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.
No material clinical or coverage changes in this revision.
Coverage Criteria
Initial Therapy
Covered when ALL of the following are met for the specified indication
Measurements required
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
| J0775 | Injection, collagenase, clostridium histolyticum, 0.01 mg [Xiaflex] |
| M72.0 | Palmar fascial fibromatosis (Dupuytren) |
| N48.6 | Induration penis plastica (Peyronie's disease) |
Provider Actions & 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
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).
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 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.
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
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