Xiaflex (collagenase clostridium histolyticum) coverage
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Medical benefit policy governing coverage criteria and utilization management for Xiaflex injections for Dupuytren's contracture and Peyronie's disease across Univera Healthcare lines of business; applies to providers administering the drug and prior authorization reviewers.
No material clinical or coverage changes in this revision.
Coverage Criteria
Dupuytren's Contracture
Covered when ALL of the following are met:
Provider must specify location of cord (hand, finger(s), joint(s))
Provider attestation required
Separate vials/syringes required if treating two joints in same hand
Peyronie's Disease
Covered when ALL of the following are met:
Provider attestation required
Approval duration 12 months; not covered for Managed Medicaid/HARP
Xiaflex (collagenase clostridium histolyticum) is covered only for the treatment of Dupuytren's contracture and Peyronie’s disease. Uses outside these indications, including any cosmetic purpose, are excluded from coverage. The drug is administered under the medical benefit and must be used in accordance with the clinical criteria and dosing in this policy.
For Managed Medicaid/HARP members, the use of Xiaflex for the treatment of Peyronie’s disease is not a covered benefit. Requests for Xiaflex in Peyronie’s disease under Managed Medicaid/HARP must be denied as not covered by that line of business.
Retreatment with Xiaflex for Peyronie’s disease will not be authorized when the penis is functionally straight (curvature ≤ 20 degrees) following prior treatment cycles, or when additional treatment is not expected to provide clinical benefit. In addition, retreatment should not be approved when the intended use is cosmetic or otherwise not medically indicated.
Coding
| J0775 | Injection, collagenase, clostridium histolyticum, 0.01 mg |
Provider Actions & Documentation
Prior authorization required
Prior authorization is required under the medical benefit for Xiaflex; requests must meet the documented age, diagnosis, provider training/certification, and clinical severity criteria described for Dupuytren's contracture or Peyronie's disease.
- Applies to both initial and recertification requests per policy guidelines.
- HCPCS code J0775 applies to billing (see coding section).
Step therapy and LCD/NCD interactions
Step therapy requirements may be imposed in addition to any applicable NCD/LCD; when an indication is not addressed by an LCD/NCD, off‑label review (per Pharmacy-32) may require prior alternative therapies where appropriate.
- For Medicare Advantage members, step therapy can be applied on top of NCD/LCD criteria.
- Off‑label requests will be reviewed under the health plan’s Off‑Label Use policy which may require alternatives prior to approval.
Required clinical documentation
Submit clinical documentation with every initial and recertification request, including progress notes documenting prior treatments/treatment history, diagnostic testing/imaging, and results showing ongoing benefit for continuation requests.
- Continued approval requires documentation of improvement or stability at recertification.
- Provider attestation may be required for certain provider qualifications.
Anatomic and baseline documentation required
Document the specific anatomic location treated: for Dupuytren’s specify the treated hand, finger(s), and joint(s)/palmar cord; for Peyronie’s document plaque location and baseline penile curvature (degrees) at start of therapy.
- Dupuytren’s: identify MCP or PIP joint and the palpable cord being treated.
- Peyronie’s: record plaque at site of maximum curvature and baseline curvature in degrees (30–90° required).
Off‑label requests subject to review and possible denial
All requests will be reviewed to ensure use for an appropriate, supported indication; off‑label uses are subject to off‑label review and may be denied if criteria or supporting evidence are not met.
- Policy references the health plan’s Off‑Label Use of FDA Approved Drugs Policy (Pharmacy-32) for such reviews.
- Denial may result when off‑label use lacks sufficient supporting evidence or does not meet criteria.
Medicaid: manufacturers must participate in MDRP
Products manufactured by companies not participating in the Medicaid Drug Rebate Program will not be covered under Medicaid Managed Care/HARP; do not submit requests for non‑participating manufacturer products for these lines of business.
- Refer to the Medicaid list of participating labelers for current manufacturer status.
- This restriction applies specifically to Medicaid Managed Care/HARP members per New York State requirements.
Background
Fibroproliferative disorders such as Dupuytren's contracture and Peyronie’s disease involve excessive collagen deposition that creates palpable cords (Dupuytren's) or plaques (Peyronie’s) leading to contracture or penile curvature and functional impairment. Collagenase clostridium histolyticum (Xiaflex) enzymatically digests collagen when injected directly into the cord or plaque; treatment is performed by a health care professional in an office-based setting and is followed by a manipulation or penile modeling procedure per the prescribing regimen.
Definitions
Initial Therapy Criteria
Initial therapy rules
Initial authorization criteria by indication
Approval duration 6 months for non-Managed Medicaid/HARP; Managed Medicaid/HARP 4 weeks
Approval duration 12 months; not covered for Managed Medicaid/HARP
Recertification / Continued Approval
Recertification / Continued Approval
Continued approval requirements
Clinical documentation (progress notes, prior treatments, diagnostic testing, imaging) must be submitted for each recertification request
Step Therapy
| Step | Description |
|---|---|
| {"text":"1","status":""},{"text":"No explicit step-failure requirements are listed in this policy; however, step therapy may be imposed in addition to any applicable LCD/NCD requirements and off‑label review may require prior alternative therapies when appropriate.","status":""} |
Quantity Limits
Site of Care
Office administration and site-of-care review
Xiaflex is administered by a health care professional and is reviewed under the medical benefit; it is typically an office‑based procedure and the requested site of care may affect approval timeframe and review.
- Site-of-care review may impact approval timeframe and is subject to plan review.
- Administration includes injection followed by a manipulation or modeling procedure per indication-specific guidance.
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