CurrentBlue Cross Blue Shield - IowaPolicy 05.02.85

Xiaflex (collagenase clostridium histolyticum) drug coverage

Coverage policy for Xiaflex for treatment of Dupuytren's contracture and Peyronie's disease, describing prior authorization, documentation, prescriber requirements, dosing limits, and billing codes for Wellmark Blue Cross and Blue Shield members.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyXiaflex (collagenase clostridium histolyticum) drug coverage

Policy CodePolicy 05.02.85

Change TypeNo material changes

Effective DateDec 7, 2022

Next Review DateJan 1, 2026

Key ActionSubmit prior authorization with chart documentation including tabletop test or plaque and curvature measurements and prior injection history.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 moDupuytren auth

12 moPeyronie’s auth

3Max per cord

8Max per course

J0775HCPCS

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inv-01: Dupuytren's Initial Therapy

Authorization of 6 months may be granted for the treatment of Dupuytren's contracture when ALL of the following criteria are met:

Dupuytren initial authorization: 1. Member has a finger flexion contracture with a palpable cord in a metacarpophalangeal (MCP) or proximal interphalangeal (PIP) joint prior to initiating Xiaflex therapy; 2. Contracture is at least 20 degrees prior to initiating therapy; 3. Positive tabletop test (inability to place affected finger(s) and palm flat on a table) prior to initiating therapy; 4. Member is 18 years of age or older; 5. Member will receive up to 3 injections maximum per cord (4 weeks apart) as part of the current treatment.see text

Authorization duration: 6 months

inv-02: Peyronie's Initial Therapy

Authorization of 12 months may be granted for the treatment of Peyronie's disease when ALL of the following criteria are met:

Peyronie's initial authorization: 1. Stable Peyronie's disease without clinical changes for at least 3 months; 2. Palpable plaque and curvature deformity of at least 30 degrees and less than 90 degrees prior to initiating Xiaflex therapy; 3. Intact erectile function (with or without medication); 4. Member is 18 years of age or older; 5. Member will receive a maximum of one treatment course with a maximum of 8 injections total, including any injections the patient has received for previous treatment.see text

Authorization duration: 12 months

inv-03: Dupuytren's Continuation Therapy

Authorization of 6 months may be granted for continuation of Dupuytren's treatment when ALL of the following criteria are met:

Dupuytren continuation: 1. Member meets all initial authorization criteria; 2. Continuing treatment for the same cord (if treating a new cord or a previously treated cord following recurrence, member must meet all initial authorization criteria); 3. Member has received less than 3 injections total per cord (4 weeks apart).see text

Authorization duration: 6 months

inv-04: Peyronie's Continuation Therapy

Authorization of 12 months may be granted for continuation of Peyronie's treatment when ALL of the following criteria are met:

Peyronie's continuation: 1. Member meets all initial authorization criteria; 2. Member has curvature deformity of at least 15 degrees at the time of the continuation request; 3. Member has received less than 8 injections total, including any injections the patient has received for any previous treatment.see text

Authorization duration: 12 months; Xiaflex is considered not medically necessary if these criteria are not met.

Coverage will not be provided for cosmetic use (for example, cellulite reduction treatment).

If the member does not meet the policy criteria described for Dupuytren's contracture or Peyronie's disease (including the specific curvature/contracture thresholds, documentation requirements, and limits on total injections), Xiaflex is considered not medically necessary and coverage will be denied.

Coding and Billing

HCPCS / Drug Billing CodesHCPCSCovered

J0775

Injection, collagenase, clostridium histolyticum, 0.01 mg

Contracture / Curvature thresholds

Dupuytren's contracture thresholdContracture is at least 20 degrees prior to initiating Xiaflex therapy.

Peyronie's initial curvature thresholdCurvature deformity of at least 30 degrees and less than 90 degrees prior to initiating Xiaflex therapy.

Peyronie's continuation curvature thresholdCurvature deformity of at least 15 degrees at the time of the continuation request.

Continuation injections limit (Peyronie's)Member has received less than 8 injections total, including prior injections.

Provider Actions & Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required. Submit chart notes or medical records documenting the diagnosis and clinical findings, including the tabletop test for Dupuytren's contracture or documentation of palpable plaque and curvature and erectile function for Peyronie's disease. For continuation requests, include the number of injections the member has received to date.

Dupuytren's: affected joint, degree of contracture, positive tabletop test (new starts and continuation), number of injections received (continuation only).
Peyronie's: palpable plaque, degree of curvature, intact erectile function (new starts and continuation), number of injections received (continuation only).

