Hyaluronic Acid Derivatives - PA, NF
Indications for Prior Authorization
Durolane/Euflexxa/Hyalgan/Sodium Hyaluronate/Supartz FX/Gelsyn-3/Genvisc 850/Triluron/TriVisc/Visco-3 (sodium hyaluronate), Gel-One (cross-linked hyaluronate), Monovisc/Orthovisc/Hymovis (hyaluronan), Synvisc/Synvisc-One (hylan), Synojoynt
-
For diagnosis of Osteoarthritis (OA) of the knee
Indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics (e.g., acetaminophen).
Criteria
Euflexxa, Gelsyn-3
Prior Authorization (Initial Authorization)
Length of Approval: 3 Week(s)
- Diagnosis of osteoarthritis of the knee AND
- Trial and failure, contraindication, or intolerance to two of the following: [A]
- Acetaminophen
- Duloxetine
- Formulary non-steroidal antiinflammatory drugs (e.g., ibuprofen, naproxen)
- Topical capsaicin
- Tramadol
- Trial and failure, contraindication, or intolerance to intra-articular steroid injection (e.g., methylprednisolone, triamcinolone) [20]
Euflexxa, Gelsyn-3
Prior Authorization (Reauthorization)
Length of Approval: 3 Week(s)
- Patient demonstrates improvement in pain with previous course of treatment AND
- At least 6 months have elapsed since last injection of the prior treatment cycle [8]
Durolane
Prior Authorization (Initial Authorization)
Length of Approval: 1 Month(s)
- Diagnosis of osteoarthritis of the knee AND
- Trial and failure, contraindication, or intolerance to two of the following: [A]
- Acetaminophen
- Duloxetine
- Formulary non-steroidal antiinflammatory drugs (e.g., ibuprofen, naproxen)
- Topical capsaicin
- Tramadol
- Trial and failure, contraindication, or intolerance to intra-articular steroid injection (e.g., methylprednisolone, triamcinolone) [20]
Durolane
Prior Authorization (Reauthorization)
Length of Approval: 1 Month(s)
- Patient demonstrates improvement in pain with previous course of treatment AND
- At least 6 months have elapsed since last injection of the prior treatment cycle [8]
Gel-One, Monovisc, Synvisc-One
Prior Authorization (Initial Authorization)
Length of Approval: 1 Month(s)
- Diagnosis of osteoarthritis of the knee AND
- Trial and failure, contraindication, or intolerance to two of the following: [A]
- Acetaminophen
- Duloxetine
- Formulary non-steroidal antiinflammatory drugs (e.g., ibuprofen, naproxen)
- Topical capsaicin
- Tramadol
- Trial and failure, contraindication, or intolerance to intra-articular steroid injection (e.g., methylprednisolone, triamcinolone) [20] AND
- Trial and failure or intolerance to Euflexxa AND
- Trial and failure or intolerance to one of the following:
- Durolane
- Gelsyn-3
Gel-One, Monovisc, Synvisc-One
Prior Authorization (Reauthorization)
Length of Approval: 1 Month(s)
- Patient demonstrates improvement in pain with previous course of treatment AND
- At least 6 months have elapsed since last injection of the prior treatment cycle [8]
Gel-One, Monovisc, Synvisc-One
Non Formulary
Length of Approval: 1 Month(s)
- Diagnosis of osteoarthritis of the knee AND
- Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication, or intolerance to two of the following: [A]
- Acetaminophen
- Duloxetine
- Formulary non-steroidal antiinflammatory drugs (e.g., ibuprofen, naproxen)
- Topical capsaicin
- Tramadol
- Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication, or intolerance to intra-articular steroid injection (e.g., methylprednisolone, triamcinolone) [20] AND
- Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure or intolerance to Euflexxa AND
- Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure or intolerance to one of the following:
- Durolane
- Gelsyn-3
Genvisc 850, Hyalgan, Supartz FX [B], TriVisc, Visco-3
Prior Authorization (Initial Authorization)
Length of Approval: 5 Week(s)
- Diagnosis of osteoarthritis of the knee AND
- Trial and failure, contraindication, or intolerance to two of the following: [A]
