Hyaluronan Derivatives
DESCRIPTION
Hyaluronan, also known as hyaluronic acid, is a naturally occurring glycosaminoglycan with viscoelastic properties. It is found throughout the body in the extracellular matrix of connective, epithelial and neural tissues, the umbilical cord and the aqueous and vitreous humors of the eye.
Hyaluronan derivatives for clinical use are known as hyaluronate sodium or sodium hyaluronate. They are highly purified viscoelastic solutions obtained from chicken combs or bacterial cells. Hyaluronan derivatives have been developed for use in surgery (opthalmic and cosmetic), topical applications for wound care and viscosupplementation (intra-articular injection).
Examples of hyaluronan derivatives for use in opthalmic surgery are Healon®, Healon5®, Healon GV® and ProVisc®.
An example of hyaluronan derivatives for topical use in wound care is Bionect®.
Examples of hyaluronan derivatives for viscosupplementation (intra-articular injection) are Euflexxa®, Hyalgan®, Orthovisc®, Supartz®, Synvisc® and Synvisc-One®.
REFER TO DECISION SUPPORT TREE
POLICY
Use of hyaluronan derivatives for the following is considered medically necessary:
Opthalmic surgery (e.g., cataract surgery, corneal transplant, glaucoma surgery, insertion of intraocular lens, surgery on anterior chamber, retinal detachment repair)
Topical conditions (e.g., wound care, including dermal ulcers)
Use of hyaluronan derivatives for viscosupplementation (intra-articular injection) is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Use of hyaluronan derivatives for the treatment of other conditions/diseases including, but not limited to the treatment of osteoarthritis of joints other than the knee is considered investigational.
Use of hyaluronan derivatives for the treatment of other conditions/diseases, including, but not limited to the treatment of facial wrinkles is considered cosmetic.
MEDICAL APPROPRIATENESS
Hyaluronan derivatives for viscosupplementation (intra-articular injection) is considered medically appropriate if ALL of the following criteria are met:
Documented diagnosis of osteoarthritis of the knee
Treatment is ANY ONE of the following:
Initial course of treatment with ALL of the following:
Knee pain interferes with functional activities (e.g., ambulation, prolonged standing, etc.)
Lack of functional improvement following a three month minimum trial of conservative nonpharmacological therapy including documentation of ALL the following:
Education
Support as indicated (e.g., assistive device, brace)
Physical therapy
Pain fails to respond adequately to simple analgesics, e.g., acetaminophen
Lack of functional improvement following a minimum three month trial of non-steroidal anti-inflammatory drug (NSAID) therapy, or the individual is unable to tolerate NSAID therapy
Trial of a minimum of one injection of a steroid agent into the affected knee(s) with ANY ONE of the following results:
Unsatisfactory pain relief
Pain relief lasting less than three months
Repeated course(s) of treatment if ALL of the following:
Significant pain relief was achieved with the initial/prior course of treatment
Initial/prior course of treatment has been completed for 6 months or longer
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).
A review of the published literature found no controlled studies that validate the use of hyaluronan derivatives in the treatment/prevention of any other conditions/diseases.
SOURCES
Abbott Medical Optics, Inc. (2010, November). Healon® sodium hyaluronate. Retrieved March 21, 2011 from http://www.amo-inc.com/pdf/Healon_DFU.pdf.
Abbott Medical Optics, Inc. (2010, November). Healon5® sodium hyaluronate. Retrieved March 21, 2011 from http://www.amo-inc.com/pdf/Healon5_DFU.pdf.
Abbott Medical Optics, Inc. (2010, November). HealonGV® sodium hyaluronate. Retrieved March 21, 2011 from http://www.amo-inc.com/pdf/HealonGV_DFU.pdf.
Alcon Laboratories, Inc. (2005, January). Provisc® (sodium hyaluronate) opthalmic viscosurgical device. Retrieved May 18, 2010 from http://ecatalog.alcon.com/pi/ProVisc_us_en.pdf.
BlueCross BlueShield Association. Medical Policy Reference Manual. (7:2009). Intra-articular Hyaluronan Injections for Osteoarthritis (2.01.31). Retrieved June 15, 2010 from BlueWeb.
DePuy Mitek, Inc. (2005, June). Orthovisc® high molecular weight hyaluronan. Retrieved May 18, 2010 from http://www.orthoviscline.com/sites/default/files/file/Orthovisc_Package_Insert.pdf.
Ferring Pharmaceuticals, Inc. (2010, September). Product information, Euflexxa® (1% sodium hyaluronate). Retrieved March 21, 2011 from http://www.euflexxa.com/files/euflexxa_physician.pdf.
Genzyme Biosurgery, a division of Genzyme Corp. (2010, January). SynviscOne® hylan G-F 20. Retrieved March 21, 2011 from http://www.synviscone.com/~/media/Files/SynviscOne/PI/Synvisc-OnePI-70240104.pdf.
Genzyme Biosurgery, a division of Genzyme Corp. (2010, March). Synvisc® hylan G-F 20. Retrieved March 21, 2011 from http://www.synviscone.com/~/media/Files/SynviscOne/PI/synvisc_PI.pdf.
JSJ Pharmaceuticals, Inc. (2008, July). Bionect® (hyaluronic acid sodium salt, 0.2%). Retrieved May 18, 2010 from http://www.bionect.com/images/bionect-pi.pdf.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2011). Hyaluronic acid. Retrieved March 21, 2011, from MICROMEDEX Healthcare Series.
Sanofi-Aventis U.S. LLC. (2009, January). Hyalgan® (sodium hyaluronate). Retrieved May 18, 2010 from http://products.sanofi-aventis.us/hyalgan/hyalgan.pdf.
Smith & Nephew, Inc. (2007, January). Supartz® (sodium hyaluronate). Retrieved May 18, 2010 from http://global.smith-nephew.com/us/patients/images/Clinical_Therapies/PackageInsert.pdf.
ORIGINAL EFFECTIVE DATE: 7/1998
MOST RECENT REVIEW DATE: 5/3/2011
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
Hyaluronan Derivatives (Bionect®, Euflexxa®, Healon®, Healon5®, Healon GV®, Hyalgan®, Orthovisc®, ProVisc®, Supartz®, Synvisc® and Synvisc-One®)
Is the requested medication being used to treat facial wrinkles?
If yes, this does not meet medical necessity and/or medical appropriateness criteria
If no, go to question #2
Does the individual have a diagnosis of osteoarthritis of the knee?
If yes, go to question #3
If no, this does not meet medical necessity and/or medical appropriateness criteria
Is this an initial request for treatment?
If yes, go to question #4
If no, go to question #5
Does the individual show evidence of ALL of the following?
Knee pain interferes with functional activities (e.g., ambulation, prolonged standing, etc.)
Lack of functional improvement following a three month minimum trial of conservative nonpharmacological therapy including documentation of ALL the following:
Education
Support as indicated (e.g., assistive device, brace)
Physical therapy
Pain fails to respond adequately to simple analgesics, e.g., acetaminophen
Lack of functional improvement following a minimum three month trial of non-steroidal anti-inflammatory drug (NSAID) therapy, or the individual is unable to tolerate NSAID therapy
Trial of a minimum of one injection of a steroid agent into the affected knee(s) with ANY ONE of the following results:
Unsatisfactory pain relief
Pain relief lasting less than three months
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, this does not meet medical necessity and/or medical appropriateness criteria
Has the individual had prior treatment with ALL the following results?
Significant pain relief was achieved with the prior course of treatment
Prior course of treatment has been completed for 6 months or longer
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.