CurrentAmbetter NevadaPolicy CP.PMN.313

Tebipenem Pivoxil (Utebzi) Coverage Criteria

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Prior authorization and medical-necessity coverage for oral tebipenem pivoxil (Utebzi) in adults with complicated urinary tract infection, including pyelonephritis, when specified clinical, culture, specialist, renal function, alternative-treatment, duration, and dose criteria are met.

Policy Summary

PayerAmbetter Nevada

PolicyTebipenem Pivoxil (Utebzi) Coverage Criteria

Policy CodePolicy CP.PMN.313

Change TypeNo material change

Effective DateDec 1, 202635d

Last ReviewNov 1, 20265d

Next Review DateNot specified

Key ActionSubmit documentation showing that all applicable approval criteria are met for Utebzi.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

AdultsMinimum age

5Covered susceptible pathogens

10 daysMaximum treatment course

2,400 mgMaximum daily dose

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CurrentAmbetter NevadaPolicy CP.PMN.313

Tebipenem Pivoxil (Utebzi) Coverage Criteria

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Policy Summary

PayerAmbetter Nevada

PolicyTebipenem Pivoxil (Utebzi) Coverage Criteria

Policy CodePolicy CP.PMN.313

Change TypeNo material change

Effective DateDec 1, 202635d

Last ReviewNov 1, 20265d

Next Review DateNot specified

Key ActionSubmit documentation showing that all applicable approval criteria are met for Utebzi.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

AdultsMinimum age

5Covered susceptible pathogens

10 daysMaximum treatment course

2,400 mgMaximum daily dose

Minimum renal function

300 mgTablet strength

Coverage Criteria

Initial therapy: complicated urinary tract infection

Covered when all of the following are met.

Initial approval for complicated urinary tract infection

Clinical eligibility
- Diagnosis of complicated urinary tract infection, including pyelonephritis
- Specialist: Prescribed by or in consultation with an infectious disease specialist
- Age: Member is at least 18 years old>= 18 years
- Susceptible pathogen
  - Pathogen: Escherichia coli
  - Pathogen: Klebsiella pneumoniae
  - Pathogen: Enterobacter cloacae species complex
  - Pathogen: Klebsiella oxytoca
  - Pathogen: Enterococcus faecalis
- Renal function: eGFR is documented and is at least 15 mL/min>= 15 mL/min
- Alternative treatment status
  - Treatment failure: Failure of at least two IDSA-recommended antibiotics to which the isolated pathogen is susceptible per culture and susceptibility testing>= 2 antibiotics
    Unless clinically significant adverse effects are experienced or all are contraindicated
  - Resistance or lack of susceptibility
    Trimethoprim-sulfamethoxazole class: Resistance or lack of susceptibility to at least one agent>= 1 agent
    Fluoroquinolone class: Resistance or lack of susceptibility to at least one agent, such as ciprofloxacin or levofloxacin>= 1 agent
- Treatment duration: Total treatment period does not exceed 10 days<= 10 days
  Approval is up to 10 days per treatment course
- Dose does not exceed 2,400 mg or 8 tablets per day<= 2,400 mg (8 tablets) per day

Other diagnoses and indications

Other diagnoses or indications must meet one of the listed pathways.

Other diagnoses or indications

Recent label change pathway: If the drug underwent a label change within the last 6 months that is not reflected in this policy, refer to the applicable no-coverage or non-formulary policy for the relevant line of businesswithin the last 6 months
Off-label pathway: If the requested use is not specifically listed as a non-authorized indication and the recent-label-change pathway does not apply, refer to the applicable off-label use policy for the relevant line of business

Continuation therapy: complicated urinary tract infection

Continued coverage requires all of the following.

Continuation therapy for complicated urinary tract infection

Eligibility for continuation
- Existing benefit or prior approval: Member is currently receiving medication through a Centene benefit or previously met initial approval criteria
- Continuity of care: Member is currently receiving medication and is enrolled in a state and product with continuity-of-care regulations
  Refer to state-specific addenda for CC.PHARM.03A and CC.PHARM.03B
Response to therapy: Member is responding positively to therapy

Non-FDA-approved indications that are not addressed in this policy are not authorized. Coverage may be considered only when sufficient documentation of efficacy and safety is provided under the applicable off-label use policy or evidence of coverage documents for the member’s line of business.

Clinical and Quantity Parameters

Minimum age

Minimum ageAt least 18 years

Applies toAdults requesting coverage for complicated urinary tract infection

Clinical contextInitial approval requires diagnosis of cUTI, including pyelonephritis

Minimum eGFR

Minimum eGFRAt least 15 mL/min

DocumentationEstimated glomerular filtration rate must be documented

Applies toInitial approval for complicated urinary tract infection

Prior Authorization and Documentation

Prior Authorization

Initial Prior Authorization Required

Prior authorization is required for initial Utebzi therapy. Submit documentation demonstrating that all applicable approval criteria are met for the requested treatment course.

