CurrentAvMedPolicy N/A

Zevtera (ceftobiprole) IV prior authorization — indications: ABSSSI, CABP, SAB/bacteremia

Clinical prior-authorization criteria for inpatient/outpatient medical use of Zevtera (ceftobiprole) IV, specifying indications, age limits, required specialist prescriber, culture/sensitivity and prior antibiotic trial/resistance documentation required for approval. Intended for AvMed prescribers and providers seeking coverage.

Policy Summary

PayerAvMed

PolicyZevtera (ceftobiprole) IV prior authorization — indications: ABSSSI, CABP, SAB/bacteremia

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a signed prior authorization form and provide complete documentation including culture/sensitivity results and chart notes showing trial and failure or laboratory-proven resistance to all listed alternative IV antibiotics as applicable.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3specified covered indications

7authorization length — ABSSSI/CABP (new start)

42authorization length — SAB (new start)

72minimum inpatient duration to qualify for continuation

Medical Necessity Criteria for Zevtera (ceftobiprole) IV

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General Authorization Requirements

All of the following must be met for approval:

ALL of the following

Prescribed by an infectious disease specialist
Prescriber signature required on request form (stamps not valid)
Documentation including labs, diagnostics, and chart notes must be provided; incomplete information may delay or deny authorization

ALL of the following

Prescribed by an infectious disease specialist
Prescriber signature required on request form (stamps not valid)
Documentation including labs, diagnostics, and chart notes must be provided; incomplete information may delay or deny authorization

ABSSSI — New Start

Covered for acute bacterial skin and skin structure infections (ABSSSI) when ALL of the following are met:

ALL of the following

Diagnosis: ABSSSI
Member is 18 years of age or older>= 18 years
Prescribed by an infectious disease specialist
Provider submits date medication was started inpatient (if applicable)
Provider has submitted lab cultures from current hospital admission or office visit collected within the last 7 days

CABP — New Start

Covered for community-acquired bacterial pneumonia (CABP) when ALL of the following are met:

ALL of the following

Diagnosis: community-acquired bacterial pneumonia (CABP)
Member is 3 months of age or older>= 3 months
Prescribed by an infectious disease specialist
Provider submits date medication was started inpatient (if applicable)
Provider has submitted lab cultures from current hospital admission or office visit collected within the last 7 days

Staphylococcus aureus bloodstream infections (SAB) including right-sided infective endocarditis — New Start

Covered for SAB/bacteremia when ALL of the following are met:

ALL of the following

Diagnosis: Staphylococcus aureus bloodstream infections (SAB) (bacteremia), including right-sided infective endocarditis
Member is 18 years of age or older>= 18 years
Prescribed by an infectious disease specialist
Provider submits date medication was started inpatient (if applicable)
Provider has submitted lab cultures from current hospital admission or office visit collected within the last 7 days

Continuation of Therapy (following inpatient administration)

Covered when ALL of the following are met for continuation after inpatient start:

ALL of the following

Member is currently on Zevtera for more than 72 hours inpatient> 72 hours inpatient
progress notes must be submitted
Prescribed by an infectious disease specialist
Provider has submitted inpatient lab culture sensitivity results showing resistance to ALL preferred antibiotics except for Zevtera (i.e., Zevtera is the only agent to which organism is sensitive)

Administration / Site

Documentation of where medication will be provided must be submitted:

ANY of the following

Location/site of drug administration with NPI or DEA number of administering location
Specialty Pharmacy (if applicable)

What Providers Must Do

Prior Authorization

Submit PA form with prescriber signature

Prescriber must sign and clearly print their name on the prior authorization request for Zevtera (J0681); preprinted stamps are not valid. All required documentation (labs, cultures, progress notes) must be submitted with the PA or authorization may be delayed or denied.

J0681

Documentation Required

Submit culture and sensitivity results

Submit culture and susceptibility results obtained from the current hospital admission or office visit collected within the last 7 days demonstrating the organism is sensitive to Zevtera or showing resistance to all preferred alternative antibiotics for the indicated diagnosis.

