CurrentCignaPolicy IP0373

Medical Necessity Criteria for Delafloxacin (Baxdela)

Cigna coverage policy specifying medical necessity criteria for oral delafloxacin (Baxdela) in adults for ABSSSI and CABP, including required prior failure/contraindication/intolerance to first-line therapies, durations, continuation rules, and exclusions for other uses. IV delafloxacin not addressed.

Policy Summary

PayerCigna

PolicyMedical Necessity Criteria for Delafloxacin (Baxdela)

Policy CodePolicy IP0373

Change TypeNo material change

Effective Date

Next Review Date

Key ActionProviders must document failure, contraindication, or intolerance to an appropriate first-line therapy before oral delafloxacin is considered medically necessary for ABSSSI or CABP.

SourceLink

POLICY UPDATE CHANGES

No material clinical/coverage changes

2Covered Indications (adult)

14dMax duration ABSSSI

10dMax duration CABP

1Policy pages

Coverage Summary

This Cigna coverage policy (IP0373) addresses oral delafloxacin (Baxdela) for adults for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP). Intravenous delafloxacin is not addressed by this policy. Use for these indications is subject to medical necessity review and requires documentation of prior failure, contraindication, or intolerance to appropriate first-line therapies. When available, selection or modification of therapy should be guided by culture and susceptibility data and, in the absence of such data, by local epidemiology for empiric therapy.

Initial Therapy Criteria

Medical Necessity Criteria - Initial Therapy

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

ref_strictness_unchecked_field_ref_DO_NOT_EDIT_meowx2q0dfsdklfjklsdjfkl23sdasfSDfadsfref-DO-NOT-EDIT-THIS-FIELD-0001_REF_ALIGNMENT_FIX_WHEN_PARSING_ERROR_XYZ1234_ref_b1_0___DO_NOT_EDIT_THIS_FIELD_3f

ref

Continuation Therapy Criteria

Billing Rule

Authorization duration limits

Initial approval durations: ABSSSI up to 14 days; CABP up to 10 days. Reauthorization beyond initial approval is not applicable.

Not Covered / Exclusions

Denial Risk

Unapproved indications denial risk

Claims for uses other than ABSSSI or CABP in adults may be denied as experimental, investigational, or unproven.

Provider Actions & Authorization

Documentation Required

Document prior failure/contraindication/intolerance

Providers must document failure, contraindication, or intolerance to an appropriate first-line therapy before oral delafloxacin is considered medically necessary for ABSSSI or CABP.

Prior Authorization

Prior authorization required per policy

Coverage is subject to medical necessity review per this policy (policy identifier IP0373); authorization durations specified for approved indications must be adhered to.

Clinical Evidence & References

Prescribing information assessed: Baxdela prescribing information; 2021. Assessed October 2, 2023. The prescribing information advises that Baxdela should be used only to treat or prevent infections proven or strongly suspected to be caused by susceptible bacteria, and that culture and susceptibility information should be considered when available; in the absence of such data, local epidemiology and susceptibility patterns may inform empiric therapy.

Background & Definitions

Policy supports medical necessity review for oral delafloxacin (Baxdela) for adult treatment of ABSSSI and CABP. Intravenous delafloxacin is not addressed. Providers must document failure, contraindication, or intolerance to appropriate first-line therapies before oral delafloxacin is considered medically necessary. Use should be guided by culture and susceptibility data when available and by local epidemiology for empiric therapy.

Term	Definition
ABSSSI
Acute bacterial skin and skin structure infections
CABP
Community-acquired bacterial pneumonia