RetiredUnitedHealthcarePolicy CSLA2026D0099F

Xiaflex (Collagenase Clostridium Histolyticum) (for Louisiana Only)

Defines medical benefit drug coverage criteria for Xiaflex (collagenase clostridium histolyticum) for treatment of Dupuytren's contracture and Peyronie's disease for UnitedHealthcare Community Plan in Louisiana.

Policy Summary

PayerUnitedHealthcare

PolicyXiaflex (Collagenase Clostridium Histolyticum) (for Louisiana Only)

Policy CodePolicy CSLA2026D0099F

Change TypeRetired for Louisiana membershiproutine review noted

Effective DateJan 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization and document diagnosis, age ≥18, measurable contracture/curvature, functional limitation, and dosing per FDA labeling (0.58 mg per injection).

SourceLink

POLICY UPDATE CHANGES

04/01/2026 Retired policy; Louisiana plan membership disenrolled on Apr. 1, 2026.

01/01/2026 routine review; no content changes.

0.58 mgper-injection dose

30°min Peyronie's curvature

3max injections per cord

2max injections same hand

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria for Xiaflex

Initial Therapy — Dupuytren's

Covered when ALL of the following are met

Dupuytren_initial: Patient has diagnosis of Dupuytren's contracture with a palpable cord; patient is 18 years of age or older; Xiaflex is prescribed and administered by a healthcare provider experienced in injection procedures of the hand and in the treatment of Dupuytren's contracture; documented contracture of at least 20 degrees flexion for a metacarpophalangeal (MP) or proximal interphalangeal (PIP) joint; documentation that the flexion deformity results in functional limitations; patient has not received surgical treatment on the selected primary joint within the last 90 days; if two injections (two vials) are requested, they are for either one cord affecting two joints in the same finger or two cords affecting two joints in the same hand; Xiaflex dosing is in accordance with FDA approved labeling: 0.58 mg per injection into a palpable cord; total number of injections does not exceed three injections per cord at approximately 4-week intervals; authorization is for no more than two injections in the same handsee text

Follow-up/continuation criteria in separate set

Continuation Therapy — Dupuytren's

Covered when ALL of the following are met

Dupuytren_continuation: Patient has previously received Xiaflex; documentation of positive clinical response to Xiaflex; treatment request is for at least one of the following: the MP or PIP contracture remains in the affected cord since the previous injection and the contracture is > 5 degrees, OR a different MP or PIP contracture will be injected; if two injections (two vials) are requested, use is for either one cord affecting two joints in the same finger or two cords affecting two joints in the same hand; patient has not received surgical treatment (e.g., fasciectomy, fasciotomy) on the selected primary joint within the last 90 days; the previous treatment was at least 4 weeks ago; Xiaflex dosing is in accordance with FDA approved labeling: 0.58 mg per injection into a palpable cord; total number of injections does not exceed three injections per cord at approximately 4-week intervals; authorization is for no more than two injections in the same handsee text

Continuation requires prior positive response

Initial Therapy — Peyronie's

Covered when ALL of the following are met

Peyronie_initial: Patient has diagnosis of Peyronie's disease with both a palpable plaque AND curvature deformity of greater than or equal to 30 degrees at the start of therapy; patient is 18 years of age or older; Xiaflex is prescribed and administered by a healthcare provider experienced in the treatment of male urological diseases; Xiaflex dosing is in accordance with FDA approved labeling: 0.58 mg per injection into a Peyronie's plaque; authorization is for no more than two injections and 6 weeks durationsee text

REMS certification required for Peyronie's per FDA

Continuation Therapy — Peyronie's

Covered when ALL of the following are met

Peyronie_continuation: Patient has previously received Xiaflex; documentation of positive clinical response to Xiaflex; last treatment was at least 6 weeks ago; documented curvature deformity of greater than or equal to 15 degrees remaining since last treatment cycle; patient has received less than four treatment cycles (i.e., less than eight injections); Xiaflex dosing is in accordance with FDA approved labeling: 0.58 mg per injection into a Peyronie's plaque; authorization is for no more than two injections and 6 weeks durationsee text

REMS requirements for prescribers/sites apply

Xiaflex is considered unproven and not medically necessary for any other uses beyond the indications and coverage criteria specifically described in this policy.

