Collagenase Clostridium Histolyticum (Xiaflex)

OFFICE ADMINISTRATION

Indications for Prior Authorization:

  • Dupuytren's contracture (hand) in Adults
  • Peyronie's Disease

Patients must meet the following criteria for the indications above:

  • Patient must have a palpable cord

Dupuytren's Contracture

  • Diagnosis of Dupuytren's Contracture AND
  • Have at least one finger (not thumb) flexion contracture with a palpable cord of 20 to 100 degrees in the metatarsophalangeal joint (MP) or a proximal interphalageal (PIP) joint

Peyronie's Disease

  • Diagnosis of Peyronie's disease diagnosed by a urologist (prescriber need not be urologist)

The drug is not approved for any use not mentioned above:

  • Any condition not listed above as an approved condition

Dosing:

  • Xiaflex must be administered by a healthcare provider experienced in injection procedures of the hand

Dupuytren's Contracture

  • The dose of Xiaflex is 0.58 mg per injection into a palpable cord with a contracture of a metacarpophalangeal (MP) joint or a proximal interphalangeal (PIP) joint
  • Approximately 24 hours after injection, perform a finger extension procedure to facilitate cord disruption
  • Four weeks after the initial injection and finger extension, if a MP or PIP contracture remains, the cord may be re-injected with a single dose of 0.58 mg. Repeat finger extension in 24 hours
  • Injections and finger extension procedures may be administered up to 3 times per cord at approximately 4-week intervals

Peyronie’s Disease

  • Up to 2 injections of 0.58 mg injected into target plaque, administered 1 to 3 days apart
  • For each plaque causing the curvature deformity, up to four treatment cycles may be administered
  • Each treatment cycle consists of two injections given at six-week intervals for up to four cycles (maximum of 8 injections per plaque for the entire treatment course)

Approval:

  • Initial approval to assess patient’s response
  • Renew for 2 more injections if contracture persists
  • Maximum treatment 3 injections per cord

 

Last review date: July 20, 2016