J0681

Documentation Required

Submit trial/failure documentation

For new starts, provide chart notes documenting trial and failure of all listed IV antibiotics for the specific indication OR provide laboratory documentation showing resistance to the entire list of those antibiotics.

J0681

Documentation Required

Submit inpatient progress notes for continuation

For continuation after inpatient initiation, submit inpatient progress notes showing the member has received Zevtera for more than 72 hours and include inpatient culture sensitivity results demonstrating that Zevtera is the only agent to which the organism is sensitive.

J0681

Prior Authorization

Urgent review contact

If a standard review would jeopardize the member’s life or health, the practitioner should call the AvMed Pre-Authorization Department to request an urgent review.

Clinical Background

Zevtera (ceftobiprole) is an intravenous cephalosporin antibiotic indicated for certain serious bacterial infections and is requested under HCPCS code J0681.

Authorization for Zevtera requires documentation of appropriate culture and sensitivity testing from the current hospital admission or office visit collected within the last 7 days, showing that the causative organism is sensitive to Zevtera. For approval in the indications described (ABSSSI, CABP, or Staphylococcus aureus bloodstream infections including right‑sided infective endocarditis), the prescriber must be an infectious disease specialist and the prescribing physician must sign and clearly print their name on the prior authorization request (preprinted stamps are not valid).

For new outpatient or inpatient starts, approval also requires either chart documentation of trial and failure of the complete list of specified alternative IV antibiotics for the indication, or laboratory‑proven resistance on cultures (from within 7 days) to that entire list of alternatives before Zevtera will be authorized. For continuation following inpatient initiation, the member must have been on Zevtera for more than 72 hours inpatient with inpatient culture sensitivity results demonstrating that Zevtera is the only agent to which the organism is sensitive.

Member must meet ONE of the following

Provider submits chart notes documenting trial and failure of ALL the following IV antibiotics: daptomycin, dicloxacillin, cefazolin, cephalexin, clindamycin, nafcillin, oxacillin, sulfamethoxazole-trimethoprim, vancomycin, ceftaroline and ertapenem
trial and failure of entire list required
Cultures (from most recent visit/admission within 7 days) show resistance to ALL the following IV antibiotics: daptomycin, dicloxacillin, cefazolin, cephalexin, clindamycin, nafcillin, oxacillin, sulfamethoxazole-trimethoprim, vancomycin, ceftaroline and ertapenem
laboratory-proven resistance to entire list required

ALL of the following

Diagnosis: ABSSSI
Member is 18 years of age or older>= 18 years
Prescribed by an infectious disease specialist
Provider submits date medication was started inpatient (if applicable)
Provider has submitted lab cultures from current hospital admission or office visit collected within the last 7 daysculture collected within 7 days
Lab cultures must show that bacteria is sensitive to Zevtera
Member must meet ONE of the following
- Provider submits chart notes documenting trial and failure of ALL the following IV antibiotics: daptomycin, dicloxacillin, cefazolin, cephalexin, clindamycin, nafcillin, oxacillin, sulfamethoxazole-trimethoprim, vancomycin, ceftaroline and ertapenem
  trial and failure of entire list required
- Cultures (from most recent visit/admission within 7 days) show resistance to ALL the following IV antibiotics: daptomycin, dicloxacillin, cefazolin, cephalexin, clindamycin, nafcillin, oxacillin, sulfamethoxazole-trimethoprim, vancomycin, ceftaroline and ertapenem
  laboratory-proven resistance to entire list required

