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HYLAN G-F 20

Clinical Criteria Summary

This criteria document covers 6 drugs across 3 drug classes.
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  • HYALURONATE SODIUM INJ
  • HYALURONATE SODIUM INJ
  • HYALURONATE SODIUM INJ
  • HYALURONATE SODIUM INJ
  • HYLAN G-F 20
  • HYLAN G-F 20 INJ

Criteria for Viscosupplementation (Hyaluronic Acid / Hylan G-F 20) for Osteoarthritis of the Knee

Exclusion Criteria

  • Known hypersensitivity or allergy to hyaluronate or hylan preparations (applies to all hyaluronic acid and hylan products)
  • Knee joint infection, skin disease or infection in the area of the injection site (applies to all hyaluronic acid and hylan products)

Inclusion Criteria

  • Documented symptomatic (pain/stiffness) OA of the knee which interferes with functional activities (e.g., ambulation, prolonged standing) and/or is associated with significant pain (applies to all hyaluronic acid and hylan products)
  • Adequate trial (2 to 3 months) of non-pharmacologic measures (e.g., cane/crutches, bracing/orthotics, weight loss, physical therapy/exercise) has not resulted in adequate improvement in pain/function (applies to all hyaluronic acid and hylan products)
  • Therapeutic trial of at least 3 analgesics (e.g., acetaminophen, topical capsaicin or topical NSAIDs, oral NSAIDs or duloxetine) has not resulted in adequate improvement in pain/function; OR patient is unable to tolerate or is not a candidate for NSAIDs or other oral therapies (applies to all hyaluronic acid and hylan products)
  • Patient and/or provider have elected to continue conservative (nonsurgical) treatment for OA (applies to all hyaluronic acid and hylan products)

Administration, Monitoring, and Drug-Specific Considerations

  • Use limited to specialists in Orthopedics, Rheumatology, and Physical Medicine and Rehabilitation (applies to all hyaluronic acid and hylan products)
  • All hyaluronic acid or hylan products are for intra-articular use only (applies to all hyaluronic acid and hylan products)
  • Patients with more advanced stages of OA and near complete loss of joint space may be less likely to benefit from therapy (applies to all hyaluronic acid and hylan products)
  • Avian source products (Gel-One, Hyalgan, Supartz, Synvisc, Synvisc-One): Administer with caution in patients with a known allergy to avian proteins, feathers, or eggs
  • Non-avian source products (Durolane, Euflexxa, Gel-Syn 3, GenVisc 850, Hymovis, Monovisc, Orthovisc, Synojoynt, Trivisc): Can be used in patients with an allergy to avian proteins
  • Safety/efficacy of concomitant administration with other intra-articular agents has not been established (applies to all hyaluronic acid and hylan products)
  • Pseudosepsis or severe acute inflammatory reactions (SAIR) reported specifically with Synvisc, typically occurring with the second or third injection in a course or with subsequent courses
  • Repeat courses should not be administered within 6 months of the last injection (applies to all hyaluronic acid and hylan products)

Source Documents