CurrentCareSourcePolicy N/A

Hyaluronic Acid Derivatives (Intraarticular) — Knee Osteoarthritis Coverage Criteria

This policy governs prior authorization and medical benefit coverage for intraarticular hyaluronic acid derivative injections for knee osteoarthritis for CareSource members; it specifies authorization criteria, dosing per product, and situations not recommended for approval.

Policy Summary

PayerCareSource

PolicyHyaluronic Acid Derivatives (Intraarticular) — Knee Osteoarthritis Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateN/A

Next Review DateOct 9, 2024

Key ActionObtain prior authorization and document radiologic confirmation plus verification of prior conservative and pharmacologic therapies before approval of one course per treated knee.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥15listed products

1 course/kneeauthorization allowance

≥6 monthsminimum interval

Prior authadministrative

Not recommendednon-knee joints

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Coverage Criteria for Intraarticular Hyaluronic Acid Derivatives

FDA-Approved Indication: Knee osteoarthritis

Covered when ALL of the following are met for Osteoarthritis of the Knee (approve one course per treated knee):

Radiologic confirmation: Diagnosis of the knee to be treated is confirmed by radiologic evidence of knee osteoarthritis (examples: X-ray, MRI, CT scan, ultrasound)

Initial vs Repeat Therapy

A Initial Therapy: Patient has tried at least TWO of the following modalities: (i) at least one course of physical therapy OR oral/topical NSAID(s); AND (ii) at least TWO pharmacologic therapies (trial of two or more NSAIDs (oral and/or topical) counts as one pharmacologic therapy) which may include tramadol, acetaminophen, duloxetine; AND (iii) at least TWO injections of intraarticular corticosteroids to the affected knee; AND product is administered by or under the supervision of a physician specializing in rheumatology, orthopedic surgery, or physical medicine and rehabilitation (physiatrist).
[verification of therapies required]
B Repeat Course: According to the prescriber, the patient had a response to the previous course of hyaluronic acid derivative therapy for osteoarthritis of the knee AND at least 6 months have elapsed since the last injection with any hyaluronic acid derivative AND product is administered by or under the supervision of a physician specializing in rheumatology, orthopedic surgery, or physical medicine and rehabilitation (physiatrist).
Examples of response include reduced joint pain, tenderness, morning stiffness, improved mobility

Dosing per product: Approve ONE of the following dosing regimens depending on product: Durolane, Gel-One, Monovisc, Synvisc-One = 1 injection; Hymovis = up to 2 injections 1 week apart; Orthovisc = up to 4 injections 1 week apart; Euflexxa, Gelsyn-3, sodium hyaluronate 1% injection, SynoJoynt, Synvisc, Triluron, TriVisc, Visco-3 = up to 3 injections 1 week apart; GenVisc 850, Hyalgan, Supartz FX = up to 5 injections 1 week apart.

Dose listed is for one knee; bilateral treatment requires appropriate quantity per knee

Use of intraarticular hyaluronic acid derivatives for osteoarthritis or other pathologic conditions involving joints other than the knee (for example: hand, hip, ankle, shoulder, temporomandibular joint [TMJ], adhesive capsulitis, subacromial impingement) is not recommended. The prescribing information for these agents notes that safety and effectiveness for injections into non‑knee joints have not been established, and guideline guidance does not support routine use in these indications.

Use of intraarticular hyaluronic acid for acute ankle sprain is not recommended by this policy due to insufficient and inconclusive data regarding benefit; additional studies are required to determine a role for these products in acute ankle sprain management.

Coverage for intraarticular hyaluronic acid derivatives is not recommended for situations that are not specifically included in the policy's Recommended Authorization Criteria. The authorization criteria define the covered indications and required documentation; requests outside those criteria may be denied and will be reviewed as new evidence becomes available.

Intraarticular hyaluronic acid injections for joints other than the knee are considered not medically necessary because safety and effectiveness have not been established for these anatomic sites and supporting evidence is lacking for non‑knee pathologies.

Product List and Coding Rules

Listed Hyaluronic Acid Productsmixed

Euflexxa	sodium hyaluronate injection (Ferring)
Durolane	sodium hyaluronate injection (Bioventus)
Gel-One	sodium hyaluronate injection (Seikagaku/Zimmer)
GenVisc 850	sodium hyaluronate injection (OrthogenRx)
Gelsyn-3	sodium hyaluronate injection (Bioventus)
Monovisc	high molecular weight hyaluronan injection (Anika)
Hymovis	high molecular weight viscoelastic hyaluronan injection (Fidia)
Orthovisc	high molecular weight hyaluronan injection (Anika)
Sodium hyaluronate 1% injection	(Teva)
Supartz FX	sodium hyaluronate injection (Seikagaku/Bioventus)

1–10 of 17

1/2

Minimum Interval Before Repeat Course

Minimum interval before repeat courseAt least 6 months must have elapsed since the last injection with any hyaluronic acid derivative.

Provider Requirements, Prior Authorization, and Denial Triggers

Prior Authorization

Prior authorization required — one course per treated knee

Prior Authorization is recommended for medical benefit coverage; approve one course of therapy per treated knee when the patient meets the policy Criteria and Dosing (radiologic confirmation and prior therapy verification required).

Approvals are provided for the number of injections noted in the dosing section.
Extended approvals allowed if patient continues to meet Criteria and Dosing.

Step Therapy

Therapy prerequisites — nonpharmacologic plus ≥2 pharmacologic trials

Authorization requires documented trials of conservative nonpharmacologic therapy plus pharmacologic treatments: the patient must have tried at least one course of physical therapy or oral/topical NSAID(s) and at least two pharmacologic therapies (examples include tramadol, acetaminophen, duloxetine); verification of therapies is required.

A trial of two or more NSAIDs (oral and/or topical) counts as one pharmacologic therapy.

Definitions and Course of Therapy

inv-14: Course of therapy

Definition of course of therapyA product-specific regimen defined by number of injections per treated knee (ranges from single injection up to five injections given one week apart depending on product)

One-injection productsDurolane, Gel-One, Monovisc, Synvisc-One — 1 injection per course

Two-injection productHymovis — up to 2 injections given 1 week apart per course

Three- to four-injection productsEuflexxa, Gelsyn-3, Sodium Hyaluronate 1% injection, SynoJoynt, Synvisc, Triluron, TriVisc, Visco-3 — up to 3 injections; Orthovisc — up to 3–4 injections given 1 week apart

Five-injection productsGenVisc 850, Hyalgan, Supartz FX — up to 5 injections given 1 week apart per course

Background

Hyaluronic acid derivatives are intraarticular products intended to restore synovial fluid viscosity and elasticity and provide symptomatic relief for patients with knee osteoarthritis who have not adequately responded to nonpharmacologic therapies and simple analgesics. These agents are administered as a product‑specific course of therapy (ranging from a single injection up to five injections given at approximately one‑week intervals depending on the product) and are intended to improve pain, stiffness, and function in appropriately selected patients.