CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Collagenase (Xiaflex) intralesional therapy - Coverage Criteria

Policy governing coverage, prior authorization, dosing, and renewal criteria for intralesional collagenase (Xiaflex) for members (Medicaid, Commercial, Medicare) of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyCollagenase (Xiaflex) intralesional therapy - Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 1, 2020

Next Review DateN/A

Key ActionObtain prior authorization and submit documentation demonstrating FDA-approved indication or supporting clinical literature; bill using HCPCS J0775.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3 monthsinitial auth duration (Dupuytren's)

6 weeksinitial auth duration (Peyronie's)

180units per period (Dupuytren's)

180units per period (Peyronie's)

J0775HCPCS code

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Coverage Criteria

Initial Approval Criteria

Covered when ALL of the following initial criteria are met:

Common criteria: Patient is at least 18 years old; Medicare members who received this medication within the past 365 days are not subject to Step Therapy.age >= 18

Dupuytren's contracture initial criteria: Patient has a palpable cord; documented flexion contracture of 20°–100° in an MP joint or 20°–80° in a PIP joint; positive table top test (inability to place affected finger(s) and palm flat against a table); no surgical treatment on the selected joint within 90 days before the first injection; documentation that the flexion deformity results in functional limitations.MP 20–100°, PIP 20–80°

FDA-labeled indication

Peyronie's disease initial criteria: Prescriber is enrolled in the Xiaflex REMS Program; patient has a palpable penile plaque; stable disease with penile curvature >30° and <90°; intact erectile function (with or without medications); no ventral curvature, isolated hourglass deformity, or calcified plaque; plaque does not involve the penile urethra; to be used with penile modeling procedures; patient has not exceeded 4 treatment cycles per plaque; patient has not received a collagenase injection for this condition within the past 6 weeks.>30° and <90° curvature

FDA-labeled indication; REMS required

Renewal Criteria

Renewal/Continuation criteria — coverage may be renewed when ALL of the following are met:

General renewal criteria: Patient continues to meet indication-specific relevant criteria and there is absence of unacceptable toxicity from the drug.

Examples of unacceptable toxicity listed in policy (e.g., hypersensitivity, tendon rupture, corporal rupture)

Dupuytren's renewal: Documented disease response with reduction in contracture of the treated joint compared to baseline; patient has not exceeded 3 injections per joint/cord; patient has not received a collagenase injection for this condition within the past 4 weeks.<=3 injections per joint; >=4 weeks since last injection

Peyronie's renewal: Documented disease response defined by reduction in penile curvature compared to baseline or improvement in PDQ Bother score; patient continues to have penile curvature deformity ≥15° after prior cycle(s); patient has not exceeded 4 total treatment cycles per plaque; patient has not received a collagenase injection for this condition within the past 6 weeks; absence of unacceptable toxicity (including corporal rupture).

General Coverage Criteria

Covered when usage meets FDA-approved labeling and/or is supported by relevant clinical literature, and when prescriber documentation demonstrates medical necessity and consideration of more cost-effective options.

General coverage conditions: Use consistent with FDA-approved labeling OR supported by relevant clinical literature; prescriber-submitted documentation demonstrating medical necessity; consideration of more cost-effective alternatives where appropriate; for Medicare members, NCD/LCD criteria supersede these criteria; individualized review will be given based on information submitted.

Specific stepwise or numeric criteria not present in this document chunk.

For Peyronie's disease, coverage is excluded when the plaque or deformity meets any of the following conditions: ventral curvature deformity, an isolated hourglass deformity, a calcified plaque, or when the plaque involves the penile urethra. These anatomic features are listed in the policy's Peyronie's disease initial criteria as conditions that preclude use of intralesional collagenase.

No additional explicit exclusions are specified in this portion of the document beyond those listed for specific indications; the policy states that coverage criteria were drafted to align with FDA labeling and the clinical literature and that individual consideration will be given for requests based on submitted clinical information.

Use of intralesional collagenase is not supported when indication-specific entry criteria are not met. Examples include absence of a palpable cord for Dupuytren's, lack of documented flexion contracture within the specified degree ranges (MP 20°–100° or PIP 20°–80°), failure to document a positive tabletop test or functional limitation for Dupuytren's, or for Peyronie's the absence of a palpable penile plaque, unstable disease, curvature outside the required range (>30° and <90°), or presence of excluded plaque characteristics (ventral/hourglass/calcified/urethral-involving).

The document does not specify additional fixed exclusions beyond the indication-specific criteria and states that determinations will be made on an individualized basis. Reviewers will evaluate prescriber-submitted information for consistency with FDA labeling and relevant literature when making coverage decisions.

Coding and Dosing

Covered HCPCSHCPCSCovered

J0775

Injection, collagenase, clostridium histolyticum, 0.01 mg

NDCNDC

66887-0003-xx

Xiaflex 0.9 mg powder for injection: 66887-0003-xx

Covered Diagnosis CodesICD-10Covered

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

inv-11: Dose per injection/day

Dose per injection0.58 mg per injection

Dupuytren's administrationInject 0.58 mg into each palpable cord with a contracture of an MP or PIP joint; up to two cords in same hand per visit

Peyronie's administrationEach treatment cycle: inject 0.58 mg into the target plaque once on each of two days (1–3 days apart)

inv-12: Maximum injections per cord (Dupuytren's)

Maximum injections per cordUp to 3 injections total per cord

Interval between injectionsApproximately 4-week intervals between injections

Provider Actions, Prior Authorization, and Denials

Prior Authorization

Prior Authorization Required

Prior authorization is required for Xiaflex. Prescribers must submit documentation supporting a medically accepted indication consistent with FDA labeling or relevant clinical literature. For Medicare members, National Coverage Determinations (NCD) or Local Coverage Determinations (LCD) take precedence; Neighborhood will apply these criteria only in the absence of applicable NCD/LCD rules.

Prior authorization required
Medicare members subject to NCD/LCD rules

Step Therapy

Step Therapy Preference / Exemption

Where applicable, Neighborhood emphasizes step therapy to ensure cost‑effective options are used first. Medicare members who have previously received Xiaflex within the past 365 days are exempt from step therapy requirements.

Step therapy preference: use cost-effective options first when applicable
Step therapy exemption for Medicare members treated within prior 365 days

Definitions and Clinical Terms

inv-23: Positive table top test

DefinitionInability to simultaneously place the affected finger(s) and palm flat against a table top

Use in policyUsed as an inclusion/assessment criterion for Dupuytren's contracture

Clinical implicationIndicates functional impairment from finger contracture

inv-24: Stable Peyronie's disease

Curvature rangePenile curvature deformity >30° and <90°

Stability and functionDisease must be in stable phase; intact erectile function (with or without medications)

Exclusions

Background

Xiaflex (collagenase clostridium histolyticum) is FDA-approved for both Dupuytren's contracture and Peyronie's disease. Randomized, double‑blind, placebo‑controlled trials demonstrated that collagenase reduced finger contractures in Dupuytren's and reduced penile curvature in Peyronie's compared with placebo. Common adverse events reported in trials include injection-site reactions, swelling, bruising, and pain.