CurrentNeighborhood Health Plan of Rhode IslandPolicy UM ONC_1468

Antiemetics (ondansetron, granisetron, palonosetron, netupitant/fosnetupitant, aprepitant/fosaprepitant, rolapitant, granisetron patch/ER)

Defines coverage, inclusion/exclusion, dosing limits, and coding for antiemetic drugs used for prevention and treatment of chemotherapy- or radiation-induced nausea and vomiting for members managed by the payer's utilization management program.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAntiemetics (ondansetron, granisetron, palonosetron, netupitant/fosnetupitant, aprepitant/fosaprepitant, rolapitant, granisetron patch/ER)

Policy CodePolicy UM ONC_1468

Change TypeNo material changes

Effective DateJan 31, 2025

Next Review DateJan 8, 2025

Key ActionObtain prior authorization for antiemetic medication requests; continuation requests may be exempt if continuity conditions are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

20+HCPCS/J/Q/S codes listed

12+antiemetic products named

dose limitssingle-dose maximums specified

multiplecommittee review dates

Coverage Criteria

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Inclusion criteria — Antiemesis

Covered when ALL of the following are met

Continuation exemption: The member has not experienced disease progression on the requested medication; the requested medication was used within the last year without a lapse of more than 30 days of active authorization; and no additional medication(s) are being added to the continuation request.

Section II.A

Prophylaxis prior to chemotherapy: Zofran (ondansetron), Kytril (granisetron), Aloxi (palonosetron), Sustol (granisetron extended release), Akynzeo (netupitant/fosnetupitant + palonosetron), and Sancuso (granisetron patch) may be used as prophylaxis prior to the administration of low, moderate, or high emetogenic risk chemotherapy. Only Zofran (ondansetron) or Kytril (granisetron) may be used before radiation to the upper abdomen or total body irradiation, or for treatment of radiation- or anticancer therapy–induced nausea/vomiting (see exclusion criteria for other agents).

Section II.B.1

NK1 antagonist combination: Emend (fosaprepitant/aprepitant), Cinvanti (aprepitant injection), or Varubi (rolapitant) should be used in combination with dexamethasone and one of the following 5-HT3 antagonists: Zofran (ondansetron), Kytril (granisetron), or Aloxi (palonosetron) prior to administration of low, moderate, or high emetogenic risk chemotherapy.

Section II.B.2

The following agents are specifically identified in exclusions when used for prevention or treatment of radiation‑ or total body irradiation (TBI)‑induced nausea and vomiting, or for treatment of breakthrough nausea/vomiting: Aloxi (palonosetron), Akynzeo (netupitant/palonosetron — oral or fosnetupitant/palonosetron injection), Sancuso (granisetron patch), Sustol (granisetron extended‑release), Emend (fosaprepitant injection / oral aprepitant), Cinvanti (aprepitant injection), and Varubi (rolapitant oral). These uses are excluded under the policy.

Use of an NK1 receptor antagonist — specifically Emend (fosaprepitant/aprepitant), Cinvanti (aprepitant injection), or Varubi (rolapitant) — is excluded when prescribed without concomitant administration of a 5‑HT3 receptor antagonist (for example, Zofran/ondansetron, Kytril/granisetron, or Aloxi/palonosetron) and dexamethasone.

Requests will be excluded if the administered dose exceeds the policy’s specified single‑dose maximums. Policy single‑dose limits include, among others: IV ondansetron (Zofran) ≤ 16 mg, oral ondansetron ≤ 24 mg, granisetron ≤ 2 mg IV/PO, Sancuso patch 3.1 mg, Anzemet (dolasetron) 100 mg, Aloxi (palonosetron) 0.25 mg IV / 0.5 mg PO, Akynzeo 300 mg/0.5 mg (oral) or 235 mg/0.25 mg (IV), and Sustol 10 mg. Additional single‑dose maximums apply for NK1 agents: aprepitant oral ≤ 125 mg, fosaprepitant injection ≤ 150 mg, rolapitant oral ≤ 180 mg, and aprepitant injection ≤ 130 mg.

Investigational or off‑label uses of antiemetics that lack sufficient supporting evidence are excluded. Adequacy of evidence is determined by whether published literature or CMS‑recognized compendia adequately represent the patient and tumor characteristics, the administered oncologic regimen, and whether study outcomes are clinically meaningful and supported by appropriate study design and peer‑reviewed publication standards.