- Acetaminophen
- Duloxetine
- Formulary non-steroidal antiinflammatory drugs (e.g., ibuprofen, naproxen)
- Topical capsaicin
- Tramadol
- Trial and failure, contraindication, or intolerance to intra-articular steroid injection (e.g., methylprednisolone, triamcinolone) [20] AND
- Trial and failure or intolerance to Euflexxa AND
- Trial and failure or intolerance to one of the following:
- Durolane
- Gelsyn-3
Genvisc 850, Hyalgan, Supartz FX [B], TriVisc, Visco-3
Prior Authorization (Reauthorization)
Length of Approval: 5 Week(s)
- Patient demonstrates improvement in pain with previous course of treatment AND
- At least 6 months have elapsed since last injection of the prior treatment cycle [8]
Hyalgan, Supartz FX [B], TriVisc, Visco-3
Non Formulary
Length of Approval: 5 Week(s)
- Diagnosis of osteoarthritis of the knee AND
- Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication, or intolerance to two of the following: [A]
- Acetaminophen
- Duloxetine
- Formulary non-steroidal antiinflammatory drugs (e.g., ibuprofen, naproxen)
- Topical capsaicin
- Tramadol
- Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication, or intolerance to intra-articular steroid injection (e.g., methylprednisolone, triamcinolone) [20] AND
- Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure or intolerance to Euflexxa AND
- Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure or intolerance to one of the following:
- Durolane
- Gelsyn-3
Sodium Hyaluronate, Synojoynt, Synvisc, Triluron
Prior Authorization (Initial Authorization)
Length of Approval: 3 Week(s)
- Diagnosis of osteoarthritis of the knee AND
- Trial and failure, contraindication, or intolerance to two of the following: [A]
- Acetaminophen
- Duloxetine
- Formulary non-steroidal antiinflammatory drugs (e.g., ibuprofen, naproxen)
- Topical Capsaicin
- Tramadol
- Trial and failure, contraindication, or intolerance to intra-articular steroid injection (e.g., methylprednisolone, triamcinolone) [20] AND
- Trial and failure or intolerance to Euflexxa AND
- Trial and failure or intolerance to one of the following:
- Durolane
- Gelsyn-3
Sodium Hyaluronate, Synojoynt, Synvisc, Triluron
Prior Authorization (Reauthorization)
Length of Approval: 3 Week(s)
- Patient demonstrates improvement in pain with previous course of treatment AND
- At least 6 months have elapsed since last injection of the prior treatment cycle [8]
Synvisc
Non Formulary
Length of Approval: 3 Week(s)
- Diagnosis of osteoarthritis of the knee AND
- Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication, or intolerance to two of the following: [A]
- Acetaminophen
- Duloxetine
- Formulary non-steroidal antiinflammatory drugs (e.g., ibuprofen, naproxen)
- Topical Capsaicin
- Tramadol
- Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication, or intolerance to intra-articular steroid injection (e.g., methylprednisolone, triamcinolone) [20] AND
- Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure or intolerance to Euflexxa AND
- Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure or intolerance to one of the following:
- Durolane
- Gelsyn-3
Orthovisc
Prior Authorization (Initial Authorization)
Length of Approval: 4 Week(s)
- Diagnosis of osteoarthritis of the knee AND
- Trial and failure, contraindication, or intolerance to two of the following: [A]
- Acetaminophen
- Duloxetine
- Formulary non-steroidal antiinflammatory drugs (e.g., ibuprofen, naproxen)
- Topical Capsaicin
- Tramadol
- Trial and failure, contraindication, or intolerance to intra-articular steroid injection (e.g., methylprednisolone, triamcinolone) [20] AND
- Trial and failure or intolerance to Euflexxa AND
- Trial and failure or intolerance to one of the following:
- Durolane
- Gelsyn-3
Orthovisc
Prior Authorization (Reauthorization)
Length of Approval: 4 Week(s)
