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Medical Policy: 05.01.32
Original Effective Date: February 2011
Reviewed: February 2012
Revised:
Benefit Application
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
Description:
Collagenases are enzymes that digest native collagen and are being evaluated for treatment of fibroproliferative disorders such as Dupuytren’s contractures and Peyronie’s disease. Clostridial collagenase is a bacterial collagenase derived from Clostridium histolyticum. Treatment of Dupuytren’s contracture consists of injection of collagenase into the cord followed by manipulation of the finger if contracture persists. Injection may be performed up to 3 times at 4-week intervals.
Injection with clostridial collagenase is intended to provide a non-operative treatment option for fibroproliferative disorders. Fibrotic tissue disorders, characterized by excessive collagen deposits, can affect the musculoskeletal system, causing pain and limitation of movement and reduction of joint range of motion. Dupuytren’s disease and adhesive capsulitis are such musculoskeletal disorders; Peyronie’s disease is another example.
The mechanisms that contribute to the pathology of fibroproliferative disorders are poorly understood. In Dupuytren’s disease, collagen deposition results in nodules and cords in the palm and fingers, resulting in pitting of the overlying cutis and flexion contractures. The standard of care for Dupuytren’s disease is surgery, most commonly open fasciectomy. Other surgical procedures are percutaneous fasciotomy and needle fasciotomy. Surgery is recommended in patients with functional impairment and metacarpophalangeal-joint contracture of 30 degrees or more. Adhesive capsulitis or “frozen shoulder” is treated with physiotherapy and immobilization in combination with analgesics or nonsteroidal anti-inflammatory drugs. Corticosteroid injection is used with caution. The prevalence of Dupuytren’s disease and adhesive capsulitis is estimated at 306% and 2-3%, respectively, in the general population and increases with advancing age. Both conditions are more common in patients with diabetes or thyroid disease. Dupuytren’s disease is more common in men and adhesive capsulitis more common in women.
Peyronie’s disease is the development of abnormal scar tissue, or plaques, in the tunica albuginea layer of the penis causing distortion, curvature, and pain usually during erection. It occurs in 3-9% of men, most commonly between the ages of 45 and 60. In some cases, plaque does not cause severe pain or curvature, and the condition resolves on its own. In severe cases, erectile dysfunction can occur. The goal of treatment is to reduce pain and maintain sexual function. Treatments in early stages (before calcification) include vitamin E or para-aminobenzoate tablets although studies of oral therapies demonstrate inconsistent benefit. Intralesional injection therapy consisting if injection of interferon-alpha-2b or calcium-channel blockers is the current standard of therapy. Surgical procedures involve the excision of hardened tissue and skin graft, the removal or plication of tissue opposite the plaque to reduce curvature, a penile implant, or a combination of these.
In February 2010, the U.S. Food and Drug Administration (FDA) approved Auxillium Pharmaceutical Inc.’s biologics license application for clostridial collagenase histolyticum (Xiaflex) for treatment of adult patients with Dupuytren’s contracture with a palpable cord. The FDA labeling for Xiaflex states that up to 3 injections at 4-week intervals may be given into a palpable Dupuytren’s cord with a contracture of a metacarpophalangeal (MP) joint or a proximal interphalangeal (PIP) joint.
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Prior Approval:
Not applicable
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Policy:
Injectable clostridial collagenase histolyticum (Xiaflex™) may be considered medically necessary for the treatment of adults with Dupuytren’s contracture with a palpable cord. Injections may be administered up to 3 times per cord at intervals not less than 4 weeks. Only 1 cord may be injected at a time. If there are other cords with contractures, each cord is injected in sequential order.
Injectable clostridial collagenase histolyticum (Xiaflex™) is considered investigational for all other fibroproliferative disorders including, but not limited to the following:
- Peyronie’s disease
- Adhesive capsulitis of the shoulder or hip
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Procedure Codes and Billing Guidelines:
- To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9-CM diagnostic codes.
- J0775 Injection, collagenase clostridium histolyticum, 0.01 mg.
- 20527 Injection, enzyme (eg, collagenase), palmar fascial cord (ie, Dupuytren's contracture)
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Selected References:
- 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 Dec;35(12):2027-38.e1.
- Hurst LC, Badalamente MA, Hentz VR et al. Injectable collagenase clostridium histolyticum for Dupuytren’s contracture. N Engl J Med. 2009 Sep 3;361(10):968-79.
- Thomas A, Bayat A. The emerging role of Clostridium histolyticum collagenase in the treatment of Dupuytren disease. Ther Clin Risk Manag. 2010 Nov 4;6:557-72.
- Russell S, Steers W, McVary KT. Systematic evidence-based analysis of plaque injection therapy for Peyronie’s disease. Eur Urol 2007; 51(3):640-7.
- Jordan GH. The use of intralesional clostridial collagenase injection therapy for Peyronie’s disease: a prospective, single-center, non-placebo-controlled study. J Sex Med 2008; 5(1):180-7.
- Shih B, Bayate A. Scientific understanding and clinical management of Dupuytren disease. Nat Rev Theumatol. 2010 Dec; 6(12):715-26. Epub 2010 Nov 9.
- 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):534-9, 39 e1.
- Ralph D, Gonzalez-Cadavid N, Mirone V et al. The management of Peyronie's disease: evidence-based 2010 guidelines. J Sex Med 2010; 7(7):2359-74.
- Desai SS, Hentz VR. Collagenase clostridium histolyticum for Dupuytren's contracture. Expert Opin Biol Ther 2010; 10(9):1395-404.
- Holzer LA, Holzer G. Injectable collagenase clostridium histolyticum for Dupuytren's contracture. N Engl J Med 2009; 361(26):2579; author reply 79-80.
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Policy History:
Date Reason Action
February 2011 Literature review New policy
February 2012 Annual review Policy renewed
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Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
assist in administering plan benefits and constitute neither offers of
coverage nor medical advice. Wellmark medical policies contain only a
partial, general description of plan or program benefits and do not
constitute a contract. Wellmark does not provide health care services
and, therefore, cannot guarantee any results or outcomes.
Participating providers are independent contractors in private
practice and are neither employees nor agents of Wellmark or its
affiliates. Treating providers are solely responsible for medical
advice and treatment of members. Our medical policies may be updated
and therefore are subject to change without notice.
*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.
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