Collagenase Clostridium Histolyticum for Dupuytren’s Contracture
DESCRIPTION
Dupuytren’s contracture is a thickening of the fibrous tissue layer underneath the skin of the palm and fingers. Small, usually painless, nodules develop in the connective tissue on the palm side of the hand. The nodules may thicken and contract, forming tough cord-like bands of tissue causing one or more fingers to flex toward the palm. Dupuytren's contracture usually progresses very slowly. It may never progress beyond lumps in the palm. In severe cases, it may become difficult or even impossible to extend the fingers. The ring finger is affected most often, followed by the little, middle, and index fingers.
Collagenase is an enzyme derived from the fermentation of Clostridium histolyticum. Clostridium histolyticum collagenase (i.e., Xiaflex™), a proteinase, hydrolyzes collagen resulting in lysis of collagen deposits. The goal of treatment with Xiaflex™ when injected directly into a Dupuytren’s cord is collagen disruption so the contracture may be reduced and range of motion may be improved.
Xiaflex™ should be administered by a healthcare provider experienced in injection procedures of the hand and in the treatment of Dupuytren’s contracture.
REFER TO DECISION SUPPORT TREE
POLICY
Clostridium histolyticum collagenase (i.e., Xiaflex™) for the treatment of Dupuytren’s contracture is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Clostridium histolyticum collagenase (i.e., Xiaflex™) for the treatment of other conditions/diseases is considered investigational.
MEDICAL APPROPRIATENESS
Clostridium histolyticum collagenase (i.e., Xiaflex™) for the treatment of Dupuytren’s contracture is considered medically appropriate if ALL of the following criteria are met:
The individual is 18 years of age or older
The contracture has a palpable cord
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
Tennessee State law requires coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is relative to life-threatening illnesses, such as cancer, AIDS, and coronary heart disease and recognized in one of the standard reference compendia (As defined in the statute: The United States Pharmacopoeia Drug Information, The American Medical Association Drug Evaluations, & The American Hospital Formulary Service Drug Information) or in the medical literature. This law is applicable to all fully insured members. The law is not applicable to self-funded accounts, but coverage for off-label uses may be provided based on the contractual agreement.
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
For appropriate dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., The American Hospital Formulary Service Drug Information).
SOURCES
American Society for Surgery of the Hand (ASSH). (2010, March). Dupuytren's Disease. Retrieved March 2, 2010 from http://www.assh.org/Public/HandConditions/Pages/Dupuytren'sDisease.aspx.
MICROMEDEX Healthcare Series. Drugdex Evaluations. (2010). Collagenase. Retrieved March 1, 2010 from MICROMEDEX Healthcare Series.
U. S. Food and Drug Administration. (2010, February). Center for Drug Evaluation and Research. BLA approval 125338/0. Retrieved March 1, 2010 from http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125338s000ltr.pdf.
U. S. Food and Drug Administration. (2010, February). Center for Drug Evaluation and Research. Medication guide Xiaflex™ (collagenase clostridium histolyticum). Retrieved March 1, 2010 from http://www.fda.gov/downloads/Drugs/DrugSafety/UCM200615.pdf.
U. S. Food and Drug Administration. (2010, February). Center for Drug Evaluation and Research. Xiaflex™ (collagenase clostridium histolyticum). Retrieved March 1, 2010 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125338lbl.pdf.
ORIGINAL EFFECTIVE DATE: 8/14/2010
MOST RECENT REVIEW DATE: 8/14/2010
ID_BT
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
Pharmaceutical Decision Support Tree
Collagenase Clostridium Histolyticum (Xiaflex™) for Dupuytren’s Contracture
Does the individual have a diagnosis of Dupuytren’s contracture and ALL of the following?
The individual is 18 years of age or older
The contracture has a palpable cord
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, this does not meet medical necessity and/or medical appropriateness criteria
This document has been classified as public information.