Clinical Policy: Collagenase Clostridium Histolyticum (Xiaflex)

Reference Number: CP.PHAR.82
Effective Date: 10.01.11
Last Review Date: 08.25
Line of Business: Commercial, HIM*, Medicaid*

[Coding Implications](Coding Implications)
[Revision Log](Revision Log)

See [Important Reminder](See Important Reminder) at the end of this policy for important regulatory and legal information.

Description

Collagenase clostridium histolyticum (Xiaflex®) is a combination of bacterial collagenases.

*For New York Essential Plans and New York Medicaid (including CHIP), use of Xiaflex for the treatment of Peyronie’s Disease is a benefit exclusion and will NOT be authorized.

FDA Approved Indication(s)

Xiaflex is indicated for the treatment of:

• Adult patients with Dupuytren’s contracture (DC) with a palpable cord
• Adult men with Peyronie’s disease (PD) with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy

Policy/Criteria

Approval duration: 3 months (up to 2 injections)

B. Peyronie’s Disease* (must meet all):

* This criteria does NOT apply to New York Essential Plans and New York Medicaid (including CHIP) as treatment for Peyronie’s Disease is a benefit exclusion.

Approval duration: 3 months (up to 2 injections)

C. Other diagnoses/indications (must meet 1 or 2):

1. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b):
   a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or
   b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.

II. Continued Therapy

A. Dupuytren’s Contracture (must meet all):

Approval duration: 3 months (up to 2 injections, total of 3 injections per affected cord)

B. Peyronie’s Disease (must meet all):

Approval duration: 3 months (up to 2 injections)

C. Other diagnoses/indications (must meet 1 or 2):

1. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b):
   a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or
   b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.

III. Diagnoses/Indications for which coverage is NOT authorized:

A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid, or evidence of coverage documents.

CLINICAL POLICY

Collagenase Clostridium Histolyticum

IV. Appendices/General Information

Appendix A: Abbreviation/Acronym Key

DC: Dupuytren’s contracture
PD: Peyronie’s disease
FDA: Food and Drug Administration
PIP: proximal interphalangeal joint
MP: metacarpophalangeal joint

Appendix B: Therapeutic Alternatives

Not applicable

Appendix C: Contraindications/Boxed Warnings

• Contraindication(s): Peyronie’s plaques that involve the penile urethra; hypersensitivity to Xiaflex or collagenase used in other therapeutic applications.
• Boxed warning(s): corporal rupture (penile fracture) or other serious penile injury in the treatment of Peyronie’s disease.

V. Dosage and Administration

VI. Product Availability

Lyophilized powder for reconstitution (single-use glass vials): 0.9 mg of collagenase clostridium histolyticum

Coding Implications

Codes referenced in this clinical policy are for informational purposes only. Inclusion or exclusion of any codes does not guarantee coverage. Providers should reference the most up-to-date sources of professional coding guidance prior to the submission of claims for reimbursement of covered services.

Reviews, Revisions, and Approvals

CLINICAL POLICY

Collagenase Clostridium Histolyticum

Important Reminder