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Injectable Clostridial Collagenase for Fibroproliferative Disorders

Commercial Policy
Version Date: February 2022

Restricted Product(s):

  • collagenase clostridium histolyticum (Xiaflex® ) intralesional injection for administration by a healthcare professional

FDA Approved Use:

  • For treatment of adults with Dupuytren’s contracture with a palpable cord
  • *For treatment of adult men with Peyronie’s disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy

*Use of the restricted product for treatment of Peyronie’s disease may be considered a benefit exclusion for some benefit plans. Please refer to the Member’s Benefit Booklet for availability of benefits. Member's benefits may vary according to benefit design; therefore, member benefit language should be reviewed before applying the terms of this medical policy.

Criteria for Medical Necessity:

The restricted product(s) may be considered medically necessary when the following criteria are met:

  1. The patient has a diagnosis of Dupuytren’s contracture; AND
    1. The patient is 18 years of age or older; AND
    2. The patient has a palpable cord; AND
    3. The patient will NOT be receiving more than three injections at intervals of at least 30 days; AND
    4. The patient will NOT be receiving injections for more than two cords in the same hand at a single treatment visit; OR
  2. The patient has a diagnosis of Peyronie’s disease; AND
    1. The patient is 18 years of age or older; AND
    2. The patient has a palpable penile plaque; AND
    3. The patient has a penile curvature deformity of at least 30 degrees at the start of therapy; AND
    4. The patient has NOT received previous treatment courses** with the requested agent for the same penile plaque; AND
    5. The patient will NOT receive more than one full treatment course (8 injections total) for each plaque causing curvature deformity**.

**Two injections and one penile modeling procedure are considered one treatment cycle, and four cycles (total of 8 injections and 4 penile modeling procedures) are considered one full treatment course for each plaque causing curvature deformity.

Duration of Approval:

Dupuytren’s contracture: 90 days (3 visits)

Peyronie’s disease: 180 days (8 injections or 4 treatment cycles; 8 visits) **maximum of four cycles (8 injections) total from initiation

FDA Label Reference

MedicationIndicationDosingHCPCSMaximum Units*
collagenase clostridium histolyticum (Xiaflex®)
intralesional injection		Dupuytren’s contracture in patients ≥18 years oldInject 0.58 mg into each palpable cord with a contracture of a metacarpophalangeal joint or a proximal interphalangeal joint; up to 2 joints in same hand may be treated during a treatment visit; injections may be given up to 3 times per cord at ~4 week intervalsJ07753 visits
Peyronie’s disease in patients ≥18 years oldOne treatment cycle is two 0.58 mg injections into the target plaque (1-3 days apart) and 1 penile modeling procedure (1-3 days after 2nd injection); one treatment course is up to 4 cycles (total of 8 injections and 4 penile modeling procedures) for each plaque causing curvature deformity, with each cycle repeated at ~6 week intervals8 visits**

*Maximum units/visits allowed for duration of approval

**Approval is ONLY up to a maximum of 8 injections for each plaque

References:

All information referenced is from FDA package insert unless otherwise noted below.

  1. Bainbridge C, Gerber RA, Szczypa PP, et al. Efficacy of collagenase in patients who did and did not have previous hand surgery for Dupuytren's contracture. J Plast Surg Hand Surg. 2012 Sep;46(3-4):177-83.
  2. Coleman S, Gilpin D, Tursi J, et al. Multiple concurrent collagenase clostridium histolyticum injections to Dupuytren's cords: an exploratory study. BMC Musculoskelet Disord. 2012 Apr 27;13:61.
  3. Gelbard M, Goldstein I, Hellstrom WJ, et al. Clinical efficacy, safety and tolerability of collagenase clostridium histolyticum for the treatment of peyronie disease in 2 large double-blind, randomized, placebo controlled phase 3 studies. J Urol. 2013; 190(1):199-207.
  4. Nehra A, Alterowitz R, Culkin DJ, et al. American Urological Association Education and Research, Inc. Peyronie's Disease: AUA Guideline. J Urol. 2015 Sep;194(3):745-53.
  5. Peimer CA, Blazar P, Coleman S, et al. Dupuytren contracture recurrence following treatment with collagenase clostridium histolyticum (CORDLESS study): 3-year data. J Hand Surg Am. 2013;38(1):12-22.
  6. Russo GI, Cacciamani G, Cocci A, et al. EAU-YAU Men’s Health Working Group. Comparative Effectiveness of Intralesional Therapy for Peyronie's Disease in Controlled Clinical Studies: A Systematic Review and Network Meta-Analysis. J Sex Med. 2019 Feb;16(2):289-299.
  7. 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.

Policy Implementation/Update Information:

February 2022: Criteria change: Removed continuation criteria for Peyronie’s disease and adjusted approval to a maximum of 8 injections (8 visits) total from initiation for each plaque.

January 2022: Criteria update: Adjusted number of visits for Peyronie’s disease duration of approval for initial and continuation for clarity with no change to policy intent.

June 2021: Criteria change: Added continuation criteria with no change to policy intent; added maximum units; medical policy formatting change. Policy notification given 4/16/2021 for effective date 6/16/2021.

*Further historical criteria changes and updates available upon request from Medical Policy and/or Corporate Pharmacy.

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