Colorado Rocky Mountain Health Plans Xiaflex Coverage

Coverage Criteria for Xiaflex (CCH)

Dupuytren's contracture — Initial Therapy

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 one of the following: one cord affecting two joints in the same finger OR two cords affecting two joints in the same hand; Xiaflex dosing per FDA-approved labeling: 0.58 mg per injection into a palpable cord; total injections do not exceed three injections per cord at approximately 4-week intervals; authorization is for no more than two injections in the same hand

Dupuytren's contracture — Continuation Therapy

Covered when ALL of the following are met:

Dupuytren_continuation: Patient has previously received Xiaflex; documentation of positive clinical response to Xiaflex; treatment request is for at least one of the following: the same MP or PIP contracture remains in affected cord since previous injection and the contracture is > 5 degrees, OR a different MP or PIP contracture will be injected; if two injections (two vials) are requested, they are for one of the following: one cord affecting two joints in the same finger OR 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; the previous treatment was at least 4 weeks ago; Xiaflex dosing per FDA-approved labeling: 0.58 mg per injection into a palpable cord; total injections do not exceed three injections per cord at approximately 4-week intervals; authorization is for no more than two injections in the same hand

Peyronie's disease — Initial Therapy

Covered when ALL of the following are met:

Peyronie_initial: Patient has diagnosis of Peyronie's disease with a palpable plaque AND curvature deformity of greater than or equal to 30 degrees at the start of therapy; 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 per FDA-approved labeling: 0.58 mg per injection into a Peyronie's plaque; authorization is for no more than two injections and 6 weeks duration

Peyronie's disease — Continuation Therapy

Covered when ALL of the following are met:

Peyronie_continuation: Patient has previously received Xiaflex; documentation of positive clinical response to Xiaflex; last treatment was at least 6 weeks ago; documented curvature deformity of ≥ 15 degrees remaining since last treatment cycle; patient has received less than four treatment cycles (i.e., less than eight injections); Xiaflex dosing per FDA-approved labeling: 0.58 mg per injection into a Peyronie's plaque; authorization is for no more than two injections and 6 weeks duration

Xiaflex (collagenase clostridium histolyticum) is considered unproven and not medically necessary for any uses other than the covered indications specified in this policy (Dupuytren's contracture with a palpable cord and Peyronie's disease with a palpable plaque).

Operational change: this policy's prior exclusions have been revised. The previous language stating the policy did not apply to the state of Indiana has been removed, and language specific to Louisiana has also been removed.

Coverage is limited to the two labeled indications: Dupuytren's contracture with a palpable cord and Peyronie's disease with a palpable plaque. Any other indication or presentation — including cases without a palpable cord (Dupuytren's) or without a palpable plaque or required curvature thresholds (Peyronie's) — is excluded and considered not medically necessary.

Procedure, HCPCS, and Diagnosis Codes; Clinical Thresholds

Procedure CPT Codes (referential)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

Diagnosis ICD-10 Codes (referential)ICD-10

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

Dupuytren's contracture — Initial contracture threshold

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

Age requirementPatient is 18 years of age or older

Provider requirementPrescribed and administered by a healthcare provider experienced in injection procedures of the hand and in treatment of Dupuyren's contracture

Functional impactDocumentation that the flexion deformity results in functional limitations is required

Peyronie's disease — Initial curvature threshold

Prior Authorization, Documentation, and Coverage Governance

Prior Authorization

Prior Authorization Required

Prior authorization is required when the coverage criteria are met. Submit requests with complete clinical documentation to support medical necessity before services are rendered.

A prior authorization is required for Xiaflex (collagenase clostridium histolyticum) for the covered indications described in this policy.
Authorization limits: no more than two injections in the same hand for Dupuytren's contracture; for Peyronie’s disease, authorization is for no more than two injections and a 6‑week duration.
Dosing must follow FDA‑approved labeling: 0.58 mg per injection into a palpable cord or plaque; total injections do not exceed three injections per cord for Dupuytren's and less than four treatment cycles for Peyronie’s (fewer than eight injections).

Denial Risk

Clinical Background and Drug Information

Dupuytren's contracture is a slowly progressive fibroproliferative disorder of the palmar fascia characterized by formation of nodules and cords that can produce finger flexion contractures involving the metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints. Clinical impact ranges from cosmetic change to functional limitation when flexion deformity impairs hand use; treatment options include surgical and enzyme injection approaches, with Xiaflex (collagenase clostridium histolyticum) indicated for patients meeting the criteria described in this policy.

Xiaflex / CCH — Definition & prescribing summary

DrugXiaflex (collagenase clostridium histolyticum, CCH)

Dosing per FDA label0.58 mg per injection (single injection into a palpable cord or Peyronie’s plaque)

Formulation/usePrescription injectable collagenase for intralesional administration

Indications in policyCovered for Dupuytren's contracture (palpable cord) and Peyronie's disease (palpable plaque) when criteria met

Key Clinical Definitions

Definition — Dupuytren's contracture

DefinitionProgressive fibrosis of the palmar fascia characterized by nodules and cords that can lead to finger flexion contractures involving the metacarpophalangeal (MCP) and/or proximal interphalangeal (PIP) joints.

