CurrentUnitedHealthcarePolicy IEXD0226.06

Xiaflex (collagenase clostridium histolyticum) for Dupuytren's contracture and Peyronie's disease

Defines UnitedHealthcare medical policy for use of Xiaflex for treatment of Dupuytren's contracture and Peyronie's disease, specifying eligibility, dosing, limits, and continuation criteria for covered use.

Policy Summary

PayerUnitedHealthcare

PolicyXiaflex (collagenase clostridium histolyticum) for Dupuytren's contracture and Peyronie's disease

Policy CodePolicy IEXD0226.06

Change TypeMaterial clinical revisions

Effective DateJan 1, 2025

Next Review Date

Key ActionSubmit prior authorization with documentation of diagnosis, palpable cord or plaque, degree of deformity (degrees), prior treatment/surgery history, and planned dosing consistent with FDA labeling (0.58 mg per injection).

SourceLink

POLICY UPDATE CHANGES

Added criterion requiring the patient has not received surgical treatment on the selected primary joint within the last 90 days for Dupuytren's initial therapy.

Replaced prior documentation requirement about deformity progression/severity with 'documentation that the flexion deformity results in functional limitations' for Dupuytren's initial therapy.

Added criterion for continuation therapy that patient has not received surgical treatment (e.g., fasciectomy, fasciotomy) on the selected primary joint within the last 90 days.

Added language that authorization for Peyronie's disease is for no more than 6 weeks duration.

0.58 mgFDA-approved per-injection dose

≤3Max injections per cord

≤2Limit injections per hand

≥30°Peyronie's baseline curvature

Coverage Criteria for Xiaflex (collagenase clostridium histolyticum)

Initial Therapy - Dupuytren's Contracture

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; the total number of injections does not exceed three injections per cord at approximately four‑week intervals; authorization is for no more than two injections in the same hand

Follow FDA dosing and interval limits

Continuation Therapy - Dupuytren's Contracture

Covered when ALL of the following are met

Policy Summary

PayerUnitedHealthcare

PolicyXiaflex (collagenase clostridium histolyticum) for Dupuytren's contracture and Peyronie's disease

Policy CodePolicy IEXD0226.06

Change TypeMaterial clinical revisions

Effective DateJan 1, 2025

Next Review Date

SourceLink

On This Page

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.

Coding and Clinical Thresholds

Covered CPT Codes (reference)CPT

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

ICD-10 Diagnosis Codes (reference)ICD-10

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

Minimum contracture/curvature thresholds for initial therapy (Dupuytren's and Peyronie's)

Dupuytren's contracture — initial thresholdDocumented contracture of at least 20 degrees flexion for a metacarpophalangeal (MP) or proximal interphalangeal (PIP) joint

Dupuytren's contracture — continuation thresholdFor continuation, an MP or PIP contracture remains >5 degrees since previous injection or a different MP/PIP contracture will be injected

Peyronie's disease — initial thresholdCurvature deformity of greater than or equal to 30 degrees at the start of therapy

Peyronie's disease — continuation thresholdFor continuation, documented residual curvature deformity of ≥15 degrees since last treatment cycle (per continuation rules) and fewer than four treatment cycles received

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Xiaflex (collagenase clostridium histolyticum) for the indications described in this policy. Requests must include supporting clinical documentation demonstrating that the member meets the applicable Coverage Rationale criteria for Dupuytren's contracture or Peyronie's disease.

Affected codes: HCPCS J0775; CPT 20527, 26341

Step Therapy

There is no formal sequential step-therapy algorithm required prior to authorization. However, the policy requires documentation of prior treatments and surgical history where applicable (e.g., no surgical treatment on the selected primary joint within the last 90 days for Dupuytren's). For Peyronie's disease, prior treatments and timing (at least 6 weeks between cycles for continuation) should be documented when applicable.

Documentation Required

Required Documentation

Provide complete documentation with the authorization request to avoid delays or denials. Required elements include: diagnosis (Dupuytren's contracture with palpable cord or Peyronie's disease with palpable plaque), objective severity measures (e.g., degrees of contracture/curvature), patient age (≥18 years), treating provider specialty and experience (hand injection experience for Dupuytren's; provider experienced in male urological diseases for Peyronie's), prior treatment history (including dates of prior injections or surgery), and documentation of functional limitation or positive clinical response for continuation requests.

Dupuytren's: palpable cord, ≥20° MP or PIP contracture for initial therapy; contracture >5° for continuation; no surgery on selected joint within prior 90 days; no more than two injections authorized in the same hand; dosing per FDA label (0.58 mg per injection); ≤3 injections per cord ~4-week intervals.
Peyronie's: palpable plaque and ≥30° curvature for initial therapy; ≥15° remaining curvature for continuation; patient ≥18 years; dosing per FDA label (0.58 mg per injection); authorization ≤2 injections and 6 weeks duration; <4 treatment cycles for continuation (<8 injections).

Denial Risk

Triggers for Denial

Denial risks include incomplete or missing documentation of diagnosis, absence of a palpable cord/plaque, insufficient objective severity (degrees of contracture/curvature), patient age under 18, prior recent surgery on the selected joint within exclusion windows, requests exceeding authorized injection limits or dosing not consistent with FDA labeling, and use for indications other than Dupuytren's contracture or Peyronie's disease.

Common denial reasons: missing palpable cord/plaque, lack of documented functional limitation or positive response, prior surgical treatment within exclusion period, requests for >2 injections in the same hand (Dupuytren's), requests exceeding 3 injections per cord, or continuation requests without evidence of benefit.

Background and Clinical Context

Dupuytren's contracture is a progressive fibrotic condition of the palmar fascia that produces palpable cords and finger flexion deformities; intralesional collagenase (Xiaflex) enzymatically disrupts the collagenous cords to allow manual extension and improved finger extension. The policy’s Peyronie’s disease criteria reflect the mechanism and trial evidence in which intralesional Xiaflex is injected into a palpable penile plaque to reduce curvature and associated bother.

For Peyronie’s disease the policy specifies FDA‑aligned dosing of 0.58 mg per injection, limits authorization to no more than two injections with a treatment authorization duration of 6 weeks, and requires a palpable plaque and baseline curvature of ≥30° for initial therapy; continuation criteria require prior response and at least a 6‑week interval between treatments with residual curvature ≥15° and fewer than four treatment cycles.

Definitions

Palpable cord — definition for clinical exam target

DefinitionA fibrous cord in the palmar fascia (Dupuytren's) or a penile plaque (Peyronie's) that can be felt on physical examination and is the intended target for collagenase injection

Clinical relevancePresence of a palpable cord or plaque is required for coverage and must be documented for initial and continuation therapy

Exam implicationPalpable cord/plaque guides intralesional injection placement and is part of prior authorization documentation

Table top test — definition and relevance to Dupuytren's entry criteria

DefinitionAn inability to place the affected finger and palm flat against a table top (i.e., the finger cannot lie fully extended on a surface)

Role in trialsUsed as an entry criterion in Dupuytren's studies to document functional impact of the contracture

Policy relevanceTable top test documents functional limitation and supports medical necessity when demonstrating contracture meeting the degree threshold