CurrentEmblemHealthPolicy N/A

Xiaflex (collagenase clostridium histolyticum) Intralesional

Medical coverage criteria and utilization management for intralesional Xiaflex for Dupuytren's contracture and Peyronie's disease for EmblemHealth members.

Policy Summary

PayerEmblemHealth

PolicyXiaflex (collagenase clostridium histolyticum) Intralesional

Policy CodePolicy N/A

Change TypeMaterial clinical revisions (criteria and dosing limits updated)

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization using HCPCS code J0775 and submit clinical documentation demonstrating diagnosis, measurable curvature/contracture, functional limitation and treatment history.

SourceLink

POLICY UPDATE CHANGES

Added requirement that patient has not received surgical treatment (e.g., fasciectomy, fasciotomy) on the selected joint within 90 days before the first injection for Dupuytren's contracture.

For Peyronie's disease, added exclusion of ventral curvature deformity, isolated hourglass deformity or calcified plaque.

Updated dosing limits and renewal criteria including maximum treatment cycles and minimum intervals between injections.

58 unitsbillable units per injection day

180 unitsmax units per 28-42 day period

3max injections per Dupuytren joint

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Coverage Criteria for Xiaflex (collagenase) Intralesional Therapy

Initial Therapy — Covered when ALL of the following are met for the specified diagnosis

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

Dupuytren initial criteria: 1) Patient is 18 years or older; 2) Patient has a palpable cord; 3) Documented flexion contracture of 20° to 100° in a metacarpophalangeal (MP) joint or 20° to 80° in a proximal interphalangeal (PIP) joint; 4) Positive table top test (inability to place the affected finger(s) and palm flat on a table); 5) Flexion deformity results in functional limitations; 6) Patient has not received surgical treatment (e.g., fasciectomy, fasciotomy) on the selected joint within 90 days before the first injection; 7) Dosing limits apply: 58 billable units per cord up to 3 times approximately 4 weeks apart (≈180 billable units every 28 days).

Peyronie initial criteria: 1) Patient is 18 years or older; 2) Patient has a palpable penile plaque; 3) Stable disease with curvature deformity >30° and <90°; 4) Intact erectile function (with or without medications); 5) No ventral curvature deformity, isolated hourglass deformity, or calcified plaque; 6) Plaques do not involve the penile urethra; 7) Treatment will be used in combination with penile modeling procedures; 8) Patient has not exceeded 4 treatment cycles for each plaque causing the curvature deformity; 9) Patient has not received a collagenase injection for this condition within the past 6 weeks; 10) Dosing limits: 58 billable units on each of 2 days 1–3 days apart every 6 weeks, maximum of 4 treatment cycles (8 injections) (≈180 billable units every 42 days).

Continuation / Renewal Therapy

Renewal may be granted when ALL of the following are met

Peyronie renewal: 1) EDVS status has been checked for Medicaid patients; 2) Patient's curvature deformity is ≥15°; 3) Absence of unacceptable toxicity from the drug (examples: anaphylaxis, allergic reactions, abnormal coagulation, corporal rupture/penile fracture, other serious penile injury, acute post-injection back pain reactions); 4) Disease response defined by reduction in curvature from baseline or improvement in the PDQ Bother domain score; 5) Patient has not exceeded 4 total treatment cycles for each plaque causing the curvature deformity; 6) Patient has not received a collagenase injection for this condition within the past 6 weeks.

Dupuytren renewal: 1) Absence of unacceptable toxicity from the drug (examples: anaphylaxis, allergic reactions, abnormal coagulation, tendon rupture, or other serious injury to the injected extremity); 2) Disease response defined by reduction in contracture of the selected primary joint compared to baseline; 3) Patient has not exceeded 3 injections per joint/cord; 4) Patient has not received a collagenase injection for this condition within the past 4 weeks.

Coverage excludes patients with certain plaque or deformity characteristics and those who exceed specified cycle or injection limits. Specifically, for Peyronie’s disease coverage excludes members with ventral curvature deformity, isolated hourglass deformity, or calcified plaque, and excludes plaques that involve the penile urethra. Requests will also be denied when a patient has exceeded the program’s maximum treatment limits (see renewal and dosing criteria).

