CurrentBlue Cross Blue Shield - IowaPolicy 05.02.85

Xiaflex (collagenase clostridium histolyticum) drug policy — Coverage Criteria

Defines coverage, prior authorization, documentation, and clinical criteria for Xiaflex use for Dupuytren's contracture and Peyronie's disease for Wellmark Blue Cross and Blue Shield members.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyXiaflex (collagenase clostridium histolyticum) drug policy

Policy CodePolicy 05.02.85

Change TypePeriodic review (no material change)

Effective DateDec 7, 2022

Next Review Date

Key ActionObtain prior authorization: initial approvals up to 6 months for Dupuytren's and up to 12 months for Peyronie's when criteria are met.

SourceLink

POLICY UPDATE CHANGES

Reviewed: January 2025; Revised: October 2022 (history lines present in policy history).

2FDA-approved indications covered

6 moDupuytren's initial auth

12 moPeyronie's initial auth

J0775HCPCS code

3/cordMax injections (Dupuytren's)

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

Initial Therapy - Dupuytren's contracture

Authorization of 6 months may be granted for the treatment of Dupuytren's contracture when ALL of the following are met:

Dupuytren initial criteria: Member has a finger flexion contracture with a palpable cord in a metacarpophalangeal (MCP) or proximal interphalangeal (PIP) joint prior to initiating Xiaflex therapysee node text

Positive tabletop test: Member had a positive tabletop test (inability to simultaneously place the affected finger(s) and palm flat against a table) prior to initiating Xiaflex therapysee node text

Contracture degree: Contracture is at least 20 degrees prior to initiating Xiaflex therapy>= 20 degrees

Age requirement: Member is 18 years of age or olderage >= 18

Dose and frequency limits: Planned treatment: up to 3 injections maximum per cord, administered 4 weeks apart<= 3 injections per cord

Authorization up to 6 months

Initial Therapy - Peyronie's disease

Authorization of 12 months may be granted for the treatment of Peyronie's disease when ALL of the following are met:

Peyronie's initial: stability: Male member has stable Peyronie's disease without clinical changes (e.g., no worsening curvature) for at least 3 months prior to initiating Xiaflex therapy>= 3 months

Palpable plaque: Member has a palpable plaque prior to initiating Xiaflex therapysee node text

Curvature degree: Curvature deformity is at least 30 degrees and less than 90 degrees prior to initiating Xiaflex therapy>= 30 and < 90 degrees

Continuation Therapy - Dupuytren's contracture

Authorization of 6 months may be granted for continuation when ALL of the following are met:

Dupuytren continuation: initial criteria: Member meets all initial authorization criteria for Dupuytren's contracturesee initial criteria

Same cord: Member is continuing treatment for the same cord. For treatment of a new cord or a previously treated cord following recurrence, member must meet all initial authorization criteriasame cord

Prior injections limit: Member has received less than 3 injections total per cord (injections spaced 4 weeks apart)< 3 injections per cord

For new cords or recurrence, initial criteria must be met

Continuation Therapy - Peyronie's disease

Authorization of 12 months may be granted for continuation when ALL of the following are met:

Peyronie's continuation: initial criteria: Member meets all initial authorization criteria for Peyronie's diseasesee initial criteria

Curvature at continuation: Member has curvature deformity of at least 15 degrees at the time of the continuation request>= 15 degrees

Prior injections limit: Member has received less than 8 injections total, including any injections the patient has received for any previous treatment< 8 injections total

Authorization up to 12 months

Coverage will not be provided for cosmetic use of Xiaflex (for example, cellulite reduction treatment).

If the member does not meet the applicable coverage criteria described in this policy, Xiaflex is considered not medically necessary and is not covered.

Initial Therapy

Initial Therapy — Initial authorization criteria and limits for Xiaflex by indication

Initial authorization criteria and limits for Xiaflex by indication.

Dupuytren initial: Palpable cord in MCP or PIP; positive tabletop test prior to therapy; contracture >=20 degrees; age >=18; up to 3 injections per cord (4 weeks apart)see text

Authorization up to 6 months

Peyronie's initial: Stable disease >=3 months; palpable plaque; curvature >=30 and <90 degrees; intact erectile function; age >=18; maximum one treatment course up to 8 injections total (including prior treatments)see text

Authorization up to 12 months

Continuation Therapy

Continuation Therapy — Continuation authorization rules mirror initial criteria with additional limits

Continuation authorization rules mirror initial criteria with additional limits on prior injections and, for Peyronie's, a lower curvature threshold at continuation.

