CurrentViva HealthPolicy IC-0363

Akynzeo (fosnetupitant/palonosetron) IV for prevention of chemotherapy-induced nausea and vomiting (CINV)

Prior authorization policy for intravenous Akynzeo for adults receiving emetogenic chemotherapy, defining initial and renewal criteria, dosing, coding, and limitations for Viva Health.

Policy Summary

PayerViva Health

PolicyAkynzeo (fosnetupitant/palonosetron) IV for prevention of CINV

Policy CodePolicy IC-0363

Change TypeNo material change

Effective Date

Next Review DateApr 1, 2026

Key ActionObtain prior authorization (initially issued for 180 days, renewable every 180 days) and document age ≥18, failed prior 5-HT3 + NK-1 RA therapy, chemotherapy emetogenicity, and concomitant meds.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18minimum patient age

6 monthsinitial authorization

1/7dmax units

J1454HCPCS

235/0.25 mgstrength per vial

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Initial Therapy

Covered when ALL of the following are met:

Age: Member is at least 18 years of age≥18 years

Prerequisite therapy failure: Member has failed with another generically available 5-HT3 receptor antagonist in combination with a neurokinin-1 receptor antagonist (NK-1 RA) while receiving the current anticancer chemotherapy regimen (failure = two or more documented episodes of vomiting attributed to the current regimen)failure defined as >=2 vomiting episodes

Emetogenicity and concomitant medications

HEC pathway: Member receiving HEC AND Akynzeo used with dexamethasone with or without olanzapine
HEC regimens listed in policy (e.g., cisplatin, carboplatin, etc.)
MEC pathway: Member receiving MEC AND Akynzeo used with dexamethasone AND (member has additional CINV risk factors OR prior failure with corticosteroid + 5-HT3 antagonist OR used as part of a 4-drug regimen with olanzapine and dexamethasone if not previously given)
MEC regimens listed in policy

Risk factors or prior failure alternatives for MEC: If receiving MEC, one of the following must apply: additional CINV risk factors, prior failure with corticosteroid + 5-HT3 antagonist, or use as part of a 4-drug regimen including olanzapine and dexamethasone if not previously given; also applies to members who experienced emesis on a prior cycle with a 3-drug regimen

Member risk factors are listed in the policy (e.g., younger age, female sex, prior CINV, low alcohol use, motion sickness, etc.)

Continuation / Renewal

Renewal authorized when ALL of the following are met:

Continued indication: Member continues to meet the indication-specific relevant criteria identified in initial approval (concomitant therapy requirements, performance status, etc.)

(Prerequisite therapy requirement is not re-applied at renewal)

Clinical benefit: Beneficial response as evidenced by reduction in nausea and/or vomiting

Tolerability: Absence of unacceptable toxicity from the drug (examples include severe hypersensitivity reactions, serotonin syndrome)

Requests for Akynzeo for breakthrough emesis, for repeat dosing in multi-day emetogenic chemotherapy regimens, or for chemotherapy‑induced nausea and vomiting (CINV) related to an anthracycline plus cyclophosphamide regimen are not covered.

Regimen / Setting	Concomitant medications	Coverage status
Highly emetogenic chemotherapy (HEC) regimens (examples: cisplatin, carboplatin, dacarbazine, doxorubicin, FOLFOX, FOLFIRINOX, FOLFIRI, oxaliplatin)	Dexamethasone with or without olanzapine	Covered when ALL initial criteria are met (member ≥18 years, prior failure with a 5-HT3 antagonist + NK-1 RA if required, single IV dose on Day 1 given ~30 minutes before chemotherapy).
Moderately emetogenic chemotherapy (MEC) regimens (examples: cyclophosphamide, melphalan, irinotecan, bendamustine, temozolomide, idarubicin, AC [any anthracycline + cyclophosphamide])	Dexamethasone; addition of olanzapine or authorization requires additional CINV risk factors or prior failure with corticosteroid + 5‑HT3 antagonist or use as part of a 4‑drug regimen as specified	Covered when ALL initial criteria are met and MEC-specific conditions apply (risk factors or prior failure as documented).
Not covered uses	Breakthrough emesis, repeat dosing in multi‑day emetogenic chemotherapy regimens, or CINV related to an anthracycline plus cyclophosphamide regimen	Not covered

first-line

Use: Administered on Day 1 prior to each chemotherapy cycle as CINV prophylaxis; single-dose IV administration (contents of 1 vial administered IV approximately 30 minutes before chemotherapy)Day 1, approximately 30 minutes prior to chemotherapy

1 vial = fosnetupitant 235 mg / palonosetron 0.25 mg (1 billable unit)

Billing, Units, and Diagnosis Codes

Covered HCPCS CodesHCPCSCovered

J1454

Injection, fosnetupitant 235 mg and palonosetron 0.25 mg; 1 billable unit = fosnetupitant 235 mg and palonosetron 0.25 mg

NDCsNDC

69639-0102-xx	Akynzeo single-dose vial (lyophilized powder) 235 mg/0.25 mg
69639-0105-xx	Akynzeo single-dose vial (solution; to-be-diluted) 235 mg/0.25 mg per 20 mL
69639-0106-xx	Akynzeo single-dose vial (solution; ready-to-use) 235 mg/0.25 mg per 20 mL

Covered Diagnosis Codes (ICD-10)ICD-10Covered

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

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1/2

inv-07: Max units per time — 1 billable unit per 7 days

Maximum billable units1 billable unit per 7 days

Unit definitionHCPCS billing units correspond to J1454 (1 billable unit = fosnetupitant 235 mg/palonosetron 0.25 mg)

Time windowMeasured over a 7-day period

Provider Requirements and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial authorization will be provided for 180 days (6 months). Authorization may be renewed every 180 days thereafter.