PathologyNodules and cords arise from fibroblastic proliferation and abnormal collagen deposition; dermal tethering and loss of extension may occur.

Clinical impactCan cause joint stiffness, loss of full extension, and functional limitations over time.

Definition — Peyronie's disease

DefinitionAcquired penile fibrosis of the tunica albuginea resulting in penile curvature deformity, pain, and possible erectile dysfunction; often associated with a palpable plaque.

Etiology/course

Initial Therapy Rules and Requirements

Initial therapy rules

Covered when ALL of the following are met:

Initial_general_adult_prescriber_dosing_REMS: Patient is 18 years of age or older; Xiaflex is prescribed and administered by a healthcare provider experienced in the treatment relevant to the indication (hand for Dupuytren's; male urological diseases for Peyronie's); dosing is in accordance with FDA-approved labeling: 0.58 mg per injection; when applicable, site/prescriber certification and training requirements (e.g., Xiaflex REMS for Peyronie's) are met

Continuation Therapy Rules and Requirements

Continuation therapy rules

Covered when ALL of the following are met:

Continuation_general: Patient has previously received Xiaflex; documentation of positive clinical response to Xiaflex; minimum intervals since prior treatment are met (Dupuytren's: at least 4 weeks since previous treatment; Peyronie's: at least 6 weeks since previous treatment); documented remaining deformity meets continuation thresholds (Dupuytren's: contracture > 5 degrees since previous injection; Peyronie's: curvature ≥ 15 degrees remaining since last treatment cycle); dosing per FDA-approved labeling: 0.58 mg per injection; limits on total cycles/injections as specified in coverage criteria are respected

Step Therapy and Sequencing

Step	Requirement
Policy step-therapy requirement	No explicit step-therapy sequence is required. Coverage is determined by meeting the applicable clinical criteria for initial or continuation therapy for Dupuytren's contracture or Peyronie's disease (see coverage criteria).
Failure/fallback requirement	The policy does not require failure of other therapies prior to authorization; prior authorization is granted only when the submitted request meets the specified clinical criteria (diagnosis, degree of contracture/curvature, provider experience, dosing per FDA labeling, and quantity/timing limits).
Applicable indications	Dupuytren's contracture with a palpable cord (initial: ≥20° MP or PIP contracture; continuation: >5° remaining since prior injection) and Peyronie's disease with a palpable plaque (initial: ≥30° curvature; continuation: ≥15° remaining since last treatment).
Authorization notes	Prior authorization is required. Dosing must follow FDA labeling (0.58 mg per injection). Limits: Dupuytren's — ≤3 injections per cord (~4‑week intervals) and authorization for no more than 2 injections in the same hand; Peyronie's — authorization for no more than 2 injections and 6 weeks duration; continuation limits per criteria.

Quantity and Authorization Limits

Xiaflex — Quantity and authorization limits

Dupuytren's limitsUp to 3 injections per cord at approximately 4-week intervals; authorization limited to no more than 2 injections in the same hand.

Peyronie's limitsAuthorization for no more than 2 injections per treatment course and duration limited to 6 weeks per cycle.

Per-injection doseEach injection contains 0.58 mg of collagenase per FDA-approved labeling.

Cycle and total limitsContinuation for Peyronie's allowed if patient has received less than four treatment cycles (i.e., less than eight injections).

Site of Care and REMS Requirements

Prior Authorization

Xiaflex REMS certification required for Peyronie's disease

For Peyronie's disease, prescribers and healthcare sites must be certified in the Xiaflex REMS program; prescribers must enroll and complete training, and healthcare sites must be certified to ensure Xiaflex is dispensed only for certified prescribers.

REMS-required prescriber certification and training for Peyronie's disease
Healthcare site certification required to dispense Xiaflex for Peyronie's

Policy Revision History and Updates

2026-04-01state_scope_changeLatest

Removed language indicating the policy did not apply to Indiana (policy now applies to Indiana).

2026-04-01state_scope_change

Removed content and language pertaining to the state of Louisiana (Louisiana-specific exclusion language eliminated).

2026-04-01archival

Archived prior policy versions CS2026D0099K and CSIND0099.06.

OpenPayer

Xiaflex (Collagenase Clostridium Histolyticum) — Medical Benefit Drug Policy

Coverage Criteria for Xiaflex (CCH)

Procedure, HCPCS, and Diagnosis Codes; Clinical Thresholds

Prior Authorization, Documentation, and Coverage Governance

Clinical Background and Drug Information

Key Clinical Definitions

Initial Therapy Rules and Requirements

Continuation Therapy Rules and Requirements

Step Therapy and Sequencing

Quantity and Authorization Limits

Site of Care and REMS Requirements

Policy Revision History and Updates