- Patient demonstrates improvement in pain with previous course of treatment AND
- At least 6 months have elapsed since last injection of the prior treatment cycle [8]
Orthovisc
Non Formulary
Length of Approval: 4 Week(s)
- Diagnosis of osteoarthritis of the knee AND
- Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication, or intolerance to two of the following: [A]
- Acetaminophen
- Duloxetine
- Formulary non-steroidal antiinflammatory drugs (e.g., ibuprofen, naproxen)
- Topical Capsaicin
- Tramadol
- Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication, or intolerance to intra-articular steroid injection (e.g., methylprednisolone, triamcinolone) [20] AND
- Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure or intolerance to Euflexxa AND
- Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure or intolerance to one of the following:
- Durolane
- Gelsyn-3
Hymovis
Prior Authorization (Initial Authorization)
Length of Approval: 2 Week(s)
- Diagnosis of osteoarthritis of the knee AND
- Trial and failure, contraindication, or intolerance to two of the following: [10, 20, A]
- Acetaminophen
- Duloxetine
- Formulary non-steroidal antiinflammatory drugs (e.g., ibuprofen, naproxen)
- Topical Capsaicin
- Tramadol
- Trial and failure, contraindication, or intolerance to intra-articular steroid injection (e.g., methylprednisolone, triamcinolone) [20] AND
- Trial and failure or intolerance to Euflexxa AND
- Trial and failure or intolerance to one of the following:
- Durolane
- Gelsyn-3
Hymovis
Prior Authorization (Reauthorization)
Length of Approval: 2 Week(s)
- Patient demonstrates improvement in pain with previous course of treatment AND
- At least 6 months have elapsed since last injection of the prior treatment cycle [8]
Hymovis
Non Formulary
Length of Approval: 2 Week(s)
- Diagnosis of osteoarthritis of the knee AND
- Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication, or intolerance to two of the following: [10, 20, A]
- Acetaminophen
- Duloxetine
- Formulary non-steroidal antiinflammatory drugs (e.g., ibuprofen, naproxen)
- Topical Capsaicin
- Tramadol
- Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication, or intolerance to intra-articular steroid injection (e.g., methylprednisolone, triamcinolone) [20] AND
- Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure or intolerance to Euflexxa AND
- Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure or intolerance to one of the following:
- Durolane
- Gelsyn-3
P & T Revisions
2024-11-05, 2023-08-01, 2022-08-04, 2021-11-24, 2021-07-19, 2021-03-15, 2021-02-15, 2020-06-30, 2020-01-23, 2020-01-08, 2019-09-23, 2019-07-27, 2019-07-27
References
- Euflexxa Prescribing Information. Ferring Pharmaceuticals Inc. Parsippany, NJ. July 2016.
- Gel-One Prescribing Information. Zimmer Inc. Warsaw, IN. May 2011.
- Hyalgan Prescribing Information. Fidia Pharma USA Inc. Parsippany, NJ. May 2014.
- Orthovisc Prescribing Information. DePuy Mitek. Raynham, MA. June 2005.
- Synvisc Prescribing Information. Genzyme Biosurgery. Ridgefield, NJ. September 2014.
- Synvisc-One Prescribing Information. Genzyme Biosurgery. Ridgefield, NJ. September 2014.
- 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;65(4):465-474.
- Tasciotaoglu F, Oner C. Efficacy of intra-articular sodium hyaluronate in the treatment of knee osteoarthritis. Clin Rheumatol 2003;22:112-117.
- Huskisson EC, Donnelly S. Hyaluronic acid in the treatment of osteoarthritis of the knee. Rheumatology 1999;38:602-607.
- Jevsevar DS, Brown GA, Jones DL, et al. The American Academy of Orthopaedic Surgeons evidence-based guideline on: treatment of osteoarthritis of the knee, 2nd edition. J. Bone Joint Surg Am. 2013;95(20):1885-6.
- Monovisc Prescribing Information, DePuy Mitek. Raynham, MA. March 2014.
- Genvisc 850 Prescribing Information. OrthogenRx, Inc. Doylestown, PA. October 2015.
