CurrentmhnPolicy CP.PMN.74

Clinical Policy: Granisetron (Sancuso, Sustol)

Defines medical necessity criteria, prior-authorization and continuation requirements, dosing limits, covered indications (chemotherapy-, radiation-, and postoperative-induced nausea/vomiting), product-specific age limits, and state-specific step-therapy/redirection exceptions for granisetron products across commercial, HIM, and Medicaid lines.

Policy Summary

Payermhn

PolicyClinical Policy: Granisetron (Sancuso, Sustol)

Policy CodePolicy CP.PMN.74

Change TypeRoutine updates; state redirection exceptions added

Effective DateNov 1, 2016

Next Review Date

Key ActionProvider must submit documentation supporting that member has met all approval criteria.

POLICY UPDATE CHANGES

Clarified age requirement for Sancuso or Sustol (applies to those products only).

Allowed bypassing redirection (step therapy) for states with regulations against step therapy in certain oncology settings; Appendix E lists applicable states.

Modified PONV approval duration to 'one time dose' and removed inactive HCPCS code J3490.

Routine annual updates to references and appendices; no significant clinical changes reported.

3Covered Indications (chemotherapy, radiation, PONV)

≥18Age requirement (Sancuso/Sustol)

4Dose limit categories listed

MultipleStates with step-therapy exceptions (Appendix E)

Coverage Summary

Policy CP.PMN.74 designates granisetron (including Sancuso and Sustol) as covered_with_criteria for prevention and treatment of chemotherapy-, radiation-, and postoperative-induced nausea/vomiting. Product-specific age limits require Age ≥ 18 years for Sancuso and Sustol (the tablet age restriction does not apply). Dose and duration limits are specified per product. The policy includes state-specific step-therapy/redirection exceptions detailed in Appendix E.

Quick thresholds

Age requirement for Sancuso or Sustol≥ 18 years

Granisetron tablet max daily dose2 mg/day

Granisetron injection max dose (chemo)10 mcg/kg

Sustol maximum10 mg per 7 days

Sancuso maximum1 patch per 7 days

PONV IV dose (max)1 mg once (per operation)

Initial Therapy Criteria

I. Initial Approval Criteria - D. Other diagnoses/indications

must meet 1 or 2

ANY of the following

If this drug has recently (within the last 6 months) undergone a label change not yet reflected in this policy, refer to applicable no-coverage or non-formulary policies (CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16)
If the requested use is NOT specifically listed under section III AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business (CP.CPA.09, HIM.PA.154, CP.PMN.53)

Continuation Therapy Criteria

II. Continued Therapy - A. Chemotherapy or Radiation-induced N/V

must meet all

ALL of the following

ANY of the following
- Currently receiving medication via Centene benefit or member has previously met initial approval criteria
- Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums CC.PHARM.03A and CC.PHARM.03B)
Member is responding positively to therapy
ANY of the following

Diagnoses / Indications Not Authorized

III. Diagnoses/Indications NOT authorized

Non-FDA approved indications which are not addressed in this policy are not authorized unless there is sufficient documentation of efficacy and safety per off-label use policies or evidence of coverage documents

Provider Actions & Prior Authorization Requirements

Prior Authorization

Documentation required for prior authorization

Provider must submit documentation (office notes, labs, or other clinical information) demonstrating the member meets all approval criteria for granisetron prior authorization requests.

Office chart notes
Laboratory results
Other supporting clinical information

Step Therapy

Step therapy / redirection requirement

For most requests, the member must have failed a formulary 5-HT3 receptor antagonist (ondansetron preferred) at up to maximally indicated doses unless contraindicated or clinically significant adverse effects are experienced. Requests for treatment associated with cancer in states listed in Appendix E may bypass redirection/step therapy per state regulations.

Applicable Codes

HCPCS Injection Codes (informational)HCPCS

J1627	Injection, granisetron extended release, 0.1 mg
J1626	Injection, granisetron hydrochloride, 100 mcg

Clinical Evidence & References

References reviewed include FDA prescribing information (2022-2024) and guideline sources such as ASCO and NCCN (2020-2025). The policy notes alignment with FDA-approved indications and incorporates ASCO/NCCN recommendations in Appendix D regarding emetic risk and recommended antiemetic regimens.

Background

Granisetron is a 5-HT3 receptor antagonist available as oral tablet, intravenous injection, a transdermal patch (Sancuso), and an extended-release subcutaneous injection (Sustol). The policy aligns coverage to FDA-approved indications and dosing for each formulation and enforces product-specific dose limits (e.g., tablet 2 mg/day; injection 10 mcg/kg; Sancuso 1 patch/7 days; Sustol 10 mg/7 days). The policy applies step-therapy redirection to generic granisetron (ondansetron preferred as the initial formulary 5-HT3), with allowance to bypass redirection in states listed in Appendix E that have regulations against step therapy in certain oncology settings.

Revision History

04.27.21material_change

Added allowance to bypass redirection (step therapy) for states with regulations against step therapy in certain oncology settings and added details in Appendix E (states listed).

08.03.21update

Appendix E updated to include Nevada (added to list of states with step-therapy/regulatory exceptions).