For Dupuytren’s contracture, approvals are limited to the per-cord authorization period and renewal restrictions described in the policy: approval is granted for 12 weeks per cord for non‑Medicaid members and may not be renewed. Other patient-level exclusions include failure to meet the documented contracture thresholds or absence of a palpable cord, as required by the initial coverage criteria.

Xiaflex must be administered only by clinicians experienced with the relevant procedure who have completed the Xiaflex REMS certification; use by providers who are not experienced or not REMS‑certified may be considered inappropriate due to risk of serious complications. This policy follows the document’s requirement that administration be performed by experienced hand injection clinicians for Dupuytren’s or by urologists for Peyronie’s disease.

Authorization durations and cautions: for non‑Medicaid members, Dupuytren's approvals are granted for 12 weeks per cord and generally are not renewable; Peyronie’s approvals are granted for 6 weeks per approval and may be renewed up to 4 times. Providers should note these limits and ensure REMS certification, appropriate documentation of disease stability and severity, and adherence to injection interval and cycle limits when requesting authorization.

Billing Codes and Diagnosis Codes

Applicable Procedure CodesHCPCSCovered

J0775

Injection, collagenase, clostridium histolyticum, 0.01 mg

Applicable NDCsNDC

66887-0003-01

Xiaflex 0.9mg Solution Reconstituted J0775 Injection, collagenase, clostridium histolyticum, 0.01 mg

ICD-10 DiagnosesICD-10

M72.0	Palmar fascial fibromatosis [Dupuytren]
N48.6	Induration penis plastica

Curvature / contracture thresholds

Dupuytren's contractureDocumented flexion contracture of 20° to 100° in a metacarpophalangeal (MP) joint or 20° to 80° in a proximal interphalangeal (PIP) joint

Age requirementPatient is 18 years of age or older for both indications

Dupuytren surgical exclusionPatient has not received surgical treatment (e.g., fasciectomy, fasciotomy) on the selected joint within 90 days before the first injection

Provider Requirements and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required. Use HCPCS code J0775 (Injection, collagenase, clostridium histolyticum, 0.01 mg) when requesting coverage.

Prior authorization required for Xiaflex (HCPCS J0775).

Documentation Required

Medicaid-specific EDVS and Supply Limit

For Medicaid members, the Erectile Dysfunction Verification System (EDVS) status must be checked and documented before approval. If the patient is on the sex offender list and a medical director approves treatment, approvals for Medicaid members are limited to a maximum 30-day supply. Renewals for Medicaid members must be requested every 30 days with verification of EDVS status on each renewal.

Medicaid-only: EDVS check required.
Medicaid-only: Maximum 30-day supply per approval when patient is on the sex offender list; renew every 30 days with EDVS verification.

Background and Rationale

Collagenase clostridium histolyticum (Xiaflex) is a combination of proteinases that hydrolyze native triple‑helical collagen in pathologic cords and plaques. Intralesional injection produces enzymatic disruption of collagen‑rich tissue, which can lead to mechanical weakening of Dupuytren cords or Peyronie’s plaques and reduction in contracture or penile curvature when combined with appropriate modeling or manual disruption.

Clinically, this mechanism translates to reduction in deformity and patient bother when administered by trained clinicians: for Dupuytren’s, enzymatic degradation of the cord facilitates improved joint extension; for Peyronie’s, enzymatic softening of the plaque can reduce curvature when used in combination with penile modeling procedures.

Definitions and Provider Qualifications

Collagenases / mechanism

DefinitionCollagenases are proteinases that hydrolyze collagen in its native triple helical conformation under physiological conditions, resulting in lysis of collagen deposits

Provider qualification / REMS

REMS certificationXiaflex must be administered only by clinicians who have received certification in the Xiaflex Risk Evaluation and Mitigation Strategy (REMS) Program

Risk rationaleUse by providers not experienced or not REMS-certified may be considered inappropriate due to risk of serious complications or damage