ModifiedUnitedHealthcarePolicy CSLA2026D0099F

Xiaflex La Cs

UnitedHealthcare Louisiana medical benefit drug policy for Xiaflex governing coverage criteria for treatment of Dupuytren's contracture and Peyronie's disease, continuation criteria, applicable codes, and policy retirement notice.

Policy Summary

PayerUnitedHealthcare

PolicyXiaflex La Cs

Policy CodePolicy CSLA2026D0099F

Change TypeRetired (effective 2026-04-01); routine review 01/01/2026

Effective DateJan 1, 2026

Next Review Date

Key ActionAuthorization must document criteria above and is limited per policy: Dupuytren — no more than three injections per cord and no more than two injections in the same hand; Peyronie's — authorization for no more than two injections and 6 weeks duration (per request).

SourceLink

POLICY UPDATE CHANGES

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

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

2Covered Indications

<=3Max injections per cord

2Max injections per hand (Dupuytren)

>=30°Peyronie's minimum curvature

Coverage Summary

coverage_stance: covered_with_criteria. This UnitedHealthcare Louisiana medical benefit drug policy (Policy Number CSLA2026D0099F) was effective 2026-01-01 with last review 2026-01-01, and the policy is marked retired effective 2026-04-01 per the revision history. The policy governs coverage criteria for Xiaflex (collagenase clostridium histolyticum) for the treatment of Dupuytren's contracture and Peyronie's disease and includes specific initial and continuation criteria, dosing and limits.

High-level covered indications: Xiaflex is covered for adult patients with Dupuytren's contracture with a palpable cord (initial and continuation criteria apply) and for adult men with Peyronie's disease with a palpable plaque and curvature deformity of at least 30° at the start of therapy. For details on required documentation, dosing (0.58 mg per injection), injection limits (e.g., ≤ 3 injections per cord, ≤ 2 injections per hand for Dupuytren's; authorization limits for Peyronie's), and continuation criteria, refer to the detailed criteria sections of the policy.

Dupuytren's contracture - Initial therapy

ALL of the following

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) joint contracture or proximal interphalangeal (PIP) joint contracture>= 20 degrees
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<= 90 days since surgery (must be >90 days)
If two injections (two vials) are requested, they must be for ONE of
- One cord affecting two joints in the same finger
- 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
0.58 mg per injection
The total number of injections does not exceed three injections per cord at approximately 4-week intervals<= 3 injections per cord; ~4-week intervals
Authorization is for no more than two injections in the same hand<= 2 injections per hand

Key thresholds — Dupuytren

Dupuytren MP/PIP contracture (initial)>= 20 degrees

Time since prior surgery on selected joint> 90 days (patient must not have had surgery within last 90 days)

Interval since previous Xiaflex treatment (continuation)>= 4 weeks

Max injections per cord<= 3 injections per cord (approximately 4-week intervals)

Max injections per hand (authorization limit)<= 2 injections in the same hand

Dupuytren's contracture - Continuation therapy

ALL of the following

Patient has previously received Xiaflex
Documentation of positive clinical response to Xiaflex
Treatment request is for at least ONE of the following
- Metacarpophalangeal (MP) or proximal interphalangeal (PIP) contracture remains in affected cord since previous injection and the contracture is > 5 degrees> 5 degrees
  Instructions for Use: a different MP or PIP contracture may be targeted
If two injections (two vials) are requested, use is for ONE of
- One cord affecting two joints in the same finger
- 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<= 90 days since surgery (must be >90 days)
The previous treatment was at least 4 weeks ago>= 4 weeks since prior Xiaflex treatment
Xiaflex dosing is in accordance with FDA approved labeling: 0.58 mg per injection into a palpable cord
0.58 mg per injection
The total number of injections does not exceed three injections per cord at approximately 4-week intervals<= 3 injections per cord; ~4-week intervals
Authorization is for no more than two injections in the same hand<= 2 injections per hand

Peyronie's disease - Initial therapy

ALL of the following

Diagnosis requirements
- Patient has diagnosis of Peyronie's disease with a palpable plaque
- Curvature deformity of greater than or equal to 30 degrees at the start of therapy>= 30 degrees
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
0.58 mg per injection
Authorization is for no more than two injections and 6 weeks duration<= 2 injections; duration 6 weeks

Key thresholds — Peyronie's

Peyronie's disease initial curvature>= 30 degrees

Max injections per treatment request<= 2 injections per authorization (per cycle)

Duration per authorization6 weeks

Max treatment cycles< 4 cycles; < 8 injections total

Interval since previous treatment (continuation)>= 6 weeks since last treatment

Peyronie's disease - Continuation therapy

ALL of the following

Patient has previously received Xiaflex
Documentation of positive clinical response to Xiaflex
Last treatment was at least 6 weeks ago>= 6 weeks since last treatment
Documented curvature deformity of ≥ 15 degrees remaining since last treatment cycle>= 15 degrees
Patient has received less than four treatment cycles [i.e., less than eight injections (two injections per cycle)]< 4 cycles; < 8 injections total
Xiaflex dosing is in accordance with FDA approved labeling: 0.58 mg per injection into a Peyronie's plaque
0.58 mg per injection
Authorization is for no more than two injections and 6 weeks duration<= 2 injections; duration 6 weeks

Unproven / Exclusions

Other uses

ANY of the following

Xiaflex is considered unproven and not medically necessary for any other uses

Operational note: Claims for Xiaflex for indications other than Dupuytren's contracture or Peyronie's disease will be considered unproven and not medically necessary and may be denied. Providers must follow the policy's documentation and authorization requirements and submit supporting clinical evidence as outlined in the policy.

