sierra health and life Xiaflex Coverage Update

Coverage Criteria for Xiaflex

Initial Therapy — Dupuytren's Contracture

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

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) joint 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 is in accordance with the U.S. FDA approved labeling: 0.58 mg per injection into a palpable cord; the total number of injections does not exceed 3 injections per cord at approximately 4-week intervals; authorization is for no more than 2 injections in the same hand.see text

From policy Dupuytren's initial therapy criteria

Continuation Therapy — Dupuytren's Contracture

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

Dupuytren_continuation: Patient previously received Xiaflex; documentation of positive clinical response to Xiaflex; treatment request is for at least one of the following: 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, use is 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 is in accordance with the U.S. FDA approved labeling: 0.58 mg per injection into a palpable cord; the total number of injections does not exceed 3 injections per cord at approximately 4-week intervals; authorization is for no more than 2 injections in the same hand.see text

From policy Dupuytren's continuation criteria

Initial Therapy — Peyronie's Disease

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

Peyronies_initial: Patient has diagnosis of Peyronie's disease with both of the following: 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 is in accordance with the U.S. 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.see text

From policy Peyronie's initial therapy criteria

Continuation Therapy — Peyronie's Disease

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

Peyronies_continuation: Patient 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 4 treatment cycles (i.e., less than 8 injections, 2 injections per cycle); Xiaflex dosing is in accordance with the U.S. 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.see text

From policy Peyronie's continuation criteria

Indications and medical necessity framing

Policy asserts Xiaflex is proven for specified indications and medically necessary when listed criteria are met.

Dupuytren's contracture: Xiaflex is proven for the treatment of Dupuytren's contracture with a palpable cord; Xiaflex is medically necessary for treatment when all of the listed criteria are met.

See policy for specific listed criteria.

Peyronie's disease: Xiaflex is proven for the treatment of adult men with Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy; Xiaflex is medically necessary for treatment when all of the listed criteria are met.>=30 degrees

REMS requirements apply due to risk of corporal rupture.

Xiaflex (collagenase clostridium histolyticum) is considered unproven and not medically necessary for any uses other than the specified indications. The policy limits coverage to the FDA‑labeled indications — treatment of Dupuytren's contracture with a palpable cord and treatment of Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy — and only when the detailed criteria for initial or continuation therapy in this policy are met.

Requests for Xiaflex outside of these specified indications (including diagnoses or clinical situations not listed in the policy) should be considered not medically necessary and are excluded from coverage unless supporting evidence and documented rationale meet the policy's covered criteria.

Use of Xiaflex for Peyronie's disease is subject to the FDA Risk Evaluation and Mitigation Strategy (REMS) because of the risk of corporal rupture or other serious penile injury. Prescribers must be enrolled and trained in the Xiaflex REMS program, and healthcare sites must be certified—coverage may be denied if REMS certification requirements are not met.

Clinicians should ensure REMS enrollment and site certification are in place before initiating therapy for Peyronie's disease and include documentation of REMS compliance with any prior authorization submission.

In summary, Xiaflex is covered only for the two FDA‑approved indications described in this policy (Dupuytren's contracture with a palpable cord; Peyronie's disease with a palpable plaque and ≥ 30° curvature at baseline) and only when the specific coverage criteria for initial or continuation therapy are satisfied.

Any other use of Xiaflex not explicitly listed in the policy is considered not medically necessary and is excluded from coverage.

Coding and Measurement Thresholds

Covered CPT Codes (reference list)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 CodesICD-10

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

Measurement thresholds for therapy — Dupuytren's and Peyronie's

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

Dupuytren's — continuation thresholdAffected MP or PIP contracture remains in the treated cord with >5° remaining since previous injection, or a different MP or PIP contracture will be injected

Injection limits — Dupuytren'sDosing per FDA labeling 0.58 mg per injection; up to 3 injections per cord at ~4‑week intervals; authorization no more than 2 injections in the same hand

Peyronie's — initial therapy thresholdCurvature deformity ≥30° at the start of therapy with a palpable plaque

Peyronie's — continuation thresholdDocumented curvature ≥15° remaining since last treatment cycle; patient has received fewer than 4 treatment cycles (<8 injections)

Provider Requirements, Authorization, and REMS

Prior Authorization

Provider Requirements and Authorization

Prior authorization is required for Xiaflex. Providers must obtain prior authorization with documentation that the member meets indication-specific criteria (e.g., Dupuytren's contracture with a palpable cord and documented contracture/functional limitation; Peyronie's disease with palpable plaque and curvature ≥30° at start of therapy). Authorization limits (e.g., number of injections, timing between injections) must be met and documented.

Affected codes: J0775, 20527, 26341 (reference only; member plan governs payment)
Dupuytren's initial: document palpable cord, age ≥18, contracture ≥20° for MP or PIP, functional limitation, provider experienced in hand injections, no surgery on primary joint within 90 days, dosing per FDA, ≤3 injections per cord, authorization ≤2 injections in same hand
Dupuytren's continuation: prior Xiaflex, positive clinical response, indicated remaining or new contracture (>5°), ≥4 weeks since prior treatment, other dosing and authorization limits as above
Peyronie's initial: document palpable plaque and curvature ≥30° at start, age ≥18, provider experienced in male urological disease, dosing per FDA, authorization ≤2 injections and 6 weeks duration
Peyronie's continuation: prior Xiaflex, positive response, last treatment ≥6 weeks prior, documented curvature ≥15° remaining, <4 treatment cycles (<8 injections), dosing per FDA, authorization ≤2 injections and 6 weeks duration
REMS: prescribers must be enrolled and trained in the Xiaflex REMS program and healthcare sites must be certified; use for Peyronie's may be denied if REMS requirements are not met

Key Definitions

Palpable cord — definition

DefinitionA cord-like fibrous band in the palmar fascia associated with Dupuytren's contracture, often formed from progression of nodules into longitudinal bands detectable on physical exam

Clinical relevancePresence of a palpable cord is a required physical finding for the FDA‑labeled indication and coverage of Xiaflex for Dupuytren's contracture

Associated findingsMay produce finger flexion contractures (MP or PIP joints) and functional limitation

Palpable plaque — definition

DefinitionA fibrotic plaque in the tunica albuginea detectable on examination associated with Peyronie's disease

Clinical relevancePresence of a palpable plaque plus curvature ≥30° at therapy start is required for the FDA‑labeled indication and coverage of Xiaflex for Peyronie's disease

Background and Clinical Context

Dupuytren's contracture is a progressive fibroproliferative disorder of the palmar fascia characterized by formation of nodules and cord‑like fibrous bands in the palm. These cords can produce fixed flexion deformities of the fingers, most commonly affecting the metacarpophalangeal (MP) and proximal interphalangeal (PIP) joints, and may cause functional limitation of hand activities.

Clinical eligibility for Xiaflex in Dupuytren's is based on the presence of a palpable cord, measurable joint contracture (typically ≥ 20° at an MP or PIP joint for initial therapy), and documentation that the deformity results in functional impairment; treatment is intended to enzymatically disrupt the collagenous cord to improve finger extension.

Policy Revision History

2026-01-01revisionLatest

Revised coverage rationale to clarify that Xiaflex is 'proven' for Dupuytren's contracture with a palpable cord and is 'medically necessary' when all listed criteria are met; similarly clarified wording for Peyronie's disease as 'proven' for adult men with a palpable plaque and curvature ≥30° and 'medically necessary' when listed criteria are met.

2026-01-01archival

Archived prior policy version 2025D0099E.

OpenPayer

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