Summary
Auxilium (and BioSpecifics Technologies) have finally received approval for release of XIAFLEX, the first FDA approved nonsurgical treatment for Dupuytren's Contracture. XIAFLEX is injected directly into the Dupuytren's cord and enzymatically disrupts the collagen. When successful, the contracture is released and range of motion is improved.
Analysis
XIAFLEX has been studied closely for the last 10 years and numerous articles have been published in peer review journals. The efficacy has been confirmed with excellent data reported.
This treatment is an alternative to open fasciectomy. Open fasciectomy is performed in a hospital or ambulatory surgery center, there is a large open incision, recovery is slow and prolonged, complications are not unusual and the disease still has a recurrence rate of about 50%. It is also an alternative to Needle Aponeurotomy, a minimally invasive technique developed in France, but is practiced by only a handful of Hand Surgeons in the US. There is no other drug competition at this time.
XIAFLEX can be performed in an office setting and is injected directly into a palpable cord. The hand recovers function quickly and the complication rate is very low (much lower than fasciectomy).
The Auxilium marketing team has been reaching to Hand Surgeons for over a year, getting them prepared and excited about the release. Now the marketing has begun for patients, many of which are already aware of the product through educational sites and bulletin boards. There are many patients afflicted with Dupuytren's Contracture who have held off having open fasciectomy and have been waiting for something better.
As of today, pricing has not been set. Distribution channels have been arranged, but the actual cost of the injections and amount of reimbursement to Hand Surgeons has not been disclosed. Also, so far, no specific CPT code is available for billing for the office procedure.
In conclusion, I believe this is a major advancement in the treatment of Dupuytren's Contracture and will allow a quicker recovery for patients.