Documentation Required

Continuation Requirements

Provide medical record documentation to support continuation requests: the member must meet all initial authorization criteria, be continuing treatment for the same cord (Dupuytren's) or have the required minimum curvature at time of continuation (Peyronie's), and have received fewer than the maximum allowed injections.

Dupuytren's continuation: meets all initial criteria; same cord as initial treatment (new cord or recurrence requires meeting initial criteria); < 3 injections total per cord (4 weeks apart).
Peyronie's continuation: meets all initial criteria; curvature ≥ 15 degrees at time of continuation request; < 8 injections total (including prior treatments).
Authorization durations: Dupuytren's — up to 6 months; Peyronie's — up to 12 months.

Denial Risk

Denial Risk If Criteria Unmet

If the criteria for initial or continuation therapy are not met, Xiaflex is considered not medically necessary and may be denied.

Denial risk if tabletop test, plaque/curvature documentation, or injection counts are missing or do not meet policy thresholds.

Initial Therapy Criteria

inv-15: Initial Therapy

Initial authorization may be granted when ALL applicable indication-specific criteria below are met:

Dupuytren initial (combined): 1. Finger flexion contracture with a palpable cord in an MCP or PIP joint prior to initiating Xiaflex; 2. Contracture >= 20 degrees prior to initiating therapy; 3. Positive tabletop test prior to initiating therapy; 4. Member is >= 18 years of age; 5. Up to 3 injections maximum per cord (4 weeks apart) as part of the current treatment.see text

Authorization duration: 6 months

Peyronie's initial (combined): 1. Stable disease without clinical changes for >= 3 months; 2. Palpable plaque and curvature deformity >= 30 degrees and < 90 degrees prior to initiating therapy; 3. Intact erectile function (with or without medication); 4. Member is >= 18 years of age; 5. Maximum of one treatment course with up to 8 injections total (including prior injections).see text

Authorization duration: 12 months

Continuation Therapy Criteria

inv-16: Continuation Therapy

Continuation authorization may be granted when ALL applicable continuation criteria are met; continuation requirements mirror initial criteria with additional limits:

Dupuytren continuation (combined): 1. Member meets all initial authorization criteria; 2. Continuing treatment for the same cord (new cord or recurrence requires meeting initial criteria); 3. Member has received less than 3 injections total per cord (4 weeks apart).<3 injections per cord

Authorization duration: 6 months

Peyronie's continuation (combined): 1. Member meets all initial authorization criteria; 2. Curvature deformity of at least 15 degrees at the time of the continuation request; 3. Member has received less than 8 injections total, including any prior injections.>=15 degrees and <8 injections total

Authorization duration: 12 months; Xiaflex is considered not medically necessary for members who do not meet these criteria.

Quantity Limits

Xiaflex — per-cord limit

Per-cord injection limitUp to 3 injections maximum per cord (4 weeks apart) as part of the current treatment.

Xiaflex — total course limit

Maximum injections per treatment courseMaximum of 8 injections total per treatment course, including any injections the patient has received for any previous treatment.

Site of Care Requirements

Note

Office administration — experienced provider and REMS for Peyronie's

Administer Xiaflex only in the office by a clinician experienced in the appropriate injection procedures; for Peyronie's disease the provider must have completed the Xiaflex REMS program requirements.

Dupuytren's: provider experienced in hand injection procedures and treatment of Dupuytren's contracture.
Peyronie's: provider experienced in urological disease treatment and completed Xiaflex REMS requirements.

Background

Xiaflex (collagenase clostridium histolyticum) is indicated for adult patients with Dupuytren's contracture with a palpable cord and for adult men with Peyronie's disease with a palpable plaque and a curvature deformity meeting the policy thresholds. Prior authorization is required and approvals are granted only when the indication-specific criteria are met (for example, Peyronie's continuation requires current curvature of at least 15 degrees and fewer than 8 injections total), consistent with product labeling and the policy's coverage criteria.

Definitions

Positive tabletop test

Positive tabletop test — definitionInability to simultaneously place the affected finger(s) and palm flat against a table.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyXiaflex (collagenase clostridium histolyticum) drug coverage

Policy CodePolicy 05.02.85

Change TypeNo material changes

Effective DateDec 7, 2022

Next Review DateJan 1, 2026

Key ActionSubmit prior authorization with chart documentation including tabletop test or plaque and curvature measurements and prior injection history.

SourceLink

On This Page

OpenPayer

Xiaflex (collagenase clostridium histolyticum) drug coverage

Coverage Criteria

Coding and Billing

Provider Actions & Prior Authorization

Initial Therapy Criteria

Continuation Therapy Criteria

Quantity Limits

Site of Care Requirements

Background

Definitions