CurrentPremera BluecrossPolicy 5.01.595

Injectable Clostridial Collagenase for Fibroproliferative Disorders

Defines medical necessity criteria, limits, documentation, coding, and benefit application for collagenase clostridial histolyticum (Xiaflex) injections for Dupuytren's contracture, Peyronie's disease, and other fibroproliferative disorders; includes length of approval and investigational determinations for other indications.

Policy Summary

PayerPremera Bluecross

PolicyInjectable Clostridial Collagenase for Fibroproliferative Disorders

Policy CodePolicy 5.01.595

Change TypeAnnual literature review; references added

Effective DateJun 1, 2026

Next Review Date

Key ActionSome plans may require prior authorization before injection of collagenase clostridium histolyticum; providers should contact member customer service to determine specific benefit requirements.

SourceLink

POLICY UPDATE CHANGES

Policy updated with literature review through January 8, 2026; references added. Policy statements unchanged.

Policy renumbered from 5.01.19 to 5.01.595 on 04/01/19; prior policy replaced.

2FDA-approved indications covered (Dupuytren's, Peyronie's)

1Investigational indication called out (adhesive capsulitis)

4Peyronie's treatment cycle limit (cycles)

Coverage Summary

This policy addresses the use of injectable clostridial collagenase (Xiaflex) for FDA-approved indications—Dupuytren's contracture (adults with a palpable cord; treatment limits including up to 3 injections per cord at intervals of at least 30 days and maximum 2 joints in the same hand per visit) and Peyronie's disease (men with a palpable plaque and curvature ≥30°; maximum of 4 treatment cycles). The policy takes a mixed coverage stance: Xiaflex is covered when specified medical necessity criteria and FDA labeling limits are met for these approved indications, while use for other indications (including adhesive capsulitis) is designated investigational. The policy also notes REMS requirements for Peyronie's disease per FDA labeling.

Quick facts and thresholds

Policy number5.01.595

Effective dateJun. 1, 2026

Last reviewMay 25, 2026

Peyronie's curvature threshold>= 30 degrees

Peyronie's max treatment cyclesMaximum of 4 cycles (each cycle = 2 injection procedures)

Dupuytren's injections per cordUp to 3 injections at intervals of at least 30 days

Dupuytren's joints per visitLimit to 2 joints in the same hand per treatment visit

Initial Therapy Criteria

Dupuytren's contracture - Medical Necessity

Xiaflex may be considered medically necessary when ALL of the following are met:

Palpable cord: The individual has Dupuytren's contracture with a palpable cord
Injection frequency: Injections may be administered up to 3 times at intervals of at least 30 daysUp to 3 injections at ≥30-day intervals
Consistent with FDA labeling
Joints per visit: Treatment is limited to 2 joints in the same hand per treatment visit, consistent with FDA labeling2 joints per hand per treatment visit

Peyronie's disease - Medical Necessity

Xiaflex may be considered medically necessary when ALL of the following are met (subject to benefit coverage for sexual dysfunction treatment):

Palpable plaque: The individual has a diagnosis of Peyronie's disease with a palpable plaque
Curvature threshold: Has a curvature deformity of at least 30 degrees at the start of therapy, consistent with FDA labeling>= 30 degrees
Consistent with FDA labeling
Treatment cycles: Treatment is limited to a maximum of 4 treatment cycles (each cycle consists of 2 injection procedures)Maximum of 4 cycles (each cycle = 2 injections)
See Treatment cycle definition

Authorization Length and Re-authorization

Authorization length and re-authorization

Approval durations and re-authorization rules:

Non-formulary exception reviews for Xiaflex may be approved up to 12 monthsUp to 12 months
Dupuytren's usual approval: All other reviews for Xiaflex may be approved up to 3 months for the treatment of Dupuytren's contractureUp to 3 months
Peyronie's usual approval: All other reviews for Xiaflex may be approved up to 6 months for the treatment of Peyronie's diseaseUp to 6 months
Dupuytren's re-authorization same cord: Re-authorization of Xiaflex for the treatment of Dupuytren's contracture for the same palpable cord is considered investigational
Dupuytren's re-authorization different cord: Re-authorization of Xiaflex for the treatment of Dupuytren's contracture for a different palpable cord will be reviewed as a new request
Peyronie's re-authorization: Re-authorization of Xiaflex for the treatment of Peyronie's disease is considered investigational

Unproven / Not Medically Necessary

Adhesive capsulitis and other indications

Investigational / Not medically necessary:

