Akynzeo (netupitant and palonosetron)

POLICY NUMBER

L.5.01.531

Akynzeo (netupitant and palonosetron) capsules

Akynzeo (fosnetupitant and palonosetron) injection

Please perform a formulary drug search on your patient’s Member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific Member’s benefit plan.

DESCRIPTION

Akynzeo capsules are an oral combination product of netupitant, a substance P/neurokinin 1 (NK-1) receptor antagonist, and palonosetron, a serotonin-3 (5-HT3) receptor antagonist. Both netupitant and palonosetron are anti-nausea and anti-emetic agents. Akynzeo for injection is a combination of palonosetron and fosnetupitant, a prodrug of netupitant.

Akynzeo (netupitant and palonosetron) capsule is indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. Akynzeo (fosnetupitant and palonosetron) for injection and for intravenous use are indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy. Palonosetron prevents nausea and vomiting during the acute phase and netupitant prevents nausea and vomiting during both the acute and delayed phase after cancer chemotherapy.

POLICY

Akynzeo (netupitant and palonosetron) capsules and Akynzeo (fosnetupitant and palonosetron) injection are considered not medically necessary for the prevention of chemotherapy-induced nausea and vomiting as there is insufficient evidence of greater clinical benefit when compared to other available treatment options.

POLICY EXCEPTIONS

State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

1. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

2. appropriate with regard to standards of good medical practice; and

3. not solely for the convenience of the Member, his or her Provider; and

4. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

POLICY HISTORY

07/28/2020: New policy added. Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee.

01/22/2021: Policy description updated regarding Akynzeo capsules and Akynzeo for injection. Policy statement revised to state that Akynzeo (netupitant and palonosetron) capsules and Akynzeo (fosnetupitant and palonosetron) injection are considered not medically necessary for the treatment chemotherapy-induced nausea and vomiting as there is insufficient evidence of greater clinical benefit when compared to other available treatment options. Policy Guidelines updated to define medically necessary.

07/13/2021: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Updated drug name at the top of the policy. Policy Guidelines updated to remove definition of investigative. Sources updated.

02/01/2023: Policy Exceptions updated to add the following: State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.

10/01/2024: Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Sources updated.

09/09/2025: Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Policy description updated regarding indications for Akynzeo (fosnetupitant and palonosetron). Policy statement revised to change "treatment" to "prevention." Sources updated.

SOURCE(S)

Akynzeo prescribing information, Helsinn Therapeutics (U.S.), Inc. December 2023. Last accessed June 2025.

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

Not Medically Necessary Codes

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