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DESCRIPTIONCollagenases are enzymes that digest native collagen and are being evaluated for treatment of fibroproliferative disorders such as Dupuytren’s contracture 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 done 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 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 contractures of 30 degrees or more. There is no effective pharmacotherapy. Adhesive capsulitis or “frozen shoulder” is treated with physiotherapy and mobilization 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 3-6% 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 (e.g., Potaba) although studies of oral therapies demonstrate inconsistent benefit. Intralesional injection therapy consisting of injection of interferon-alpha-2b or calcium channel-blockers (e.g., verapamil) is the current standard of therapy. Surgical procedures involve the excision (removal) of hardened tissue and skin graft, the removal or pinching (plication) of tissue opposite the plaque to reduce curvature (called the Nesbit procedure), a penile implant, or a combination of these.
In February 2010, the FDA approved Auxilium 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.
In December 2013, FDA expanded the indications for Xiaflex to include Peyronie disease. Xiaflex is approved for men with a palpable penile plaque and penile curvature more than 30°. FDA labeling states that a treatment course consists of a maximum of 4 cycles, each of which consists of 2 Xiaflex injection procedures. In clinical trials of Xiaflex for Peyronie disease, corporeal rupture was reported as an adverse event in 0.5% of Xiaflex-treated patients. An additional 0.9% of Xiaflex-treated patients experienced a combination of penile ecchymosis or hematoma, sudden penile detumescence, and/or a penile “popping” sound or sensation, such that a diagnosis of corporal rupture could not be excluded. Severe penile hematoma was reported in 3.7% of patients. Because of these complications, FDA required a boxed warning label for Xiaflex as a treatment for Peyronie disease. Xiaflex is available for the treatment of Peyronie disease only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) Program. Required components of the REMS program are that prescribers are certified with the program by enrolling and completing training in the administration of Xiaflex for Peyronie disease and that healthcare sites are certified with the program and ensure that Xiaflex is only dispensed for use by certified prescribers.
POLICYPrior Authorization is required.
Xiaflex for the treatment of Dupuytren’s contracture in adult patients with a palpable cord may be considered medically necessary, for up to three injections at intervals of at least thirty days. Inject up to two cords in the same hand at a treatment visit. If a patient has other cords with contractures, inject those cords at another treatment visit. Approximately 24-72 hours following an injection, a finger extension procedure can be performed if a contracture persists.
Xiaflex administered by a certified provider through the Xiaflex REMS Program (see Policy Guidelines) may be considered medically necessary for the treatment of Peyronie’s disease in adult men with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy. For each plaque causing the curvature deformity, up to four treatment cycles may be administered. Each treatment cycle may be repeated at approximately 6-week intervals. If the curvature deformity is less than 15 degrees after the first, second or third treatment cycle, or if further treatment is not clinically indicated, then subsequent treatment cycles should not be administered.
Xiaflex is considered investigational for all other indications including, but not limited to adhesive capsulitis.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
A Risk Evaluation and Mitigation Strategy (REMS) is a strategy to manage known or potential serious risks associated with a drug and is required by the Food and Drug Administration (FDA) to ensure that the benefits of the drug outweigh its risks. Xiaflex is available for the treatment of Peyronie's disease only through the Xiaflex REMS Program. The Xiaflex REMS Program requirements include:
Investigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY07/22/2010: Approved by Medical Policy Advisory Committee
06/13/2011: Policy reviewed; no changes.
12/09/2011: Policy statement revised to state that effective 12/09/2011, injectable clostridial collagenase for the treatment of Dupuytren’s contracture in adult patients with a palpable cord may be considered medically necessary, for up to three injections at intervals of at least thirty days. Prior Authorization is required. Added HCPCS code J0775 to the Code Reference section and deleted the unlisted code J3590. Added ICD-9 code 728.6 to the Covered Codes table.
01/17/2012: Added 20527 to the Covered Codes table.
11/28/2012: Policy reviewed; no changes.
12/13/2013: Policy reviewed; no changes.
11/06/2014: Medically necessary policy statement updated to remove "Effective 12/09/2011" and add: Inject up to two cords in the same hand at a treatment visit. If a patient has other cords with contractures, inject those cords at another treatment visit. Approximately 24-72 hours following an injection, a finger extension procedure can be performed if a contracture persists.
03/03/2015: Added the following policy statement for treatment of Peyronie's disease: Xiaflex administered by a certified provider through the Xiaflex REMS Program (see Policy Guidelines) may be considered medically necessary for the treatment of Peyronie’s disease in adult men with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy. For each plaque causing the curvature deformity, up to four treatment cycles may be administered. Each treatment cycle may be repeated at approximately 6-week intervals. If the curvature deformity is less than 15 degrees after the first, second or third treatment cycle, or if further treatment is not clinically indicated, then subsequent treatment cycles should not be administered. Added the Xiaflex REMS Program requirements to the Policy Guidelines; link to program added to Sources section. Added ICD-9 code 607.85 to the Code Reference section.
SOURCE(S)Blue Cross Blue Shield Association policy # 5.01.19
Xiaflex® Prescribing Information
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.