Off‑label or investigational uses that are not generally accepted by the medical community are considered not medically necessary when they lack support in CMS‑recognized compendia or acceptable peer‑reviewed literature. The policy specifies that case reports and meeting abstracts without full peer‑reviewed articles generally do not provide adequate evidence, and study design, outcome measures and representativeness of populations should be evaluated when determining acceptance.

Coding

Covered HCPCS/J/Q/S codes (group 1)HCPCSCovered

J2405	Injection, ondansetron hydrochloride, per 1 mg.
Q0162	Ondansetron 1 mg, oral, fda approved prescription anti-emetic, for use as a complete therapeutic substitute for an iv anti-emetic at the time of chemotherapy treatment, not to exceed a 48 hour dosage regimen.
S0119	Ondansetron, oral, 4 mg (for circumstances falling under the medicare statute, use hcpcs q code).
J1626	Injection, granisetron hydrochloride, 100 mcg.
J1627	Injection, granisetron, extended-release, 0.1 mg.
J3490	granisetron transdermal patch (3.1 mg/24 hours).
Q0166	Granisetron hydrochloride, 1 mg, oral, fda approved prescription anti-emetic, for use as a complete therapeutic substitute for an iv anti-emetic at the time of chemotherapy treatment, not to exceed a 24 hour dosage regimen.
S0091	Granisetron hydrochloride, 1 mg (for circumstances falling under the medicare statute, use q0166).
J2468	Injection, palonosetron hydrochloride (posfrea), 25 micrograms.
J2469	Injection, palonosetron hcl, 25 mcg.

1–10 of 15

1/2

Covered HCPCS/J codes (group 2)HCPCSCovered

J1453	Injection, fosaprepitant, 1 mg.
J1456	Injection, fosaprepitant (teva), not therapeutically equivalent to j1453, 1 mg.
J8501	Aprepitant, oral, 5 mg.
J2797	Injection, rolapitant, 0.5 mg.
J8670	Rolapitant, oral, 1 mg.

Single dose maximums — per agent

Ondansetron (IV)Single IV dose maximum: 16 mg

Ondansetron (oral)Single oral dose maximum: 24 mg

GranisetronSingle dose maximum: 2 mg (IV or PO); Sancuso transdermal patch: 3.1 mg

Anzemet (dolasetron)Single dose maximum: 100 mg

Aloxi (palonosetron)Single dose maximums: 0.25 mg IV; 0.5 mg PO

Akynzeo (netupitant/palonosetron)Single dose maximums: Oral 300 mg/0.5 mg; IV 235 mg/0.25 mg

Provider Actions & Requirements

Prior Authorization

Prior Authorization & Continuation Criteria

Prior authorization is required for antiemetic medication requests. Continuation requests are exempt when ALL of the following are met: the member has not experienced disease progression on the requested medication; the requested medication was used within the last year without a lapse of more than 30 days of having an active authorization; and no additional medications are being added to the continuation request.

Prior authorization required for antiemetic medication requests
Continuation exemption when all continuation criteria are met (no progression, used within last year with ≤30-day lapse, no added medications)

Note

Combination Therapy Requirement

Requests for NK1 receptor antagonist agents (e.g., aprepitant, fosaprepitant, rolapitant, netupitant-containing products) must include concurrent use of dexamethasone and a 5-HT3 antagonist (ondansetron, granisetron, or palonosetron). Use of these agents without the required combination is an exclusion and may result in denial.

NK1 agents (Emend/aprepitant/Cinvanti/Varubi) require combination with dexamethasone and a 5-HT3 antagonist (Zofran, Kytril, or Aloxi)

Documentation Required

Required Supporting Documentation

Use must be supported by one of the following sources: FDA-approved product labeling, CMS‑recognized compendia, NCCN or ASCO clinical guidelines, or acceptable peer-reviewed literature that meets CMS criteria (per CMS Medicare Benefit Policy Manual Chapter 15).

