days.
PA may be denied for members <18 or for renewal/duration requests
PA may be denied if the member is under 18 years of age or if a renewal is requested (renewals are not allowed) or the initial authorization duration has been exceeded.
- Age risk: Member <18 years — PA may be denied.
- Renewal/duration risk: Renewals are not permitted; authorization may be denied if duration exceeded.
PA consideration may be based on indication and cost (NQTL)
Per the NQTL checklist, prior authorization may be considered based on the clinical indication and the cost of the drug; include indication-specific justification and any cost-related documentation if relevant to the request.
- NQTL considerations that led to PA: Indication = Consider for PA; Cost of drug = Consider for PA.
Definitions and terms
Step therapy requirements
| Step | Requirement | Failure definition | Coverage status |
|---|---|---|---|
| 1 | Trial and documented failure of palonosetron while receiving the current anticancer chemotherapy regimen is required prior to approval | Failure defined as two or more documented episodes of vomiting attributed to the current chemotherapy regimen | Covered with criteria |
| Step | Policy consideration | NQTL factors cited | Coverage status |
|---|---|---|---|
| 1 | Prior authorization may be considered based on indication and drug cost per the NQTL assessment; used to inform application of PA for this drug | Indication: Yes — consider for PA; Cost of drug: Yes — consider for PA; Safety/efficacy and misuse/abuse: No | Neutral (policy consideration for PA) |
Quantity limits and site of care
Site of care
Site‑of‑care: must be administered subcutaneously by a provider (office)
Sustol is administered subcutaneously by a healthcare provider and must be given in an office or other provider‑administered setting per the dosing instructions.
- Dose: 10 mg SC on Day 1 of chemotherapy; not more frequently than once every 7 days
- Administration: by a healthcare provider (office setting)
Background
Sustol (granisetron extended‑release) is an extended‑release formulation of the 5‑HT3 receptor antagonist granisetron, provided as a subcutaneous injection for prevention of chemotherapy‑induced nausea and vomiting (CINV). It is intended for administration by a healthcare provider as part of multi‑drug antiemetic regimens tailored to the emetogenic risk of the patient’s chemotherapy and is used when the policy’s clinical criteria (including prior palonosetron failure and regimen‑specific combination therapy requirements) are met.
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