Complicated urinary tract infection (cUTI), including pyelonephritis
Prescribing by or consultation with an infectious disease specialist
Age ≥ 18 years
Urine culture identifying a covered susceptible pathogen
eGFR ≥ 15 mL/min
Required failure, resistance, contraindication, or clinically significant adverse-effect pathway for IDSA-recommended alternatives
Total treatment period ≤ 10 days and dose ≤ 2,400 mg (8 tablets) per day

Prior Authorization

Continuation Prior Authorization Required

Continuation prior authorization is required. Document prior approval or applicable continuity-of-care eligibility, positive response to therapy, and that the requested course remains within the treatment and dose limits.

Medication Background

Tebipenem pivoxil (Utebzi) is an oral carbapenem antibacterial indicated for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, caused by specified susceptible organisms in adults with limited or no alternative oral treatment options. Covered use is subject to the policy’s clinical, culture and susceptibility, specialist, renal-function, treatment-duration, and dosing requirements.

Definitions

cUTI

AbbreviationcUTI

DefinitionComplicated urinary tract infection

Clinical scopeAn infection beyond the bladder in women or men

eGFR

AbbreviationeGFR

DefinitionEstimated glomerular filtration rate

Policy thresholdThe documented eGFR must be at least 15 mL/min for initial approval

Initial Therapy

Continuation Therapy

Continuation therapy

Continued therapy for cUTI requires all of the following.

Continuation eligibility
- Member is currently receiving medication through a Centene benefit or previously met initial approval criteria
- Member is currently receiving medication and is enrolled in a state and product with continuity-of-care regulations
  Refer to state-specific addenda for CC.PHARM.03A and CC.PHARM.03B
Positive response: Member is responding positively to therapy
Course duration:

Alternative Antibiotic Evaluation

Step	Required alternative evaluation	Approval pathway
1	Evaluate IDSA-recommended alternatives from the trimethoprim-sulfamethoxazole, fluoroquinolone, and beta-lactam classes before Utebzi approval.	The member must either have failure of at least two antibiotics to which the isolated pathogen is susceptible, or culture and susceptibility results showing resistance or lack of susceptibility to at least one agent from each class. Clinically significant adverse effects or contraindications may apply.

Tebipenem Pivoxil Quantity Limits

Tebipenem pivoxil (Utebzi)

Maximum daily dose2,400 mg per day

Tablet equivalent8 tablets per day

Maximum courseTotal treatment course up to 10 days

Tablet strength300 mg oral tablets

Policy Summary

PayerAmbetter Nevada

PolicyTebipenem Pivoxil (Utebzi) Coverage Criteria

Policy CodePolicy CP.PMN.313

Change TypeNo material change

Effective DateDec 1, 202635d

Last ReviewNov 1, 20265d

Next Review DateNot specified

Key ActionSubmit documentation showing that all applicable approval criteria are met for Utebzi.

SourceLink

On This Page

Beta-lactam class: Resistance or lack of susceptibility to at least one beta-lactam, such as cefpodoxime or cefuroxime>= 1 agent

Treatment duration: Total treatment period does not exceed 10 days and member has received fewer than 10 days of treatmenttotal <= 10 days; received < 10 days

Dose increase: If the request is for a dose increase, the new dose does not exceed 2,400 mg or 8 tablets per day<= 2,400 mg (8 tablets) per day

Applies only to dose-increase requests

Maximum treatment period

Maximum treatment periodDoes not exceed 10 days

Approval durationUp to 10 days per treatment course

Continuation requirementThe member must have received fewer than 10 days of treatment

Maximum daily dose

Maximum daily dose2,400 mg per day

Tablet equivalent8 tablets per day

Continuation dose increaseA new dose for a dose-increase request must not exceed 2,400 mg (8 tablets) per day

Alternative-antibiotic failure

Failure thresholdFailure of at least 2 IDSA-recommended antibiotics

Susceptibility requirementThe antibiotics must be ones to which the isolated pathogen is susceptible according to culture and susceptibility testing

ExceptionClinically significant adverse effects or contraindications may apply

Alternative-antibiotic resistance

Resistance thresholdResistance or lack of susceptibility to at least 1 agent from each of 3 required classes

Required classesTrimethoprim-sulfamethoxazole, a fluoroquinolone, and a beta-lactam

ExceptionClinically significant adverse effects or contraindications may apply

Member is currently receiving Utebzi through the Centene benefit or previously met initial approval criteria; alternatively, continuity-of-care regulations apply
Member is responding positively to therapy
Total treatment period does not exceed 10 days and the member has received fewer than 10 days of treatment
For a dose increase, the new dose does not exceed 2,400 mg (8 tablets) per day

Step Therapy

Required Alternative-Antibiotic Evaluation

Document the required evaluation of susceptible IDSA-recommended antibiotic alternatives before requesting Utebzi, unless clinically significant adverse effects were experienced or all applicable alternatives are contraindicated.