Acceptable supporting documentation: FDA labeling; CMS compendia; NCCN or ASCO guidelines; peer‑reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 requirements

Denial Risk

Triggers for Denial

The following are triggers for denial and are not approvable under this policy:

Use of listed agents for prevention or treatment of radiation‑induced or total body irradiation (TBI)–induced nausea/vomiting, or for treatment of breakthrough nausea/vomiting (Aloxi, Akynzeo, Sancuso, Sustol, Emend, Cinvanti, Varubi)
Use of Emend/Cinvanti/Varubi without a 5‑HT3 receptor antagonist and dexamethasone
Dosing that exceeds single‑dose maximum limits (examples include: IV ondansetron >16 mg; oral ondansetron >24 mg; granisetron >2 mg IV/PO; Sancuso patch >3.1 mg; Anzemet >100 mg; Aloxi >0.25 mg IV or >0.5 mg PO; Akynzeo >300 mg/0.5 mg oral or >235 mg/0.25 mg IV; Sustol >10 mg)
Dosing that exceeds single‑dose limits for NK1 agents (aprepitant oral >125 mg; fosaprepitant injection >150 mg; rolapitant oral >180 mg; aprepitant injection >130 mg)
Investigational or off‑label antiemetic use lacking sufficient evidence per CMS compendia or acceptable peer‑reviewed literature (including inadequate representation of patient/cancer characteristics or administered oncologic regimen in the evidence)

Definitions

Continuation request — definition and exemption criteria

DefinitionA continuation request is a request to continue a medication previously authorized; it is exempt from new-policy restrictions if all continuation criteria are met.

Exemption criterion 1Member has not experienced disease progression on the requested medication.

Exemption criterion 2Requested medication was used within the last year without a lapse of more than 30 days of having an active authorization.

Exemption criterion 3No additional medication(s) are being added to the continuation request.

Acceptable evidence for supporting use

Acceptable evidence — primary sourcesFDA‑approved product labeling

Acceptable evidence — compendia/guidelinesCMS‑recognized compendia, NCCN, or ASCO clinical guidelines

Acceptable evidence — literaturePeer‑reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 requirements

Initial Therapy Criteria

Initial therapy — Initial prophylaxis prior to chemotherapy

Initial prophylaxis prior to chemotherapy

5-HT3 options: Zofran (ondansetron), Kytril (granisetron), Aloxi (palonosetron), Sustol (granisetron extended release), Akynzeo (netupitant/fosnetupitant + palonosetron), and Sancuso (granisetron patch) may be used as prophylaxis prior to low, moderate, or high emetogenic risk chemotherapy. Only Zofran or Kytril are permitted for radiation-related prophylaxis or treatment (see exclusions).

Section II.B.1

NK1 addition: For prophylaxis prior to emetogenic chemotherapy, Emend (fosaprepitant/aprepitant), Cinvanti (aprepitant), or Varubi (rolapitant) should be given in combination with dexamethasone and one of the 5-HT3 antagonists (ondansetron, granisetron, or palonosetron).

Section II.B.2

Step	Requirement	Coverage
1
Use of an NK1 receptor antagonist (Emend [fosaprepitant/aprepitant], Cinvanti [aprepitant injection], or Varubi [rolapitant]) must be co-administered with dexamethasone and a 5-HT3 antagonist (ondansetron, granisetron, or palonosetron) prior to administration of low-, moderate-, or high-emetogenic risk chemotherapy.
Covered with criteria

Quantity Limits & Single-Dose Maximums

Ondansetron (IV/oral) — single‑dose limits

IV ondansetronSingle IV dose ≤16 mg

Oral ondansetronSingle oral dose ≤24 mg

Policy noteDoses above these single‑dose limits are excluded per policy

Granisetron and patch/ER formulations — single‑dose limits

Granisetron (IV/PO)Single dose ≤2 mg

Sancuso (granisetron patch)Patch strength: 3.1 mg (single‑dose/patch)

Sustol (granisetron ER)Single dose: 10 mg

Aloxi (palonosetron) — single‑dose limits

Aloxi (palonosetron) IVSingle IV dose: 0.25 mg

Aloxi (palonosetron) oralSingle oral dose: 0.5 mg

Policy noteUse outside these single‑dose limits is excluded

Akynzeo (netupitant/palonosetron) — single‑dose limits

Akynzeo oralNetupitant 300 mg / palonosetron 0.5 mg (single oral dose)

Akynzeo IVFosnetupitant 235 mg / palonosetron 0.25 mg (single IV dose)

Policy noteDosing must not exceed the listed single‑dose amounts

Aprepitant / Fosaprepitant / Rolapitant — single‑dose limits

Aprepitant (oral)Single oral dose ≤125 mg

Fosaprepitant (injection)Single injection dose ≤150 mg

Rolapitant (oral)Single oral dose ≤180 mg

Aprepitant (injection)Single injection dose ≤130 mg

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