Medical Policy
Effective Date:08/01/2011 Title:Xiaflex (Collagenase Clostridium Histolyticum)
Revision Date:10/01/2019 Document:BI300:00
CPT Code(s):J0775
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

  1. Xiaflex is covered only for the treatment of Dupuytren’s contracture.
  2. Dupuytren`s contracture, a progressive fibro-proliferative disorder, is characterized by nodule formation and contracture of the palmar fascia, and may result in flexion deformity of the fingers and loss of hand function.  The disease is common in men older than 40 years; and in persons who smoke, use alcohol, or have diabetes mellitus.  The symptoms of Dupuytren`s contracture are often mild and painless and do not require treatment. In some patients, however, it may progress to the next stage, in which cords of fibrous tissue form in the palm and run into the fingers or thumb, eventually, pulling them into a permanently flexed position, making it difficult to perform activities of daily living. 

3. Xiaflex requires prior authorization for diagnosis of Peyronie’s Disease (PD).
Medical Statement
  1. Collagenase clostridium histolyticum (Xiaflex) injections are considered medically necessary for the treatment of adults with Dupuytren`s contracture with a palpable cord.
  2. .   Xiaflex for the treatment of Peyronie’s disease requires prior authorization and is covered when all of the following criteria are met:

-       Diagnosis of PD with both a palpable plaque and curvature deformity of ≥ 30 degrees at the start of therapy;

-        Prescribed by or in consultation with a healthcare provider experienced in the treatment of male urological diseases;

-        Age ≥ 18 years;

-       Dose does not exceed 0.58 mg per injection (one vial per injection).

-       Approval duration: 3 months (up to 2 injections)

Request for continuation of Xiaflex for Peyronie’s disease require all of the following criteria:

1.    Member has previously met initial approval criteria;

2.    There is documented curvature deformity of ≥15 degrees remaining since last treatment cycle;

3.    Last treatment cycle was ≥ 6 weeks ago.

4.     Member has received < 4 treatment cycles (i.e. < 8 injections [2 injections per cycle]);

5.     If request is for a dose increase, new dose does not exceed 0.58 mg per injection (one vial per injection). Approval duration: 3 months (up to 2 injections)

Codes Used In This BI:

J0775 Collagenase, clost hist inj

Addendum:

1.    Effective 01/10/2019: Xiaflex is covered with prior authorization for diagnosis of Peyronie’s disease
Limits
Intentially left empty
Reference
  1. Badalamente MA, Hurst LC. Enzyme injection as nonsurgical treatment of Dupuytren`s disease. J Hand Surg Am. 2000;25(4):629-636.
  2. Badalamente MA, Hurst LC, Hentz VR. Collagen as a clinical target: Nonoperative treatment of Dupuytren`s disease. J Hand Surg Am. 2002;27(5):788-798.
  3. National Institute for Clinical Excellence (NICE). Needle fasciotomy for Dupuytren’s contracture. Interventional Procedure Guidance 43. London, UK: NICE; February 2004.
  4. Trojian TH, Chu SM. Dupuytren`s disease: diagnosis and treatment. Am Fam Physician. 2007;76(1):86-89.
  5. Swartz WM, Lalonde DH. MOC-PS(SM) CME article: Dupuytren`s disease. Plast Reconstr Surg. 2008;121(4 Suppl):1-10.
  6. 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):180-187.
  7. Hurst LC, Badalamente MA, Hentz VR, et al. Injectable collagenase clostridium histolyticum for Dupuytren`s contracture. N Engl J Med. 2009;361(10):968-979.
  8. U.S. Food and Drug Administration. FDA approves Xiaflex for debilitating hand condition. FDA News. Silver Spring, MD; FDA; February 2, 2010. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm199736.htm. Accessed Mar. 23 2011.
  9. Auxilium Pharmaceuticals, Inc. Xiaflex (collagenase clostridium histolyticum). Prescribing Information. Malvern, PA; Auxilium; February, 2010. Available at: http://www.xiaflex.com/docs/pi_medguide_combo.pdf. Accessed Mar. 23 2011.
  10. Keilholz L, Seegenschmiedt MH, Sauer R. Radiotherapy for prevention of disease progression in early-stage Dupuytren`s contracture: Initial and long-term results. Int J Radiat Oncol Biol Phys. 1996;36(4):891-897.
  11. Seegenschmiedt MH, Olschewski T, Guntrum F. Radiotherapy optimization in early-stage Dupuytren`s contracture: First results of a randomized clinical study. Int J Radiat Oncol Biol Phys. 2001;49(3):785-798.
  12. Foucher G, Medina J, Navarro R. Percutaneous needle aponeurotomy: Complications and results. J Hand Surg Br. 2003;28(5):427-431.
  13. Trojian TH, Chu SM. Dupuytren`s disease: Diagnosis and treatment. Am Fam Physician. 2007;76(1):86-89.
  14. Cheng HS, Hung LK, Tse WL, Ho PC. Needle aponeurotomy for Dupuytren`s contracture. J Orthop Surg (Hong Kong). 2008;16(1):88-90.
  15. Lellouche H. Dupuytren`s contracture: Surgery is no longer necessary. Presse Med. 2008;37(12):1779-1781.
  16. Oxfordshire NHS Trust. Surgery for Dupuytren’s contracture. Interim Treatment Threshold Statement. Priorities Forum Policy Statement. Oxford, UK: NHS; October 15, 2009.
  17. Betz N, Ott OJ, Adamietz B, et al. Radiotherapy in early-stage Dupuytren`s contracture. Long-term results after 13 years. Strahlenther Onkol. 2010;186(2):82-90.
  18. Manet MP, Roulot E, Teyssedou JP, et al. Dupuytren`s contracture: Needle aponeurotomy is an alternative to surgery. Rev Med Interne. 2010 Sep 7. [Epub ahead of print]
  19. National Institute for Health and Clinical Excellence (NICE). Radiation therapy for early Dupuytren’s disease. Interventional Procedure Guidance 368. London, UK: NICE; November 2010.
Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.