Baxdela (delafloxacin) for Injection

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1 Last Review Date: July 25th, 2018 Number: MG.MM.PH.53 Medical Guideline Disclaimer Property of EmblemHealth. All rights reserved. The treating physician or primary care provider must submit to EmblemHealth the clinical evidence that the patient meets the criteria for the treatment or surgical procedure. Without this documentation and information, EmblemHealth will not be able to properly review the request for prior authorization. The clinical review criteria expressed below reflects how EmblemHealth determines whether certain services or supplies are medically necessary. EmblemHealth established the clinical review criteria based upon a review of currently available clinical information (including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the technology, evidence-based guidelines of public health and health research agencies, evidence-based guidelines and positions of leading national health professional organizations, views of physicians practicing in relevant clinical areas, and other relevant factors). EmblemHealth expressly reserves the right to revise these conclusions as clinical information changes, and welcomes further relevant information. Each benefit program defines which services are covered. The conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty that this service or supply is covered and/or paid for by EmblemHealth, as some programs exclude coverage for services or supplies that EmblemHealth considers medically necessary. If there is a discrepancy between this guideline and a member's benefits program, the benefits program will govern. In addition, coverage may be mandated by applicable legal requirements of a state, the Federal Government or the Centers for Medicare & Medicaid Services (CMS) for Medicare and Medicaid members. All coding and web site links are accurate at time of publication. EmblemHealth Services Company LLC, ( EmblemHealth ) has adopted the herein policy in providing management, administrative and other services to HIP Health Plan of New York, HIP Insurance Company of New York, Group Health Incorporated and GHI HMO Select, related to health benefit plans offered by these entities. All of the aforementioned entities are affiliated companies under common control of EmblemHealth Inc. Definitions The fluoroquinolone Baxdela (delafloxacin) is approved for use in adults for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible bacteria. In order to reduce the development of drug-resistant bacteria and maintain the effectiveness of Baxdela, it should only be used to treat infections that are proven or strongly suspected to be caused by bacteria. Dosing Max Units (per dose and over time): ABSSSI: 600 billable units every day for 14 days Guideline Baxdela (delafloxacin) is considered medically necessary when the following criteria are met: Patient is 18 years of age or older; AND Patient has a diagnosis of acute bacterial skin and skin structure infection (ABSSSI); AND Current culture and sensitivity (C&S) report shows isolated pathogen is a gram-positive or gramnegative organism susceptible to delafloxacin, unless provider submits documentation that obtaining a C&S report is not possible

2 Page 2 of 6 Limitations/Exclusions Approval will be granted for 14 days Subsequent approvals will require a new authorization Applicable Procedure Codes C9462 J3490 Injection, delafloxacin, 1 mg Unclassified drugs Applicable Diagnosis Codes A46 Erysipelas A49.01 Methicillin susceptible Staphylococcus aureus infection, unspecified site A49.02 Methicillin resistant Staphylococcus aureus infection, unspecified site A49.1 Streptococcal infection, unspecified site H Abscess of right upper eyelid H Abscess of right lower eyelid H Abscess of eyelid right eye, unspecified eyelid H Abscess of left upper eyelid H Abscess of left lower eyelid H Abscess of eyelid left eye, unspecified eyelid H Abscess of eyelid unspecified eye, unspecified eyelid H Cellulitis of right orbit H Cellulitis of left orbit H Cellulitis of bilateral orbits H Cellulitis of unspecified orbits H60.00 Abscess of external ear, unspecified ear H60.01 Abscess or right external ear H60.02 Abscess of left external ear H60.03 Abscess of external ear, bilateral H60.10 Cellulitis of external ear, unspecified ear H60.11 Cellulitis of right external ear H60.12 Cellulitis of left external ear H60.13 Cellulitis of external ear, bilateral J34.0 Abscess, furuncle and carbuncle of nose K12.2 Cellulitis and abscess of mouth K61.0 Anal abscess K61.1 Rectal abscess K61.2 Anorectal abscess K61.3 Ischiorectal abscess K61.4 Intrasphincteric abscess L00 Staphylococcal scalded skin syndrome L01.00 Impetigo, unspecified L01.01 Non-bullous impetigo L01.02 Bockhart s impetigo L01.03 Bullous impetigo L01.09 Other impetigo L01.1 Impetiginization of other dermatoses

