Subject: Xiaflex 3043-A SGM P2020

Drug

XIAFLEX®  (collagenase clostridium histolyticum)

Policy:

 I.    INDICATIONS

       The indications below including FDA-approved indications and compendial uses are considered
       a covered benefit provided that all the approval criteria are met and the member has no
       exclusions to the prescribed therapy.

       FDA-Approved Indications
       A.  Xiaflex is indicated for the treatment of adult patients with Dupuytren’s contracture with a
            palpable cord. 
       B.  Xiaflex is indicated for the 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. 

       All other indications are considered experimental/investigational and not medically necessary.

II.   DOCUMENTATION

       Submission of the following information is necessary to initiate the prior authorization review:
       A.  Dupuytren’s contracture: Chart notes or medical record indicating the affected joint,
            contracture, and a positive table top test (for new starts and continuation) and the number
            of injections the member has received (for continuation only).
       B.  Peyronie’s disease: Chart notes or medical record indicating palpable plaque, curvature,
            intact erectile function (for new starts and continuation) and the number of injections the
            member has received (for continuation only).

III.  EXCLUSIONS

 

        Coverage will not be provided for cosmetic use (e.g., cellulite reduction treatment).

 
IV.  CRITERIA FOR INITIAL APPROVAL

        A.  Dupuytren’s contracture
             Authorization of 6 months may be granted for the treatment of Dupuytren’s contracture
             when all of the following criteria are met:     
             1.  The member has a finger flexion contracture with a palpable cord in a
                  metacarpophalangeal joint or a proximal interphalangeal joint prior to initiating Xiaflex
                  therapy.
             2.  The contracture is at least 20 degrees prior to initiating Xiaflex therapy.  
             3.  The member had a positive table top test, defined as the inability to simultaneously
                  place the affected finger(s) and palm flat against a table prior to initiating Xiaflex
                  therapy.
             4.  The member will receive a maximum of 3 injections per cord (4 weeks apart) as part of
                  the current treatment.

        B.  Peyronie’s disease  
             Authorization of 12 months may be granted for the treatment of Peyronie’s disease when
             the following criteria are met: 
             1.  The member has stable Peyronie’s disease without clinical changes (e.g., worsening
                  curvature) for at least three months.
             2.  The member has a palpable plaque and curvature deformity of at least 30 degrees and
                  less than 90 degrees prior to initiating Xiaflex therapy. 
             3.  The member has intact erectile function (with or without medication). 
             4.  The member is 18 years of age or older.
             5.  The member will receive a maximum of one treatment course with a maximum of 8
                  injections total, including any injections the patient has received for any previous
                  treatment.  

  IV.  CONTINUATION OF THERAPY  

         A.  Dupuytren’s contracture
              Authorization of 6 months may be granted for the continuation of treatment for
              Dupuytren’s contracture when all of the following criteria are met:     
              1.  The member meets all initial authorization criteria.
              2.  The member is continuing with a treatment course for the same cord. For treatment
                   of a new cord or a previously-treated cord following recurrence, member must meet
                   all initial authorization criteria.
              3.  The member has received less than 3 injections total per cord (4 weeks apart).

         B.  Peyronie’s disease  
              Authorization of 12 months may be granted for the continuation of treatment for
              Peyronie’s disease when all of the following criteria are met: 
              1.  The member meets all initial authorization criteria.
              2.  The member has curvature deformity of at least 15 degrees at the time of the
                   continuation request.
              3.  The member has received less than 8 injections total, including any injections the patient has received for any previous treatment.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Xiaflex [package insert]. Endo Pharmaceuticals Inc.; April 2021.
2. 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.
3. Nehra A, Alterowitz R, Culkin DJ, et al. Peyronie’s Disease: AUA Guideline. J Urol. 2015;194(3):745-753.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

September 27, 2021