Xiaflex - BMC HealthNet Plan

BMCHP.ORG1-888-566-0008CLINICAL COVERAGE GUIDELINES – XiaflexWELLSENSE.ORGBMCHP refers to Boston Medical Center HealthNet Plan in Massachusetts and WellSense Health Plan in New Hampshire. Boston Medical Center HealthNet Plan andWell Sense Health Plan are trade names used by Boston Medical Center Health Plan,Inc.Policy ApplicabilityBoston Medical Center HealthNet Plan Well Sense Health PlanMassHealthNew Hampshire MedicaidCommonwealth CareCommercialIntegrated Care ProgramEffective Date: 07/01/2013Policy Number: 9.169Policy Effective Date: 05/13/2010Last Review Date: 03/14/2013Approved by: Pharmacy and Therapeutics CommitteePolicy Owner/Title: Pharmacy ServicesSummary:BMC HealthNet Plan will authorize coverage of Xiaflex when appropriate criteria aremet.Description of Item or Service:Dupuytren’s contracture is a chronic, progressive and recurrent disease that affects thehands. Its symptoms are due to fibrosis and collagen deposition with palmar fascialthickening. Nodules form in the connective tissues initially and may develop into one orThis 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 – Xiaflex1 of 5

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

The recommended Xiaflex dose is 0.58mg up to three injections per cord with 4 weeksbetween each injection if no improvement is shown after the first shot.Clinical Guideline Statement:BMC HealthNet Plan may authorize coverage of Xiaflex for members meeting thefollowing clinical criteria:Prior Authorization – (Duration of Approval – Maximum of 1 year)A prior authorization request will be required for all prescriptions for Xiaflex. Theserequests will be approved when the following criteria are met:1. A diagnosis of Dupuytren’s contracture with palpable cords that significantlyimpairs daily function; AND2. A contraindication, treatment failure, or intolerance to a trial of alternativetreatments appropriate for the member’s clinical condition and disease state; AND3. The member is at least 18 years of age.Applicable CodingCodeJ0775Limitations:Medicationcollagenase clostridium histolyticumBMC HealthNet Plan will not approve coverage of Xiaflex in the following instances:1. When the above criteria are not met.Clinical Background Information and References:1. Product Information. Xiaflex (collagenase clostridium histolyticum). AuxiliumPharmaceuticals, Inc. Malvern, PA 19355. February 2010.2. Eric Brodsky, MD. FDA Perspective- Xiaflex for Advanced Dupuytren’sDisease. Available atThis 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 – Xiaflex3 of 5

http://www.dupuytrenfoundation.org/DupPDFs/2009_FDA.pdf Accessed April14, 20103. Robert P Sheon, MD, Bruce C Anderson, MD. Dupuytren’s Contracture. Up toDate online. Accessed April 14, 2010.4. Ghazi M. Rayan, MD. Dupuytren Disease: Anatomy, Pathology, Presentation,and Treatment. The Journal of Bone and Joint Surgery (American). 2007;89:189-198. Accessed April 14, 2010.5. Lawrence C. Hurst, M.D., etc. Injectable Collagenase Clostridium Histolyticumfor Dupuytren's Contracture. The New England Journal of Medicine. 2009;Volume 361:968-979Policy History:Effective Date: 05/13/2010Date of Review/Revision05/12/2011 – P&T Annual Review, no changes required07/14/2011 – policy applied to Commercial03/08/2012 – P&T Annual Review, no changes requiredLast Review Date: 03/14/2013 – P&T annual review, no changes requiredNext Review Date: 03/13/2014Approval DatesRegulatory Approval: N/AInternal Approval:Initial approval by Pharmacy & Therapeutics Committee – 05/13/2010Authorizing entityN/AIMPORTANT NOTES:‣ Not all services are covered for all products or employer groups. This medical policyexpresses the Plan's determination of whether certain services or supplies are medicallynecessary, experimental or investigational or cosmetic. The Plan has reached theseconclusions based upon the regulatory status of the technology and a review of clinicalstudies published in peer-reviewed medical literature. Even though this policy mayThis 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 – Xiaflex4 of 5

indicate that a particular service or supply is considered covered or not covered, thisconclusion is not based upon the terms of a member’s particular benefit plan. Eachbenefit plan contains its own specific provisions for coverage and exclusions. Not allservices that are determined to be medically necessary will necessarily be coveredservices under the terms of a member’s benefit plan. Members and their providers needto consult the applicable benefit plan document (e.g., Evidence of Coverage) todetermine if there are any exclusions or other benefit limitations applicable to this serviceor supply. If there is a discrepancy between this medical policy and the benefit plandocument, the provisions of the benefit plan document will govern. In addition, this policyand the benefit plan document are subject to applicable state and federal laws that maymandate coverage for certain services and supplies.‣ To the extent applicable, this Policy and/or Procedure applies to BMCHP subcontractorsand downstream entities, if any, providing services with respect to BMCHP’s IntegratedCare Program.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 – Xiaflex5 of 5