See the provider_actions denial_risk callout in the policy for further details on potential denial risk and the documentation and authorization requirements that support adjudication of Xiaflex claims.

Applicable Codes

Relevant 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

Relevant HCPCS / J-codeHCPCS

J0775

Injection, collagenase, clostridium histolyticum, 0.01 mg

Relevant ICD-10 diagnosis codesICD-10

M72.0

Palmar fascial fibromatosis [Dupuytren]

Provider Actions

Prior Authorization

Authorization required with specific limits

Authorization must document that the member meets the policy criteria for the requested indication and must reflect the specific injection limits: Dupuytren's — no more than three injections per cord and no more than two injections in the same hand; Peyronie's — authorization for no more than two injections and a 6‑week duration per request.

Documentation Required

Documentation of clinical findings

Documentation must include the clinical findings listed below; for continuation requests, also document positive clinical response to prior Xiaflex.

Palpable cord (Dupuytren) or palpable plaque (Peyronie's)
Degrees of contracture (MP/PIP) or degrees of penile curvature
Functional limitations attributable to the deformity (Dupuytren)
Dates of prior treatments (surgery on the selected joint or prior Xiaflex injections)
Evidence of positive clinical response for continuation requests

Billing Rule

Dose/reporting

Dose per injection must follow FDA labeling (0.58 mg per injection). Billing uses HCPCS J0775 (0.01 mg per unit); bill units commensurate with the administered 0.58 mg dose per injection.

Injection dose: 0.58 mg per injection (FDA labeling)
J‑code J0775 = collagenase 0.01 mg — bill the number of J0775 units that equals the administered dose

Denial Risk

Not covered for other indications

Xiaflex is considered unproven and not medically necessary for indications other than Dupuytren's contracture or Peyronie's disease; claims for other uses may be denied.

Step Therapy

REMS requirement for Peyronie's disease

For Peyronie's disease only, prescribers and healthcare sites must be certified in the Xiaflex REMS Program; prescribers must enroll and complete REMS training before prescribing Xiaflex for Peyronie's.

Prescribers must be certified by enrolling and completing REMS training
Healthcare sites must be certified and ensure Xiaflex is dispensed only by certified prescribers

Clinical Evidence

39%Dupuytren RCTs: proportion achieving 0°–5° after first injection (CORD I) — example trial result

27%Dupuytren RCTs: proportion achieving 0°–5° after first injection (CORD II) — example trial result

>50%Long-term Dupuytren follow-up: successfully treated joints maintained response at 5 years

Clinical trial evidence summarized: For Dupuytren's contracture, the Phase 3 CORD I and II randomized, double-blind, placebo-controlled trials evaluated 0.58 mg injections (up to three injections per cord) and demonstrated a significantly greater proportion of collagenase-treated patients achieving contracture reduction to within 0°–5° versus placebo; improvements in range of motion were also observed. Long-term follow-up (Years 2–5) showed that more than 50% of successfully treated joints maintained response for 5 years, and retreatment studies reported clinical success in a proportion of recurrent joints after up to three injections.

For Peyronie's disease, the IMPRESS I and II randomized, double-blind, placebo-controlled trials (up to four treatment cycles, two injections per cycle) showed a significant improvement in penile curvature (approximately 33% change from baseline) and significant reductions in patient-reported bother versus placebo. Additional single-arm and observational studies reported variable but generally supportive findings for curvature improvement with the 0.58 mg dosing regimen.

Note: Because of the risk of serious penile injury with Peyronie's treatment, prescribers and sites must be certified in the Xiaflex REMS Program (REMS requirement referenced in background).

Background & Definitions

Background and regulatory notes: Xiaflex is FDA-indicated for the treatment of adult patients with Dupuytren's contracture with a palpable cord and for adult men with Peyronie's disease with a palpable plaque and curvature deformity of at least 30° at the start of therapy. Due to the risk of corporal rupture or other serious penile injury when treating Peyronie's disease, Xiaflex is available only through the Xiaflex REMS Program, which requires prescriber and healthcare site certification and prescriber completion of REMS training before prescribing.

Scope note: This policy applies to the state of Louisiana and is the UnitedHealthcare Louisiana medical benefit drug policy governing coverage criteria for Xiaflex. Per the policy history, the document was retired effective April 1, 2026, and Louisiana plan membership was disenrolled on that date.

Term	Definition
{"text":"Injection dose","status":""},{"text":"0.58 mg per injection into a palpable cord or plaque per FDA labeling","status":""}
{"text":"Treatment cycle (Peyronie's)","status":""},{"text":"Two injections given 1–3 days apart, repeated approximately every 6 weeks; up to 4 cycles (8 injections) evaluated in trials","status":""}

Policy Summary

PayerUnitedHealthcare

PolicyXiaflex La Cs

Policy CodePolicy CSLA2026D0099F

Change TypeRetired (effective 2026-04-01); routine review 01/01/2026

Effective DateJan 1, 2026

Next Review Date

SourceLink

On This Page

OpenPayer

Xiaflex La Cs

Coverage Summary

Dupuytren's contracture - Initial therapy

Dupuytren's contracture - Continuation therapy

Peyronie's disease - Initial therapy

Peyronie's disease - Continuation therapy

Unproven / Exclusions

Applicable Codes

Provider Actions

Clinical Evidence

Background & Definitions

Revision History