Dupuytren continuation: Meets initial criteria; continuing same cord; fewer than 3 injections total per cord<3 injections per cord

New cord or recurrence requires meeting initial criteria

Peyronie's continuation: Meets initial criteria; curvature >=15 degrees at continuation; fewer than 8 injections total (including prior treatments)<8 injections total; >=15 degrees

Authorization up to 12 months

Coding

Covered HCPCS CodesHCPCSCovered

J0775

Injection, collagenase, clostridium histolyticum, 0.01 mg

Contracture / Curvature Degree Thresholds

Dupuytren's contracture thresholdContracture ≥ 20 degrees prior to initiating Xiaflex therapy

Peyronie's disease initial thresholdCurvature deformity ≥ 30 degrees and < 90 degrees prior to initiating Xiaflex therapy

Peyronie's disease continuation thresholdCurvature deformity ≥ 15 degrees at continuation (per continuation rules)

Provider Actions & Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required before Xiaflex (collagenase clostridium histolyticum) is administered. Initial authorizations: Dupuytren's contracture — up to 6 months; Peyronie's disease — up to 12 months. Ensure the request documents the condition, severity measures, and prior treatment history.

Initial authorization duration: Dupuytren's contracture — 6 months
Initial authorization duration: Peyronie's disease — 12 months

Step Therapy

Continuation / Step Requirements

Continuation (renewal) requests must document that the member continues to meet the initial authorization criteria and must include the number of prior injections and treatment details. For Dupuytren's, continuation is only for the same cord and prior injection counts must be shown. For Peyronie's, continuity must show current curvature and total injections received.

Continuation requests must meet ALL initial criteria
Document the number of prior injections and dates
Dupuytren's continuation: same cord only; new or recurrent cords require meeting initial criteria again
Peyronie's continuation: show current curvature >= 15 degrees and total injections < 8

Documentation Required

Required Clinical Documentation

Submit chart notes or medical records supporting the diagnosis and clinical findings. For Dupuytren's contracture include the affected joint, presence of contracture, and a positive tabletop test (required for new starts and continuations). For Peyronie's disease include presence of a palpable plaque, measured curvature, and documentation of intact erectile function (required for new starts and continuations). For continuation requests include the number of injections the member has received to date.

Dupuytren's documentation: affected joint, contracture, positive tabletop test (new and continuation), number of injections for continuation
Peyronie's documentation: palpable plaque, measured curvature (degrees), intact erectile function (new and continuation), number of injections for continuation

Denial Risk

Denial Risk for Insufficient Criteria

Xiaflex is considered not medically necessary if the stated clinical criteria are not met. Denials will be issued when required severity thresholds, documentation (e.g., tabletop test, plaque, curvature degrees, erectile function), or allowable injection limits are not satisfied.

Dupuytren's: failure to provide positive tabletop test or meet initial/continuation criteria may result in denial
Peyronie's: lacking stable disease ≥3 months (for initial), plaque, curvature ≥30° and <90° (initial) or ≥15° (continuation), intact erectile function, or exceeding injection limits (8 total) will result in denial

Step Therapy / Limits

Continuation requirement	Coverage label
Member meets all initial authorization criteria; continuing treatment course for the same cord (new cord or recurrence requires meeting initial criteria)
Member has received fewer than 3 injections total per cord (injections spaced 4 weeks apart)
For Peyronie's disease: member meets all initial authorization criteria; current curvature deformity ≥ 15 degrees
For Peyronie's disease: member has received fewer than 8 injections total (including prior treatments)
Coverage decision: continuation requests that meet the above requirements are covered; Xiaflex is not medically necessary if criteria are not met

Quantity Limits

Xiaflex — Quantity Limits

Dupuytren's injections per cordUp to 3 injections maximum per cord (administered 4 weeks apart)

Peyronie's injections per courseMaximum of one treatment course with up to 8 injections total (includes prior treatments)

Site of Care

Note

Administer only by providers experienced in the condition (hand or urology + REMS)

Xiaflex must be administered by a provider experienced in the relevant condition: hand injection experience for Dupuytren's contracture, and a provider experienced in urological disease who has completed the Xiaflex REMS program for Peyronie's disease.

Administration may occur in office or infusion center settings but must be by the specified experienced provider.

Definitions

Positive Tabletop Test

Positive tabletop test definitionInability to simultaneously place the affected finger(s) and palm flat against a table

Use in assessmentRequired prior to initiating Xiaflex therapy for Dupuytren's contracture (document in chart notes)

Clinical implicationA positive test indicates functional impairment from the contracture

Background

Xiaflex (collagenase clostridium histolyticum) is indicated for 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. Continuation of therapy for Peyronie's may be authorized for up to 12 months when the member meets initial criteria, has a curvature deformity of at least 15 degrees at the time of the continuation request, and has received fewer than 8 injections total (including prior treatments).

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyXiaflex (collagenase clostridium histolyticum) drug policy

Policy CodePolicy 05.02.85

Change TypePeriodic review (no material change)

Effective DateDec 7, 2022

Next Review Date

Key ActionObtain prior authorization: initial approvals up to 6 months for Dupuytren's and up to 12 months for Peyronie's when criteria are met.

SourceLink

On This Page

Erectile function: Member has intact erectile function (with or without medication)see node text

Age requirement: Member is 18 years of age or olderage >= 18

Treatment course limit: Member will receive a maximum of one treatment course with a maximum of 8 injections total, including any prior injections<= 8 injections total

Authorization up to 12 months