INTRA-ARTICULAR HYALURONAN INJECTIONS Coverage for services, procedures, medical devices and drugs are dependent upon benefit eligibility as outlined in the member's specific benefit plan. This Medical Coverage Guideline must be read in its entirety to determine coverage eligibility, if any. The section identified as Description defines or describes a service, procedure, medical device or drug and is in no way intended as a statement of medical necessity and/or coverage. The section identified as Criteria defines criteria to determine whether a service, procedure, medical device or drug is considered medically necessary or experimental or investigational. State or federal mandates, e.g., FEP program, may dictate that any drug, device or biological product approved by the U.S. Food and Drug Administration (FDA) may not be considered experimental or investigational and thus the drug, device or biological product may be assessed only on the basis of medical necessity. Medical Coverage Guidelines are subject to change as new information becomes available. For purposes of this Medical Coverage Guideline, the terms "experimental" and "investigational" are considered to be interchangeable. BLUE CROSS, BLUE SHIELD and the Cross and Shield Symbols are registered service marks of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield Plans. All other trademarks and service marks contained in this guideline are the property of their respective owners, which are not affiliated with BCBSAZ. Description: Intra-articular injection of hyaluronan (HA) into osteoarthritic joints is thought to replace HA, restore the viscoelastic properties of the synovial fluid and improve pain and function. Intra-articular hyaluronan injections include, but are not limited to: Euflexxa (1% Sodium hyaluronate) Gel-One (Hyaluronan hydrogel) Hyalgan (Sodium hyaluronate) Monovisc (Sodium hyaluronate) OrthoVisc (Hyaluronan, Sodium hyaluronate) Supartz (Sodium hyaluronate) Synvisc (Hylan, Hylan GF 20) Synvisc-One (Hylan G-F 20) O196.18.docx Page 1 of 7
Definitions: Osteoarthritis: Degenerative joint disease that occurs when the cartilage in joint wears down and the bone surfaces rub against each other. Also referred to as degenerative arthritis or inflammatory osteoarthritis. Chondrolmalacia Patella: Softening and degeneration of the cartilage underneath the kneecap. May be considered a form of osteoarthritis. Criteria: Initial course of intra-articular hyaluronan injections for treatment of painful osteoarthritis of the knee is considered medically necessary with documentation of ALL of the following: 1. Failure to respond to at least 3 months of conservative treatment (e.g., exercise, physical therapy, activity modification, knee bracing, analgesics, topical capsaicin cream, nonsteroidal antiinflammatories, unless otherwise clearly documented as contraindicated) 2. Failure to respond to aspiration and injection of intra-articular steroids 3. Pain which interferes with functional activities e.g., ambulation, prolonged standing) and the pain cannot be attributed to other forms of joint disease 4. Total knee replacement is not scheduled within 6 months of starting treatment 1. Course of treatment is ONE of the following: Weekly injections for 3-5 weeks with Hyalgan or Supartz Weekly injections for 3-4 weeks with OrthoVisc Weekly injections for 3 weeks with Euflexxa or Synvisc One injection of Synvisc-One, Gel-One or Monovisc O196.18.docx Page 2 of 7
