CurrentmhnPolicy CP.PHAR.82

Collagenase Clostridium Histolyticum (Xiaflex) coverage

Defines medical necessity criteria, dosing limits, and authorization rules for Xiaflex (collagenase clostridium histolyticum) for Dupuytren's contracture and Peyronie's disease for members covered by the payer.

Policy Summary

Payermhn

PolicyCollagenase Clostridium Histolyticum (Xiaflex) coverage

Policy CodePolicy CP.PHAR.82

Change TypeNo material changes

Effective DateOct 1, 2011

Next Review DateAug 25, 2025

Key ActionPrior authorization required with documentation showing the member meets all indication-specific criteria and dosing limits.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

0.58 mgmaximum dose per injection

3 monthsapproval duration (per)

Up to 3max injections per cord (DC)

Up to 4treatment cycles (PD)

J0775billing code referenced

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inv-01: Initial Therapy - Dupuytren's Contracture

Covered when ALL of the following are met:

Dupuytren's initial

Diagnosis of DC with a palpable cord
Provider: Prescribed by or in consultation with a healthcare provider experienced in injection procedures of the hand and in the treatment of DC
Age ≥ 18 years
Recent surgery: Member has not received surgical treatment (e.g., fasciectomy, fasciotomy) on the selected primary joint within the last 90 days
Two injections requested: If two injections (two vials) are requested, they are for one of the following: (a) one cord affecting two joints in the same finger OR (b) two cords affecting two joints in the same hand
Dose does not exceed 0.58 mg per injection (one vial per injection)<=0.58 mg

inv-02: Initial Therapy - Peyronie's Disease

Covered when ALL of the following are met:

Peyronie's initial

Diagnosis of PD with both of the following: (a) palpable plaque AND (b) curvature deformity of ≥ 30 degrees at the start of therapy>=30 degrees
Provider: Prescribed by or in consultation with a healthcare provider experienced in the treatment of male urological diseases
Age ≥ 18 years
Dose does not exceed 0.58 mg per injection (one vial per injection)<=0.58 mg

inv-03: Continued Therapy - Dupuytren's Contracture

Continued therapy is covered when ALL of the following are met:

Dupuytren's continued

Prior therapy status: Member currently receiving medication via Centene benefit OR member has previously met initial approval criteria OR member is enrolled in a state/product with continuity of care regulations
Timing: Last treatment was ≥ 4 weeks ago>=4 weeks
Injections per cord: Member has not received more than two total injections per affected cord<=2 injections per cord

inv-04: Continued Therapy - Peyronie's Disease

Continued therapy is covered when ALL of the following are met:

Peyronie's continued

Prior therapy status: Member currently receiving medication via Centene benefit OR member has previously met initial approval criteria OR member is enrolled in a state/product with continuity of care regulations
Residual curvature: Documented curvature deformity of ≥ 15 degrees remaining since last treatment cycle>=15 degrees
Timing: Last treatment cycle was ≥ 6 weeks ago>=6 weeks

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized for coverage unless the provider submits sufficient documentation supporting efficacy and safety in accordance with the applicable off‑label use policies: CP.CPA.09 (commercial), HIM.PA.154 (health insurance marketplace), or CP.PMN.53 (Medicaid), or unless coverage is supported by the member's evidence‑of‑coverage documents.

Coverage decisions and the administration of benefits for requests under this policy are subject to all terms, conditions, exclusions, and limitations of the member's coverage documents (for example, evidence of coverage, certificate of coverage, policy or contract). State and federal requirements and any applicable Health Plan administrative policies and procedures also apply; where state Medicaid provisions conflict with this policy, the state provisions take precedence.

Uses for indications that are not addressed in this policy are not authorized unless the provider supplies adequate off‑label documentation consistent with the Health Plan's off‑label use requirements or the applicable evidence‑of‑coverage provisions.

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required. Provider must submit documentation demonstrating the member meets all indication‑specific criteria (see Dupuytren's Contracture and Peyronie's Disease sections).

Prior authorization required for covered indications (Dupuytren's Contracture, Peyronie's Disease).
If two injections (two vials) are requested, justification per Dupuytren's criteria must be provided (one cord affecting two joints in same finger OR two cords affecting two joints in same hand).

Billing Rule

Coding and Prior Authorization Guidance

Codes referenced are informational only. Inclusion or exclusion of any codes does not guarantee coverage; providers should verify current coding guidance prior to claim submission.

HCPCS: J0775 — Injection, collagenase, clostridium histolyticum, 0.01 mg (informational).
Providers are responsible for correct coding and should reference the most up-to-date professional coding sources before billing.

Documentation Required

Required Documentation

Provider must submit supporting clinical documentation (e.g., office chart notes, imaging, lab results, procedure notes) showing the member meets all approval criteria for the requested indication.

Documentation should demonstrate diagnosis (palpable cord or plaque), degree of deformity (e.g., curvature ≥ 30° for Peyronie’s), prior treatments/surgeries and dates (e.g., no surgical treatment on selected primary joint within last 90 days for Dupuytren's).
If requesting multiple injections, include rationale and how dosing limits per policy are met (dose ≤ 0.58 mg per injection).

