Collagenase Clostridium Histolyticum
66887-0003-XX Xiaflex 0.9 MG SOLR (ENDO PHARMACEUTICALS)
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.
Collagenase clostridium histolyticum for the treatment of the following is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Collagenase clostridium histolyticum for the treatment of other conditions/diseases is considered investigational.
Collagenase clostridium histolyticum is considered medically appropriate if ANY ONE of the following:
Treatment of Dupuytren’s contracture if ALL of the following:
Individual is 18 years of age or older
Individual has a palpable cord
Documented flexion contracture of 20° to 100° in a metacarpophalangeal (MP) joint or 20° to 80° in a proximal interphalangeal (PIP) joint
Documentation of a positive “table top test” defined as the inability to simultaneously place the affected finger(s) and palm flat against a table top
Documentation that the flexion deformity results in functional limitations
Treatment of Peyronie’s disease if ALL of the following:
Individual is 18 years of age or older
Individual has a palpable plaque on penis
Individual has stable disease with penis curvature deformity of >30 degrees and < 90 degrees
Individual has intact erectile function (with or without use of medications)
Individual does not have isolated hourglass deformity or calcified plaque
The plaque(s) do not involve the penile urethra
Individual has Not exceeded 4 treatment cycles for each plaque causing the curvature deformity
Individual has Not received a collagenase injection for this condition within the past 6 weeks
Collagenase clostridium histolyticum is considered medically appropriate for renewal if ALL of the following criteria are met:
Individual continues to meet initial approval criteria
A diagnosis of ANY ONE of the following:
Dupuytren’s contracture if ALL of the following:
Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include the following: anaphylaxis and allergic reactions; abnormal coagulation; tendon ruptures or other serious injury to the injected extremity, etc.
Disease response as indicated by reduction in contracture of the selected primary joint compared to baseline
Individual has NOT exceeded 3 injections per joint
Peyronie’s disease if ALL of the following:
Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include the following: anaphylaxis and allergic reactions; abnormal coagulation; corporal rupture (penile fracture) or other serious injury to the penis, etc.
Disease response as indicated by improvement in penile curvature deformity
Further treatment is clinically indicated as the patient has penis curvature deformity of at least 15 degrees after the previous treatment cycle(s)
Individual has not exceeded 4 total treatment cycles for each plaque causing the curvature deformity
Individual has not received a collagenase injection for this condition within the past 6 weeks
|INDICATION(S)||DOSAGE & ADMINISTRATION|
Inject 0.58 mg into each palpable cord with a contracture of a metacarpophalangeal (MP) joint or a proximal interphalangeal (PIP) joint
· Up to two joints/cords in the same hand may be treated during a treatment visit. If a patient has other cords with contractures, those cords must be treated at another visit.
· May administer up to 3 injections total per cord at approximately 4-week intervals.
Each treatment cycle entails injection of 0.58 mg 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 total treatment cycles may be administered. Each treatment cycle may be repeated at approximately 6 week intervals.
If the curvature deformity is less than 15 degrees after the first, second or third treatment cycle, or if further treatment is not clinically indicated, then subsequent treatment cycles should not be administered
LENGTH OF AUTHORIZATION
Dupuytren’s contracture: Coverage will be for 3 months and is eligible for renewal for a maximum of 3 injections per joint/cord
Peyronie’s Disease: Coverage will be for 1 month and is eligible for renewal for a maximum of 4 total treatment cycles for each plaque causing the curvature deformity.
Refer to DOSAGE LIMITS below
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.
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.
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).
Bella AJ, Lee JC, Grober ED, et al. 2018 Canadian Urological Association guideline for Peyronie’s disease and congenital penile curvature. Can Urol Assoc J. 2018 May; 12(5): E197–E209.
BlueCross BlueShield Association. Medical Policy Reference Manual. (12:2017). Injectable clostridial collagenase for fibroproliferative disorders (5.01.19). Retrieved December 5, 2018 from BlueWeb.
Lexi-Comp Online. (2018). AHFS DI. Collagenase clostridium histolyticum. Retrieved December 5, 2018 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Evaluations. (2018, November). Collagenase. Retrieved December 5, 2018 from MICROMEDEX Healthcare Series.
Nehra A, Alterowitz R, Culkin DJ, et. al. Peyronie's Disease: AUA Guideline. J Urol. 2015 Sep;194(3):745-53. doi: 10.1016/j.juro.2015.05.098.
U. S. Food and Drug Administration. (2018, June). Center for Drug Evaluation and Research. Xiaflex® (collagenase clostridium histolyticum) for injection, for intralesional use. Retrieved December 5, 2018 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125338s102lbl.pdf.
ORIGINAL EFFECTIVE DATE: 8/14/2010
MOST RECENT REVIEW DATE: 4/2/2019
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.
This document has been classified as public information.
Maximum billable units per dose and over time by indication as a Medical Benefit 0.01 mg = 1 billable unit