CurrentMass General Brigham Health PlanPolicy N/A

Xiaflex (collagenase clostridium histolyticum) coverage

Defines prior authorization, quantity limits, and medical necessity criteria for Xiaflex for Dupuytren's contracture and Peyronie's disease for Mass General Brigham Health Plan members.

Policy Summary

PayerMass General Brigham Health Plan

PolicyXiaflex (collagenase clostridium histolyticum) coverage

Policy CodePolicy N/A

Change TypeCriteria revisedauthorization allowance added

Effective DateAug 1, 2025

Next Review DateMay 14, 2025

Key ActionSubmit prior authorization with documentation of diagnosis, objective contracture/curvature measurement, age, prior treatments, and prior Xiaflex cycles/injections as applicable.

SourceLink

POLICY UPDATE CHANGES

Added language allowing authorization for members new to the plan within the past 90 days who are currently receiving the requested medication.

Updated criteria for Dupuytren's contracture to require age ≥18, diagnosis with a palpable cord, finger flexion contracture at MCP or PIP joint prior to therapy, and contracture ≥20 degrees prior to starting therapy.

3 monthsApproval duration (Dupuytren's)

6 monthsInitial approval (Peyronie's)

≤4Max cycles (Peyronie's)

8Max injections

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30°Min curvature (Peyronie's)

Coverage Criteria for Xiaflex

Initial Therapy - Dupuytren's Contracture

Covered for Dupuytren's contracture when ALL of the following are met

Dupuytren's initial criteria

Diagnosis of Dupuytren's contracture with a palpable cord
Age: Member is 18 years of age or older>=18 years
Anatomic finding: Finger flexion contracture with palpable cord in metacarpophalangeal joint or proximal interphalangeal joint prior to therapy initiation
Severity: Contracture is at least 20 degrees prior to therapy initiation>=20 degrees

Or prior plan continuation: Authorization may be granted for members new to the plan within the past 90 days who are currently receiving the requested medication

Initial Therapy - Peyronie's Disease

Covered for Peyronie's disease when ALL of the following are met

Peyronie's initial criteria

Diagnosis of Peyronie's disease with a palpable plaque
Age: Member is 18 years of age or older>=18 years
Duration: Peyronie's disease symptoms have been present for at least 12 months>=12 months
Severity: Curvature deformity is at least 30 degrees at the start of therapy

Continuation Therapy - Peyronie's Disease

Reauthorization/Continuation criteria for Peyronie's disease

Peyronie's continuation

Response threshold: Curvature deformity is greater than 15 degrees after the first, second or third treatment cycle>15 degrees
Maximum cycles/injections: Maximum of four treatment cycles or a total of eight injection procedures and four penile modeling procedures<=4 cycles; <=8 injections; <=4 modeling procedures

Approval duration note: Approvals for Peyronie's disease initial requests will be granted for 6 months; reauthorization limited per maximum cycles/injections

This medication is designated as specialty and must be filled at a contracted specialty pharmacy. Non‑specialty pharmacy fills are not permitted under the benefit structure. Contact information for specialty and non‑specialty medication submission is provided in the policy for prior authorization and dispensing coordination.

Use of Xiaflex is not supported when the entry criteria are not met. Examples that would result in denial include: absence of a palpable cord for Dupuytren's contracture or absence of a palpable plaque for Peyronie's disease; patient age 18 years; insufficient severity (e.g., Dupuytren's contracture 20° or Peyronie's curvature 30° at therapy initiation); or lack of required prior treatments for Peyronie's disease (no documented ≥6‑month trial of appropriate alternatives when indicated).

Coding and Measurement Thresholds

Codes referencedmixed

N/A	No specific CPT/HCPCS/ICD-10 codes listed in document

Minimum contracture/curvature — numeric thresholds for initiation and continuation

Dupuytren's contracture — initiation thresholdContracture is at least 20 degrees prior to therapy initiation

Peyronie's disease — initiation thresholdCurvature deformity is at least 30 degrees at the start of therapy

Peyronie's disease — continuation thresholdCurvature deformity remains greater than 15 degrees after the first, second, or third treatment cycle

Peyronie's disease — maximum treatment limitsMaximum of four treatment cycles or a total of eight injection procedures and four penile modeling procedures

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Authorization rules include an allowance for members who are new to the plan within the past 90 days and are currently receiving the requested medication (this does not apply when the product was obtained as samples or via manufacturer patient assistance programs).

Prior authorization required for new-to-plan members within 90 days if currently receiving therapy (excludes samples and patient assistance programs).