ALL of the following

Diagnosis: ABSSSI
Member is 18 years of age or older>= 18 years
Prescribed by an infectious disease specialist
Provider submits date medication was started inpatient (if applicable)
Provider has submitted lab cultures from current hospital admission or office visit collected within the last 7 daysculture collected within 7 days
Lab cultures must show that bacteria is sensitive to Zevtera
Member must meet ONE of the following
- Provider submits chart notes documenting trial and failure of ALL the following IV antibiotics: daptomycin, dicloxacillin, cefazolin, cephalexin, clindamycin, nafcillin, oxacillin, sulfamethoxazole-trimethoprim, vancomycin, ceftaroline and ertapenem
  trial and failure of entire list required
- Cultures (from most recent visit/admission within 7 days) show resistance to ALL the following IV antibiotics: daptomycin, dicloxacillin, cefazolin, cephalexin, clindamycin, nafcillin, oxacillin, sulfamethoxazole-trimethoprim, vancomycin, ceftaroline and ertapenem
  laboratory-proven resistance to entire list required

Member must meet ONE of the following

Provider submits chart notes documenting trial and failure of ALL the following IV antibiotics: ampicillin-sulbactam, azithromycin, ceftriaxone, cefotaxime, doxycycline, levofloxacin, linezolid, vancomycin, ertapenem, delafloxacin (Baxdela) and ceftaroline
trial and failure of entire list required
Cultures (from most recent visit/admission within 7 days) show resistance to ALL the following IV antibiotics: ampicillin-sulbactam, azithromycin, ceftriaxone, cefotaxime, doxycycline, levofloxacin, linezolid, vancomycin, ertapenem, delafloxacin (Baxdela) and ceftaroline
laboratory-proven resistance to entire list required

ALL of the following

Diagnosis: community-acquired bacterial pneumonia (CABP)
Member is 3 months of age or older>= 3 months
Prescribed by an infectious disease specialist
Provider submits date medication was started inpatient (if applicable)
Provider has submitted lab cultures from current hospital admission or office visit collected within the last 7 daysculture collected within 7 days
Lab cultures must show that bacteria is sensitive to Zevtera
Member must meet ONE of the following
- Provider submits chart notes documenting trial and failure of ALL the following IV antibiotics: ampicillin-sulbactam, azithromycin, ceftriaxone, cefotaxime, doxycycline, levofloxacin, linezolid, vancomycin, ertapenem, delafloxacin (Baxdela) and ceftaroline
  trial and failure of entire list required
- Cultures (from most recent visit/admission within 7 days) show resistance to ALL the following IV antibiotics: ampicillin-sulbactam, azithromycin, ceftriaxone, cefotaxime, doxycycline, levofloxacin, linezolid, vancomycin, ertapenem, delafloxacin (Baxdela) and ceftaroline
  laboratory-proven resistance to entire list required

ALL of the following

Diagnosis: Staphylococcus aureus bloodstream infections (SAB) (bacteremia), including right-sided infective endocarditis
Member is 18 years of age or older>= 18 years
Prescribed by an infectious disease specialist
Provider submits date medication was started inpatient (if applicable)
Provider has submitted lab cultures from current hospital admission or office visit collected within the last 7 daysculture collected within 7 days
Lab cultures must show that bacteria is sensitive to Zevtera
Member must meet ONE of the following
- Provider submits chart notes documenting trial and failure of ALL the following IV antibiotics: azithromycin, ceftriaxone, levofloxacin, doxycycline, daptomycin, cefazolin, nafcillin, oxacillin, vancomycin
  trial and failure of entire list required
- Cultures (from most recent visit/admission within 7 days) show resistance to ALL the following IV antibiotics: azithromycin, ceftriaxone, levofloxacin, doxycycline, daptomycin, cefazolin, nafcillin, oxacillin, vancomycin
  laboratory-proven resistance to entire list required

OpenPayer

Zevtera (ceftobiprole) IV prior authorization — indications: ABSSSI, CABP, SAB/bacteremia

Medical Necessity Criteria for Zevtera (ceftobiprole) IV

Relevant Billing and Diagnosis Codes

What Providers Must Do

Key Clinical Thresholds and Authorization Durations

Clinical Background

Defined Terms