Prior Auth Protocol

FDA Approved Indications:

Treatment of adult patients with Dupuytren's contracture with a palpable cord
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

Health Net Approved Indications and Usage Guidelines:

OR

Diagnosis of Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy

Coverage is Not Authorized For:

Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature.

General Information:

Dupuytren's contracture is a relatively common disorder characterized by progressive fibrosis of the palmar fascia. Joint stiffness and a loss of full extension develop insidiously over decades. As the scarring process progresses, nodules form on the palmar fascia and the finger gradually loses its flexibility, with contractures that typically affect the metacarpophalangeal (MP) joint, the proximal interphalangeal joint (PIP), or both, resulting in impaired hand function and deformity.
Xiaflex should be administered by a healthcare provider experienced in injection procedures of the hand and in the treatment of patients with Dupuytren's contracture.
A Risk Evaluation and Mitigation Strategy (REMS) is a strategy to manage known or potential serious risks associated with a drug and is required by the Food and Drug Administration to ensure that the benefits of the drug outweigh its risks. In order for Auxilium to communicate certain risks to ensure that Xiaflex is injected properly, Auxilium has worked with the FDA to develop materials to communicate the risks of tendon rupture and hypersensitivity reactions. Contact www.XIAFLEXREMS.com or call 1-877-942-3539.
Xiaflex is only available through a managed distribution program called Xiaflex Xperience. Under this program only enrolled qualified healthcare professionals may have access to Xiaflex; and only enrolled healthcare sites may receive Xiaflex orders.

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
pentoxifylline (Trental)	400 PO BID	400 PO BID

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Xiaflex	Dupuytren's contracture Inject 0.58 mg into a palpable Dupuytren's cord with a contracture of a metacarpophalangeal (MP) joint or a proximal interphalangeal (PIP) joint. Up to two injections in the same hand may be administered during a treatment visit. Injections and finger extension procedures may be administered at approximately 4-week intervals up to a maximum of 3 times per cord. Peyronie's disease Inject 0.58 mg XIAFLEX into the target plaque once on each of two days, 1 to 3 days apart. Perform a penile modeling procedure 1 to 3 days after the second injection of each treatment cycle. For each plaque causing the curvature deformity, up to four treatment cycles may be administered. Each treatment cycle may be repeated at approximately six-week intervals.	Dupuytren's contracture 6 months or to member's renewal period, whichever is sooner. Peyronie's disease 6 months or to member's renewal period, whichever is sooner.

Product Availability:

Single-use, glass vial: containing 0.9 mg of collagenase clostridium histolyticum

References:

Xiaflex [package insert.] Chesterbrook, PA: Auxilium Pharmaceuticals, Inc; October 2014.
DRUGDEX^R System [Internet database]. Greenwood Village, CO. Thompson Healthcare. Updated periodically. Accessed July 22, 2013.