CurrentUnitedHealthcarePolicy 2025D0099E

Xiaflex (collagenase clostridium histolyticum) therapy — Dupuytren's contracture and Peyronie's disease

Medical necessity and coverage criteria for Xiaflex injections for Dupuytren's contracture and Peyronie's disease for UnitedHealthcare members and providers who administer or request authorization for these treatments.

Policy Summary

PayerUnitedHealthcare

PolicyXiaflex (collagenase clostridium histolyticum) therapy — Dupuytren's contracture and Peyronie's disease

Policy CodePolicy 2025D0099E

Change TypeNo material change

Effective DateJan 1, 2025

Next Review Date

Key ActionSubmit prior authorization requests that document diagnosis, palpable cord or plaque, baseline contracture/curvature measurements, functional limitation, and adherence to dosing and quantity limits.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2indications covered

0.58 mgFDA dose

3max injections/cord

2Peyronie's max per cycle

90 dayssurgical exclusion window

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Coverage Criteria for Xiaflex (collagenase clostridium histolyticum)

inv-01: Dupuytren's contracture — Initial therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Dupuytren initial criteria: Patient has diagnosis of Dupuytren's contracture with a palpable cord; and Patient is 18 years of age or older; and Xiaflex is prescribed and administered by a healthcare provider experienced in injection procedures of the hand and in the treatment of Dupuytren's contracture; and Documented contracture of at least 20 degrees flexion for a metacarpophalangeal (MP) joint contracture or proximal interphalangeal (PIP) joint contracture; and Documentation that the flexion deformity results in functional limitations; and Patient has not received surgical treatment on the selected primary joint within the last 90 days; and If two injections (two vials) are requested, they are for one of the following: one cord affecting two joints in the same finger; or two cords affecting two joints in the same hand; and Xiaflex dosing is in accordance with the U.S. Food and Drug Administration (FDA) approved labeling: 0.58 mg per injection into a palpable cord; and The total number of injections does not exceed 3 injections per cord at approximately 4-week intervals; and Authorization is for no more than 2 injections in the same hand

inv-02: Dupuytren's contracture — Continuation of therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Dupuytren continuation criteria: Patient has previously received Xiaflex; and Documentation of positive clinical response to Xiaflex; and Treatment request is for at least one of the following: metacarpophalangeal (MP) or proximal interphalangeal (PIP) contracture remains in affected cord since previous injection and the contracture is > 5 degrees; or a different MP or PIP contracture will be injected; and If two injections (two vials) are requested, use is for one of the following: one cord affecting two joints in the same finger; or two cords affecting two joints in the same hand; and Patient has not received surgical treatment (e.g., fasciectomy, fasciotomy) on the selected primary joint within the last 90 days; and The previous treatment was at least 4 weeks ago; and Xiaflex dosing is in accordance with the U.S. Food and Drug Administration (FDA) approved labeling: 0.58 mg per injection into a palpable cord; and The total number of injections does not exceed 3 injections per cord at approximately 4-week intervals; and Authorization is for no more than 2 injections in the same hand

inv-03: Peyronie's disease — Initial therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Peyronie's initial criteria: Patient has diagnosis of Peyronie's disease with both of the following: palpable plaque; and curvature deformity of greater than or equal to 30 degrees at the start of therapy; and Patient is 18 years of age or older; and Xiaflex is prescribed and administered by a healthcare provider experienced in the treatment of male urological diseases; and Xiaflex dosing is in accordance with the U.S. Food and Drug Administration (FDA) approved labeling: 0.58 mg per injection into a Peyronie's plaque; and Authorization is for no more than two injections and 6 weeks duration

inv-04: Peyronie's disease — Continuation of therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Peyronie's continuation criteria: Patient has previously received Xiaflex; and Documentation of positive clinical response to Xiaflex; and Last treatment was at least 6 weeks ago; and Documented curvature deformity of greater than or equal to 15 degrees remaining since last treatment cycle; and Patient has received less than 4 treatment cycles (i.e., less than 8 injections); and Xiaflex dosing is in accordance with the U.S. Food and Drug Administration (FDA) approved labeling: 0.58 mg per injection into a Peyronie's plaque; and Authorization is for no more than two injections and 6 weeks duration

Xiaflex (collagenase clostridium histolyticum) is considered unproven and not medically necessary for any other uses beyond the indications and criteria specifically described in this policy (Dupuytren's contracture and Peyronie's disease).

Coding and Clinical Thresholds

Applicable HCPCS (example identified in policy header)HCPCS

J0775

Injection, collagenase clostridium histolyticum, 0.01 mg (example billing unit — actual policy lists applicable codes in 'Applicable Codes' section)

inv-07: Dupuytren's contracture minimum contracture — Initial therapy

ThresholdDocumented contracture of at least 20 degrees flexion for a metacarpophalangeal (MP) or proximal interphalangeal (PIP) joint for initial Dupuytren's therapy

Applies toInitial therapy requests only

Age requirementPatient is 18 years of age or older

Provider requirementProvider experienced in hand injection procedures and treatment of Dupuytren's

inv-08: Dupuytren's continuation residual — Residual contracture

ThresholdContracture remaining > 5 degrees in the affected cord since previous injection for continuation of therapy

Prior Authorization, Documentation, and Quantity Limits

Prior Authorization

Prior Authorization Required

Prior authorization required when requesting Xiaflex. Requests must meet the listed initial or continuation criteria for the applicable indication. Requests that do not meet documented criteria for the indicated diagnosis (for example, no palpable cord for Dupuytren's contracture or no palpable plaque for Peyronie's disease) are not eligible.

