Subject: Hyaluronates 1765-A SGM P2022

Drug

DUROLANE  (hyaluronic acid)

EUFLEXXA  (1% sodium hyaluronate)

GEL-ONE  (cross-linked hyaluronate)

GELSYN-3  (sodium hyaluronate 0.84%)

GENVISC 850  (sodium hyaluronate)

HYALGAN  (sodium hyaluronate)

HYMOVIS  (high molecular weight viscoelastic hyaluronan)

MONOVISC  (high molecular weight hyaluronan)

ORTHOVISC  (high molecular weight hyaluronan)

SUPARTZ FX  (sodium hyaluronate)

SYNOJOYNT  (1% sodium hyaluronate)

SYNVISC  (hylan G-F 20)

SYNVISC ONE  (hylan G-F 20)

TRILURON  (sodium hyaluronate)

TRIVISC  (sodium hyaluronate)

VISCO-3  (sodium hyaluronate)

1% sodium hyaluronate

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
                anding).
           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.

 

Place of Service:

Outpatient

The above policy is based on the following 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.; September 2017.
8. Monovisc [package insert]. Bedford, MA: Anika Therapeutics, Inc.; July 2020.
9. Orthovisc [package insert]. Bedford, MA: Anika Therapeutics, Inc.; September 2016.
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; September 2014.
13. Synvisc One [package insert]. Ridgefield, NJ: Genzyme Biosurgery; September 2014.
14. Triluron [package insert]. Florham Park, NJ: Fidia Pharma USA Inc.: July 2019.
15. Trivisc [package insert]. Doylestown, PA: OrthogenRx, Inc.; November 2019.
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. OARSIguidelines for the non-surgical management of knee 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.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

June 26, 2022