Adhesive capsulitis investigational: Xiaflex is considered investigational for adhesive capsulitis
Other indications investigational: Xiaflex is considered investigational for all other indications not specifically listed (including but not limited to adhesive capsulitis)

Applicable Codes

Relevant CPT codes (procedures described in policy)CPT

20527	Injection, enzyme (e.g., collagenase), palmar fascial cord (ie, Dupuytren's contracture)
26341	Manipulation, palmar fascial cord (ie, Dupuytren's cord), post enzyme injection (e.g., collagenase), single cord
54200	Injection procedure for Peyronie disease
54205	Injection procedure for Peyronie disease; with surgical exposure of plaque
54235	Injection of corpora cavernosa with pharmacologic agent(s) (e.g., papaverine, phentolamine)

Drug HCPCS / J-codeHCPCS

J0775

Injection, collagenase clostridium histolyticum, 0.01 mg

Provider Actions & Billing Rules

Prior Authorization

Prior authorization may be required

Some plans may require prior authorization before injection of collagenase clostridium histolyticum; providers should contact member customer service to determine specific benefit requirements.

Documentation Required

Medical record documentation required

Submit medical records documenting diagnosis/condition and history and physical examination documenting severity to show medical necessity criteria are met.

Billing Rule

Adhere to FDA labeling limits when billing

Limit treatments per FDA labeling: Dupuytren's — up to 3 injections per cord at intervals of at least 30 days and treatment limited to 2 joints in the same hand per treatment visit; Peyronie's — curvature ≥30° at start of therapy and a maximum of 4 treatment cycles (each cycle = 2 injection procedures). When billing, use the relevant procedure and drug codes: 20527, 26341, J0775, 54200, 54205, 54235.

Codes: 20527, 26341, J0775, 54200, 54205, 54235
Dupuytren's: up to 3 injections per cord at ≥30-day intervals; max 2 joints per hand per visit
Peyronie's: curvature ≥30° required; maximum of 4 cycles (2 injections per cycle)

Documentation Required

Peyronie's disease benefit verification

Verify that the member's benefit plan covers treatment of sexual dysfunction because many plans exclude diagnosis and treatment of sexual dysfunctions; if excluded, Xiaflex for Peyronie's disease may not be covered. For benefit questions, providers should contact customer service using the telephone number on the back of the member's ID card.

Documentation Required

REMS / training requirements for Peyronie's

For Peyronie's disease, adhere to FDA REMS requirements: prescribers must enroll and complete training and health care sites must be certified per the Xiaflex REMS program; document compliance with prescriber training and site certification as required.

Clinical Evidence

Clostridial collagenase (Xiaflex) is an enzyme derived from Clostridium histolyticum developed to break down collagen in fibroproliferative disorders and has FDA approvals for Dupuytren's contracture and Peyronie's disease; the Peyronie's indication is available only through a restricted program with REMS requirements. Systematic reviews, randomized controlled trials, and comparative studies demonstrate short- to medium-term clinically important benefits for Dupuytren's contracture, but important evidence gaps remain regarding long-term durability and impact on quality of life. For Peyronie's disease, RCTs show short-term improvements in curvature and symptom distress, but long-term health outcome benefits and comparative evidence are lacking. Evidence for adhesive capsulitis is very limited; one small randomized substudy found no benefit and increased adverse events.

Evidence summaries

Dupuytren's evidence summarySystematic reviews, RCTs and comparative studies show clinically important short- to medium-term benefits but gaps remain in long-term durability and quality-of-life data; evidence insufficient to determine net health outcome definitively.

Peyronie's evidence summaryDouble-blind RCTs show short-term improvement in penile curvature and symptom distress; long-term health outcome benefits and comparisons to other therapies are lacking; evidence insufficient to determine net health outcome.

Adhesive capsulitis evidence summaryVery limited evidence; one small RCT substudy found no benefit over placebo and increased adverse events; considered investigational.

Policy Summary

PayerPremera Bluecross

PolicyInjectable Clostridial Collagenase for Fibroproliferative Disorders

Policy CodePolicy 5.01.595

Change TypeAnnual literature review; references added

Effective DateJun 1, 2026

Next Review Date

SourceLink

On This Page

OpenPayer

Injectable Clostridial Collagenase for Fibroproliferative Disorders

Coverage Summary

Initial Therapy Criteria

Authorization Length and Re-authorization

Unproven / Not Medically Necessary

Applicable Codes

Provider Actions & Billing Rules

Clinical Evidence

Definitions

Medicare Determinations

Revision History