Initial prior authorization: 180 days
Renewal prior authorization: every 180 days

Step Therapy

Prerequisite Therapy

Member must have failed treatment with a generically available 5-HT3 receptor antagonist in combination with an NK-1 receptor antagonist while receiving the current anticancer chemotherapy regimen. Failure is defined as two or more documented episodes of vomiting attributed to the current chemotherapy regimen.

Examples of 5-HT3 antagonists: ondansetron, granisetron, palonosetron
Examples of NK-1 RAs: aprepitant, fosaprepitant, rolapitant

Documentation Required

Required Clinical Documentation

Documentation must include: member age (≥18 years), evidence of failed prior therapy with a generically available 5-HT3 antagonist plus an NK-1 RA while on the current chemotherapy regimen, the emetogenicity of the current chemotherapy (HEC or MEC), details of concomitant antiemetic regimen (dexamethasone ± olanzapine or olanzapine-containing 4-drug regimens when applicable), prior episodes of vomiting attributed to chemotherapy, response to treatment for renewals (reduction in nausea/vomiting), and absence of unacceptable toxicity.

Confirm member is ≥18 years of age
Record prior therapy trials and documented failure (≥2 vomiting episodes)
Specify chemotherapy emetogenicity (HEC or MEC) and concurrent antiemetics used
For renewal: document clinical benefit and absence of unacceptable toxicity (e.g., severe hypersensitivity, serotonin syndrome)

Denial Risk

Not Covered Conditions

Akynzeo is not covered for certain uses. Requests for these indications should be denied.

Breakthrough emesis
Repeat dosing in multi-day emetogenic chemotherapy regimens
CINV related to an anthracycline plus cyclophosphamide chemotherapy regimen

Background

Akynzeo is a fixed intravenous combination of fosnetupitant (an NK‑1 receptor antagonist prodrug) and palonosetron (a 5‑HT3 receptor antagonist) used for the prevention of chemotherapy‑induced nausea and vomiting (CINV). It is administered as a single IV dose on Day 1 prior to chemotherapy and is intended to be used in specified combinations with corticosteroids and, when appropriate, olanzapine depending on the emetogenicity of the chemotherapy regimen.

Per the policy, authorization for Akynzeo requires documented failure of a generically available 5‑HT3 antagonist plus an NK‑1 RA while receiving the current chemotherapy regimen (failure is defined as two or more documented episodes of vomiting attributed to that regimen). For members receiving highly emetogenic chemotherapy (HEC), Akynzeo must be used in combination with dexamethasone with or without olanzapine. For members receiving moderately emetogenic chemotherapy (MEC), Akynzeo must be used with dexamethasone and meet additional criteria (presence of risk factors for CINV, prior failure with corticosteroid plus a 5‑HT3 antagonist, or use as part of a 4‑drug regimen including olanzapine and dexamethasone if not previously given).

Definitions

inv-13: Failure — defined as two or more documented episodes of vomiting attributed to the current chemotherapy regimen.

Failure (definition)Two or more documented episodes of vomiting attributed to the current chemotherapy regimen

Context for useUsed to document prior treatment failure with a 5-HT3 antagonist plus an NK-1 RA while on the current anticancer regimen

Documentation requirementEpisodes must be attributable to the current chemotherapy regimen (per policy note)

inv-14: HEC / MEC — lists of agents/regimens considered HEC or MEC per references

HEC — selected single agentsIncludes agents such as Cisplatin, Carboplatin, Carmustine, Ifosfamide, Dacarbazine, Doxorubicin, Mechlorethamine

HEC — multi-drug regimensIncludes regimens considered HEC such as FOLFOX, FOLFIRI, FOLFIRINOX/FOLFOXIRI

MEC — selected agentsIncludes agents such as Cyclophosphamide, Epirubicin, Melphalan (≥140 mg/m2), Bendamustine, Irinotecan (liposomal)

MEC — other examplesIncludes agents/regimens listed as moderately emetogenic (e.g., Clofarabine, Cytarabine >200 mg/m2, Temozolomide)

OpenPayer

Akynzeo (fosnetupitant/palonosetron) IV for prevention of chemotherapy-induced nausea and vomiting (CINV)

Coverage Criteria for Akynzeo (IV)

Billing, Units, and Diagnosis Codes

Provider Requirements and Documentation

Background

Definitions