CurrentEmblemHealthPolicy MG.MM.PH.60

Akynzeo (fosnetupitant and palonosetron) Injection — Coverage Criteria

Policy governing medical necessity and coverage criteria for Akynzeo injection used with dexamethasone to prevent acute and delayed chemotherapy-induced nausea and vomiting in adults receiving highly emetogenic chemotherapy; applies to EmblemHealth/ConnectiCare members.

Policy Summary

PayerEmblemHealth

PolicyAkynzeo (fosnetupitant and palonosetron) Injection — Coverage Criteria

Policy CodePolicy MG.MM.PH.60

Change TypeUpdated HEC chartsadded exclusionsICD-10 updates

Effective Date

Next Review DateFeb 10, 2025

Key ActionObtain prior authorization demonstrating the patient meets initial criteria; approvals provided for up to 6 months and may be renewed.

SourceLink

POLICY UPDATE CHANGES

Updated HEC charts and added initial-criteria exclusions for breakthrough emesis, repeat dosing in multi-day regimens, and CINV related to anthracycline plus cyclophosphamide.

Addition of updated ICD-10 codes.

6 monthsinitial authorization length

1 vial/daydosing limit

J1454procedure code

2 NDCsNDCs

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Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Initial Criteria

Age: Patient is 18 years of age or older
Concomitant medication: Akynzeo will be used in combination with dexamethasone
Chemotherapy emetogenicity: Patient is undergoing highly emetogenic cancer chemotherapy (HEC)
Prior trial/failure: Patient has failed a trial of a 5-HT3 receptor antagonist in combination with an NK1 receptor antagonist while receiving the current chemotherapy regimen, defined as either: two or more episodes of vomiting attributed to the current chemotherapy regimen; OR clinically significant adverse effects attributed to the 5-HT3 or NK1 receptor antagonist; OR contraindications to alternative 5-HT3 or NK1 receptor antagonists
Exclusions: Akynzeo is NOT covered for any of the following: breakthrough emesis; repeat dosing in multi-day emetogenic chemotherapy regimens; or CINV related to an anthracycline plus cyclophosphamide chemotherapy regimen (examples listed in policy)

Indication statement: Akynzeo is indicated in combination with dexamethasone for prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy in adults

Continuation/Renewal — Covered when ALL of the following are met

Covered when ALL of the following are met

Renewal Criteria

Continued eligibility: Patient continues to meet the criteria identified in the initial approval criteria
Disease response: Documented disease response
Toxicity: Absence of unacceptable toxicity from the drug (examples include severe hypersensitivity reactions, serotonin syndrome)

Authorization length: Coverage will be provided for 6 months and may be renewed

Akynzeo is not covered for the management of breakthrough emesis. The policy also excludes Akynzeo for repeat dosing in multi-day emetogenic chemotherapy regimens. Additionally, Akynzeo is not covered for chemotherapy‑induced nausea and vomiting (CINV) that is related to an anthracycline plus cyclophosphamide (AC) chemotherapy regimen as specified in the exclusions.

Use of Akynzeo for prevention of nausea and vomiting associated with an anthracycline plus cyclophosphamide chemotherapy regimen is considered investigational and not covered under this policy.

Regimen / Agent	Coverage status	Notes / Details
Trabectedin
not_covered
Listed among regimens/agents for which Akynzeo is not covered.

Applicable Codes and Limits

Applicable Procedure CodesHCPCSCovered

J1454

Injection, fosnetupitant 235 mg and palonosetron 0.25 mg

Applicable NDCsNDC

69639-0102-01	Injection, fosnetupitant 235 mg and palonosetron 0.25 mg
69639-0105-01	Injection, fosnetupitant 235 mg and palonosetron 0.25 mg

Applicable ICD-10 DiagnosesICD-10

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

1–10 of 16

1/2

Maximum vial per chemotherapy day

Maximum per chemotherapy day1 vial (fosnetupitant 235 mg and palonosetron 0.25 mg) on day 1 of chemotherapy per 7 days

Dose frequency limitOne administration permitted on day 1 of a chemotherapy course; subsequent doses limited to one per 7-day interval

Applicable product formulationVial containing fosnetupitant 235 mg and palonosetron 0.25 mg

What Providers Must Do

Prior Authorization

Prior Authorization Required

Prior authorization is required. Approval will be provided for up to 6 months and may be renewed.

Prior authorization required for initiation of therapy
Authorization duration: up to 6 months; renewal possible

Note

Clinical Evidence Submission

The treating physician or primary care provider must submit clinical evidence that the member meets the policy criteria for preauthorization. Without this documentation, EmblemHealth will not be able to properly review the request for preauthorization or for post-payment review.

Include documentation demonstrating the member meets all applicable policy criteria (see Initial Criteria)
Clinical rationale and supporting records should be provided with the request

Documentation Required

Documentation Requirement

Requests that lack the required clinical documentation will not be properly reviewed and may be denied.

Omissions of necessary clinical notes, prior treatment history, or evidence of failure/intolerance may result in denial

Step Therapy

Required Trial of 5-HT3 + NK1

Prior to approval, the member must have a documented trial and failure of a 5-HT3 receptor antagonist in combination with an NK1 receptor antagonist during the current chemotherapy regimen. Failure is defined as one of the following: two or more episodes of vomiting attributed to the current chemotherapy regimen; clinically significant adverse effects attributed to the 5-HT3 or NK1 agents; or contraindication(s) to alternative 5-HT3 or NK1 agents.

Examples of 5-HT3 agents: ondansetron, granisetron, palonosetron
Examples of NK1 agents: aprepitant, fosaprepitant, rolapitant
Document number and timing of vomiting episodes, adverse effects, or specific contraindications

Key Definitions

Akynzeo (fosnetupitant and palonosetron) injection — definition and indication summary

Drug descriptionCombination injection of palonosetron (5-HT3 receptor antagonist) and fosnetupitant (NK1 receptor antagonist)

Indication summaryIndicated in combination with dexamethasone for prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy in adults

Mechanism notesPalonosetron prevents acute-phase CINV; fosnetupitant prevents both acute and delayed-phase CINV

Highly Emetogenic Chemotherapy (HEC) — examples and notes

Core HEC examplesIncludes agents such as dacarbazine, cisplatin-containing regimens, mechlorethamine and others listed as Highly Emetogenic Chemotherapy (HEC)

Regimens that may be considered HECFOLFOX and FOLFIRI may be considered highly emetogenic in certain patients

Agents considered HEC in certain patientsDaunorubicin and high‑dose methotrexate (>250 mg/m2) can be considered HEC in certain patients

Clinical application noteUse of Akynzeo is for prevention of CINV with HEC regimens except where exclusions apply (e.g., anthracycline + cyclophosphamide regimens as noted in policy exclusions)

Revision History

2025-02-10coding updateLatest

Added updated ICD-10 codes to the policy.

2024-04-29criteria revision

Annual review updated HEC charts and added exclusions to initial criteria for breakthrough emesis, repeat dosing in multi-day regimens, and CINV related to anthracycline plus cyclophosphamide.

2023-08-10coding update

Annual review removed ICD-10 codes R11.13, R11.14, T45.1X5D and added T45.95XA and T50.905A.

2022-03-17procedure code change

Updated procedure code to Q2055 and migrated policy to a new template.

2018-12-03procedure code update

Added J1454 and removed J3590 and C9033 from applicable procedure codes.