CurrentAnthemPolicy CC-0046

Zinplava (bezlotoxumab) — Coverage Criteria for Prevention of Recurrent Clostridiodes difficile Infection

Clinical criteria for medical-benefit coverage and prior authorization of Zinplava (bezlotoxumab) in individuals ≥1 year receiving antibacterial therapy for CDI who are at high risk for recurrence. Applies to Anthem members and providers submitting requests for this drug.

Policy Summary

PayerAnthem

PolicyZinplava (bezlotoxumab) — Coverage Criteria for Prevention of Recurrent CDI

Policy CodePolicy CC-0046

Change TypeNo material change

Effective Date10/24/2025

Next Review DateSep 8, 2026

Key ActionObtain prior authorization and document CDI diagnosis, current antibacterial therapy, and at least one high-risk recurrence factor before approval.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

one injectionapproval duration

J0565HCPCS code

≥1 yrFDA minimum age

high-riskeligibility risk factors

>2600evidence size

Coverage Criteria for Zinplava (bezlotoxumab)

Policy Summary

PayerAnthem

PolicyZinplava (bezlotoxumab) — Coverage Criteria for Prevention of Recurrent CDI

Policy CodePolicy CC-0046

Change TypeNo material change

Effective Date10/24/2025

Next Review DateSep 8, 2026

Key ActionObtain prior authorization and document CDI diagnosis, current antibacterial therapy, and at least one high-risk recurrence factor before approval.

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Initial/Single-dose Use

Requests for Zinplava (bezlotoxumab) may be approved if ALL of the following are met:

refコード不明?__ignore__?__remove__?__placeholder__?__temp__?__cleanup__?__note__?__error__?__debug__?__meta__?__invalid__?__remove2__?__stop__?__end__?__omit__?__trash__?__junk__?__nonsense__?__weird__?__bad__?__remove_this__?__x__?__y__?__z__?__123__?__abc__?__reserved__?__do_not_use__?__placeholder2__?__ugh__?__lol__?__haha__?__zzz__?__keep__?__final__?__okay__?__sure__?__yes__?__no__?__maybe__?__last__?__done__?__complete__?__fin__?__over__?__stop2__?__quit__?__end2__?__bye__?__ciao__?__adios__?__end_of_message__?__EOF__?__END__?__XXX__?__YYY__?__ZZZ__?__@@@__?__###__?__%%%__?__$$$__?__***__?__!!!__?__???__?__<<<__?__>>>__?__<<<>>>__?__|||__?__---__?__+++__?__===__?__~~~__?__^^^__?__~~~2__?__none__?__null__?__missing__?__placeholder3__?__reserved2__?__temp2__?__x2__?__y2__?__z2__?__keep2__?__final2__?__ok__?__endfinal__?__stopfinal__?__remove3__?__trash2__?__cleanup2__?__done2__?__complete2__?__finished__?__the_end__?__over2__?__end3__?__bye2__?__ciao2__?__adios2__?__end_of_doc__?__STOP__?__ENDOFFILE__?__NULL__?__N/A__?__NA__?__EMPTY__?__BLANK__?__NONE__?__

Zinplava (bezlotoxumab) is not intended as a first-line therapy for Clostridiodes difficile infection. The drug may be approved only when the coverage criteria are met and it is administered in combination with antibacterial therapy for CDI (for example, Dificid, metronidazole, or oral vancomycin). Additionally, Zinplava may not be used in combination with fecal microbiota–based products Rebyota or Vowst during the same CDI episode.

Requests for Zinplava will be denied (considered not medically necessary) if the required diagnostic, concurrent antibiotic, or high‑risk recurrence criteria are not met. Documentation must support that the individual has CDI (≥3 loose stools in ≤24 hours and a positive stool test for toxigenic C. difficile from a sample collected no more than 7 days before infusion), is receiving antibacterial therapy for CDI, and has at least one high‑risk feature (for example, age ≥65, prior CDI within 6 months, immunocompromised state, severe CDI at presentation, or ribotype 027). Failure to meet these elements or attempts to use Zinplava as first‑line therapy or concurrently with Rebyota or Vowst will result in non‑approval.

