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    v1.0.30
    OpenPayerPolicy UpdatesUrologyAnthem Xiaflex Coverage Prior Auth Policy Update |…
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    CurrentAnthemPolicy CC-0017

    Xiaflex (collagenase clostridium histolyticum) injection

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    Clinical medical necessity and prior authorization criteria for Xiaflex injections for Dupuytren's contracture and Peyronie's disease under the medical benefit, including dosing limits and coding guidance for providers.

    Policy Summary
    PayerAnthem
    PolicyXiaflex (collagenase clostridium histolyticum) injection
    Policy CodePolicy CC-0017
    Change TypeReviewed — no material changes
    Effective Date10/24/2025
    Last ReviewSep 8, 2025
    Next Review DateSep 8, 2026
    Key ActionObtain prior authorization and document diagnosis, palpable lesion measurements, and stability before administering Xiaflex.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    2Indications
    ≤3 inj/cordDupuytren limit
    ≤8 inj/plaque

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    Peyronie's limit
    CPT/HCPCS/ICDCodes listed

    Coverage Criteria

    Initial Therapy

    Covered when ALL of the following are met for the specified indication

    Dupuytren's contracture: Individual has a diagnosis of Dupuytren's contracture AND product will be injected into a palpable palmar cord that impairs the individual's functional activities AND the palpable cord measures either >=20 degrees at the metacarpophalangeal (MCP) joint OR >=20 degrees at the proximal interphalangeal (PIP) jointMCP >=20° OR PIP >=20°

    Measurements required

    Peyronie's disease: Individual has a diagnosis of Peyronie's disease AND disease is stable for at least 6 months AND penile curvature is greater than or equal to 30 degrees and less than or equal to 90 degrees AND individual has intact erectile function (with or without medications) AND documentation of palpable penile plaque(s) is providedCurvature >=30° and <=90°; stability >=6 months

    AUA guideline criteria referenced

    The following uses are excluded from coverage: treatment for cosmetic indications (including, but not limited to, treatment of cellulite) and treatment of Peyronie's plaques that involve the penile urethra.

    Requests that do not meet the clinical requirements listed in this policy are not medically necessary and will not be approved.

    Coding and Clinical Thresholds

    Covered CPT CodesCPT
    20527Injection, enzyme (eg, collagenase), palmar fascial cord (ie, Dupuytren's contracture)
    26341Manipulation, palmar fascial cord (ie, Dupuytren's cord), post enzyme injection (eg, collagenase), single cord
    HCPCSHCPCS
    J0775Injection, collagenase, clostridium histolyticum, 0.01 mg [Xiaflex]
    ICD-10 DiagnosisICD-10
    M72.0Palmar fascial fibromatosis (Dupuytren)
    N48.6Induration penis plastica (Peyronie's disease)
    inv-07: Peyronie's curvature degree — numeric threshold (>= 30° and <= 90°)
    Peyronie’s curvature degree>= 30° and <= 90°
    Supporting guidanceAUA guideline criteria referenced for curvature threshold
    Documentation requiredProvide documentation that penile curvature is >=30° and <=90°
    inv-08: Dupuytren joint contracture degree — numeric threshold (>= 20° at MCP or >= 20° at PIP)
    Dupuytren joint contracture degree>= 20° at the metacarpophalangeal (MCP) joint OR >= 20° at the proximal interphalangeal (PIP) joint
    Measurement requirement

    Provider Actions & Authorization

    Prior Authorization

    Prior Authorization Required

    Prior authorization is required. Clinical criteria and quantity limits per indication must be met and documented before approval.

    • Affected product: Xiaflex (collagenase clostridium histolyticum)
    • Quantity limits: Dupuytren's — up to 2.32 mg per 28 days; Lifetime maximum: 3 injections per affected cord. Peyronie's — 1.16 mg per 7 days; Lifetime maximum: 8 injections per Peyronie's plaque
    • REM S: Xiaflex for Peyronie's disease is available only through the REMS program due to risk of corporal rupture
    Step Therapy

    Step Therapy

    No specific step therapy requirements are specified for Xiaflex; requests will be evaluated based on indication-based clinical criteria.

    • Coverage decisions are made per indication-specific criteria for Dupuytren's contracture and Peyronie's disease (see documentation requirements and clinical criteria).

    Background

    Xiaflex (collagenase clostridium histolyticum) is a biologic collagenase indicated for injection into fibrous cords or plaques to enzymatically degrade collagen. It is used to treat Dupuytren's contracture when injections are delivered into a palpable palmar cord that impairs function with joint contracture ≥20° at the MCP or PIP, and to treat Peyronie's disease for stable disease (≥6 months) with documented palpable plaque(s), intact erectile function, and penile curvature between 30° and 90°.

    Definitions

    inv-14: stable disease — stable Peyronie's disease definition/threshold
    Stable disease definitionSymptoms (such as penile curvature and pain) stable for at least 6 months
    Guideline sourceAUA Peyronie’s Disease guideline referenced in policy
    Implication for therapyIntralesional Xiaflex recommended for stable disease meeting curvature and erectile function criteria
    inv-15: palpable palmar cord — definition noting impairment of functional activities
    Palpable palmar cord definitionA palmar cord that is palpable and impairs the individual’s functional activities
    Documentation requirementProvider must document that product will be injected into a palpable palmar cord that impairs functional activities
    Policy Summary
    PayerAnthem
    PolicyXiaflex (collagenase clostridium histolyticum) injection
    Policy CodePolicy CC-0017
    Change TypeReviewed — no material changes
    Effective Date10/24/2025
    Last ReviewSep 8, 2025
    Next Review DateSep 8, 2026
    Key ActionObtain prior authorization and document diagnosis, palpable lesion measurements, and stability before administering Xiaflex.
    SourceLink
    On This Page
    Coverage CriteriaCoding and Clinical ThresholdsProvider Actions & AuthorizationBackgroundDefinitions
    Documentation must state degree of contracture at MCP or PIP
    Injection targetProduct must be injected into a palpable palmar cord that impairs functional activities
    Documentation Required

    Required Clinical Documentation

    Required clinical documentation must accompany the prior authorization request to support medical necessity.

    • For Dupuytren's contracture: diagnosis, documentation that injection will be into a palpable palmar cord impairing functional activities, and measurement of cord contracture 20° or more at the MCP or PIP joint.
    • For Peyronie's disease: diagnosis, documentation of disease stability for ≥6 months, penile curvature ≥30° and ≤90°, intact erectile function (with or without medications), and presence of palpable penile plaque(s).
    • Documentation of prior treatments or reasons surgery is not appropriate may be relevant.
    Denial Risk

    Denial Triggers

    Denial may occur if requested use is cosmetic, criteria are unmet, or Peyronie's plaques involve the urethra.

    • Not covered for cosmetic indications (e.g., cellulite).
    • Not covered for Peyronie's plaques that involve the penile urethra.
    • Not approved when required clinical criteria or quantity limits are not met.
    Indication linkageRequired for approval of Xiaflex for Dupuytren’s contracture