CurrentAvMedPolicy N/A

Prior authorization and step-edit requirements for Vabomere (meropenem-vaborbactam)

Form and clinical criteria governing prior authorization for Vabomere for AvMed members; applies to prescribers requesting pharmacy coverage (including specialty pharmacy) for outpatient or discharge continuation therapy.

Policy Summary

PayerAvMed

PolicyPrior authorization and step-edit requirements for Vabomere (meropenem-vaborbactam)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a signed prior authorization form with prescriber info, recent culture/sensitivity results (within 7 days), and chart notes documenting trials/failures when required; fax to 1-305-671-0200.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

14 daysTypical authorization length

>=18Member age requirement

7Culture recency (days)

72Inpatient exposure threshold (hrs)

Coverage Criteria for Vabomere (meropenem-vaborbactam)

Initial therapy (New Start) for cUTI/pyelonephritis

Covered when ALL of the following are met

Primary criteria: Member is 18 years of age or older AND has a diagnosis of complicated urinary tract infection (cUTI) or pyelonephritis AND provider submits lab cultures from current hospital admission or office visit collected within the last 7 days showing organism sensitive to Vabomere

From new start criteria

Must meet one resistance/trial pathway: Either (A) provider submits chart notes documenting trial and failure of ALL listed oral antibiotics OR cultures show resistance to ALL listed oral antibiotics; OR (B) provider submits chart notes documenting trial and failure of ALL listed IV antibiotics OR cultures show resistance to ALL listed IV antibiotics

Listed oral antibiotics: nitrofurantoin, cefdinir, cephalexin, amoxicillin, amoxicillin-clavulanate, ciprofloxacin, levofloxacin, trimethoprim-sulfamethoxazole, fosfomycin. Listed IV antibiotics: ciprofloxacin, levofloxacin, ceftriaxone, cefazolin, cefepime, piperacillin-tazobactam, trimethoprim-sulfamethoxazole, gentamicin, tobramycin, amikacin, ertapenem, imipenem-cilastatin, meropenem

Policy Summary

PayerAvMed

PolicyPrior authorization and step-edit requirements for Vabomere (meropenem-vaborbactam)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

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Requirement	Details
Provider submission of supporting documentation
Provider must submit chart notes or culture/sensitivity results documenting trials and failures or laboratory evidence of resistance to required antibiotics; progress notes required for inpatient continuation >72 hours
Cultures recency
Lab cultures must be from the current hospital admission or office visit collected within the last 7 days
Culture susceptibility requirement
Lab cultures must show that the bacteria is sensitive to Vabomere or, when used to demonstrate resistance, must show resistance to all listed comparator antibiotics per the step pathway
Use of samples
Use of medication samples to initiate therapy does not meet step-edit/preauthorization criteria

Clinical and Operational Coding Notes

inv-04: Culture recency — collected within the last 7 days

RequirementLab cultures must be from the current hospital admission or office visit collected within the last 7 days

PurposeDemonstrate organism susceptibility to Vabomere or resistance to listed alternatives as required by step-edit

DocumentationProvider must submit the culture and sensitivity results with the prior authorization request

inv-05: Inpatient therapy duration threshold — member on Vabomere > 72 hours

ThresholdMember has been on Vabomere for more than 72 hours inpatient

Required documentationProgress notes from the admission must be submitted for continuation requests

Lab requirementProvider must submit lab culture sensitivity results from the admission showing resistance to all preferred antibiotics except Vabomere (sensitive)

Prior Authorization, Submission, and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required for Vabomere (meropenem and vaborbactam). The prescribing physician must sign and clearly print their name on the request form (preprinted stamps not valid). Fax the completed form to 1-305-671-0200. Incomplete, incorrect, or illegible information (including missing phone/fax numbers) may delay authorization.

Fax completed form to 1-305-671-0200
Prescriber signature and printed name required (stamps not valid)
Provide member and prescriber contact information including NPI, phone, and fax

Step Therapy

Step-edit Requirements

Approval requires meeting step-edit criteria demonstrating trial and failure of (or documented resistance to) required antibiotics. Member must be ≥18 years and have a diagnosis of complicated urinary tract infection (cUTI) or pyelonephritis. Provider must submit recent lab cultures (collected within the last 7 days) showing bacterial sensitivity to Vabomere or demonstrating resistance to required prior antibiotics as specified.

Member is 18 years of age or older
Diagnosis: complicated UTI (cUTI) or pyelonephritis
Submit lab cultures from current admission or office visit collected within the last 7 days
Lab cultures must show bacteria sensitive to Vabomere OR show resistance to required prior agents

Step Therapy

Step-edit: Required Trials or Resistance Documentation

Provider must document trials and failures (or documented resistance) of specified oral AND/OR IV antibiotics as applicable. For new starts, submit chart notes documenting trial and failure of ALL listed oral antibiotics OR cultures showing resistance to ALL listed oral antibiotics. Alternatively, submit chart notes documenting trial and failure of ALL listed IV antibiotics OR cultures showing resistance to ALL listed IV antibiotics.

Oral antibiotics required for trial/failure or documented resistance: nitrofurantoin, cefdinir, cephalexin, amoxicillin, amoxicillin-clavulanate, ciprofloxacin, levofloxacin, trimethoprim-sulfamethoxazole, fosfomycin
IV antibiotics required for trial/failure or documented resistance: ciprofloxacin, levofloxacin, ceftriaxone, cefazolin, cefepime, piperacillin-tazobactam, trimethoprim-sulfamethoxazole, gentamicin, tobramycin, amikacin, ertapenem, imipenem-cilastatin, meropenem
Cultures must be retrieved from the most recent office visit or current inpatient admission and collected within the last 7 days

Documentation Required

Required Submission Items

Required submission items include prescriber signature and printed name, member and prescriber information (including NPI, contact phone and fax), drug name/form/strength, dosing schedule, length of therapy, diagnosis and ICD code if applicable, weight (if applicable) and date obtained, and all supporting clinical documentation such as lab results, culture sensitivities, and chart notes. For continuation requests, include progress notes showing inpatient use >72 hours and inpatient culture sensitivity results.

Prescriber signature and printed name (required)
Member name, AvMed ID, date of birth
Prescriber name, NPI, office contact, phone and fax
Drug name/form/strength, dosing schedule, length of therapy, diagnosis, ICD code (if applicable)
Weight and date weight obtained (if applicable)
Lab culture sensitivity results (from current admission/visit within 7 days)
Chart notes documenting trials/failures or resistance to required antibiotics
For continuation: progress notes showing inpatient administration >72 hours

Denial Risk

Incomplete or Missing Documentation

Authorization may be delayed or denied if the form or supporting documentation is incomplete or missing. Missing items include but are not limited to: prescriber signature, contact information, lab results, culture sensitivity reports, diagnostics, and chart notes documenting prior therapy or resistance. Ensure all documentation is legible and collected within required timeframes to avoid denial.

Incomplete or illegible forms can delay processing
Missing lab results, culture sensitivities, diagnostics, or chart notes may result in denial
Ensure cultures and sensitivity reports are from within the last 7 days when required

OpenPayer

Prior authorization and step-edit requirements for Vabomere (meropenem-vaborbactam)

Coverage Criteria for Vabomere (meropenem-vaborbactam)

Step Edit and Trial Requirements

Clinical and Operational Coding Notes

Prior Authorization, Submission, and Documentation Requirements

Dispensing Site and Specialty Pharmacy

Key Definitions

Background and Clinical Context