Highmark Medical Policy Bulletin |
Section: | Injections |
Number: | I-107 |
Version: | 004 |
Topic: | Injectable Collagenase Clostridium Histolyticum (Xiaflex™) |
Effective Date: | October 29, 2012 |
Issued Date: | November 5, 2012 |
Date Last Reviewed: | 10/2010 |
Indications and Limitations of Coverage
Coverage for collagenase clostridium histolyticum (Xiaflex™) is determined according to individual or group customer benefits. Collagenase clostridium histolyticum is indicated for the treatment of adult patients with Dupuytren's contracture with a palpable cord. Treatment of Dupuytren's contracture consists of an injection of 0.58 mg collagenase into a palpable Dupuytren's cord with a contracture of a metacarpophalangeal (MP) joint or a proximal interphalangeal (PIP) joint followed approximately 24 hours after the injection by manipulation of the finger if contracture persists. Injections and finger extension procedures may be administered up to 3 times per cord at approximately 4-week intervals. The use of collagenase clostridium histolyticum for any other indication is considered experimental/investigational, and therefore not covered. A participating, preferred, or network provider can bill the member for the non-covered service. Collagenase clostridium histolyticum is not reimbursable under the prescription drug benefit Description Collagenases are enzymes that digest native collagen. Clostridial collagenase is a bacterial collagenase derived from clostridium histolyticum. Treatment of Dupuytren's contracture consists of an injection of collagenase into the cord followed by manipulation of the finger if contracture persists. Injection may be done up to 3 times at 4-week intervals. Dupuytren's disease is a benign fibroproliferative condition characterized by excessive collagen deposition causing abnormal thickening of the fascia. This results in the formation of a ropelike cord beneath the skin of the palm, stretching from the palm into the fingers. Gradually, the progression of these cords may cause the fingers to bend into the palm resulting in permanent joint contractures. Xiaflex is the first FDA-approved nonsurgical option for the treatment of adult patients with Dupuytren's contracture with a palpable cord. |
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20527 | 26341 | J0775 |
Traditional (UCR/Fee Schedule) Guidelines
Under the Federal Employee Program, all services that utilize FDA-approved drugs, devices, or biological products are eligible when intended for the treatment of a serious or life-threatening condition and when medically necessary and appropriate for the patient's condition. |
Comprehensive / Wraparound / PPO / Major Medical Guidelines
Any reference in this bulletin to non-billable services by a network provider may not be applicable to Major Medical.
Managed Care (HMO/POS) Guidelines
PRN
02/2011, Injectable collagenase clostridium histolyticum (Xiaflex™) coverage guidelines |
Badalamente MA, Hurst LC. Efficacy and safety of injectable mixed collagenase subtypes in the treatment of Dupuytren's contracture. J Hand Surg. 2007;32A:767-774. Hurst LC, Badalamente MA, Hentz VR, et al. Injectable collagenase clostridium histolyticum for Dupuytren's contracture. N Engl J Med. 2009;361(10):968-79. Xiaflex™ (collagenase clostridium histolyticum)[package insert]. Malvern, PA:Auxilium Pharmaceuticals, Inc. 02/2010. |
[Version 003 of I-107] |
[Version 002 of I-107] |
[Version 001 of I-107] |
728.6 |
Informational Only
M72.0 |