ModifiedCentenePolicy CP PMN.185

Baloxavir Marboxil (Xofluza) coverage

Defines medical necessity and prior authorization requirements for baloxavir marboxil (Xofluza) for treatment of acute uncomplicated influenza and post-exposure prophylaxis in eligible members of Centene-affiliated health plans.

Policy Summary

PayerCentene

PolicyBaloxavir Marboxil (Xofluza) coverage

Policy CodePolicy CP PMN.185

Change TypePediatric expansionadded PEP and formulation guidance

Effective DateDec 1, 2018

Next Review Date

Key ActionSubmit prior authorization with documentation that the member meets approval criteria (age, timing, lab confirmation or exposure, and oseltamivir use/exception).

SourceLink

POLICY UPDATE CHANGES

Updated pediatric age indication to include patients 5 years of age and older and removed prior weight >= 40 kg requirement.

Post-exposure prophylaxis indication and oral suspension formulation were added, with redirection to tablets unless unable to swallow.

Updated FDA Approved Indication section to specify use in healthy or high risk patients.

New indication: influenza post-exposure prophylaxis and oral suspension formulation added with redirection to oral tablets unless unable to swallow.

Pediatric age indication expanded from at least 12 years to at least 5 years for high-risk patients; removed previous weight >= 40 kg requirement.

New dosage form packets for oral suspension added.

>=5 yrsminimum age for treatment or PEP

1 dose

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Coverage Criteria for Baloxavir marboxil (Xofluza)

Initial Approval — Influenza Treatment and Post‑Exposure Prophylaxis

Covered when ALL of the following are met

Primary criteria

Age requirement: Patient is at least 5 years of age.>= 5 years
Timing for treatment: For treatment, patient has been symptomatic for no more than 48 hours.<= 48 hours since symptom onset
Laboratory confirmation / exposure clarity: Laboratory confirmation of influenza infection OR documented contact with an individual who has influenza (for post-exposure prophylaxis).
Oseltamivir use/exception: Member must use oseltamivir unless one of the following applies: high prevalence of influenza B in the community; prior oseltamivir administration in the current influenza season; documented oseltamivir community resistance this season; oseltamivir contraindication or history of clinically significant adverse effects; or other acceptable medical justification.
Examples of acceptable medical justification are provided in Appendix D.
Dosing limits: Dose must not exceed specified single-dose maximums based on weight per prescribing information.Maximum single dose = 80 mg once; weight-based dosing: <20 kg — 2 mg/kg PO once (bottles) or 30 mg packet for 15 to <20 kg; 20 to <80 kg — 40 mg PO once; >=80 kg — 80 mg PO once.
Oral suspension (bottles or packets) may be administered via enteral feeding tube when needed.

Approval duration: Approval is for a single-dose course.Approval duration: 4 weeks (one dose only)

Coverage conditions (summary from updates)

Covered when ALL of the following are met (as implied by policy updates):

Age and risk: Patient meets the FDA-approved age indication; pediatric expansion allows use in patients aged >= 5 years (per PI) including those who are high risk of influenza-related complications.age >=5 years for pediatric high-risk indication

Policy updated to expand pediatric indication to >=5 years and to align high-risk factors with CDC (Appendix D).

Indication: Use is for an FDA-approved indication as specified in the policy (treatment of acute uncomplicated influenza or post-exposure prophylaxis).post-exposure prophylaxis allowed per RT4

RT4 added post-exposure prophylaxis indication and oral suspension form.

Formulation preference: Oral tablets are preferred; oral suspension (bottles or packets) or packets are permitted when the member is unable to swallow tablets or requires enteral administration, with documented medical justification.

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider supplies sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies: CP.CPA.09 (commercial), HIM.PA.154 (Health Insurance Marketplace), or CP.PMN.53 (Medicaid) or other plan evidence of coverage documents.

A prior weight requirement of ≥ 40 kg that previously appeared in the policy has been removed following the pediatric expansion updates. Providers should use current FDA prescribing information and the policy criteria for dosing and age eligibility rather than the former weight threshold.

Re‑authorization or continuation requests are not permitted under this policy. Members must meet the initial approval criteria each time a new request for baloxavir marboxil is submitted; continuation requests alone do not satisfy coverage criteria.

If a request does not meet an FDA‑approved indication described in this policy or the provider fails to provide required supporting documentation (for example, chart notes, laboratory confirmation of influenza, documented exposure for PEP, age/weight, or acceptable medical justification for alternative formulation or oseltamivir exemption), the request is implied to be not covered. Such requests may be denied under the policy's documentation and off‑label use provisions.

