Akynzeo IV (fosnetupitant/palonosetron)
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Medical benefit pharmaceutical policy governing prior authorization and medical necessity criteria for Akynzeo IV for prevention of chemotherapy-induced nausea and vomiting across applicable Geisinger Health Plan lines of business.
No material clinical or coverage changes in this revision.
Coverage Criteria for Akynzeo IV
Commercial, Exchange, and CHIP - Covered when ALL of the following are met
Akynzeo IV will be considered medically necessary when ALL criteria are met:
Commercial/Exchange/CHIP alternative for moderately emetogenic chemotherapy
Or, for moderately emetogenic chemotherapy, coverage when ALL of the following are met:
Medicare line of business - Covered when ALL of the following are met
Akynzeo IV will be considered medically necessary for Medicare when ALL criteria are met:
Eligibility and contract-specific benefit limitations and exclusions apply. Coverage determinations found in line-of-business specific benefit documents take precedence and will supersede this policy. Providers must refer to the applicable member contract and benefit documents for any additional restrictions or limits that affect coverage for Akynzeo IV.
Dose Thresholds and Coding Notes
Provider Requirements and Authorization Actions
Prior authorization required — review by Medical Director or Designee
Prior authorization is required; requests will be reviewed by the Medical Director or their designee to determine medical necessity for Akynzeo IV.
Step requirement — prior treatment failure or contraindication required
Coverage requires documented prior treatment failure or a contraindication to specified agents before approval (see clinical criteria for required comparators and definitions of treatment failure).
- Commercial/Exchange/CHIP: treatment failure or contraindication to at least one NK-1 antagonist (e.g., fosaprepitant, aprepitant).
- Moderately emetogenic chemo alternative: treatment failure or contraindication to palonosetron AND either ondansetron or granisetron.
- Medicare: treatment failure or contraindication to a corticosteroid plus a 5-HT3 RA OR presence of NCCN-defined additional patient risk factors.
Required documentation — medical records showing indication and prior agent failure/contraindication
Submit medical record documentation demonstrating the indication: that Akynzeo is being used to prevent acute and delayed nausea and vomiting with initial and/or repeat courses of highly or moderately emetogenic chemotherapy, and documentation of treatment failure or contraindication to the required prior agents.
- For Commercial/Exchange/CHIP: documentation of use for prevention with highly or moderately emetogenic chemotherapy and failure/contraindication to at least one NK-1 antagonist.
- For the moderate-emetogenic alternative: documentation of failure/contraindication to palonosetron AND either ondansetron or granisetron.
- For Medicare: documentation of failure/contraindication to corticosteroid plus a 5-HT3 RA or documentation of NCCN-defined risk factors.
Denial triggers — lack of required indication or prior-failure documentation
Claims may be denied if the medical record does not document that Akynzeo is being used for the prevention of acute and delayed nausea and vomiting with initial or repeat courses of highly or moderately emetogenic chemotherapy, or if required documentation of prior treatment failure/contraindication is absent.
- Missing documentation that the drug is for prevention of acute and delayed CINV for initial/repeat courses.
- Missing documentation of treatment failure or contraindication to the specified prior agents per line of business criteria.
Initial Therapy — Authorization Criteria
Initial Therapy — Initial approval criteria and duration
Initial approval criteria and duration
Continuation Therapy — Renewal and Ongoing Authorization
Continuation Therapy — Authorization duration and continuation requirements
Authorization duration and continuation requirements
Step Therapy Requirements
| Line of business / setting | Step therapy requirement (prior treatment failure or contraindication) |
|---|---|
| Commercial, Exchange, and CHIP - prevention of acute and delayed nausea and vomiting with highly emetogenic chemotherapy | Medical record documentation of treatment failure or contraindication to at least one NK‑1 antagonist (e.g., fosaprepitant, aprepitant). Treatment failure = allergy, intolerable side‑effects, significant drug–drug interaction, or lack of efficacy. |
| Commercial/Exchange/CHIP - alternate for moderately emetogenic chemotherapy | Medical record documentation of treatment failure or contraindication to palonosetron AND either ondansetron or granisetron. Treatment failure = allergy, intolerable side‑effects, significant drug–drug interaction, or lack of efficacy. |
| Medicare - prevention of acute and delayed nausea and vomiting with highly or moderately emetogenic chemotherapy | Medical record documentation of treatment failure or contraindication to a corticosteroid plus a 5‑HT3 RA (e.g., ondansetron or granisetron) OR presence of additional patient‑related risk factors for CINV per NCCN. Treatment failure = allergy, intolerable side‑effects, significant drug–drug interaction, or lack of efficacy. |
Background
Akynzeo IV is a fixed intravenous combination of fosnetupitant (the prodrug of netupitant, an NK1 receptor antagonist) and palonosetron (a 5-HT3 receptor antagonist) formulated to prevent chemotherapy-induced nausea and vomiting. The two agents act together to inhibit both acute and delayed emesis and are used as part of antiemetic regimens for patients receiving highly or moderately emetogenic cancer chemotherapy.
Use of Akynzeo IV requires prior authorization and must be medically justified in the record as prevention of acute and delayed nausea and vomiting associated with initial or repeat courses of emetogenic chemotherapy. Documentation should demonstrate the clinical indication and, where required by line of business, prior treatment failure or contraindication to specified prior agents (see coverage criteria).
Definitions
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