BlueCross BlueShield of Tennessee Medical Policy Manual

Collagenase Clostridium Histolyticum

NDC CODE(S)

66887-0003-xx Xiaflex 0.9mg powder for injection (Auxilium Pharmaceuticals)

DESCRIPTION

Collagenases are types of proteases, enzymes which break down or degrade proteins.  In the human body, collagenases play important roles in normal tissue remodeling through collagen degradation, matrix breakdown and bone remodeling as well as in some pathological processes such as osteoarthritis. Collagenases are not unique to humans and are produced by other organisms including the gram-positive bacterium Clostridium histolyticum, a primary pathogen in gas gangrene and other pathologic processes. Clostridium histolyticum naturally produces ammonia and proteases, including several collagenases, which it uses to externally digest proteins into amino acids on which it feeds.  Two microbial collagenases have been isolated and purified from the fermentation of Clostridium histolyticum for clinical use.  The product, used to degrade collagen, is referred to as collagenase clostridium histolyticum.  Examples of conditions which may benefit from such collagen degradation are Dupuytren’s contracture and Peyronie’s disease.

Dupuytren’s contracture is a fibrosing disease in which the normal bands of collagen tissue that form the palmar fascia and ligaments of the fingers develop nodules which progressively increase in size.  These nodules eventually develop into shortened fascial bands which become thickened cords extending up the digits causing contractures which draw one or more of the fingers into flexion.  Surgical reduction of the cords has been the primary treatment for these contractures, however the injection of collagenase clostridium histolyticum into the thickened cords by an experienced healthcare provider skilled in injection procedures of the hand has been found to provide lysis of the collagen deposits and substantial improvement in the contractures.

Peyronie’s disease is a condition of the penis where a flat plaque of localized inflammation, possibly from trauma, forms on the top or bottom side of the penis.  The plaque, consisting of fibrotic collagen with reduced elasticity, develops into excessive scar tissue and calcification inside the tunica albuginea, the thick membrane enveloping erectile tissue.  In severe cases, penile flexibility is greatly decreased causing pain and forcing the penis to bend or arc when erect.  Severe pain and emotional distress may prohibit sexual intercourse.  Up to 30% of men with Peyronie’s disease also develop hardened tissue in other parts of the body, including Dupuytren’s contracture of the hand.  Some researchers theorize that Peyronie’s disease, as well as Dupuytren’s contracture, may be autoimmune conditions.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S) DOSAGE & ADMINISTRATION
Dupuytren’s contracture Up to 0.58mg per injection every 4 weeks for a total of 3 doses per cord. Up to two joints in the same hand may be treated during a treatment visit.
Peyronie’s Disease Inject 0.58mg into the target plaque once on each of two days, 1 to 3 days apart, according to the injection procedure. For each plaque causing the curvature deformity, up to four treatment cycles may be administered. Each treatment cycle may be repeated at approximately 6 week intervals.

APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS

BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.

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 chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).

No controlled studies were found in the published literature that validate the use of collagenase clostridium histolyticum for the treatment of other conditions or diseases.

SOURCES

BlueCross BlueShield Association. Medical Policy Reference Manual. (10:2016). Injectable clostridial collagenase for fibroproliferative disorders (5.01.19). Retrieved October 24, 2016 from BlueWeb.

Lexi-Comp Online. (2016). AHFS DI. Collagenase clostridium histolyticum. Retrieved October 24, 2016 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2016, September). Collagenase. Retrieved October 24, 2016 from MICROMEDEX Healthcare Series.

U. S. Food and Drug Administration. (2016, September). Center for Drug Evaluation and Research. Xiaflex® (collagenase clostridium histolyticum) for injection, for intralesional use. Retrieved October, 24 2016 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125338s102lbl.pdf.

ORIGINAL EFFECTIVE DATE:  8/14/2010

MOST RECENT REVIEW DATE:  2/27/2018

ID_MRx

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®)

  1. Is this the initial request for this agent?

If yes, go to question #2

If no, go to question #6

  1. Does the individual have a Dupuytren’s contracture and ALL of the following?

If yes, go to question #4

If no, go to question #3

  1. Does the individual have a diagnosis of Peyronie’s disease and ALL of the following:

If yes, go to question #5

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the request for 180 billable units every 28 days for Dupuytren’s contracture for dosage of up to 0.58mg per injection every 4 weeks for a total of 3 doses per cord with up to two joints in the same hand treated during a treatment visit for an authorization period of 3 months with eligibility of renewal for a maximum of 3 injections per joint?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the request for 180 billable units every 42 days for Peyronie’s disease for dosage of 0.58 in the target plaque once on each of two days, 1 to 3 days apart, with up to four treatment cycles for each plaque causing the curvature deformity and each treatment cycle may be repeated at approximately 6 week intervals for an authorization period maximum of 4 treatment cycles for each plaque causing the curvature deformity?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the request for a diagnosis of Dupuytren’s contracture with ALL of the following?

If yes, go to question #8

If no, go to question #7

  1. Is the request for a diagnosis of Peyronie’s disease with ALL of the following?

If yes, go to question #8

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is there absence of unacceptable toxicity from the agent including anaphylaxis and allergic reactions; excessive injection site hemorrhage; tendon ruptures or other serious injury to the injected extremity; corporal rupture (penile fracture) or other serious injury to the penis?

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.