3 Page 3 of 6 L02.01 Cutaneous abscess of face L02.02 Furuncle of face L02.03 Carbuncle of face L02.11 Cutaneous abscess of neck L02.12 Furuncle of neck L02.13 Carbuncle of neck L Cutaneous abscess of abdominal wall L Cutaneous abscess of back [any part, except buttock] L Cutaneous abscess of chest wall L Cutaneous abscess of groin L Cutaneous abscess of perineum L Cutaneous abscess of umbilicus L Cutaneous abscess of trunk, unspecified L Furuncle of abdominal wall L Furuncle of back [any part, except buttock] L Furuncle of chest wall L Furuncle of groin L Furuncle of perineum L Furuncle of umbilicus L Furuncle of trunk, unspecified L Carbuncle of abdominal wall L Carbuncle of back [any part, except buttock] L Carbuncle of chest wall L Carbuncle of groin L Carbuncle of perineum L Carbuncle of umbilicus L Carbuncle of trunk, unspecified L02.31 Cutaneous abscess of buttock L02.32 Furuncle of buttock L02.33 Carbuncle of buttock L Cutaneous abscess of right axilla L Cutaneous abscess of left axilla L Cutaneous abscess of right upper limb L Cutaneous abscess of left upper limb L Cutaneous abscess of right lower limb L Cutaneous abscess of left lower limb L Cutaneous abscess of limb, unspecified L Furuncle of right axilla L Furuncle of left axilla L Furuncle of right upper limb L Furuncle of left upper limb L Furuncle of right lower limb L Furuncle of left lower limb L Furuncle of limb, unspecified L Carbuncle of right axilla L Carbuncle of left axilla L Carbuncle of right upper limb L Carbuncle of left upper limb L Carbuncle of right lower limb L Carbuncle of left lower limb

4 Page 4 of 6 L Carbuncle of limb, unspecified L Cutaneous abscess of right hand L Cutaneous abscess of left hand L Cutaneous abscess of unspecified hand L Furuncle of right hand L Furuncle of left hand L Furuncle of unspecified hand L Carbuncle of right hand L Carbuncle of left hand L Carbuncle of unspecified hand L Cutaneous abscess of right foot L Cutaneous abscess of left foot L Cutaneous abscess of unspecified foot L Furuncle of right foot L Furuncle of left foot L Furuncle of unspecified foot L Carbuncle of right foot L Carbuncle of left foot L Carbuncle of unspecified foot L Cutaneous abscess of head [any part except face] L Cutaneous abscess of other sites L Furuncle of head [any part except face] L Furuncle of other sites L Carbuncle of head [any part except face] L Carbuncle of other sites L02.91 Cutaneous abscess, unspecified L02.92 Furuncle, unspecified L02.93 Carbuncle, unspecified L Cellulitis of right finger L Cellulitis of left finger L Cellulitis of unspecified finger L Acute lymphangitis of right finger L Acute lymphangitis of left finger L Acute lymphangitis of unspecified finger L Cellulitis of right toe L Cellulitis of left toe L Cellulitis of unspecified toe L Acute lymphangitis of right toe L Acute lymphangitis of left toe L Acute lymphangitis of unspecified toe L Cellulitis of right axilla L Cellulitis of left axilla L Cellulitis of right upper limb L Cellulitis of left upper limb L Cellulitis of right lower limb L Cellulitis of left lower limb L Cellulitis of unspecified part of limb L Acute lymphangitis of right axilla L Acute lymphangitis of left axilla L Acute lymphangitis of right upper limb

5 Page 5 of 6 L Acute lymphangitis of left upper limb L Acute lymphangitis of right lower limb L Acute lymphangitis of left lower limb L Acute lymphangitis of unspecified part of limb L Cellulitis of face L Acute lymphangitis of face L Periorbital cellulitis L Cellulitis of neck L Acute lymphangitis of neck L Cellulitis of abdominal wall L Cellulitis of back [any part except buttock] L Cellulitis of chest wall L Cellulitis of groin L Cellulitis of perineum L Cellulitis of umbilicus L Cellulitis of buttock L Cellulitis of trunk, unspecified L Acute lymphangitis of abdominal wall L Acute lymphangitis of back [any part except buttock] L Acute lymphangitis of chest wall L Acute lymphangitis of groin L Acute lymphangitis of perineum L Acute lymphangitis of umbilicus L Acute lymphangitis of buttock L Acute lymphangitis of trunk, unspecified L Cellulitis of head [any part, except face] L Cellulitis of other sites L Acute lymphangitis of head [any part, except face] L Acute lymphangitis of other sites L03.90 Cellulitis, unspecified L03.91 Acute lymphangitis, unspecified L04.0 Acute lymphadenitis face, head and neck L04.1 Acute lymphadenitis of trunk L04.2 Acute lymphadenitis of upper limb L04.3 Acute lymphadenitis of lower limb L04.8 Acute lymphadenitis of other sites L04.9 Acute lymphadenitis, unspecified L05.01 Pilonidal cyst with abscess L05.02 Pilonidal sinus with abscess L05.91 Pilonidal cyst without abscess L05.92 Pilonidal sinus without abscess L08.0 Pyoderma L08.1 Erythrasma L08.81 Pyoderma vegetans L08.82 Omphalitis not of newborn L08.89 Other specified local infection of the skin and subcutaneous tissue L08.9 Local infection of the skin and subcutaneous tissue, unspecified N48.21 Abscess of corpus cavernosum and penis N48.22 Cellulitis of corpus cavernosum and penis N61.0 Mastitis without abscess

6 Page 6 of 6 N61.1 Abscess of the breast and nipple N76.4 Abscess of vulva References 1. Baxdela (delafloxacin) tablets [prescribing information]. Lincolnshire, IL: Melinta Therapeutics, Inc; June 2017.

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