Failure of at least 2 susceptible IDSA-recommended antibiotics; or
Culture and susceptibility results showing resistance or lack of susceptibility to at least 1 agent from each class: trimethoprim-sulfamethoxazole, a fluoroquinolone, and a beta-lactam
Include relevant alternative-antibiotic treatment history, culture results, adverse effects, and contraindications

Documentation Required

Required Clinical Documentation

Provider must submit clinical documentation supporting that the member meets all applicable approval criteria.

Office or chart notes
Laboratory results, including urine culture and susceptibility testing
Other supporting clinical information relevant to the request

Documentation Required

Diagnosis and Specialist Documentation

Document a diagnosis of complicated urinary tract infection, including pyelonephritis when applicable, and that Utebzi is prescribed by or in consultation with an infectious disease specialist.

Member must be age ≥ 18 years
Include the cUTI diagnosis in the submitted clinical records
Identify the infectious disease specialist who prescribed or was consulted

Unsupported block type: documentation

Documentation Required

Renal Function and Alternatives

Document renal function and the applicable alternative-antibiotic pathway. Utebzi requires an estimated glomerular filtration rate of at least 15 mL/min.

Provide the member’s eGFR
eGFR must be ≥ 15 mL/min
Also provide evidence of failure of at least 2 susceptible IDSA-recommended antibiotics, or culture-supported resistance/lack of susceptibility across the required antibiotic classes
Clinically significant adverse effects or contraindications may substitute for the applicable alternative requirement

Documentation Required

Continuation Documentation

For continuation requests, document that the member is responding positively and specify treatment received and remaining course limits.

Treatment received must be fewer than 10 days
The total treatment period must not exceed 10 days
Document positive clinical response
A dose increase must remain ≤ 2,400 mg (8 tablets) per day

Denial Risk

Unauthorized Indication

Coverage is not authorized for non-FDA-approved indications that are not addressed in this policy unless sufficient efficacy and safety documentation supports coverage under the applicable off-label use policy or evidence of coverage documents.

For commercial plans, refer to CP.CPA.09
For health insurance marketplace/ICHRA plans, refer to HIM.PA.154
For Medicaid, refer to CP.PMN.53
Recently approved label changes or uses not reflected in this policy may require the applicable no-coverage or non-formulary policy

Denial Risk

Failure to Meet Clinical Eligibility

A request may be denied when required clinical eligibility is not demonstrated. The submitted records must support the diagnosis, age, specialist involvement, pathogen, renal function, and applicable treatment criteria.

cUTI diagnosis, including pyelonephritis when applicable
Age ≥ 18 years
Infectious disease specialist prescribing or consultation
Covered pathogen susceptible to Utebzi
eGFR ≥ 15 mL/min
All other initial or continuation criteria applicable to the request

Denial Risk

Insufficient Alternative-Antibiotic History

A request may be denied when the record does not demonstrate failure of susceptible alternative antibiotics or the required culture-supported resistance pathway.

Document failure of ≥ 2 IDSA-recommended antibiotics to which the isolated pathogen is susceptible; or
Document resistance or lack of susceptibility to at least 1 agent in each required class: trimethoprim-sulfamethoxazole, fluoroquinolone, and beta-lactam
Clinically significant adverse effects or contraindications must be documented when relied upon

Denial Risk

Duration or Dose Exceeded

Requests may be denied when the prescribed course or dose exceeds policy limits.

Total treatment period must not exceed 10 days per treatment course
Dose must not exceed 2,400 mg (8 tablets) per day
For continuation requests, the member must have received fewer than 10 days of treatment
For a dose increase, the new dose must remain within the daily maximum

IDSA

AbbreviationIDSA

DefinitionInfectious Diseases Society of America

Policy roleIDSA-recommended antibiotics are used to evaluate alternative treatment failure or resistance

Complicated urinary tract infection

DefinitionAn infection beyond the bladder in women or men

Clinical presentationsPyelonephritis, febrile or bacteremic UTI, catheter-associated UTI, or prostatitis

ContrastAn uncomplicated UTI is confined to the bladder in afebrile women or men

Total treatment period does not exceed 10 days and member has received fewer than 10 days of treatment

total <= 10 days; received < 10 days

Dose increase: For a dose increase, the new dose does not exceed 2,400 mg or 8 tablets per day<= 2,400 mg (8 tablets) per day

Applies only to dose-increase requests