Coverage for collagenase clostridium histolyticum is determined according to individual or group customer benefits. Collagenase clostridium histolyticum may be considered medically necessary for the following indications:

• Treatment of adult patients with Dupuytren's contracture with a palpable cord; and
• Treatment of adult patients with Peyronie's disease.

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.

Treatment of Dupuytren's contracture consists of an injection of 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.

A treatment course for Peyronie’s disease consists of a maximum of four (4) treatment cycles. Each treatment cycle consists of two (2) collagenase clostridium histolyticum injection procedures (in which injectable collagenase clostridium histolyticum is injected directly into the collagen-containing structure of the penis) and one penile modeling procedure performed by the health care professional.

Collagenase clostridium histolyticum is not reimbursable under the prescription drug benefit.

NOTE: Dosage recommendations per the FDA label.

Place of Service: Outpatient

The use of injectable collagenase clostridium histolyticum is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances including, but not limited to the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.

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. Collagenase clostridium histolyticum is the first FDA-approved nonsurgical option for the treatment of adult patients with Dupuytren's contracture with a palpable cord. 

Peyronie's disease is caused by scar tissue that develops under the skin of the penis. This scar tissue causes an abnormal bend during erection and can cause problems such as bothersome symptoms during intercourse.

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.

02/2011, Injectable collagenase clostridium histolyticum (Xiaflex™) coverage guidelines 
12/2013, Place of service designation included on additional medical policies
02/2014, New FDA approved indication for injectable collagenase clostridium histolyticum

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.

Gilpin D, Coleman S, Hall S et al. Injectable collagenase clostridium histolyticum: a new nonsurgical treatment for Dupuytren's disease. J Hand Surg Am. 2010;35(12):2027-2038.

Watt AJ, Curtin CM, Hentz VR. Collagenase injection as nonsurgical treatment of Dupuytren's disease: 8-year follow-up. J Hand Surg Am. 2010;35(4):534-539.

Thomas A, Bayat A. The emerging role of Clostridium histolyticum collagenase in the treatment of Dupuytren disease. Ther Clin Risk Manag. 2010;6:557-572.

Skirven TM, Bachoura A, Jacoby SM, et al. The effect of a therapy protocol for increasing correction of severely contracted proximal interphalangeal joints caused by Dupuytren disease and treated with collagenase injection. J Hand Surg Am. 2013;38(4):684-689.

Witthaut J, Jones G, Skrepnik N, et al. Efficacy and safety of collagenase clostridium histolyticum injection for Dupuytren contracture: short-term results from 2 open-label studies. J Hand Surg Am. 2013;38(1):2-11.