Subject: Xiaflex 3043-A SGM P2022

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 tabletop 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. PRESCRIBER SPECIALTIES 

A.   Dupuytren’s contracture: The medication must administered by a healthcare provider experienced in injection procedures of the hand
      and in the treatment of Dupuytren’s contracture.
B.   Peyronie’s disease: The medication must be administered by a healthcare provider experienced in the treatment of urological disease and
      who has completed the Xiaflex REMS program requirements. 

IV.  EXCLUSIONS 

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

V.   CRITERIA FOR INITIAL APPROVAL

A.   Dupuytren’s contracture^1,2
      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 tabletop 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^1,3
      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.

VI.  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]. Malvern, PA: Endo Pharmaceuticals Inc.; August 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.

November 21, 2022