Download Hyaluronic acid derivatives

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Prior Authorization Criteria
Drug: hyaluronic acid derivatives, intraarticular (sodium hyaluronate injection)
Euflexxa™
J7323
Hyalgan®
J7321
Synvisc®
J7325
Synvisc One
J7325
Supartz®
J7321
Gel-One®
J7326
Orthovisc®
J7324
Monovisc®
J3490
P&T Reviewed: 3/04, 6/05, 6/07, 6/08, 6/09, 9/09, 9/10, 12/10, 12/11, 10/12, 10/13, 10/14, 11/15
Last Revised: 6/09, 12/10, 12/11, 11/12, 4/13, 6/14
Applies to: Commercial Only
Description:
Hyaluronic acid (HA) derivatives are approved by the US Food and Drug Administration (FDA)
for the treatment of pain related to knee osteoarthritis (OA) in patients who have failed to respond
adequately to conservative nonpharmacologic therapy and to simple analgesics (eg,
acetaminophen). The use of intra-articular (IA) injections of HA derivatives are to restore the
normal properties (viscosity and elasticity) of the synovial fluid.
Criteria:
Euflexxa, Synvisc, Synvisc One:
ConnectiCare considers Euflexxa, Synvisc, and Synvisc One to be medically necessary in patients
who meet the following criteria:
 Patient has clinically diagnosed osteoarthritis of the knee.
 Patient has had an intolerance to or treatment failure of two prescription strength oral
pharmacologic therapies for osteoarthritis. (eg. Naproxen, ibuprofen , Celebrex)
 Patient has had one or more trials in the last 12 months of corticosteroid injections into
the knee joint with unsuccessful relief or relief lasting less than three months
OR
 Patient has successfully used hyaluronic acid derivative in the same knee (at least 6
months must pass before approval for a repeat course will be considered)
Criteria:
Gel-One, Hyalgan, Monovisc, Supartz, and Orthovisc:
ConnectiCare considers Gel-One, Hyalgan, Monovisc Supartz, and Orthovisc to be medically
necessary in patients who meet all of the above criteria and:
 A documented intolerance to, or treatment failure of a previous trial of Euflexxa, Synvisc,
or Synvisc One
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Dosing:
Hyalgan is given by IA injection once weekly (QW) for a total of five injections. The product
labeling also notes that studies report use of Hyalgan as three injections.
Synvisc is recommended to be administered by IA injection QW apart for a total of three
injections.
Synvisc One is administered by IA injection once.
Supartz is administered by IA injection QW one week apart for a total of five injections and use
of subcutaneous (SC) lidocaine or similar local anesthetic may be recommended prior to
injection.
Orthovisc is recommended to be given by IA injection QW for a total of three or four injections.
Euflexxa is injected at weekly intervals for 3 weeks for a total of 3 injections.
Gel-One is administered by IA injection once.
Monovisc is administered by IA injection once.
The effects of these products is generally seen for several months past the injection series. Some
data are available which describe the products being used for repeat treatment courses. Data with
Hyalgan reported that it has been used for a total of five treatment courses, repeated every 6
months and another showed that it was used for up to 8 repeat treatment cycles. Repeated courses
have also been noted with Synvisc. The product labeling for Orthovisc and Supartz states in the
precautions section that the safety and effectiveness have not been established for repeated
treatment courses.
The above criteria is based on the following reference(s):
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Hyalgan [package insert]. New York, NY: Sanofi-Synthelabo Inc.;
Synvisc Hylan G-F 20 [package insert]. Philadelphia, PA: Wyeth-Ayerst.
Supartz™ [package insert]. Memphis, TN: Smith & Nephew;
Orthovisc [package insert]. Raritan, NJ: Ortho Biotech
Hammesfahr JFR, Knopf AB, Stitik T. Safety of intra-articular hyaluronates for pain associated with osteoarthritis
of the knee. Am J Orthop. 2003;32(6):277-283.
Hamburger MI, Lakhanpal S, Mooar PA, Oster D. Intra-articular hyaluronans: a review of product-specific safety
profiles. Semin Arthritis Rheum. 2003;32:296-309.
Recommendations for the medical management of osteoarthritis of the hip and knee: 2000 update. American
College of Rheumatology Subcommittee on Osteoarthritis Guidelines. Arthritis Rheum. 2000;43(9):1905-1915.