BlueCross BlueShield of Tennessee Medical Policy Manual

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 (ophthalmic and cosmetic), topical applications for wound care and viscosupplementation (intra-articular injection).

Examples of hyaluronan derivatives for use in ophthalmic surgery are Healon®, 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®, Gel-One®, Hyalgan®, Monovisc®, Orthovisc®, Supartz®, Synvisc® and Synvisc-One®.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

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 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).

No controlled studies were found in the published literature that validate the use of hyaluronan derivatives in the treatment/prevention of any other conditions/diseases or in the treatment of osteoarthritis in joints other than the knee.

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.

Alcon Laboratories, Inc. (2005, January). Provisc® (sodium hyaluronate) ophthalmic viscosurgical device. Retrieved May 18, 2010 from http://ecatalog.alcon.com/pi/ProVisc_us_en.pdf.

Bioventus, LLC. (2012, June). Supartz® (sodium hyaluronate). Retrieved April 30, 2014 from http://www.mykneeandme.com/MyKneeDocs/PackageInsert.pdf.

BlueCross BlueShield Association. Medical Policy Reference Manual. (9:2013). Intra-articular hyaluronan injections for osteoarthritis (2.01.31). Retrieved April 30, 2014 from BlueWeb.

Ferring Pharmaceuticals, Inc. (2011, September). Product information, Euflexxa® (1% sodium hyaluronate). Retrieved April 30, 2014 from http://www.euflexxa.com/assets/euflexxa_physician-f87c5c8e9b6f9317c6cfd0b7df1b48c6.pdf.

Genzyme Biosurgery, a division of Genzyme Corp. (2010, January). SynviscOne® hylan G-F 20. Retrieved April 30, 2014 from http://synviscone.com/~/media/SynviscOneUS/Files/Synvisc-OnePI-70240104.pdf.

Genzyme Biosurgery, a division of Genzyme Corp. (2010, March). Synvisc® hylan G-F 20. Retrieved April 30, 2014 from http://www.synvisconehcp.com/media/pdf/synvisc_PI.pdf.

JSJ Pharmaceuticals, Inc. (2012, February). Bionect® (hyaluronic acid sodium salt, 0.2%). Retrieved October 12, 2012 from  http://bionect.com/new/wp-content/uploads/2012/08/bionect-pi_0612.pdf.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2014, April). Hyaluronic acid. Retrieved March 21, 2011, from MICROMEDEX Healthcare Series.  

Sanofi-Aventis U.S. LLC. (2009, January). Hyalgan® (sodium hyaluronate). Retrieved April 30, 2014 from http://products.sanofi.us/hyalgan/hyalgan.pdf.

U. S. Food and Drug Administration (2011, March). Center for Devices and Radiological Health. Gel-One® package insert. Retrieved October 12, 2012 from http://www.accessdata.fda.gov/cdrh_docs/pdf8/P080020c.pdf.

U. S. Food and Drug Administration (2014, February). Center for Devices and Radiological Health. Information for prescribers: Monovisc™ high molecular weight hyaluronan. Retrieved April 30, 2014 from http://www.accessdata.fda.gov/cdrh_docs/pdf9/P090031c.pdf.

U. S. Food and Drug Administration (2004, February). Center for Devices and Radiological Health. Orthovisc® high molecular weight hyaluronan. Retrieved April 30, 2014 from http://www.accessdata.fda.gov/cdrh_docs/pdf3/P030019c.pdf.

ORIGINAL EFFECTIVE DATE:  7/1998

MOST RECENT REVIEW DATE:  6/11/2014

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 (Euflexxa®, Gel-One®, Hyalgan®, Monovisc®, Orthovisc®, Supartz®, Synvisc®, Synvisc-One®)

  1. Is the requested medication being used to treat ANY ONE of the following?

If yes, this does not meet medical necessity and/or medical appropriateness criteria

If no, go to question #2

  1. Does the individual have request for treatment of ANY ONE of the following?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, go to question #3

  1. Does the individual have a documented diagnosis of osteoarthritis of the knee?

If yes, go to question #4

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

  1. Does the individual show evidence that this is an initial request for viscosupplementation?

If yes, go to question #5

If no, go to question #6

  1. Does the individual show evidence of ALL of the following?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, go to question #6

  1. Does the individual show evidence that this is a repeated course of treatment with ALL of the following?

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.