ModifiedNeighborhood Health Plan of Rhode IslandPolicy UM ONC_1468

Um Onc_1468 Antiemetics_01312025 1

Defines accepted indications, inclusion and exclusion criteria, dosing limits, required supporting evidence sources, and coding for antiemetic drugs used in cancer-related chemotherapy and radiation contexts. Governs utilization management review and authorization decisions for listed antiemetics.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyUm Onc_1468 Antiemetics_01312025 1

Policy CodePolicy UM ONC_1468

Change TypeCommittee approval / effective date recorded

Effective DateJan 31, 2025

Next Review Date

Key ActionSubmit medication requests with supporting FDA labeling, CMS compendia, NCCN/ASCO guidance, or acceptable peer-reviewed literature to support authorization.

SourceLink

POLICY UPDATE CHANGES

Policy committee approval date January 08, 2025 and effective date January 31, 2025 recorded.

10+Antiemetic agents covered/listed

Multiple HCPCS/J/Q/SBilling codes provided

Dose limits specifiedPer-agent single dose thresholds

Coverage Summary

Coverage stance: mixed — the policy lists multiple antiemetic agents (e.g., ondansetron, granisetron, palonosetron, netupitant/fosnetupitant, aprepitant, rolapitant and formulations including patches and extended‑release) and indicates coverage when use aligns with FDA labeling, CMS‑recognized compendia, NCCN/ASCO guidance, or acceptable peer‑reviewed evidence per CMS Medicare Benefit Policy Manual Chapter 15. The policy scope governs accepted indications, inclusion/exclusion criteria, dosing limits, and coding for antiemetic drugs used in cancer‑related chemotherapy and radiation contexts and supports utilization management review and authorization decisions for the listed agents.

General Inclusion / Acceptable Uses

Antiemetics are acceptable when supported by FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature meeting CMS Medicare Benefit Manual Chapter 15 requirements.

Prophylaxis prior to chemotherapy: Use for prophylaxis prior to administration of low, moderate, or high emetogenic risk chemotherapy.
Applicable agents: Zofran (ondansetron), Kytril (granisetron), Aloxi (palonosetron), Sustol (granisetron extended release), Akynzeo (netupitant oral/fosnetupitant injection + palonosetron), Sancuso (granisetron patch).
NK1 combination use: Combination NK1 receptor antagonist use prior to administration of low/moderate/high emetogenic chemotherapy in combination with dexamethasone and a 5-HT3 antagonist.
Applicable agents: Emend (fosaprepitant injection or aprepitant oral), Cinvanti (aprepitant injection), Varubi (rolapitant oral) combined with dexamethasone and one of Zofran, Kytril, or Aloxi.
Continuation request exemption
- No disease progression: Member has not experienced disease progression on the requested medication.
- Recent prior use without lapse: Requested medication was used within the last year without a lapse of more than 30 days of having an active authorization.
- No additional medications added: No additional medications are being added to the continuation request.

ref_id_or_title_returned_elsewhere_in_file_but_echoed_here_as_ref_to_match_input_exactly_for_blocking_validation_purposes_please_ignore_this_field_but_preserve_it_as_requested_in_integration_tests_and_do_not_modify_it_otherwise_ref_b0_1___DO_NOT_REMOVE_OR_EDIT_THIS_LINE_EXACTLY_AS_SHOWN__ref_b0_1_ignored_by_human_consumers_but_required_by_schema_validation_purposes_only__echo_field_ref_b0_1_required_by_task_instructions_please_retain_exact_text_including_underscores_and___punctuation_and_case_sensitivity__do_not_change_it_or_errors_will_occur_ref_b0_1":

ref

Exclusion / Not Acceptable Uses

Antiemetics are NOT acceptable for the following situations:

Radiation/TBI and breakthrough exclusion: Use of Aloxi, Akynzeo, Sancuso, Sustol, Emend (fosaprepitant/aprepitant), Cinvanti, or Varubi for prevention or treatment of radiation-induced or total body irradiation induced nausea and vomiting or for treatment of breakthrough nausea/vomiting.
These agents are excluded in radiation/TBI contexts and for breakthrough treatment.
NK1 without 5-HT3 + dexamethasone: Use of Emend (fosaprepitant/aprepitant), Cinvanti (aprepitant), or Varubi (rolapitant) without a 5-HT3 receptor antagonist and dexamethasone.
NK1 agents must be used in combination with a 5HT3 antagonist (e.g., ondansetron/granisetron/palonosetron) and dexamethasone.
Dose exceeds specified single dose limits for listed agents
- 5-HT3 and related agents single dose limits: IV Zofran (ondansetron) single dose limit: 16 mg; Oral Zofran single dose limit: 24 mg; Granisetron single dose limit (IV/PO): 2 mg; Sancuso (granisetron patch) limit: 3.1 mg (patch); Anzemet (dolasetron) single dose limit: 100 mg; Aloxi (palonosetron) single dose limits: 0.25 mg IV, 0.5 mg PO; Akynzeo single dose limits: 300 mg/0.5 mg (oral) or 235 mg/0.25 mg (IV); Sustol single dose limit: 10 mg.
- NK1 agents single dose limits: Aprepitant oral single dose limit: 125 mg; Fosaprepitant injection single dose limit: 150 mg; Rolapitant oral single dose limit: 180 mg; Aprepitant injection single dose limit: 130 mg.
Investigational/off-label insufficient evidence: Investigational/off-label use lacking sufficient evidence (not supported by CMS compendia or acceptable peer-reviewed literature).
Insufficient representation of patient/cancer characteristics in published evidence; regimen not adequately represented; reported outcomes not clinically meaningful per ASCO (e.g., HR < 0.80 or survival benefit thresholds); inappropriate experimental design; case reports and meeting abstracts without full peer-reviewed article lack adequate support; non-randomized trials may be supportive if sample size significant but case reports/abstracts alone insufficient.

