Viscosupplementation Treatment with Hyaluronic Acid

Durolane, Euflexxa, Gel-One, Gelsyn-3, GenVisc 850, Hyalgan, Hymovis, Monovisc, Orthovisc, Supartz FX, Synojoynt, Synvisc, Synvisc-One, Triluron, TriVisc, and Visco-3

Office Administration; intra-articular injections of hyaluronic acid

 

Indications for Prior Authorization:

 

  • Osteoarthritis of the knee

 

Coverage Criteria:

 

For diagnosis of osteoarthritis of the knee:

  • The dose of the requested product does not exceed the FDA-approved packaged labeling; AND
  • X-ray or MRI confirmation of osteoarthritis of the knee(s) or Grade 3 or 4 chondromalacia; AND
  • Failure of analgesics such as acetaminophen in doses up to three grams a day or topical analgesics unless contraindicated or experiencing side effects; AND
  • Failure of trial of two prescription strength non-steroidal anti-inflammatory drugs (NSAID) over a minimum of 1-2 weeks, unless contraindicated, or experiencing intolerable side effects.  (NSAID trial can include steroid injection); AND
  • Patient has been treated through a trial of physical therapy prior to requesting viscosupplementation; AND
  • Patient has not undergone knee surgery in the past three months; AND
  • Patient does not have "bone-on-bone" disease; AND
  • For non-preferred agents: A medically appropriate reason is provided why the patient cannot use the preferred viscosupplementation product(s) to treat osteoarthritis of the knee(s). (The health maintenance organization [HMO] medical group may manage the use of specific viscosupplementation product(s)).

 

Reauthorization:

 

For repeat course of therapy for osteoarthritis of the knee:

  • Documentation of a positive response to the most recent course of therapy, including at least 3 months of clinical improvement supported by pain relief and/or increased functional capacity; AND
  • Six months has elapsed since the administration of the previous course of viscosupplementation.

 

Authorization is not covered for the following:

 

  • The use of this drug for the following, and any other indication not listed in this policy, do not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.
    • Use in joints other than the knee
    • Grade 1 or 2 chondromalacia
    • Patient with "bone-on-bone disease"

 

Coverage Duration:

 

  • 6 months

 

Additional Information:
  • Dosing and treatment durations

  • Outerbridge Classification of Chondral Lesions
    • Grade 0 signifies normal cartilage.
    • Grade I chondral lesions are characterized by softening and swelling.
    • Grade II lesion describes a partial-thickness defect with fissures that do not exceed 0.5 inches in diameter or reach subchondral bone.
    • Grade III lesion is a fissuring of the cartilage with a diameter greater than 0.5 inches with an area reaching subchondral bone.
    • Grade IV includes erosion of the articular cartilage that exposes subchondral bone.

 

Policy Updates:
  • 07/25/2016 - Criteria reviewed
  • 08/16/2022 - P&T Committee vote to add prior authorization added back to all viscosupplements; criteria format updated, add requirement to use preferred agents, added all viscosupplements to policy. 
  • 03/01/2023 - Viscosupplement policy updates released to medical groups.

 

References:
  1. Sodium Hyaluronate 1% [package insert). North Wales, PA; Teva Pharmaceuticals; March 2019.
  2. Supartz/Supartz FX [package insert]. Durham, NC; Bioventus LLC; April 2015.
  3. Hyalgan [package insert]. Parsippany, NJ; Fidia Pharma USA Inc.; May 2014.
  4. Euflexxa [package insert]. Parsippany, NJ; Ferring Pharmaceuticals; July 2016.
  5. Synvisc/Synvisc-One [package insert]. Ridgefield, NJ; Genzyme Biosurgery; September 2014.
  6. Orthovisc [package insert]. Raynham, MA; DePuy Mitek, Inc.; September 2014.
  7. Gel-One [package insert]. Warsaw, IN; Zimmer; May 2011.
  8. Monovisc [package insert]. Raynham, MA; DePuy Mitek, Inc.; February 2014.
  9. GelSyn-3 [package insert]. Durham, NC; Bioventus LLC; December 2017.
  10. GenVisc 850 [package insert]. Doylestown, PA; OrthogenRx, Inc; November 2019.
  11. Hymovis [package insert]. Florham Park, NJ; Fidia Pharma USA Inc.; September 2017.
  12. VISCO-3 [package insert]. Durham, NC; Bioventus LLC; December 2015.
  13. Durolane [package insert]. Durham, NC; Bioventus LLC; September 2017.
  14. Trivisc [package insert]. Doylestown, PA; OrthogenRx, Inc; December 2017.
  15. Triluron [package insert]. Florham Park, NJ; Fidia Pharma USA Inc.; July 2019.
  16. Synojoynt [package insert]. Naples, FL; Arthrex, Inc.; January 2022.
  17. Slattery C, Kweon CY. Classifications in brief: outerbridge classification of chondral lesions. Clinical orthopaedics and related research. 2018 Oct;476(10):2101.

 

Last review date: March 1, 2023