Product Availability, Dosing, and Codes

Product availability (NDCs not specified)NDC

NDC not listed

Tablets: 40 mg, 80 mg; Oral suspension (bottle): 40 mg/20 mL (2 mg/mL); Oral suspension (packets): 30 mg, 40 mg

Affected codes (referenced)mixed

affected codes

Document references affected codes for prior authorization but specific CPT/HCPCS/NDC codes are not listed in these chunks.

inv-09: Maximum single dose — 80 mg once

Maximum single dose80 mg once

Source dosing contextMaximum dose applies to influenza treatment or post-exposure prophylaxis single-dose course

Administration noteOne-dose course only; oral suspension may be given via enteral feeding tube when needed

inv-10: Weight-based dosing thresholds — dosing for <20 kg, 20 to <80 kg, and >=80 kg

<20 kgOral suspension bottles: 2 mg/kg PO once; packets (for 15 kg to <20 kg): 30 mg PO once

20 to <80 kg40 mg PO once (oral suspension bottles/packets or tablets)

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for baloxavir marboxil (Xofluza). Providers must obtain prior authorization and submit documentation demonstrating the member meets the policy's approval criteria (see clinical criteria and Appendix D for high-risk factors).

Prior authorization required for all requests for baloxavir marboxil (treatment or post-exposure prophylaxis).
Requests must align with the current FDA-approved indication (age and risk-status requirements) and the plan's clinical criteria.

Step Therapy

Step Therapy Requirement — Oseltamivir First

Oseltamivir (Tamiflu) must be tried and documented as the preferred initial therapy unless an exception applies. If the member is unable to use oseltamivir due to contraindication, prior administration during the current influenza season, documented community oseltamivir resistance, high prevalence of influenza B where baloxavir may be preferred, or other acceptable medical justification (see Appendix D), baloxavir may be considered.

Step therapy: oseltamivir required first for treatment or prophylaxis unless documented exception present.

Background

Baloxavir marboxil (Xofluza) is an oral antiviral that acts as a PA endonuclease inhibitor. It is FDA‑approved for the treatment of acute uncomplicated influenza in patients who meet age and timing criteria (symptom onset within 48 hours) and for post‑exposure prophylaxis following contact with a person who has influenza. Clinical benefit may be influenced by viral susceptibility and circulating resistance patterns; providers should follow the dosing, age, and formulation guidance in the prescribing information and this policy when requesting coverage.

Definitions and Key Terms

inv-21: Baloxavir marboxil mechanism — PA endonuclease inhibitor

Mechanism of actionPA (polymerase acidic) endonuclease inhibitor

Drug nameBaloxavir marboxil (Xofluza)

Clinical implicationAntiviral activity may be affected by viral subtype and resistance patterns

inv-22: FDA approved indications — treatment and PEP age and timing specifics

Treatment indicationTreatment of acute uncomplicated influenza in patients 5 years of age and older who have been symptomatic for no more than 48 hours (healthy or high-risk)

Post-exposure prophylaxis (PEP)PEP following contact with an individual who has influenza in patients 5 years of age and older

Revision History and Policy Changes

2020-01-15added

Post-exposure prophylaxis indication and oral suspension formulation were added; policy redirected to oral tablets unless unable to swallow, minimum weight per PI and examples of acceptable medical justification for inability to use oseltamivir were included.

2020-07-01revised

FDA Approved Indication section updated to specify use in healthy or high-risk patients and references were reviewed and updated during the 4Q 2020 annual review.

2021-06-28revised

Policy Summary

PayerCentene

PolicyBaloxavir Marboxil (Xofluza) coverage

Policy CodePolicy CP PMN.185

Change TypePediatric expansionadded PEP and formulation guidance

Effective DateDec 1, 2018

Next Review Date

Key ActionSubmit prior authorization with documentation that the member meets approval criteria (age, timing, lab confirmation or exposure, and oseltamivir use/exception).

SourceLink

On This Page

Documentation Required

Required Supporting Documentation

Provider must submit supporting clinical documentation with the prior authorization request. Incomplete or missing documentation may result in denial.

Required supporting documentation includes office chart notes, diagnostic test results (e.g., laboratory confirmation of influenza where applicable), medication history showing oseltamivir use or rationale for not using oseltamivir, and any relevant specialist notes.
For oral suspension requests, include documentation that the member is unable to swallow tablets, has difficulty swallowing, or requires enteral administration.

Documentation Required

Insufficient Documentation / Non‑Covered Indication

Requests lacking required documentation or submitted for non‑FDA‑approved indications (unless adequate off‑label justification per applicable off‑label use policies) are not authorized.

Non‑FDA indications require supporting evidence per off‑label use policies (CP CPA.09, HIM.PA.154, CP PMN.53) and may still be denied if insufficient.
If documentation does not demonstrate age, indication, high‑risk status, or other required criteria, the request will not be approved.

Denial Risk

Potential Denial for Not Meeting Updated Indication

Requests that do not meet the updated FDA‑approved indication (for example, age minimum or absence of required high‑risk factors when indicated) are at high risk for denial. Ensure the request explicitly documents the indication and any high‑risk criteria per Appendix D.

Recent updates expanded pediatric use to age ≥5 years for certain high‑risk patients; verify member age and risk status.
Failure to document alignment with the current FDA‑approved indication (age, weight/minimum requirements per PI, and presence of high‑risk factors when required) may result in denial.