Xiaflex - BMC HealthNet Plan

more cord-like bands which causes the fingers, commonly the fourth and fifth, tocontract, curl and lose all flexibility. The etiology is unknown, but may be possiblyrelated to autoimmune dysfunction.The treatment options available are palliative therapies and the choice of therapy isdependent on the stage of the disease. Treatment options in the early stages of thedisease include topical vitamin A and E, physical therapy, and corticosteroid injection.For advanced stages, options include needle aponeurotomy and partial or completefasciectomy. Needle aponeuropathy has been the less invasive and more economicalalternative to fasciectomy. In needle aponeurotomy, a local anesthetic agent is applied tothe skin and a hypodermic needle is used to make a small incision to separate and cut thebands. This helps to improve the degree of finger extension. The rates of recurrence arehigh for all treatments except complete fasciectomy. Complete fasciectomy has thelowest recurrence rate, but carries the highest risk of severe complications such aspostoperative joint stiffness and loss of preoperative flexion.Xiaflex injection is an alternative treatment option approved by the FDA. Its FDAapprovedindication is for the treatment of adult patients with Dupuytren’s contracturewith palpable cords. It is composed of two microbial collagenases isolated and purifiedfrom Clostridium histolyticum bacteria. Similar to needle aponeurotomy, Xiaflextargets the cord-like band. Since the cord consists of collagen, injection of Xiaflex intothe cord results in lysis of the collagen deposits and subsequently the disruption of thecord in an enzymatic fashion rather than a mechanical one. Due to a high risk of seriousinjuries, such as tendon rupture or ligament damage, related to the injection technique, arisk evaluation and mitigation strategy (REMS) program is required by the FDA. Inaddition, the pharmaceutical company, Auxilium Pharmaceuticals Inc., makes Xiaflexavailable only through a special distribution and prescriber training program called“Xiaflex Xperience”.There are no head-to-head comparative studies of Xiaflex to needle aponeurotomyevaluating safety and effectiveness that support the choice of one treatment option overthe other. Current data suggests that both treatments are minimally invasive, carry asimilar adverse reaction/complication profile (e.g., nerve injuries, tendon injuries,infections) and can be administered in the outpatient setting by specialists. Comparisonof recurrence rates is not conclusive since they are largely dependent on the individualpatient’s disease state and post treatment care. At this time, needle aponeurotomy issignificantly less expensive than Xiaflex injection. Cost effectiveness studiescomparing these two treatments are not available.This guideline provides information on BMC HealthNet Plan clinical criteria and claims adjudication processing guidelines. Theuse of this guideline is not a guarantee of payment and will not determine how a specific claim(s) will be paid. Reimbursement isbased on member benefits and eligibility, medical necessity review, where applicable, coordination of benefits, adherence to Planpolicies, clinical coding criteria, and the BMC HealthNet Plan agreement with the rendering or dispensing provider.Reimbursement policies may be amended at BMC HealthNet Plan’s discretion. BMC HealthNet Plan will always use the mostrecent CPT and HCPCS coding guidelines. All Plan policies are developed in accordance with state, federal and accreditingorganization guidelines and requirements, including NCQA.This document is subject to further revision in response to additional terms and requirements imposed under the Integrated CareProgram, including the ICP contract.BMCHP refers to Boston Medical Center HealthNet Plan in Massachusetts and Well Sense Health Plan in New Hampshire.Boston Medical Center HealthNet Plan and Well Sense Health Plan are trade names used by Boston Medical Center Health Plan,Inc.BMC HealthNet Plan – Xiaflex2 of 5