CurrentCignaPolicy IP0373

Delafloxacin (Baxdela) — Oral therapy medical necessity (ABSSSI, CABP)

Defines Cigna's medical necessity criteria, authorization durations, and coverage stance for oral delafloxacin (Baxdela) in adults for ABSSSI and CABP; applies to Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyDelafloxacin (Baxdela) — Oral therapy medical necessity (ABSSSI, CABP)

Policy CodePolicy IP0373

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization with documentation of failure, contraindication, or intolerance to appropriate first-line therapies; initial approvals: up to 14 days for ABSSSI and up to 10 days for CABP.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2Indications covered (ABSSSI, CABP)

14 daysMax initial authorization for ABSSSI

10 daysMax initial authorization for CABP

Boxed WarningSerious fluoroquinolone safety concerns

Coverage Criteria for Oral Delafloxacin (Baxdela)

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Initial therapy — ABSSSI

Delafloxacin (Baxdela) is considered medically necessary when ONE of the following is met:

Adult ABSSSI

ABSSSI requirements
- Documentation of failure, contraindication, or intolerance to an appropriate first-line therapy (for example: ceftriaxone, cefazolin, cephalexin, clindamycin, linezolid, piperacillin-tazobactam, sulfamethoxazole-trimethoprim (SMX-TMP), vancomycin)

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title": "Initial therapy — ABSSSI

ref": "b0_0"

title":

Continuation Therapy

Continuation of therapy

Transition or continuation
- Transitioning from IV delafloxacin to oral therapy
- Started on oral delafloxacin in an inpatient facility and continuing therapy

Duration guidance: When coverage is available and medically necessary, dosage, frequency, duration of therapy, and site of care should be reasonable, clinically appropriate, and supported by evidence-based literature; adjust based upon severity, alternative available treatments, and previous response to therapy

Provider Requirements and Authorization Rules

Prior Authorization

Prior Authorization Required

Prior authorization is required for Delafloxacin (Baxdela). Initial approvals are limited to the following durations when criteria are met: up to 14 days for acute bacterial skin and skin structure infections (ABSSSI) and up to 10 days for community-acquired bacterial pneumonia (CABP). Reauthorization is not applicable.

Initial approval duration — ABSSSI: up to 14 days
Initial approval duration — CABP: up to 10 days
Reauthorization: not applicable

Step Therapy

Step Therapy Requirement

Delafloxacin is considered only after failure, contraindication, or intolerance to appropriate first-line therapies for the requested indication. Providers must document prior use and outcome of those therapies.

Step therapy expectation: trial and failure, contraindication, or intolerance to appropriate first-line agents before approval

Documentation Required

Required Clinical Documentation

Requests must include clinical documentation demonstrating failure, contraindication, or intolerance to appropriate first-line therapies specific to the indication (ABSSSI or CABP), or other documentation as specified in the medical necessity criteria (e.g., need to transition from IV to oral delafloxacin or continuation after inpatient start).

For ABSSSI: documentation of failure, contraindication, or intolerance to appropriate first-line therapy (examples: ceftriaxone, cefazolin, cephalexin, clindamycin, linezolid, piperacillin-tazobactam, SMX-TMP, vancomycin).
For CABP: documentation of failure, contraindication, or intolerance to appropriate first-line therapy (examples: amoxicillin, doxycycline, macrolide such as azithromycin or clarithromycin, respiratory fluoroquinolone such as levofloxacin or moxifloxacin, or combination therapy with amoxicillin/clavulanate or cephalosporin plus a macrolide or doxycycline).
If requesting continuation: documentation that the patient is transitioning from IV to oral delafloxacin or was started on oral delafloxacin in an inpatient setting and is continuing therapy.

Denial Risk

Lack of Prior Therapy Documentation May Lead to Denial

Requests lacking documentation of prior therapy (failure, contraindication, or intolerance to appropriate first-line agents) for the requested indication may be denied.

Absence of documented trial and failure or documented contraindication/intolerance to first-line agents is a denial risk

Denial Risk

Unsupported Indications — Not Covered

Use of delafloxacin for any indication other than ABSSSI or CABP is considered experimental, investigational, or unproven and is not covered.

Unsupported indications: any use outside of treatment for ABSSSI or CABP

Drug Background and Policy Scope

Delafloxacin (Baxdela) is an oral fluoroquinolone antibacterial indicated in adults for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP) caused by specified susceptible organisms. This policy applies only to the oral formulation of delafloxacin; the use of the intravenous formulation is not addressed here. When available, culture and susceptibility data should guide agent selection to limit resistance.

Indication scope — oral formulation only

Product scopePolicy applies only to oral delafloxacin (Baxdela) in adults; IV delafloxacin is not addressed by this coverage policy.

Indications coveredAcute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP) in adults.

Age groupAdults only (per product indication and policy scope).

Sample product noteReceipt of sample product does not satisfy coverage criteria requirements.

Safety concern — fluoroquinolone boxed warnings

Class warningDelafloxacin is a fluoroquinolone with a Boxed Warning for disabling and potentially irreversible serious adverse reactions.

Key adverse reactionsTendinitis and tendon rupture, peripheral neuropathy, and central nervous system (CNS) effects.

Special population riskMay exacerbate muscle weakness in patients with myasthenia gravis.

Clinical implicationSerious risks should be considered when prescribing; monitor patients and reserve use for appropriate indications.