Criteria: (cont.) Repeat course of intra-articular hyaluronan injections for recurrence or worsening of pain due to osteoarthritis of the knee is considered medically necessary with documentation of ALL of the following: 1. Positive response to the prior course of injections with documentation of ALL of the following: 1. Significant pain relief achieved 2. Improved range of motion (ROM) and function 3. Improvement or maintenance of activities of daily living (ADLs) 2. Minimum of 6 months has elapsed since completion of the previous course of treatment 3. Course of treatment is ONE of the following: Weekly injections for 3-5 weeks with Hyalgan or Supartz Weekly injections for 3-4 weeks with OrthoVisc Weekly injections for 3 weeks with Euflexxa or Synvisc One injection of Synvisc-One, Gel-One or Monovisc If member was approved for intra-articular hyaluronan injections prior to 01/01/14, repeat course of intra-articular hyaluronan injections on the same knee is considered medically necessary with documentation of ALL of the following: 1. Recurrence or worsening of pain due to osteoarthritis of the knee 2. Positive response to the prior course of injections with documentation of ALL of the following: Significant pain relief achieved Improved range of motion (ROM) and function Improvement or maintenance of activities of daily living (ADLs) 3. Minimum of 6 months has elapsed since completion of the previous course of treatment 4. Course of treatment is ONE of the following: Weekly injections for 3-5 weeks with Hyalgan or Supartz Weekly injections for 3-4 weeks with OrthoVisc Weekly injections for 3 weeks with Euflexxa or Synvisc One injection of Synvisc-One, Gel-One or Monovisc O196.18.docx Page 3 of 7
Criteria: (cont.) Greater than 3 courses of treatment per knee will be reviewed by the medical director(s) and/or clinical advisor(s). Intra-articular hyaluronan injections for all other indications not previously listed or if above criteria not met are considered experimental or investigational based upon: 1. Lack of final approval from the Food and Drug Administration, and 2. Insufficient scientific evidence to permit conclusions concerning the effect on health outcomes, and 3. Insufficient evidence to support improvement of the net health outcome, and 4. Insufficient evidence to support improvement of the net health outcome as much as, or more than, established alternatives, and 5. Insufficient evidence to support improvement outside the investigational setting. These indications include, but are not limited to: Pain in partial or total artificial knees Any joint other than the knee Resources: 1. 2.01.31 BCBS Association Medical Policy Reference Manual. Intra-articular Hyaluronan Injections for Osteoarthritis. Re-issue date 09/12/2013, issue date 07/10/1998. 2. Altman, R, Moskowitz, R. Intraarticular Sodium Hyaluronate (Hyalgan) in the Treatment of Patients With Osteoarthritis of the Knee: A Randomized Clinical Trial. J Rheumatol. 1998 1998;25:2203-2212. 3. American Academy of Orthopaedic Surgeons (AAOS). Treatment of Osteoarthritis of the Knee 05/18/2013 2013;2nd Edition. 4. BCBS Association. Special Report: Intra-Articular Hyaluronan Injections for the Treatment of Osteoarthritis of the Knee. 06/02/2004 2004. 5. BCBS Association Technology Assessment Program. Special Report: Intra-Articular Hyaluronan Injections for the Treatment of Osteoarthritis of the Knee. 02/2005 2005;19(No 17). O196.18.docx Page 4 of 7
Resources: (cont.) 4. BCBS Association. Special Report: Intra-Articular Hyaluronan Injections for the Treatment of Osteoarthritis of the Knee. 06/02/2004 2004. 5. BCBS Association Technology Assessment Program. Special Report: Intra-Articular Hyaluronan Injections for the Treatment of Osteoarthritis of the Knee. 02/2005 2005;19(No 17). 6. Bragantini, A, Cassini, M, et, al. Controlled Single-Blind Trial of Intra-Articularly Injected Hyaluronic Acid (Hyalgan) in Osteo-Arthritis of the Knee. Clinical Trials Journal. 1987 1987;24(No 4):333-340. 