Hyaluronic Acid Derivatives: Durolane®, Euflexxa™, Gel-One®, GelSyn-3™, GenVisc 850®, Hyalgan™, Hymovis®, Monovisc®, Orthovisc™, Supartz FX™, Synojoynt, Synvisc™, & Synvisc-One™, Triluron™, TriVisc™, VISCO-3™, & Triluron™, sodium hyaluronate 1% (Intra-Articular)
Some agents on this policy may require step therapy See “Step Therapy Requirements for Provider Administered Specialty Medications” Document at: https://www.bcbst.com/docs/providers/Comm_BC_PAD_Step_Therapy_Guide.pdf
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 or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
POLICY
I. INDICATIONS
The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.
FDA-Approved Indication
Treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics (e.g., acetaminophen)
All other indications are considered experimental/investigational and not medically necessary.
II. CRITERIA FOR INITIAL APPROVAL
Osteoarthritis (OA) of the Knee
Authorization of 12 months may be granted for treatment of osteoarthritis (OA) in the knee when all of the following criteria are met:
A. The diagnosis is supported by radiographic evidence of osteoarthritis of the knee (e.g., joint space narrowing, subchondral sclerosis, osteophytes and sub-chondral cysts) or the member has at least 5 of the following signs and symptoms:
1. Bony enlargement
2. Bony tenderness
3. Crepitus (noisy, grating sound) on active motion
4. Erythrocyte sedimentation rate (ESR) less than 40 mm/hr
5. Less than 30 minutes of morning stiffness
6. No palpable warmth of synovium
7. Over 50 years of age
8. Rheumatoid factor less than 1:40 titer (agglutination method)
9. Synovial fluid signs (clear fluid of normal viscosity and WBC less than 2000/mm3)
B. The member has knee pain which interferes with functional activities (e.g., ambulation, prolonged standing).
C. The member has experienced an inadequate response or adverse effects with non-pharmacologic treatment options (e.g., physical therapy, regular exercise, insoles, knee bracing, weight reduction).
D. The member has experienced an inadequate response or intolerance or has a contraindication to a trial of an analgesic (e.g., acetaminophen up to 3 to 4 grams per day, non-steroidal anti-inflammatory drugs [NSAIDs], topical capsaicin cream) for at least 3 months.
E. The member has experienced an inadequate response or intolerance or has a contraindication to a trial of intraarticular steroid injections for at least 3 months.
F. The member is not scheduled to undergo a total knee replacement within 6 months of starting treatment.
III. CONTINUATION OF THERAPY
Authorization of 12 months may be granted for continued treatment of osteoarthritis in the knee when all of the following criteria are met:
A. Member meets all criteria for initial approval.
B. Member has experienced improvement in pain and functional capacity following the previous injections.
C. At least 6 months has elapsed since the last injection in the prior completed series of injections.
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.
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).
REFERENCES
1. Durolane [package insert]. Durham, NC: Bioventus LLC; September 2017.
2. Euflexxa [package insert]. Parsippany, NJ: Ferring Pharmaceuticals, Inc.; July 2016.
3. Gel-One [package insert]. Warsaw, IN: Zimmer, Inc.; May 2011.
4. Gelsyn-3 [package insert]. Durham, NC: Bioventus LLC; December 2017.
5. GenVisc 850 [package insert]. Doylestown, PA: OrthogenRx, Inc.; November 2019.
6. Hyalgan [package insert].Florham Park, NJ: Fidia Pharma USA Inc.; August 2017.
7. Hymovis [package insert]. Florham Park, NJ: Fidia Pharma USA Inc.; June 2021.
8. Monovisc [package insert]. Bedford, MA: Anika Therapeutics, Inc.; July 2020.
9. Orthovisc [package insert]. Bedford, MA: Anika Therapeutics, Inc.; November 2021.
10. Supartz FX [package insert]. Durham, NC: Bioventus LLC; April 2015.
11. Synojoynt [package insert]. North Wales, PA: Teva Pharmaceuticals USA, Inc.; March 2019.
12. Synvisc [package insert]. Ridgefield, NJ: Genzyme Biosurgery; May 2023.
13. Synvisc One [package insert]. Ridgefield, NJ: Genzyme Biosurgery; May 2023.
14. Triluron [package insert]. Florham Park, NJ: Fidia Pharma USA Inc.: July 2019.
15. Trivisc [package insert]. Doylestown, PA: OrthogenRx, Inc.; September 2018.
16. Visco-3 [package insert]. Warsaw, IN: Zimmer; May 2017.
17. 1% Sodium Hyaluronate [package insert]. North Wales, PA: Teva Pharmaceuticals USA, Inc.; March 2019.
18. Jordan KM, Arden NK, Doherty M, et al. EULAR recommendations 2003: an evidence based approach to the management of knee osteoarthritis: report of a task force of the standing committee for international clinical studies including therapeutic trials (ESCISIT). Ann Rheum Dis. 2003;62:1145-1155.
19. Hochberg MC, Altman RD, April KT, et al. American College of Rheumatology 2012 recommendations for the use of nonpharmacologic and pharmacologic therapies in osteoarthritis of the hand, hip, and knee. Arthritis Care Res. 2012;64(4):465-474.
20. Neustadt DH. Intra-articular injections for osteoarthritis of the knee. Cleve Clin J Med. 2006;73(10):897-911.
21. Zhang W, Moskowitz RW, Nuki G, et al. OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines. Osteoarthritis Cartilage. 2008;16(2):137-162.
22. McAlindon TE, Bannuru RR, Sullivan MC, et al. OARSI guidelines for the non-surgical management of knee osteoarthritis. Osteoarthritis Cartilage. 2014;22(3):363-88.
23. Kolasinski SL, Tuhina N, Hochberg MC, et al. 2019 American College of Rheumatology/Arthritis Foundation Guidelines for the management of osteoarthritis of the hand, hip, and knee. Arthritis Rheumatol. 2020 Jan 6. doi: 10.1002/art.41142. [Epub ahead of print]
24. Bannuru RR, Osani MC, Vaysbrot EE, et al. OARSI guidelines for the non-surgical management of knee, hip, and polyarticular osteoarthritis. Osteoarthritis Cartilage. 2019;27(11):1578-1589.
25. Scali JJ. Intra-articular hyaluronic acid in the treatment of osteoarthritis of the knee: a long term study. Eur J Rheumatol Inflamm. 1995;15(1):57-62.
ORIGINAL EFFECTIVE DATE: 7/98
MOST RECENT REVIEW DATE: 8/13/2024
ID_CHS
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.
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