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. Examples of fibroproliferative disorders include Dupuytren's contracture, and Peyronie's disease.
Dupuytren’s contracture 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.
Coverage is subject to the specific terms of the member's benefit plan.
Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.
Collagenase clostridium histolyticum (e.g. Xiaflex®) may be considered medically necessary for ANY ONE of the following indications and their respective criteria listed below:
The use of collagenase clostridium histolyticum for any other indication is considered experimental/investigational, and therefore not covered. Scientific evidence does not support its use for any other indications.
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. Patients may be eligible for the following treatment:
Note: *Collagenase clostridium histolyticum injections for Dupuytren’s contracture should be administered by a healthcare provider experienced in injection procedures of the hand and certified in the *Xiaflex Risk Evaluation and Mitigation Strategy (REMS) Program. A copy of the REMS certification must be attached to the claim.
Treatment for Peyronie’s disease may be considered medically necessary for a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy.
The injection of the corpora cavernosa with pharmacologic agent(s) (e.g., papaverine, phentolamine) may be considered medically necessary to determine where the injection of Xiaflex should be administered on the penis. If the penis does not detumesce, then an injection of a medication to pharmacologically reduce the swelling may be considered medically necessary.
The injection of the corpora cavernosa is considered an integral part of a doctor's medical care. Payment for the medical care performed on the same date of service includes the allowance for this procedure. 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.
Note: *Collagenase clostridium histolyticum injections for Peyronie's disease should be administered by a healthcare provider experienced in the treatment of male urological diseases and certified in the *Xiaflex Risk Evaluation and Mitigation Strategy (REMS) Program. A copy of the REMS certification must be attached to the claim.
Procedure code 54235 is considered an integral part of a doctor's medical care. Payment for the medical care performed on the same date of service includes the allowance for this procedure.
*Xiaflex Risk Evaluation and Mitigation Strategy (REMS) Program
REMS is a program 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. Auxilium has worked with the FDA to develop materials to communicate to healthcare providers and patients, the potential serious risks associated with use of Xiaflex.
Each indication has separate REMS requirements and educational material.
Xiaflex is available only through the Xiaflex Risk Evaluation and Mitigation Strategy (REMS) Program. Required components of the Xiaflex REMS Program include the following:
Collagenase clostridium histolyticum is not reimbursable under the prescription drug benefit.
Note: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Blue Cross Blue Shield of North Dakota may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.
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