BlueCross BlueShield of Tennessee Medical Policy Manual

Hyaluronan Derivatives for Intra-Articular Injection

NDC CODE(S)

89130-2020-XX Durolane 60 MG/3ML PRSY (BIOVENTUS)

 

87541-0300-XX - Gel-One  30 MG/3ML PRSY (ZIMMER)

 

89122-0724-XX - Hyalgan 20 MG/2ML SOLN (FIDIA PHARMACEUTICAL USA)

 

54569-5543-XX - Hyalgan 20 MG/2ML SOSY (A-S MEDICATION SOLUTIONS)

 

89130-4444-XX - Supartz FX 25 MG/2.5ML SOSY (BIOVENTUS)

 

55566-4100-XX - Euflexxa 20 MG/2ML SOSY (FERRING)

 

89130-3111-XX - Gelsyn-3 16.8 MG/2ML SOSY (BIOVENTUS)

 

50653-0006-XX - GenVisc 850 25 MG/2.5ML SOSY (ORTHOGENRX)

 

89122-0496-XX - HYMOVIS 8 MG/1 ML SOL (FIDIA PHARMACEUTICAL USA)

 

59676-0820-XX - Monovisc 88 MG/4ML SOSY (DEPUY MITEK)

 

59676-0360-XX - OrthoVisc 30 MG/2ML SOSY (DEPUY MITEK)

 

58468-0090-XX - Synvisc 16 MG/2ML SOSY (GENZYME)

 

58468-0090-XX - Synvisc One 48 MG/6ML SOSY (GENZYME)

 

         N/A                 TriVisc 25 MG/2.5ML PRSY (ORTHOGENRX)

 

87541-0301-XX - Visco-3  25mg/2.5 mL (BIOVENTUS)

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; however, this policy addresses only the use of hyaluronan derivatives for use in intra-articular injection or viscosupplementation.

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S) DOSAGE & ADMINISTRATION
Durolane 60 mg intra-articularly x 1 administration
Euflexxa 20 mg intra-articularly once weekly x 3 administrations
Gel-One 30 mg intra-articularly x 1 administration
GelSyn-3 16.8 mg intra-articularly once weekly x 3 administrations
GenVisc 850 25 mg intra-articularly once weekly x 5 administrations
Hyalgan 20 mg intra-articularly once weekly x 5 administrations
Hymovis 24 mg intra-articularly once weekly x 2 administrations
Monovisc 88 mg intra-articularly x 1 administration
Orthovisc 30 mg intra-articularly once weekly x 4 administrations
Supartz/Supartz FX 25 mg intra-articularly once weekly x 5 administrations
Synvisc 16 mg intra-articularly once weekly x 3 administrations
Synvisc-One 48 mg intra-articularly x 1 administration
TriVisc 25 mg intra-articular once weekly x 3 administrations
Visco-3 25 mg intra-articularly once weekly x 3 administrations

LENGTH OF AUTHORIZATION

Coverage will be provided for a period of 6 months and may be renewed.

Click here to view DOSAGE LIMITS

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 hyaluronan derivatives for intra-articular injection for the treatment or prevention of other conditions or diseases.

SOURCES

Bioventus, LLC. (2015, April). Seikagaku Corp. Supartz FX™ (sodium hyaluronate). Retrieved March 3, 2016 from http://www.supartzfx.com/wp-content/uploads/2015/07/SUPARTZ_FX_Package_Insert.pdf.

BlueCross BlueShield Association. Medical Policy Reference Manual. (10:2014). Intra-articular hyaluronan injections for osteoarthritis (2.01.31). Retrieved March 2, 2016 from BlueWeb.

Ferring Pharmaceuticals, Inc. (2015, June). Bio-Technology General (Israel) Ltd. Product information, Euflexxa® (1% sodium hyaluronate). Retrieved March 3, 2016 from http://hcp.euflexxa.com/assets/euflexxa_physician-8a3b1d7a37c7ddb9ea6ba54465fa1d50.pdf.

Fidia Pharma USA, Inc. (2011, November). Hyalgan® (sodium hyaluronate).Retrieved March 3, 2016 from http://www.hyalgan.com/download/hyalgan_pi.pdf.

Genzyme Biosurgery, a division of Genzyme Corp. (2014, September). Synvisc® hylan G-F 20. Retrieved March 3, 2016 from http://products.sanofi.us/synvisc/synvisc.pdf.

Genzyme Biosurgery, a division of Genzyme Corp. (2014, September). Synvisc-One® hylan G-F 20. Retrieved March 3, 2016 from http://products.sanofi.us/synviscone/synviscone.pdf.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2016, January). Hyaluronic acid. Retrieved March 2, 2016, from MICROMEDEX Healthcare Series.

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.

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 (2015, December). Center for Devices and Radiological Health. Visco-3® (sodium hyaluronate) full prescribing information. Retrieved December 27, 2017 from https://www.accessdata.fda.gov/cdrh_docs/pdf/P980044S027d.pdf.

U. S. Food and Drug Administration (2017, August). Center for Devices and Radiological Health. DUROLANE® INSTRUCTIONS FOR USE. Retrieved December 27, 2017 from https://www.accessdata.fda.gov/cdrh_docs/pdf17/P170007D.pdf.

U. S. Food and Drug Administration (2017, November). Center for Devices and Radiological Health. TriVisc™ (sodium hyaluronate) full prescribing information. Retrieved December 27, 2017 from https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160057D.pdf.

ORIGINAL EFFECTIVE DATE:  7/1998

MOST RECENT REVIEW DATE:  1/9/2018

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.

This document has been classified as public information.

 

 

DOSAGE LIMITS

Maximum billable units per dose and over time by indication as a Medical Benefit

AGENT

1 Billable Unit

# Billable Unit/ Admin

# Admins / Knee / 180 days

MAX UNITS/180 days*

Durolane

1 dose

1

1

2

Euflexxa

1 dose

1

3

6

Gel-One

1 dose

1

1

2

GelSyn-3

0.1 mg

168

3

1008

GenVisc 850

1 mg

25

5

250

Hyalgan; Supartz; Supartz FX

1 dose

1

5

10

Hymovis

1 mg

24

2

96

Monovisc

1 dose

1

1

2

Orthovisc

1 dose

1

4

8

Synvisc

1 mg

16

3

96

Synvisc-One

1 mg

48

1

96

TriVisc

1 dose

1

3

6

Visco-3

1 dose

1

3

6

  *Max units are based on administration to both knees