Step Therapy

Step Therapy Required for Peyronie's Disease

Step therapy applies for Peyronie's disease: member must have had an inadequate response, intolerance, or contraindication to a trial of appropriate conservative therapies (minimum 6 months), or an approved exception must be documented.

Step therapy requirement: trial of conservative therapy >= 6 months (e.g., pentoxifylline or intralesional verapamil) or documented exception.

Definitions and Clinical Findings

Palpable cord / plaque — definition of required clinical finding for diagnosis

Required clinical finding for Dupuytren'sA palpable cord consistent with Dupuytren's contracture is required for diagnosis prior to Xiaflex therapy

Required clinical finding for Peyronie'sA palpable plaque consistent with Peyronie's disease is required for diagnosis prior to Xiaflex therapy

Age requirement linked to clinical findingMember must be 18 years of age or older for either condition

Background

Xiaflex (collagenase clostridium histolyticum) is a combination of bacterial collagenases indicated for treatment of adult Dupuytren's contracture with a palpable cord and for adult men with Peyronie's disease with a palpable plaque and significant curvature. For Dupuytren's the policy requires documentation of diagnosis with a palpable cord, patient age ≥18, finger flexion contracture at the MCP or PIP joint prior to therapy, and a contracture of at least 20 degrees prior to initiation. For Peyronie's disease the policy requires diagnosis with a palpable plaque, age ≥18, symptoms present ≥12 months, curvature deformity of at least 30 degrees at the start of therapy, and documentation of inadequate response/contraindication/intolerance to a ≥6‑month trial of appropriate alternative treatments; prescriber should be a urologist or similarly experienced clinician.

Revision History

2025-05-14policy_updatedLatest

Reviewed and updated at P&T; added language allowing authorization for members new to the plan within the past 90 days who are currently receiving the requested medication, and updated Dupuytren's criteria to require age ≥18, diagnosis with a palpable cord, finger flexion contracture at MCP or PIP joint, and contracture ≥20 degrees prior to starting therapy (effective 2025-08-01).

2016-11-28reviewed

Policy reviewed.

2017-11-27

Policy Summary

PayerMass General Brigham Health Plan

PolicyXiaflex (collagenase clostridium histolyticum) coverage

Policy CodePolicy N/A

Change TypeCriteria revisedauthorization allowance added

Effective DateAug 1, 2025

Next Review DateMay 14, 2025

Key ActionSubmit prior authorization with documentation of diagnosis, objective contracture/curvature measurement, age, prior treatments, and prior Xiaflex cycles/injections as applicable.

SourceLink

On This Page

Prior therapy: Inadequate response, contraindication, or intolerance to a trial (>=6 months) of appropriate alternative treatments such as pentoxifylline or intralesional verapamil>=6 months trial

Prescriber is a urologist or otherwise experienced in the treatment of male urological diseases

Or prior plan continuation: Authorization may be granted for members new to the plan within the past 90 days who are currently receiving the requested medication

Documentation Required

Required Clinical Documentation

Required clinical documentation must be submitted with the authorization request. Documentation should include diagnosis, objective measurements of contracture/curvature, patient age, prior treatments and their durations, and prescriber specialty when applicable.

Diagnosis (Dupuytren's contracture with palpable cord; Peyronie's disease with palpable plaque).
Objective measurements: finger flexion contracture degrees for Dupuytren's; curvature degrees for Peyronie's disease.
Age: member is 18 years or older.
Prior treatments: details and duration (including trial of conservative therapy for Peyronie's disease >= 6 months).
Prescriber specialty: urologist or clinician experienced in male urological diseases for Peyronie's disease.

Denial Risk

Denial Triggers and Provider Actions

Denial may be triggered if required criteria are not met. Examples include members under 18 years of age, absence of a palpable cord or plaque, insufficient degree of contracture/curvature (e.g., Dupuytren's <20 degrees; Peyronie's <30 degrees at start of therapy), or lack of documented trial of conservative therapy for Peyronie's disease.

Denial triggers: member < 18 years of age.
Denial triggers: no palpable cord (Dupuytren's) or no palpable plaque (Peyronie's).
Denial triggers: contracture/curvature below required thresholds (Dupuytren's <20°; Peyronie's <30° at therapy start).
Denial triggers: no documented ≥6-month trial of alternative conservative treatments for Peyronie's disease (unless contraindicated or intolerant).

2020-03-18reviewed_and_updated

Reviewed and updated at P&T meeting.

2020-07-22updated

Reviewed and updated July P&T; approval limitation duration included effective 2020-10-01.