CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Xiaflex (collagenase) (Intralesional) — Coverage Criteria

Policy governing coverage and authorization requirements for intralesional collagenase (Xiaflex) for Dupuytren's contracture and Peyronie's disease for Medicaid, Commercial, and Medicare members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyXiaflex (collagenase) (Intralesional) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date01/01/2020

Next Review Date06/11/2025

Key ActionObtain prior authorization and document age, palpable cord/plaque, measured contracture/curvature thresholds, prior surgeries, and dosing/intervals per policy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3max injections per joint/cord (Dupuytren's)

4max treatments per plaque (Peyronie's)

180billable units (Dupuytren's)

180billable units (Peyronie's)

J0775HCPCS code

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Coverage Criteria

Initial Therapy — coverage provided when ALL of the following initial criteria for the specific condition are met.

Coverage is provided when ALL of the following initial criteria for the specific condition are met.

General: Patient is at least 18 years old; Medicare members who received this medication within the past 365 days are exempt from step therapy.

Dupuytren's Initial: Patient has a palpable cord; documented flexion contracture of ≥20° in a metacarpophalangeal (MP) joint or specified proximal interphalangeal (PIP) joint thresholds; positive table top test (inability to place affected finger(s) flat on a table); no surgical treatment on the selected joint within the prior 90 days; flexion deformity results in functional limitations; dosing and administration consistent with policy (0.58 mg injected into each palpable cord, up to 2 cords in the same hand per visit, up to 3 injections per cord at ~4-week intervals).

Peyronie's Initial: Prescriber is enrolled in the Xiaflex REMS Program; patient has a palpable penile plaque; disease is stable with penile curvature deformity between 30° and 90°; patient has intact erectile function (with or without medications); no ventral curvature deformity, isolated hourglass deformity, calcified plaque, or plaques involving the urethra; treatment will be used in combination with modeling procedures; patient has not exceeded 4 treatments per plaque; patient has not received a collagenase injection for this condition within the past 6 weeks; dosing and administration consistent with policy (0.58 mg per injection, treatments may be repeated at ~6-week intervals).

Renewal Criteria — coverage renewal requires ongoing benefit and absence of unacceptable toxicity.

Coverage renewal requires ongoing benefit and absence of unacceptable toxicity.

Dupuytren's Renewal: Patient continues to meet indication-specific criteria; absence of unacceptable toxicity (examples include hypersensitivity/anaphylaxis, abnormal coagulation, tendon rupture or other serious injury to the injected extremity, vasovagal reactions); demonstrable disease response as reduction in contracture of the treated primary 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 policy-specified interval.

Peyronie's Renewal: Patient continues to meet indication-specific criteria; absence of unacceptable toxicity (examples include hypersensitivity/anaphylaxis, abnormal coagulation, corporal rupture or other serious penile injury, acute post-injection reactions, vasovagal reactions); treatment response demonstrated by reduction in penile curvature compared to baseline or improvement in PDQ Bother score; residual curvature ≥15° after prior treatment cycle(s); patient has not exceeded 4 total treatments per plaque; patient has not received a collagenase injection for this condition within the past 6 weeks.

General coverage criteria (summary)

Covered when consistent with FDA-approved labeling and relevant clinical literature; documentation submitted by the prescriber supports the medical necessity decision.

General requirement: Use must follow FDA-approved labeling and relevant clinical literature; prescriber must submit supporting documentation for individual consideration.

For Medicare members, plan criteria apply only if no NCD or LCD exists.

Coverage excludes treatment of Peyronie's disease when the plaque or deformity involves anatomical or morphological features that were not included in the FDA‑approved indication and are specifically listed as exclusions. Excluded presentations include ventral curvature deformity, isolated hourglass deformity, calcified plaque, and plaques that involve the urethra.

For Medicare members, the plan’s coverage criteria apply only when there is no applicable Centers for Medicare & Medicaid Services determination. Specifically, National Coverage Determinations (NCDs) or Local Coverage Determinations (LCDs) take precedence; Neighborhood’s criteria will be applied only in the absence of an NCD or LCD.

Treatment will not be supported when the policy’s clinical thresholds or required findings are not met. Examples include absence of a palpable cord for Dupuytren's or a palpable plaque for Peyronie's, or when measured deformity is below policy thresholds (for example, Dupuytren's contracture less than 20° in an MP joint, or Peyronie's penile curvature less than 30°), or when documented functional limitation or stability requirements are not present. Requests lacking the required documentation (age ≥18, positive table top test for Dupuytren's, or other indication‑specific findings) are also not supported.

Coding

HCPCS Covered CodesHCPCSCovered

J0775

Injection, collagenase, clostridium histolyticum, 0.01 mg

NDCNDCCovered

66887-0003-XX

Xiaflex 0.9 mg powder for injection (NDC)

Covered Diagnosis CodesICD-10Covered

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

Contracture/Curvature thresholds — initiation and renewal

Dupuytren's contracture — MP joint thresholdDocumented flexion contracture of ≥20° in a metacarpophalangeal (MP) joint (study entry criteria: 20–100°)

Dupuytren's contracture — PIP joint thresholdDocumented flexion contracture in a proximal interphalangeal (PIP) joint consistent with study criteria (20–80° as reported in trials)

Peyronie's disease — initiation curvature thresholdPenile curvature deformity of ≥30° and ≤90° (stable disease) required for initiation of therapy

Peyronie's disease — renewal/residual curvature thresholdResidual penile curvature ≥15° after prior treatment cycle(s) required for consideration of additional treatment

Maximum treatments — Dupuytren'sMaximum of 3 injections per joint/cord (policy length/renewal limits)

Provider Actions & Authorization

Prior Authorization

Prior Authorization and Length of Authorization

Prior authorization is required. Lengths of authorization: Dupuytren's contracture — coverage for 3 months, eligible for renewal for up to 3 injections per joint/cord; Peyronie's disease — coverage for 6 weeks, eligible for renewal for up to 4 total treatment cycles per plaque causing the curvature deformity.

Dupuytren's: 3 months, renewal up to 3 injections per joint/cord
Peyronie's: 6 weeks, renewal up to 4 treatment cycles per plaque

Prior Authorization

Prior authorization and review

Requests will be reviewed against FDA labeling and relevant clinical literature. For Medicare members, these coverage criteria apply only in the absence of an applicable NCD or LCD. The plan will give individual consideration to each request based on information submitted by the prescriber and other plan data.

Coverage aligned with FDA-approved labeling and clinical literature
Medicare: NCD/LCD supersede; otherwise plan criteria apply
Individual consideration based on prescriber-submitted information and plan data

Definitions

Positive table top test definition

Positive table top test — definitionInability to simultaneously place the affected finger(s) flat against a table top

Clinical context — use in trialsPositive table top test was required for entry in Dupuytren's trials as the inability to place the affected finger(s) flat on a table

Documentation requirementProviders must document a positive table top test when submitting for coverage for Dupuytren's treatment

Background

Xiaflex (collagenase clostridium histolyticum) is FDA‑approved for treatment of Dupuytren's contracture and Peyronie's disease. Clinical trials demonstrated reduction in contracture for Dupuytren's and improvement in penile curvature and patient‑reported bother scores for Peyronie's. Common adverse events documented in the evidence include injection site reactions, swelling, bruising, and pain. Neighborhood’s coverage criteria are intended to align use with FDA labeling and relevant clinical literature to ensure appropriate patient selection and to minimize risk of adverse effects.