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INDEX:
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

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


Background

Dupuytren’s contracture initially can be managed with observation and non-surgical therapy.  It will regress without treatment in about 10% of patients.  Injection of steroids into the nodule has been shown to reduce the need for surgery.  Surgical referral should be made when metacarpophalangeal (MCP) joint contracture reaches 30 degrees or when proximal interphalangeal (PIP) joint contracture occurs at any degree.  In-office percutaneous needle aponeurotomy is an alternative to surgery (Trojian and Chu, 2007).

Swartz and Lalonde (2008) stated that treatment of Dupuytren`s disease is offered to symptomatic patients with painful nodular or disabling contracture.  Limited fasciectomy of the involved abnormal structures followed by hand therapy is standard treatment, but it is associated with serious potential complications.  Moreover, recurrence is common.  New treatments include the injection of clostridial collagenase, which works by breaking down the excessive build-up of collagen in the hand.

In a phase II open-label clinical trial, Badalamente and Hurst (2000) examined the clinical safety and effectiveness of clostridial collagenase injection as a non-surgical treatment of Dupuytren`s disease.  A total of 35 patients entered the study (3 women and 32 men).  The mean age was 65 years.  The first 6 patients were treated following a dose escalation protocol and received 300, 600, 1200, 2400, 4800, and 9600 units (U) collagenase injected into the cord that was causing contracture of the MCP joint.  There were no beneficial clinical effects of these injections.  The remaining 29 patients had collagenase injections at a dose level of 10,000 U into cords that are causing contractures of 34 MCP joints, 9 PIP joints, and 1 thumb.  Twenty-eight of the 34 MCP joint contractures corrected to normal extension (0 degrees) and 2 of the 34 MCP joint contractures corrected to 5 degrees of normal extension, with full range of motion, within 1 to 14 days of injection.  In patients with PIP joint contractures, 4 of the 9 joints corrected to normal (0 degrees).  One PIP joint corrected to within 10 degrees of normal and 2 corrected to within 15 degrees of normal.  There were 2 failures; these patients required surgery.  The mean follow-up period was 20.0 +/- 5.6 months for the MCP joints and 14.1 +/- 6.6 months for the PIP joints.  Clostridial collagenase injection of Dupuytren`s cords causing MCP and PIP joint contractures appears to have merit as non-surgical treatment of this disorder.  The authors stated that pending further placebo, double-blind studies, collagenase injection to treat Dupuytren`s disease may be a safe and effective alternative to surgical fasciectomy.

Badalamente et al (2002) reported that in a series of controlled phase II clinical trials, excessive collagen deposition in Dupuytren`s disease has been targeted by a unique non-operative method using clostridial collagenase injection therapy to lyse and rupture finger cords causing MCP and/or PIP joint contractures.  A total of 49 patients were treated in a random, placebo-controlled trial of one dose of collagenase versus placebo at 1 center.  Subsequently 80 patients were treated in a random, placebo-controlled, dose-response study of collagenase at 2 test centers.  The results of these studies indicated that non-operative collagenase injection therapy for Dupuytren`s disease is both a safe and effective method of treating this disorder in the majority of patients as an alternative to surgical fasciectomy.

In a prospective, randomized, double-blind, placebo-controlled, multi-center study, Hurst et al (2009) examined the effects of injectable collagenase clostridium histolyticum for the treatment of Dupuytren`s contracture.  These investigators enrolled 308 patients with joint contractures of 20 degrees or more.  The primary MCP or PIP joints of these patients were randomly assigned to receive up to 3 injections of collagenase clostridium histolyticum (at a dose of 0.58 mg per injection) or placebo in the contracted collagen cord at 30-day intervals.  One day after injection, the joints were manipulated. The primary end point was a reduction in contracture to 0 to 5 degrees of full extension 30 days after the last injection.  Twenty-six secondary end points were evaluated, and data on adverse events were collected.  Collagenase treatment significantly improved outcomes.  More cords that were injected with collagenase than cords injected with placebo met the primary end point (64.0 % versus 6.8 %, p < 0.001), as well as all secondary end points (p < or = 0.002).  Overall, the range of motion in the joints was significantly improved after injection with collagenase as compared with placebo (from 43.9 to 80.7 degrees versus from 45.3 to 49.5 degrees, p < 0.001).  The most commonly reported adverse events were localized swelling, pain, bruising, pruritus, and transient regional lymph-node enlargement and tenderness.  Three treatment-related serious adverse events were reported: 2 tendon ruptures and 1 case of complex regional pain syndrome.  No significant changes in flexion or grip strength, no systemic allergic reactions, and no nerve injuries were observed.  The authors concluded that collagenase clostridium histolyticum injection significantly reduced contractures and improved the range of motion in joints affected by advanced Dupuytren`s disease.


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.
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