This policy was retired for Louisiana plan membership as of 04/01/2026; members in the Louisiana plan were disenrolled on April 1, 2026. The document was effective January 1, 2026 through March 31, 2026 and applied only to the state of Louisiana while active.

Scope: This Medical Benefit Drug Policy applied only to the state of Louisiana during its effective window and governed coverage of Xiaflex for Dupuytren's contracture and Peyronie's disease for UnitedHealthcare Community Plan members in Louisiana. Governance note: coverage determinations were to follow the policy criteria while active, and the policy history documents the retirement and disenrollment effective 04/01/2026.

Coding and Clinical Thresholds

Procedure CPT CodesCPT

20527	Injection, enzyme (e.g., collagenase), palmar fascial cord (i.e., Dupuytren's contracture).
26341	Manipulation, palmar fascial cord (i.e., Dupuytren's cord), post enzyme injection (e.g., collagenase), single cord

HCPCSHCPCS

J0775

Injection, collagenase, clostridium histolyticum, 0.01 mg

Diagnosis Codes (examples)ICD-10

M72.0

Palmar fascial fibromatosis [Dupuytren]

Contracture / Curvature thresholds — Dupuytren's & Peyronie's

Dupuytren's — initial therapy thresholdDocumented contracture ≥20° flexion for an MP or PIP joint required for initial authorization.

Dupuytren's — continuation thresholdFor continuation, treated MP or PIP contracture remaining in same cord must be >5° to qualify; prior positive clinical response required.

Dupuytren's — injection limitsPer-label dosing 0.58 mg per injection; total ≤3 injections per cord at ~4‑week intervals; authorization limited to ≤2 injections in the same hand.

Peyronie's — initial therapy thresholdPalpable plaque plus curvature deformity ≥30° at start of therapy required for initial authorization.

Peyronie's — continuation thresholdFor continuation, documented curvature deformity of ≥15° remaining since last treatment cycle and prior positive clinical response; last treatment ≥6 weeks prior; fewer than four treatment cycles to date.

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required — requests must meet criteria for initial or continuation therapy. Authorization limits (e.g., no more than two injections in the same hand for Dupuytren's; no more than two injections and 6 weeks duration for Peyronie's) and FDA dosing must be documented.

Affected therapies: Xiaflex for Dupuytren's contracture and Peyronie's disease
Documentation must show FDA-consistent dosing: 0.58 mg per injection
Dupuytren's: authorization limits — no more than two injections in the same hand; total injections ≤ 3 per cord at ~4-week intervals
Peyronie's: authorization limits — no more than two injections and 6 weeks duration; continuation criteria limit total cycles (<4 cycles / <8 injections)

Note

Reference Benefit-Plan Requirements

Reference and comply with the applicable federal, state, and contractual benefit-plan requirements. When there is a conflict between this policy and a member's benefit plan (including federal or state mandates), the benefit-plan terms govern. This policy is informational and may be superseded by plan-specific contractual requirements.

Background

Dupuytren's contracture is a progressive fibroproliferative disease of the palmar fascia characterized by formation of nodules and cords in the superficial palmar fascia that can produce flexion contractures of the metacarpophalangeal (MP) and proximal interphalangeal (PIP) joints. The nodules arise from proliferation of fibroblasts and extracellular matrix leading to palpable cords that can limit finger extension and cause functional hand impairment.

Definitions and Safety Programs

Dupuytren's contracture — definition

DefinitionProgressive fibroproliferative disease of the palmar fascia characterized by nodules and cords that cause flexion contractures of the metacarpophalangeal (MCP) and/or proximal interphalangeal (PIP) joints.

PathologyMarked by fibroblastic proliferation and disorderly collagen deposition with fascial thickening and nodule/cord formation.

Clinical courseBenign, slowly progressive; nodules may progress over years into cords producing gradual loss of finger extension and functional limitation.

Xiaflex REMS — prescriber and site certification

REMS requirementXiaflex is available for Peyronie's disease only through the Xiaflex REMS Program due to risk of corporal rupture (penile fracture) or other serious penile injury.

Prescriber certification

Revision History

2026-04-01retirementLatest

Policy retired for Louisiana plan membership; members disenrolled effective April 1, 2026.

2026-01-01routine_review

Routine review performed with no content changes noted; previous policy version CSLA2025D0099E archived.