Note

Cross‑Reference / Coverage Routing

If the requested use is not specifically listed in the coverage sections and the drug label changed within the last 6 months, follow the referenced formulary/non‑formulary or off‑label policies for the applicable line of business. If not a recent label change and the use is not listed, refer to the off‑label use policy.

For formulary drugs or PDL: see CP.CPA.190 (commercial), HIM.PA.33 (marketplace), CP.PMN.255 (Medicaid).
For non‑formulary drugs/PDL: see CP.CPA.190 (commercial), HIM.PA.103 (marketplace), CP.PMN.16 (Medicaid).
For off‑label requests: see CP.CPA.09 (commercial), HIM.PA.154 (marketplace), CP.PMN.53 (Medicaid).

Note

Administrative Coverage Decision Note

Coverage decisions are subject to all terms, conditions, exclusions and limitations of the member's coverage documents and applicable Health Plan administrative policies and procedures.

This policy is a guide to medical necessity and does not guarantee payment.
State and federal requirements and Health Plan-level administrative policies may affect coverage determinations.

Quantity Limits and Dosing

Xiaflex quantity limits and injection limits

Approval period limitUp to 2 injections per approval period (3 months)

Maximum injections per cord (DC)Up to 3 injections per affected cord total

Maximum injections and cycles (PD)Up to 8 injections total (maximum 4 treatment cycles; each cycle = 2 injections + modeling)

Documentation Required

Office administration and associated procedures

Administration is intralesional and performed in an appropriate clinical setting; injections and associated procedures (finger extension for Dupuytren's, modeling for Peyronie's) should be performed by experienced providers.

Dupuytren's: intralesional injections with finger extension 24–72 hours after injection; up to 3 injections per cord at ~4-week intervals.
Peyronie's: intralesional injections into Peyronie's plaque with modeling procedures; treatment course up to 4 cycles (maximum 8 injections).

Step Therapy / Routing

When requested use is not listed or label recently changed	Required routing / referenced policies
If the drug has undergone a label change within the last 6 months (e.g., new approval, age expansion, new dosing) that is not yet reflected in this policy	Refer to either: (a) the no coverage criteria policy for drugs on the formulary/PDL (CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, CP.PMN.255 for Medicaid) OR (b) the non‑formulary policy for drugs not on the formulary/PDL (CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, CP.PMN.16 for Medicaid).
If the requested use is not specifically listed under section III (Diagnoses/Indications not authorized) AND the label-change routing above does not apply	Refer to the off‑label use policy for the applicable line of business: CP.CPA.09 (commercial), HIM.PA.154 (health insurance marketplace), or CP.PMN.53 (Medicaid).

Definitions

Dupuytren's contracture (DC)

DefinitionDupuytren's contracture (DC): a hand condition with palpable cords leading to metacarpophalangeal (MP) or proximal interphalangeal (PIP) joint contractures.

Typical manifestationPalpable cord with MP or PIP joint contracture that may be treated with intralesional Xiaflex injections and finger extension procedures.

Age populationApplies to adults (Age ≥ 18 years) when meeting clinical criteria.

Peyronie's disease (PD)

DefinitionPeyronie's disease (PD): a male urological condition characterized by a palpable penile plaque and curvature deformity.

Diagnostic requirementDiagnosis requires a palpable plaque and, for initial therapy, curvature deformity of ≥ 30 degrees at start of therapy.

Treatment course notePD treatment cycles consist of two injections plus a penile modeling procedure; up to 4 cycles (8 injections) total per treatment course.

Xiaflex (definition and reference)

Drug identityXiaflex (collagenase clostridium histolyticum) per FDA prescribing information referenced (Xiaflex Prescribing Information, July 2023).

AdministrationIntralesional injection into palpable cord (DC) or plaque (PD) as described in prescribing information.

Reference access datePrescribing information accessed April 15, 2025.

Background

Xiaflex (collagenase clostridium histolyticum) is a combination of bacterial collagenases indicated for the treatment of adult Dupuytren's contracture with a palpable cord and for adult men with Peyronie's disease who have a palpable plaque and a curvature deformity of at least 30 degrees at the start of therapy, per the product prescribing information and referenced clinical guidance. Administration is intralesional: for Dupuytren's the regimen involves injection into the palpable cord followed by finger‑extension procedures, and for Peyronie's treatment cycles consist of two intralesional injections plus modeling. Prior authorization is required with documentation demonstrating the member meets the indication‑specific criteria and that dosing does not exceed 0.58 mg per injection.

OpenPayer

Collagenase Clostridium Histolyticum (Xiaflex) coverage

Coverage Criteria

Initial Therapy

Continuation / Ongoing Therapy

Coding

Provider Actions & Requirements

Quantity Limits and Dosing

Step Therapy / Routing

Definitions

Background

Coding References & Metadata