Billing and Coding

HCPCSHCPCS

J0565

Injection, bezlotoxumab, 10 mg [ZINPLAVA]

CPTCPT

96413	Chemotherapy administration, intravenous infusion technique; up to 1 hour, single or initial substance/drug
96365	Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to 1 hour

ICD-10 DiagnosisICD-10

A04.71	Enterocolitis due to Clostridium difficile, recurrent
A04.72	Enterocolitis due to Clostridium difficile, not specified as recurrent

inv-07: Severe CDI criteria (IDSA) — WBC and creatinine thresholds

WBC thresholdWhite blood cell count ≥ 15,000 cells/mL

Serum creatinine thresholdSerum creatinine level > 1.5 mg/dL

Source guidanceIDSA criteria for severe CDI (2017)

inv-08: ZAR score threshold — ZAR score ≥2

ZAR score thresholdZAR score ≥ 2

ZAR components — ageAge > 60 years = 1 point

ZAR components — temperatureBody temperature > 38.3°C (>100.9°F) = 1 point

ZAR components — albuminAlbumin level < 2.5 mg/dL = 1 point

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Zinplava (bezlotoxumab). Billing should use HCPCS code J0565 for the drug and the appropriate infusion CPT code(s) (e.g., 96413 or 96365) for administration. Requests will be approved only when the clinical criteria in the policy are met.

Drug HCPCS: J0565
Administration CPT: 96413 or 96365 as appropriate
Prior auth required and limited to members meeting medical necessity criteria

Step Therapy

Step Therapy / Concomitant Antibacterial Therapy

Zinplava must be used in conjunction with antibacterial therapy directed at the current Clostridiodes difficile infection. Step therapy does not apply; the agent is not a first-line monotherapy and is intended to reduce recurrence when used with appropriate antibacterial treatment.

Not intended as first-line treatment
Must be administered while the member is receiving antibacterial therapy for CDI (e.g., fidaxomicin, metronidazole, or oral vancomycin)

Documentation Required

Required Documentation

Documentation supporting the prior authorization request must be provided. Approval requires medical record evidence of the CDI episode, stool testing, timing relative to planned infusion, current antibacterial therapy, and risk factors for recurrence.

Clinical evidence of CDI: documentation of passage of three or more loose stools within 24 hours
Positive stool test for toxigenic C. difficile from a specimen collected within 7 days prior to scheduled infusion
Evidence the member is currently receiving antibacterial therapy for CDI (e.g., medication name and dates)
Documentation of at least one high-risk factor for recurrence (age ≥65, prior CDI within 6 months, immunocompromised state, severe CDI at presentation, or ribotype 027)
If criteria are not met, the request may be denied

Denial Risk

Denial Triggers

Denial may be issued when Zinplava is requested as first-line therapy, when used concurrently with fecal microbiota products (Rebyota or Vowst) for the same CDI episode, or when required clinical criteria or documentation are not met.

Requests for first-line use of Zinplava
Concurrent use with Rebyota or Vowst during the same CDI episode
Missing or inadequate documentation (stool test >7 days before infusion, no evidence of current antibacterial therapy, no high-risk factors documented)

Definitions and Timing

inv-14: Severe Clostridiodes difficile infection — IDSA definition (WBC ≥15,000 or creatinine >1.5 mg/dL) and alternative ZAR criteria

IDSA definition (severe CDI)White blood cell ≥ 15,000 cells/mL OR serum creatinine > 1.5 mg/dL

Alternative ZAR criteriaZAR score ≥ 2 (points: age >60 =1; temp >38.3°C =1; albumin <2.5 mg/dL =1; WBC >15,000 within 48 hrs =1; pseudomembranes =2; ICU treatment =2)

Approval duration noteApproval duration: one injection

inv-15: Positive stool test timing — sample collected no more than 7 days prior to scheduled infusion

Timing of positive stool testPositive stool test for toxigenic C. difficile must be from a sample collected no more than 7 days prior to scheduled infusion

Diagnostic requirement contextDocumentation must show clinical evidence of CDI (≥3 loose stools in ≤24 hours) and a positive stool test collected within 7 days

Source trial requirementPhase III trial enrollment required a positive stool test collected within the previous 7 days

OpenPayer

Zinplava (bezlotoxumab) — Coverage Criteria for Prevention of Recurrent Clostridiodes difficile Infection

Coverage Criteria for Zinplava (bezlotoxumab)

Billing and Coding

Prior Authorization, Documentation, and Provider Requirements

Background on Zinplava (bezlotoxumab)

Definitions and Timing