7. California Technology Assessment Forum. Hyaluronic Acid for Treatment of Osteoarthritis of the Knee: Repeated Injections and Progression to Knee Replacement. 02/08/2012. 8. Drug Facts and Comparisons. Hyaluronic Acid Derivatives (Hyalgan, Supartz, Synvisc, Orthovisc). 11/2004, accessed 2005. 9. External Consultant Review. Orthopedic. 03/28/2005 2005. 10. External Consultant Review. Orthopedic. 05/31/2005 2005. 11. External Consultant Review. Orthopedic Surgery. 10/2006 2006. 12. External Consultant Review. Orthopedic. 10/2006 2006. 13. External Consultant Review. Orthopedic Surgery. 02/27/2008 2008. 14. FDA. Gel-One. 03/22/11. 15. Ferring Pharmaceuticals. Euflexxa Package Insert. 10/2005 2005. O196.18.docx Page 5 of 7
Resources: (cont.) 16. Genzyme. Synvisc Package Insert. 10/07/2003 2003. 17. Genzyme. Synvisc Package Insert. 06/07/2004 2004. 18. Genzyme. Synvisc One (Hylan G-F 20) Package Insert. 03/19/2009 2009. 19. Genzyme, Clancy, A. Synvisc Repeat Treatment Letter, Synvisc Package Insert & Synvisc Patient Information. Letter 10/25/2006, Package Insert & Patient Information 11/15/2004. 20. Genzyme, Clancy A. Synvisc Post Arthroscopic Use And Delay Progression to Surgery Letter, Attachments and Package Insert. Letter 10/26/2006, Package Insert 11/15/2004. 21. Genzyme, R O. Synvisc Repeat Use Letter, Attachment and Package Insert. 05/11/2005 2005. 22. Lo GH, LaValley, M, et, al. Intra-Articular Hyaluronic Acid in Treatment of Knee Osteoarthritis: A Meta Analysis. JAMA. 12/17/2003 2003;290(23):3115-3121. 23. Lussier A, Cividino, A, et, al. Viscosupplementation With Hylan for the Treatment of Osteoarthritis: Findings From clinical Practice in Canada. J Rheumatol. 1996 1996;1579-85. 24. Nephew S. Supartz Package Insert. 01/30/2007 2007. 25. Ortho Bioteck, Ali, S. OrthoVisc Repeat Use Letter, Attachments and Package Insert. 05/11/2005 2005. 26. Pritchard, C, Sripada, P, et, al. A Retrospective Comparison of the Efficacy and Tolerability of Sodium Hyaluronate and Hylan G-F 20 in the Treatment of Osteoarthritis of the Knee. Journal of Musculoskeletal Research. 2002 2002;6(3 & 4):197-205. 27. Raynauld, J, Goldsmith, C, et, al. Effectiveness and Safety of Repeat Courses of Hylan G-F 20 in Patients With Knee Osteoarthritis. OsteoArthritis and Cartilage. 2005 2005;13:111-119. 28. Sanofi Aventis, Lee, S. Hyalgan clinical studies letter. 07/07/2005 2005. 29. Sanofi-Aventis, Grunden, T. Hyalgan Repeat Use Letter and Package Insert. 05/11/2005 2005. 30. Sanofi-Synthelabo. Hyalgan Package Insert. Undated. O196.18.docx Page 6 of 7
Resources: (cont.) 31. Scali, J. Intra-Articular Hyaluronic Acid in the Treatment of Osteoarthritis of the Knee: A Long Term Study. European Journal of Rheumatology and Inflammation. 1995 1995;15. 32. Smith & Nephew, Bostic, R. Supartz Informational Packet; Letter and Package Insert. 02/28/2001 2001. 33. Waddell, DD, Cefalu, C, et, al. An Open-Label Study of a Second Course of Hylan G-F 20 for the Treatment of Pain Associated With Knee Osteoarthritis. Curr Med Res Opin. 2003 2003;19(6):499-507. 34. Wang CT, Lin J, Chang CJ, Lin YT, Hou SM. Therapeutic effects of hyaluronic acid on osteoarthritis of the knee. A meta-analysis of randomized controlled trials. J Bone Joint Surg Am. 2004 Mar 2004;86-A(3):538-545. FDA Premarket Approval Database for Acid, Hyaluronic, Intra-Articular: Euflexxa Hyalgan Monovisc OrthoVisc Supartz Synvisc Synvisc-One - FDA-approved indication: Treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and to simple analgesics, e.g., acetaminophen. FDA Premarket Approval Database for Gel-One : - FDA-approved indication: Gel-One is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to nonpharmacologic therapy, non-steroidal anti-inflammatory drugs (NSAIDs) or simple analgesics, e.g., acetaminophen. O196.18.docx Page 7 of 7