CurrentCentenePolicy CP.PMN.141

Dolasetron (Anzemet) (PDF)

Defines medical necessity criteria, initial and continued approval, dosing limits, exclusions, appendices (therapeutic alternatives, contraindications, ASCO/NCCN guidance), and state-specific step therapy bypass rules for dolasetron (Anzemet) for Centene lines of business (Commercial, HIM, Medicaid).

Policy Summary

PayerCentene

PolicyDolasetron (Anzemet) (PDF)

Policy CodePolicy CP.PMN.141

Change TypeRevised; Clarified

Effective DateSep 1, 2006

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.

SourceLink

POLICY UPDATE CHANGES

Removed 100 mg strength from Section VI as product is discontinued; references updated.

Added step therapy bypass for IL HIM per IL HB 5395.

Updated Appendix E to include Indiana.

1Covered Indication (prevention/treatment of chemo-induced nausea/vomiting)

2Minimum covered age (years)

100 mg/dayMax daily dose

50 mgAvailable tablet strength

Covered with criteria for prevention/treatment of chemotherapy-induced nausea and vomiting in members aged ≥ 2 years; aligns with ASCO/NCCN antiemesis guidance and requires step therapy with a formulary 5-HT3 antagonist (ondansetron preferred) unless state-specific bypass applies. Approval is for the projected course of chemotherapy (up to 72 hours after completion). Key thresholds: maximum 100 mg/day and available as a 50 mg tablet.

Initial Therapy Criteria — Chemotherapy-Induced Nausea/Vomiting

I. Initial Approval Criteria - Nausea and Vomiting Associated with Cancer Chemotherapy

Must meet ALL:

ALL of the following

Prescribed for the prevention or treatment of chemotherapy-induced nausea/vomiting
Age ≥ 2 years
Member is scheduled to receive cancer chemotherapy (see Appendix D)
one of
- Failure of a formulary 5-HT3 receptor antagonist (ondansetron is preferred) at up to maximally indicated doses, 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)
Dose does not exceed 100 mg per day100 mg/day
Maximum daily dose

ref': 'b1_0'

title': 'I. Initial Approval Criteria - Nausea and Vomiting Associated with Cancer Chemotherapy'

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Initial Therapy Criteria — Other Indications

I. Initial Approval Criteria - Other diagnoses/indications

Must meet ONE of the following (1 or 2):

ANY of the following

If this drug has recently (within the last 6 months) undergone a label change not reflected in this policy, follow the 'no coverage criteria' or 'non-formulary' policies for the relevant line of business as listed (see policy references 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 - Nausea and Vomiting Associated with Cancer Chemotherapy

Must meet ALL:

ALL of the following

one of
- 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 for CC.PHARM.03A and CC.PHARM.03B)
Member is responding positively to therapy
Member continues to receive cancer chemotherapy (see Appendix D)
If request is for a dose increase, new dose does not exceed 100 mg per day100 mg/day
Maximum daily dose

II. Continued Therapy - Other diagnoses/indications

Must meet ONE of the following (1 or 2):

ANY of the following

If drug recently underwent a label change not reflected in this policy, follow referenced policies for 'no coverage criteria' or 'non-formulary' as applicable
If requested use not listed under section III and criterion 1 above does not apply, refer to off-label use policy for the relevant line of business
See CP.CPA.09, HIM.PA.154, CP.PMN.53

Diagnoses / Indications Not Authorized

III. Diagnoses/Indications Not Authorized

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

Provider Actions & Authorization Requirements

Prior Authorization

Prior authorization required per Centene policy

Requests are subject to the criteria in this clinical policy and require prior authorization. Approval durations are limited to the projected course of chemotherapy up to 72 hours after completion of chemotherapy.

Documentation Required

Supportive documentation required

Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that the member has met all approval criteria.

Billing Rule

Approval duration for chemotherapy use

Approval duration for chemotherapy use: Projected course of chemotherapy up to 72 hours after completion of chemotherapy.

Step Therapy

Step therapy requirement

Failure of a formulary 5-HT3 receptor antagonist (ondansetron is preferred) at up to maximally indicated doses is required unless contraindicated or clinically significant adverse effects are experienced. State-specific bypasses to step therapy apply per Appendix E; for Illinois HIM, step therapy requirements do not apply as of 1/1/2026 per IL HB 5395.

Documentation Required

Continuity of care allowance

For continued therapy, the member qualifies if currently receiving the medication via a Centene benefit or has previously met initial approval criteria, or if the member is enrolled in a state and product with continuity of care regulations (refer to CC.PHARM.03A and CC.PHARM.03B).

Clinical Evidence & Guideline Alignment

Evidence includes the Anzemet Prescribing Information (Validus Pharmaceuticals; June 2021) and guideline recommendations from ASCO (Antiemetics Guideline Update 2020) and NCCN (Antiemesis Version 1.2025). The policy states alignment with ASCO/NCCN and lists therapeutic alternatives among 5-HT3 antagonists (e.g., ondansetron, granisetron, palonosetron and combination agents) in the appendices.

Background

Dolasetron (Anzemet) is a serotonin 5-HT3 receptor antagonist indicated for prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy in adults and children ≥ 2 years. Mechanism: 5-HT3 receptor antagonist. Therapeutic alternatives include other 5-HT3 antagonists and combination products (see appendices); the policy notes consistency with ASCO/NCCN guidance and includes appendices listing therapeutic alternatives, contraindications, and state-specific step therapy exceptions.

Revision History

06.06.24 (3Q 2024); P&T Approval Date 08.24revised

3Q 2024 annual review: removed 100 mg strength from Section VI as product is discontinued; references reviewed and updated.

04.18.25 (3Q 2025); P&T Approval Date 08.25clarifiedLatest

3Q 2025 annual review: added step therapy bypass for IL HIM per IL HB 5395; updated Appendix E with revised language and exception for Tennessee.

03.26.26revised