Pharmacy Benefit Coverage Criteria

Effective Date ...... 12/1/2020 Next Review Date… ...... 12/1/2021 Coverage Policy Number ...... P0045

Delafloxacin

Table of Contents Related Coverage Resources

Medical Necessity Criteria ...... 1 Oxazolidinone Antibiotics FDA Approved Indications ...... 2 Recommended Dosing ...... 2 Background ...... 3 References ...... 3

INSTRUCTIONS FOR USE The following Coverage Policy applies to health benefit plans administered by Cigna Companies. Certain Cigna Companies and/or lines of business only provide utilization review services to clients and do not make coverage determinations. References to standard benefit plan language and coverage determinations do not apply to those clients. Coverage Policies are intended to provide guidance in interpreting certain standard benefit plans administered by Cigna Companies. Please note, the terms of a customer’s particular benefit plan document [Group Service Agreement, Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document] may differ significantly from the standard benefit plans upon which these Coverage Policies are based. For example, a customer’s benefit plan document may contain a specific exclusion related to a topic addressed in a Coverage Policy. In the event of a conflict, a customer’s benefit plan document always supersedes the information in the Coverage Policies. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan document. Coverage determinations in each specific instance require consideration of 1) the terms of the applicable benefit plan document in effect on the date of service; 2) any applicable laws/regulations; 3) any relevant collateral source materials including Coverage Policies and; 4) the specific facts of the particular situation. Coverage Policies relate exclusively to the administration of health benefit plans. Coverage Policies are not recommendations for treatment and should never be used as treatment guidelines. In certain markets, delegated vendor guidelines may be used to support medical necessity and other coverage determinations.

Medical Necessity Criteria

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

1. Treatment of adults with acute bacterial skin and skin structure infections (ABSSSI) when there is failure, contraindication, or intolerance to appropriate first line therapy (for example: ceftriaxone, cefazolin, cephalexin, clindamycin, linezolid, piperacillin-tazobactam, vancomycin)

2. Treatment of adults with community-acquired bacterial pneumonia (CABP) when there is failure, contraindication or intolerance to appropriate first line therapy (for example: amoxicillin, doxycycline, macrolide (i.e., azithromycin or clarithromycin), respiratory fluoroquinolone (i.e., levofloxacin or moxifloxacin) or combination therapy with amoxicillin/clavulanate or cephalosporin AND a macrolide or doxycycline)

3. For the continuation of delafloxacin (Baxdela™) to complete a course of therapy when ONE of the following is met: a. The individual is transitioning from intravenous (IV) delafloxacin to oral therapy OR b. The individual was started on oral delafloxacin in an inpatient facility and is continuing therapy

Authorization is for a single course of therapy as follows: o Acute bacterial skin and skin structure infections (ABSSSI) for a treatment duration up to 14 days o Community-acquired bacterial pneumonia (CABP) for a treatment duration up to 10 days Page 1 of 3 Pharmacy Benefit Clinical Criteria: P0045

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

Delafloxacin (Baxdela™) is considered experimental, investigational or unproven for ANY other use.

Note: Receipt of sample product does not satisfy any criteria requirements for coverage.

FDA Approved Indications

FDA Approved Indications

Acute Bacterial Skin and Skin Structure Infections Baxdela is indicated in adults for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by the following susceptible microorganisms: 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, Enterococcus faecalis, Escherichia coli, Enterobacter cloacae, Klebsiella pneumoniae, and Pseudomonas aeruginosa.

Community-Acquired Bacterial Pneumonia Baxdela is indicated in adults for the treatment of community-acquired bacterial pneumonia (CABP) caused by the following susceptible microorganisms: Streptococcus pneumoniae, Staphylococcus aureus (methicillinsusceptible [MSSA] isolates only), Klebsiella pneumoniae, Escherichia coli, Pseudomonas aeruginosa, Haemophilus influenzae, Haemophilus parainfluenzae, Chlamydia pneumoniae, Legionella pneumophila, and Mycoplasma pneumoniae.

Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of Baxdela and other antibacterial drugs, Baxdela should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Recommended Dosing

FDA Recommended Dosing **Refer to the prescribing information (product label) for complete dosing information. The following is from the “Highlights of Prescribing Information” section of the product label. • For ABSSSI and CABP: Administer Baxdela for injection 300 mg by intravenous infusion over 60 minutes, every 12 hours, or a 450-mg Baxdela tablet orally every 12 hours. • Recommended duration of treatment: o ABSSI: 5 to 14 days o CABP: 5 to 10 days • Dosage for patients with renal impairment is based on the estimated glomerular filtration rate (eGFR).

Estimated Glomerular Filtration Rate Recommended Dosage Regimen for Baxdelac (eGFR)(mL/min/1.73m2 )a Oral Intravenousb 30-89 No dosage adjustment No dosage adjustment 15-29 No dosage adjustment 200 mg every 12 hours

Page 2 of 3 Pharmacy Benefit Clinical Criteria: P0045 End Stage Renal Disease Not Recommendedd (ESRD) (<15 including hemodialysis) a. Estimate of GFR based on a Modification of Diet in Renal Disease (MDRD) equation. b. All intravenous doses of Baxdela are administered over 60 minutes. c. For a total treatment duration of 5 to 14 days for ABSSI or 5 to 10 days for CABP d. Not recommended due to insufficient information to provide dosing recommendations.

Drug Availability Injection: Supplied as sterile, lyophilized powder containing 300 mg delafloxacin (equivalent to 433 mg delafloxacin meglumine) in a single-dose vial.

Tablet: Supplied as tablets containing 450 mg delafloxacin (equivalent to 649 mg delafloxacin meglumine).

Background Delafloxacin is a fluoroquinolone antibiotic approved in adults for oral or intravenous use in the treatment of acute bacterial skin and skin structure infections (ABSSSI) and community-acquired pneumonia (CAP) due to susceptible bacteria. As with other fluoroquinolones, there is a Boxed Warning regarding disabling and potentially irreversible serious adverse reactions including tendinitis and tendon rupture, peripheral neuropathy, and central nervous system (CNS) effects. Fluoroquinolones may also exacerbate muscle weakness in patients with myasthenia gravis.

References

1. Baxdela (delafloxacin) [product information]. Lincolnshire, Illinois: Melinta Therapeutics, Inc. Oct 2019. 2. Delafloxacin Meglumine Oral. Drug Facts and Comparisons. Facts & Comparisons® eAnswers [online]. Available from Wolters Kluwer Health, Inc. 3. McEvoy GK, Snow EK, Kester L, Litvak K, Miller J, Welsh OH, eds. AHFS DI (Lexi-Comp Online). Bethesda, MD: American Society of Health-System Pharmacists; 2020.

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