- Hymovis Prescribing Information. Fidia Pharma USA Inc. Parsippany, NJ. October 2015.
- Gelsyn-3 Prescribing Information. Bioventus LLC. Durham, NC. July 2016.
- Durolane Prescribing Information. Bioventus LLC. Durham, NC. September 2017.
- Supartz FX Prescribing Information. Bioventus LLC. Durham, NC. April 2015.
- TriVisc Prescribing Information. OrthogenRx, Inc. Doylestown, PA. November 2017.
- Visco-3 Prescribing Information. Bioventus, LLC. Durham, NC. May 2017.
- Sodium Hyaluronate Prescribing Information. Teva Pharmaceuticals USA, Inc. North Wales, PA. March 2019.
- Kolasinski S, Neogi T, Hochberg M et al. 2019 American College of Rheumatology/Arthritis Foundation Guideline for the Management of Osteoarthritis of the Hand, Hip, and Knee. Arthritis Care Res (Hoboken).
- Triluron Prescribing Information. Fidia Pharma USA Inc. Florham Park, NJ. March 2019.
End Notes
- The American College of Rheumatology (ACR)(2019) strongly recommends the following for knee osteoarthritis (OA): topical NSAIDs, oral NSAIDs, and intraarticular glucocorticoid injection. The ACR conditionally recommends the following for knee OA: Topical capsaicin, intraarticular glucocorticoid injection compared to other injections, acetaminophen, duloxetine, and tramadol. The ACR conditionally recommends against intraarticular hyaluronic acid injection for knee OA.
- Supartz has been discontinued by the manufacturer. Supartz has been replaced by Supartz FX, which is the same product but with expanded safety labeling for repeat injections. [16]
Revision History
- 2024-11-05: 2024 UM Annual Review. Update reauth criteria to state "Patient demonstrates" instead of "Documentation of"
- 2023-08-01: 2023 UM Annual Review. No changes
- 2022-08-04: Added Synojoynt.
- 2021-11-24: Updated guideline to add Non-Formulary criteria for Hymovis, Synvisc-One, Gel-one, Hyalgan, Monovisc, Orthovisc, Supartz FX, Synvisc, Trivisc, Visco-3.
- 2021-07-19: 2021 UM Annual Review.
- 2021-03-15: Added P&T approval and P&T revision dates. No changes to criteria.
- 2021-02-15: Per PA team feedback, remove "fill count" verbiage for Durolane, Gel-one, Monovisc, Synvisc-One.
- 2020-06-30: 2020 UM Annual Review.
- 2020-01-23: Updated guideline to include Triluron and modified criteria based on recommendations from the 2019 American College of Rheumatology Guideline on Osteoarthritis.
- 2020-01-08: Updated guideline criteria box to include Synvisc
- 2019-09-23: Updated approval length for Duralane, Gel-One, Monovisc, and Synvisc-One.
- 2019-07-27: Added Sodium Hyaluronate to existing PA criteria with an embedded step through current preferred products (Euflexxa, Synvisc, or Synvisc-One). Listed ibuprofen and naproxen as examples of NSAIDs and methylprednisolone and triamcinolone as examples of intra-articular corticosteroid injections due to NCQA audit results. Effective 1/1/2020: Reformatted criteria to include an embedded step through newly preferred hyaluronic acid derivatives: Euflexxa AND either Durolane or Gelsyn-3. No other changes to clinical intent of the criteria. Criteria follow current OA treatment guideline recommendations from ACR (new 2019 version pending, currently in the Peer Review stage) and AAOS. JM 7/11/2019
- 2019-07-27: Added Sodium Hyaluronate to existing PA criteria with an embedded step through current preferred products (Euflexxa, Synvisc, or Synvisc-One). Listed ibuprofen and naproxen as examples of NSAIDs and methylprednisolone and triamcinolone as examples of intra-articular corticosteroid injections due to NCQA audit results. Effective 1/1/2020: Reformatted criteria to include an embedded step through newly preferred hyaluronic acid derivatives: Euflexxa AND either Durolane or Gelsyn-3.
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