BlueCross BlueShield of Tennessee Medical Policy Manual

Hyaluronan Derivatives for Intra-Articular Injection

NDC CODE(S)

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)

 

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)

 

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)

 

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

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.

REFER TO DECISION SUPPORT TREE

POLICY

·       Hyaluronan derivative intra-articular injection for the treatment of osteoarthritis of the knee is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)

·       Hyaluronan derivative intra-articular injection for the treatment of other conditions/diseases is considered investigational.  

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

·       Hyaluronan derivative intra-articular injection is considered medically appropriate if ALL of the following criteria are met:

RENEWAL CRITERIA

·       Hyaluronan derivative intra-articular injection is considered medically appropriate for renewal if ALL of the following criteria are met:

INDICATION(S) DOSAGE & ADMINISTRATION
Gel-One 30 mg (1 dose) x 1 dose
Euflexxa 20 mg (1 dose) once weekly x 3 doses
Gel-Syn 16.8 mg once weekly x 3 doses
GenVisc 850 25 mg once weekly x 5 doses
Hyalgan 20 mg (1 dose) once weekly x 5 doses
Monovisc 88 mg (1 dose) x 1 dose
Orthovisc 30 mg (1 dose) once weekly x 4 doses
Supartz/Supartz FX 25 mg (1 dose) once weekly x 5 doses
Synvisc 16 mg once weekly x 3 doses
Synvisc-One 48 mg x 1 dose
Hymovis 24 mg once weekly x 2 doses

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 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. (2012). Provisc® (sodium hyaluronate) ophthalmic viscosurgical device. Retrieved March 3, 2016 from http://ecatalog.alcon.com/PI/Provisc_us_en.pdf.

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.

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. (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.

ORIGINAL EFFECTIVE DATE:  7/1998

MOST RECENT REVIEW DATE:  12/1/2016

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

Hyaluronan Derivatives for Intra-Articular Injection (Euflexxa®, Gel-One®, Gel-Syn™, GenVisc® 850, Hyalgan®, Hymovis®,  Monovisc®, Orthovisc®, Supartz®/Supartz® FX, Synvisc®, Synvisc®-One)

 

1.     Is this the first request for treatment with this agent?

 

If yes, go to question # 2

If no, go to question # 8

 

2.     Does the individual have a documented 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

 

3.     Does the individual have documented trial and failure of conservative therapy (including physical therapy, pharmacotherapy [e.g., non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen (up to 1 g 4 times/day) and/or topical capsaicin cream]) has been attempted and has not resulted in functional improvement after at least 3 months?

 

If yes, go to question # 4

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

 

4.     Does the individual show evidence of failure to adequately respond to aspiration and injection of intraarticular steroids?

 

If yes, go to question # 5

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

 

5.     Does the individual report pain that interferes with functional activities such as ambulation or prolonged standing?

 

If yes, go to question # 6

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

 

6.     Is there an absence of contraindications to the injections themselves, such as an active joint infection or bleeding disorder?

 

If yes, go to question # 7

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

 

7.     Is the request for billable units and dosage of ANY ONE of the following (note: 1-Maximum units are doubled when the claim is submitted with bilateral ICD 10 codes)?

 

Product

Units Per Knee

Dosage

Gel-One

1 billable unit every 180 days

30 mg (1 dose) x 1 dose

Euflexxa

1 billable unit per 180 days

20 mg (1 dose) once weekly x 3 doses

Gel-Syn

504 billable units every180 days

16.8 mg once weekly x 3 doses

GenVisc 850

125 billable units every180 days

25 mg once weekly x 5 doses

Hyalgan

5 billable units every 180 days

20 mg (1 dose) once weekly x 5 doses

Monovisc

1 billable unit every180 days

88 mg (1 dose) x 1 dose

Orthovisc

4 billable units every180 days

30 mg (1 dose) once weekly x 4 doses

Supartz/Supartz FX

5 billable units every 180 days

25 mg (1 dose) once weekly x 5 doses

Synvisc

48 billable units every180 days

16 mg once weekly x 3 doses

Synvisc-One

48 billable units every180 days

48 mg x 1 dose

Hymovis

48 billable units every180 days

24 mg once weekly x 2 doses

 

If yes, this satisfies medical necessity and medical appropriateness criteria

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

 

8.     Does the medical record demonstrate a reduction in the dose of NSAIDS (or other analgesics or anti-inflammatory medication) during the 6-month period following the previous series of injections?

 

If yes, go to question # 9

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

 

9.     Is there objective documentation in the medical record of significant improvement in pain and functional capacity as the result of the previous injections?

 

If yes, go to question # 10

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

 

10.  Is there absence of unacceptable toxicity from the previous injections?

 

If yes, this satisfies medical necessity and medical appropriateness criteria for a 6 month renewal

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

This document has been classified as public information.