Prior authorization is required for both Dupuytren's contracture and Peyronie's disease indications.
See clinical criteria for initial and continuation therapy for each indication.

Documentation Required

Required Clinical Documentation

Documentation must include diagnosis-specific findings and baseline measurements prior to authorization.

Dupuytren's contracture: diagnosis with a palpable cord and documented contracture of ≥20° flexion for MP or PIP joint; documentation that the flexion deformity results in functional limitations.

Background

Dupuytren's contracture is a benign, slowly progressive fibroproliferative disease of the palmar fascia that can form nodules and longitudinal cords producing finger flexion contractures over time. The pathologic process involves proliferation of fibroblasts and myofibroblasts with collagen deposition, leading to cords that can be palpated and that restrict extension of the affected digits.

Intralesional collagenase (Xiaflex) enzymatically disrupts the collagen within a palpable cord with the goal of reducing flexion deformity and improving finger extension; treatment decisions are based on documented palpable cords, degree of contracture, functional limitation, and provider experience in hand injection procedures.

Key Definitions

inv-17: Palpable cord (Dupuytren's) — Definition and clinical relevance

DefinitionA longitudinal band (cord) in the palmar fascia formed from fibroblastic proliferation and collagen deposition that can be palpated and may cause finger flexion contracture

Clinical relevancePresence of a palpable cord is required documentation for Xiaflex treatment for Dupuytren's contracture

Associated findingsCords may develop from nodules and lead to progressive loss of finger extension at the MP or PIP joints

inv-18: Palpable plaque (Peyronie's) — Definition and clinical relevance

DefinitionA fibrotic lesion of the tunica albuginea that can be palpated and is associated with penile curvature deformity (palpable plaque)

Clinical relevanceA palpable plaque plus curvature ≥30 degrees at baseline is required for initial Xiaflex therapy in Peyronie's disease

Policy Summary

PayerUnitedHealthcare

PolicyXiaflex (collagenase clostridium histolyticum) therapy — Dupuytren's contracture and Peyronie's disease

Policy CodePolicy 2025D0099E

Change TypeNo material change

Effective DateJan 1, 2025

Next Review Date

SourceLink

On This Page

Applies toContinuation therapy requests when treating same MP or PIP contracture

Timing requirementPrevious treatment was at least 4 weeks prior to the request

DocumentationMust document prior positive clinical response to Xiaflex

inv-09: Peyronie's disease minimum curvature — Start and continuation thresholds

Initial therapy thresholdCurvature deformity ≥ 30 degrees at the start of therapy

Continuation thresholdDocumented curvature deformity ≥ 15 degrees remaining since last treatment cycle to continue therapy

Age requirementPatient is 18 years of age or older

Provider requirementProvider experienced in treatment of male urological diseases

Peyronie's disease: diagnosis with a palpable plaque and curvature deformity ≥30° at the start of therapy.

Patient age (≥18 years) and that the provider is experienced in the relevant injection/treatment (hand for Dupuytren's; male urologic diseases for Peyronie's).

For all requests, include dosing plan consistent with FDA labeling (0.58 mg per injection) and recent surgical history for the target joint/plaque (no surgical treatment on the selected primary joint within the last 90 days for Dupuytren's; applicable exclusions for Peyronie's).

Documentation Required

Continuation Documentation

For continuation (reauthorization) requests include prior treatment details and objective evidence of benefit or ongoing need.

Evidence patient previously received Xiaflex and documentation of positive clinical response.
Timing of last treatment: Dupuytren's — previous treatment was at least 4 weeks ago; Peyronie's — last treatment was at least 6 weeks ago.
Provide residual contracture/curvature measurements: Dupuytren's — contracture >5° in the affected cord since previous injection or injection planned for a different MP/PIP contracture; Peyronie's — documented curvature ≥15° remaining since last treatment cycle.
Number of prior cycles/injections to demonstrate remaining eligibility (see quantity limits).

Billing Rule

Quantity Limits

Quantity and dosing limits are enforced; requests exceeding these limits require review and may be denied.

Dupuytren's dosing: 0.58 mg per injection into a palpable cord; total injections do not exceed 3 injections per cord at approximately 4-week intervals; authorization is for no more than 2 injections in the same hand. Two vials may be used only when treating one cord affecting two joints in the same finger or two cords affecting two joints in the same hand.
Peyronie's dosing: 0.58 mg per injection into a Peyronie's plaque; authorization is for no more than two injections per authorization and a 6-week duration per cycle. Continuation: patient must have received <4 treatment cycles (i.e., <8 injections total) to remain eligible.
Requests for injections beyond these limits (e.g., >3 injections per cord for Dupuytren's, >2 injections authorized in same hand, or >8 injections/4 cycles for Peyronie's) will require special review or will be denied.

Step Therapy

No formal step therapy is required; coverage is contingent on meeting the described clinical criteria. There is no requirement to try alternative therapies before Xiaflex when all clinical criteria are met.

Coverage is based on meeting initial or continuation clinical criteria rather than specific prior-step treatments.
If clinical documentation does not meet criteria, the request is not eligible regardless of prior therapies.

Treatment implicationPalpable plaque is the target for intralesional Xiaflex injections and must be documented for authorization