10.04.21annual_review

Added HIM line of business; removed Kytril as product is no longer marketed; added redirection to generic granisetron and updated HCPCS codes; references reviewed and updated.

Definitions & Scope

Glossary: PONV — postoperative nausea and vomiting; 5-HT3 — serotonin 5-hydroxytryptamine, type 3 receptor.

Summary: This policy defines medical necessity criteria, prior-authorization and continuation requirements, dosing limits, covered indications (chemotherapy-, radiation-, and postoperative-induced nausea/vomiting), product-specific age limits (Sancuso/Sustol ≥18), and state-specific step-therapy/redirection exceptions. It applies across Commercial, HIM, and Medicaid lines of business.

Policy Summary

Payermhn

PolicyClinical Policy: Granisetron (Sancuso, Sustol)

Policy CodePolicy CP.PMN.74

Change TypeRoutine updates; state redirection exceptions added

Effective DateNov 1, 2016

Next Review Date

Key ActionProvider must submit documentation supporting that member has met all approval criteria.

On This Page

Member must use generic granisetron, unless contraindicated or clinically significant adverse effects are experienced

Request is for treatment associated with cancer for a State with regulations against step therapy in certain oncology settings (see Appendix E)

State exemption

ANY of the following

Member continues to receive cancer chemotherapy (see Appendix D)
Member continues to receive radiation therapy

Dose increase limit (if request is for a dose increase)

Intravenous injection: 10 mcg/kg
IV maximum
Tablet: 2 mg (2 tablets) per day
Tablet maximum
Sustol: 10 mg per 7 days
Sustol maximum
Sancuso: 1 patch per 7 days
Sancuso maximum

II. Continued Therapy - B. Postoperative Nausea and Vomiting

must meet all

ALL of the following

Re-authorization is not permitted; Members must meet the initial approval criteria
No re-authorization for PONV; one-time dose

II. Continued Therapy - C. Other diagnoses/indications

must meet 1 or 2

ANY of the following

If drug label changed within last 6 months not reflected here, refer to no-coverage/non-formulary policies (CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16)
If requested use not listed under section III and criterion 1 above does not apply, refer to off-label use policies (CP.CPA.09, HIM.PA.154, CP.PMN.53)

Failure of formulary 5-HT3 (ondansetron preferred) required unless contraindicated
Appendix E lists states where redirection/step therapy may be bypassed
State-specific exceptions apply (see Appendix E)

Billing Rule

Dose limits enforced

Claims will be limited to the policy dose maxima. Applicable HCPCS codes: J1626 and J1627. Policy dose maxima: IV injection 10 mcg/kg; tablet maximum 2 mg per day; Sustol 10 mg per 7 days; Sancuso one patch per 7 days; for PONV IV injection maximum 1 mg (one time dose).

Affected HCPCS codes: J1626, J1627
IV (chemotherapy): 10 mcg/kg
Tablet maximum: 2 mg/day
Sustol maximum: 10 mg per 7 days
Sancuso maximum: 1 patch per 7 days
PONV IV: 1 mg once (one time dose)

Documentation Required

Continuity of care

For continued therapy, providers must document that the member is responding positively to treatment and provide prior authorization history or evidence of enrollment in applicable continuity of care regulations (refer to state-specific addendums CC.PHARM.03A and CC.PHARM.03B).

Document positive response to therapy
Provide prior authorization history OR
Document enrollment in CC.PHARM.03A / CC.PHARM.03B when applicable

Prior Authorization

No re-authorization for PONV

Re-authorization for postoperative nausea and vomiting (PONV) is not permitted. Approval for PONV is limited to a single one-time dose and the member must meet the initial approval criteria.

No re-authorization permitted for PONV
Single one-time dose approval only
Initial approval criteria must be met

10.04.22template_change

Template changes applied to other diagnoses/indications and continued therapy section.

02.23p_t_approval

PONV criteria re-added with age requirement for IV requests; IV dose limits added for chemotherapy-induced N/V; redirection bypass language generalized to apply to states with step-therapy regulations (Appendix E).

04.19.23appendix_update

Appendix E updated to include Oklahoma.

08.23p_t_approval

3Q 2023 annual review: allowance for bypassing redirection if state regulations do not allow step therapy in certain oncology settings; Appendix E updated to include Oklahoma.

04.19.23-06.05.24appendix_updates

Appendix E expanded over time to include additional states (e.g., Oklahoma, Mississippi added 06.05.24) to specify where redirection/step therapy may be bypassed.

06.06.243Q_2024_review

3Q 2024 annual review: no significant clinical changes; for PONV changed approval duration language to 'one time dose' instead of 'one time approval'; removed inactive HCPCS code J3490 used for Sancuso; references reviewed and updated.

08.24p_t_approval

P&T approval for 3Q 2024 updates including PONV duration wording change and removal of inactive HCPCS J3490.

10.10.24clarification

Applied P&T clarification: clarified age requirement to state 'If request is for Sancuso or Sustol: Age ≥ 18 years' (age restriction does not apply to tablets).

06.26.253Q_2025_review

3Q 2025 annual review: no significant changes; Appendix E language and Tennessee exception updated; references reviewed and updated.

08.25policy_last_reviewLatest

Last review date recorded as 08.25 (policy status CURRENT); effective date remains 2016-11-01 per policy header.