Sunflower Health PlanCommercial Clinical Policy

BAXDELA, Delafloxacin Meglumine Form


BAXDELA, Delafloxacin Meglumine Initial Approval Criteria

Notes: Approval duration: Up to 14 days for ABSSSI or up to 10 days for CABP, whichever is less.

Indications

(857134) Is the diagnosis for the patient either Acute Bacterial Skin and Skin Structure Infection (ABSSSI) or Community-Acquired Bacterial Pneumonia (CABP)? 
(857135) Is the patient 18 years of age or older? 
(857136) If the request is for continuation of therapy initiated in an acute care hospital from which the patient was discharged, does documentation support this? 
(857137) Does a Culture and Sensitivity (C&S) report confirm the current infection pathogen is susceptible to delafloxacin or has the provider documented that obtaining a C&S report is not feasible? 
(857138) Has there been a failure of at least two formulary antibiotics, one being a fluoroquinolone to which the isolated pathogen is susceptible according to the C&S report, unless contraindicated or adverse effects were experienced? 

YesNoN/A
YesNoN/A
YesNoN/A

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Effective Date

12/01/2017

Last Reviewed

NA

Original Document

  Reference



Delafloxacin (Baxdela®) is a fluoroquinolone antibiotic. FDA Approved Indication(s) Baxdela is indicated in adults for the treatment of:
• Acute bacterial skin and skin structure infections (ABSSSI) caused by the following susceptible microorganisms: o Gram-positive organisms: Staphylococcus aureus (including methicillin-resistant [MRSA] and methicillin-susceptible [MSSA] isolates), Staphylococcus haemolyticus, Staphylococcus lugdunensis, Streptococcus agalactiae, Streptococcus anginosus Group (including Streptococcus anginosus, Streptococcus intermedius, and Streptococcus constellatus), Streptococcus pyogenes, and Enterococcus faecalis o Gram-negative organisms: Escherichia coli, Enterobacter cloacae, Klebsiella pneumoniae, and Pseudomonas aeruginosa • Community-acquired bacterial pneumonia (CABP) caused by the following susceptible microorganisms:
o Gram-positive organisms: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible [MSSA] isolates only) o Gram-negative organisms: Klebsiella pneumoniae, Escherichia coli, Pseudomonas aeruginosa, Haemophilus influenzae, and Haemophilus arainfluenzae o Other organisms: Chlamydia pneumoniae, Legionella pneumophila, and Mycoplasma pneumoniae Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Baxdela is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Acute Bacterial Skin and Skin Structure Infection or Community-Acquired Bacterial Pneumonia (must meet all):

  1. Diagnosis of ABSSSI or CABP;

  2. Age ≥ 18 years;
    Page 1 of 7

    CLINICAL POLICY Delafloxacin

    1. Member meets one of the following (a or b): a. Request is for continuation of therapy initiated in an acute care hospital from which member was discharged; b. Both of the following (i and ii):
      i. Culture and sensitivity (C&S) report for the current infection shows isolated pathogen is susceptible to delafloxacin, unless provider submits documentation that obtaining a C&S report is not feasible; ii. Member meets one of the following (a, b, or c):
      a) Failure of ≥ 2 formulary antibiotics, one of which must be a fluoroquinolone, to which the isolated pathogen is susceptible (if available) per C&S report, unless clinically significant adverse effects are experienced or all are contraindicated;
      b) C&S report shows resistance or lack of susceptibility of the isolated pathogen to all formulary antibiotics FDA-approved for member's diagnosis;
      c) If provider documents that obtaining a C&S report is not feasible: Failure of ≥ 2 formulary antibiotics indicated for member’s diagnosis (if available), one of which must be a fluoroquinolone, unless clinically significant adverse effects are experienced or all are contraindicated;
    2. Dose does not exceed one of the following (a or b): a. IV: 600 mg (2 vials) per day; b. PO: 900 mg (2 tablets) per day. Approval duration: Duration of request, up to 14 days (ABSSSI), or up to 10 days (CABP) of total treatment, whichever is less
      B. Other diagnoses/indications (must meet 1 or 2):
    3. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
    4. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
      II. Continued Therapy A. All Indications in Section I (must meet all):
    5. Member meets one of the following (a, b, or c): Page 2 of 7

    CLINICAL POLICY Delafloxacin a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B); c. Request is for continuation of therapy initiated in an acute care hospital from which member was discharged;

  3. Member is responding positively to therapy;

  4. Member has not received more than the indicated therapy duration for current infection (a or b):
    a. ABSSSI: ≥ 14 days; b. CABP: ≥ 10 days;

    1. If request is for a dose increase, new dose does not exceed one of the following (a or b):
      a. IV: 600 mg (2 vials) per day; b. PO: 900 mg (2 tablets) per day. Approval duration: Up to 14 days (ABSSSI) or up to 10 days (CABP) of total treatment
      B. Other diagnoses/indications (must meet 1 or 2):
    2. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
    3. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
      III. Diagnoses/Indications for which coverage is NOT authorized:
      A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off-label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid or evidence of coverage documents.
      Page 3 of 7

    CLINICAL POLICY Delafloxacin IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key ABSSSI: acute bacterial skin and skin structure infection CABP: community-acquired bacterial pneumonia C&S: culture & sensitivity
    FDA: Food and Drug Administration MRSA: methicillin-resistant Staphylococcus aureus MSSA: methicillin-susceptible Staphylococcus aureus Appendix B: Therapeutic Alternatives
    This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization.
    Drug Name Dosing Regimen Dose Limit/ Maximum Dose Therapeutic alternatives include formulary fluoroquinolones or other antibiotics that are indicated for member’s diagnosis and have sufficient activity against the offending pathogen at the site of the infection. Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. Appendix C: Contraindications/Boxed Warnings • Contraindication(s): known hypersensitivity to Baxdela or other fluoroquinolones • Boxed warning(s): serious adverse reactions including tendinitis, tendon rupture, peripheral neuropathy, central nervous system effects, and exacerbation of myasthenia gravis V. Dosage and Administration
    Indication ABSSSI CABP Dosing Regimen • PO: 450 mg PO q12h • IV: 300 mg IV q12h • IV/PO: 300 mg IV q12h, then switch to 450 mg PO q12h Total Duration Maximum Dose PO: 900 mg/day
    5 to 14 days IV: 600 mg/day 5 to 10 days VI. Product Availability
    • Tablets: 450 mg
    • Lyophilized powder in a single dose vial for injection: 300 mg VII.