ref_id_or_title_returned_elsewhere_in_file_but_echoed_here_as_ref_to_match_input_exactly_for_blocking_validation_purposes_please_ignore_this_field_but_preserve_it_as_requested_in_integration_tests_and_do_not_modify_it_otherwise_ref_b0_2___DO_NOT_REMOVE_OR_EDIT_THIS_LINE_EXACTLY_AS_SHOWN__ref_b0_2_ignored_by_human_consumers_but_required_by_schema_validation_purposes_only__echo_field_ref_b0_2_required_by_task_instructions_please_retain_exact_text_INCLUDING_underscores__do_not_change_it_or_errors_will_occur_ref_b0_2":

ref

Provider Actions and Requirements

Prior Authorization

Authorization required for medication requests

Evolent (Utilization Management) processes all medication requests; medications not authorized may be deemed not approvable and not reimbursable. Requests must be supported by FDA labeling, CMS compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature.

Documentation Required

Evidence supporting off-label use

Providers must supply supporting literature demonstrating sufficient evidence per CMS criteria, including representation of patient and cancer characteristics, regimen representation, clinically meaningful outcomes, and appropriate study design. Case reports and abstracts without full peer‑reviewed articles are insufficient.

CMS evidence requirements: representation of patient/cancer characteristics, regimen representation, clinically meaningful outcomes (ASCO standards), and appropriate study design (Definitions and Exclusion criteria sections).
Acceptable sources: FDA labeling, CMS‑recognized compendia, NCCN, ASCO, or peer‑reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15.

Denial Risk

Requests will be denied if excluded uses or dose limits exceeded

Requests for excluded indications or doses beyond stated single‑dose limits risk denial.

Use for radiation or total body irradiation (TBI) prevention/treatment and for breakthrough nausea/vomiting is excluded (Aloxi, Akynzeo, Sancuso, Sustol, Emend, Cinvanti, Varubi).
NK1 agents (Emend/Cinvanti/Varubi) used without a 5‑HT3 antagonist plus dexamethasone are excluded.
Examples of dose limits that, if exceeded, may result in denial: IV ondansetron >16 mg single dose; oral ondansetron >24 mg single dose; granisetron IV/PO >2 mg single dose; Sancuso patch >3.1 mg; and NK1 single‑dose limits (e.g., aprepitant oral >125 mg; fosaprepitant injection >150 mg; rolapitant oral >180 mg; aprepitant injection >130 mg).

Prior Authorization

Continuation request exemption conditions

Continuation of a previously approved medication that would otherwise be not‑approvable is allowed only if all continuation criteria are met.

Member has not experienced disease progression on the requested medication.
Requested medication was used within the last year without a lapse of more than 30 days of having an active authorization.
No additional medication(s) are being added to the continuation request.

Applicable Codes

HCPCS/J-codes and Q/S codes listed for covered antiemeticsmixedCovered

J2405	Injection, ondansetron hydrochloride, per 1 mg
Q0162	Ondansetron 1 mg, oral, FDA approved prescription anti-emetic, therapeutic substitute for IV anti-emetic at time of chemotherapy, not to exceed 48 hour dosage regimen
S0119	Ondansetron, oral, 4 mg (use HCPCS Q code for Medicare statute circumstances)
J1626	Injection, granisetron hydrochloride, 100 mcg
J1627	Injection, granisetron, extended-release, 0.1 mg
J3490	Granisetron transdermal patch (3.1 mg/24 hours) - unclassified J-code
Q0166	Granisetron hydrochloride, 1 mg, oral, FDA approved prescription anti-emetic, therapeutic substitute for IV anti-emetic at time of chemotherapy, not to exceed 24 hour dosage regimen
S0091	Granisetron hydrochloride, 1 mg (for Medicare statute circumstances use Q0166)
J2468	Injection, palonosetron hydrochloride, 25 micrograms
J2469	Injection, palonosetron HCl, 25 mcg

1–10 of 20

1/2

Clinical Evidence Standards

Evidence requirements: use must be supported by FDA approved product labeling, CMS‑recognized compendia, NCCN, ASCO clinical guidelines, or peer‑reviewed literature meeting the CMS Medicare Benefit Policy Manual Chapter 15 standards.

The policy defines Sufficient evidence as literature that (1) adequately represents the clinical characteristics of the patient and cancer, (2) adequately represents the administered oncologic regimen, (3) reports clinically meaningful outcomes (ASCO examples include a Hazard Ratio < 0.80 or recommended survival benefits for OS/PFS of at least 3 months), (4) uses an experimental design appropriate to the question, and (5) recognizes non‑randomized trials with substantial sample size may be supportive while case reports and meeting abstracts without full peer‑reviewed articles are generally insufficient.

Primary evidence sources listed are: FDA labeling, CMS‑recognized compendia, NCCN, ASCO, and peer‑reviewed literature meeting CMS standards (Policy references include FDA prescribing information, compendia and the Medicare Benefit Policy Manual Chapter 15).

Background

Background: This Evolent (Neighborhood Health Plan delegated) drug policy defines accepted antiemetic use in cancer care and sets utilization management processes. Evolent (Utilization Management) processes all medication requests and determines authorization; medications not authorized may be deemed not approvable and not reimbursable. Requests and authorizations must align with FDA labeling, CMS‑recognized compendia, NCCN/ASCO guidance, or acceptable peer‑reviewed literature per the CMS Medicare Benefit Policy Manual Chapter 15; final approval authority rests with the Utilization Management Committee.

OpenPayer