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. 

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

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.

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.