Collagenase Clostridium Histolyticum (Xiaflex)
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.
The drug is not approved for any use not mentioned above
Patients must meet the following conditions:
- Diagnosis of Dupuytren's Contracture
- 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.
Diagnosis of Peyronie's disease diagnosed by a urologist (prescriber need not be urologist)
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)
- Initial approval to assess patient’s response.
- Renew for 2 more injections if contracture persists.
- Maximum treatment 3 injections per cord.
Western Health Advantage Pharmacy and Therapeutics Committee
Approved: September 2014 | Revised: July 2015
Last review date: July 20, 2016