CurrentCareSourcePolicy N/A

Hyaluronic Acid Derivatives (Intraarticular) — Knee Osteoarthritis

Policy governs prior authorization and coverage criteria for hyaluronic acid derivative intraarticular injections for knee osteoarthritis under medical benefit, specifying indications, dosing, provider qualifications, and non-covered uses.

Policy Summary

PayerCareSource

PolicyHyaluronic Acid Derivatives (Intraarticular) — Knee Osteoarthritis

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateOct 9, 2024

Key ActionObtain prior authorization and verify radiologic confirmation plus required prior conservative and pharmacologic therapies before approving one course per treated knee.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

one course per kneeauthorization unit

>=6 monthsrepeat interval

2required prior corticosteroid injections

varies (1-5)injections per regimen

Coverage Criteria for Intraarticular Hyaluronic Acid (Knee)

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Overall: Diagnosis of the knee to be treated is confirmed by radiologic evidence of knee osteoarthritis; AND product is administered by or under the supervision of a physician specializing in rheumatology, orthopedic surgery, or physical medicine and rehabilitation (physiatrist); AND either the Initial Therapy pathway (A) or the Repeat Therapy pathway (B) below is satisfied.

Examples of radiographic evidence include X-ray, MRI, CT, or ultrasound.

Initial Therapy (A): Patient meets ALL of the following: (i) patient has tried at least TWO of the following modalities for osteoarthritis: (a) at least one course of physical therapy for knee osteoarthritis OR oral/topical NSAIDs; AND (ii) patient has tried at least TWO of the following pharmacologic therapies with verification required: tramadol, acetaminophen, duloxetine, or other listed pharmacologic options; AND (iii) product is administered by or under supervision of a specified specialist.

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

Alternative Initial Pathway: At least TWO injections of intraarticular corticosteroids to the affected knee (when applicable per policy) may satisfy initial therapy requirements when administered as described; AND product is administered by or under supervision of a specified specialist.

Repeat Therapy (B): Prescriber documents prior response to previous hyaluronic acid derivative therapy for knee osteoarthritis; AND at least 6 months have elapsed since the last injection with any hyaluronic acid derivative; AND product is administered by or under supervision of a specified specialist.>=6 months

Examples of response include reduced joint pain, tenderness, morning stiffness, or improved mobility.

Dosing Regimens — Dosing

Dosing — approve ONE of the following per knee:

One injection products: Durolane; Gel-One; Monovisc; Synvisc-One — Approve one injection per knee.

Dose listed is for one knee; if two knees are treated, each knee requires its own syringe or vial.

Two injection product: Hymovis — Approve up to two injections given 1 week apart.

Three to four injection products: Orthovisc — Approve up to three to four injections given 1 week apart.

Three injection products: Euflexxa; Gelsyn-3; sodium hyaluronate 1% injection; SynoJoynt; Synvisc; Triluron; TriVisc; Visco-3 — Approve up to three injections given 1 week apart.

Five injection products: GenVisc 850; Hyalgan; Supartz FX — Approve up to five injections given 1 week apart.

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 for approval. The prescribing information states that safety and effectiveness in joints other than the knee have not been established, and guideline recommendations (e.g., American College of Rheumatology) do not support use in hand or hip osteoarthritis. Small trials in other joints have not provided sufficient evidence of benefit, and more data are needed before these indications can be supported.

Use of intraarticular hyaluronic acid for acute ankle sprain is not recommended for approval. Although a few small randomized trials have assessed early injection after ankle sprain, the evidence is limited and inconsistent; additional, higher-quality data are required to determine any clinical role for these products in acute ankle sprain.

Intraarticular hyaluronic acid injections are not recommended for knee conditions other than osteoarthritis (examples include chondromalacia patellae, osteochondritis dissecans, patellofemoral syndrome, and post‑ACL reconstruction). These agents are indicated for knee osteoarthritis, and adequate, well‑designed trials have not demonstrated clear benefit for other knee pathologies.

Provider Actions, Authorization, and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization is recommended for hyaluronic acid intraarticular products for knee osteoarthritis. Approvals are provided for the number of injections noted in dosing. Administration must be by or under the supervision of a physician specializing in rheumatology, orthopedic surgery, or physical medicine and rehabilitation (physiatrist). Previous therapies required in the criteria must be verified by a clinician in the Coverage Review Department when noted as [verification of therapies required].

Prior authorization recommended for hyaluronic acid derivatives for knee osteoarthritis
Administration must be by or under a supervising physician in rheumatology, orthopedic surgery, or physical medicine and rehabilitation
Verification of prior therapies required when noted in criteria

Prior Authorization

Repeat Course Authorization

Approve one repeat course per treated knee if ALL of the following are met: (1) the prescriber documents the patient had a response to the previous course of hyaluronic acid therapy for knee osteoarthritis; (2) at least 6 months have elapsed since the last injection with any hyaluronic acid derivative; and (3) the product is administered by or under the supervision of an appropriate specialist (rheumatology, orthopedic surgery, or physiatry).

One repeat course per knee allowed when response documented and >= 6 months since last injection
Repeat administration must be by/under supervising specialist

Step Therapy

Required Prior Therapies

Prior conservative therapies are required before initial approval. The knee to be treated must have radiologic confirmation of osteoarthritis (examples: X-ray, MRI, CT, ultrasound). For initial therapy, patient must have tried at least TWO pharmacologic modalities (examples include: trial of two or more NSAIDs — oral and/or topical — counts as one pharmacologic therapy; tramadol; acetaminophen; duloxetine) and at least one course of nonpharmacologic therapy such as physical therapy. When specified in the criteria, verification of these prior therapies is required.

Radiologic confirmation of knee osteoarthritis required (X-ray, MRI, CT, or ultrasound)
At least one course of physical therapy for knee osteoarthritis required
At least TWO pharmacologic therapies required (examples: oral/topical NSAIDs, tramadol, acetaminophen, duloxetine). Note: a trial of two or more NSAIDs counts as one pharmacologic therapy
Verification of prior therapies required when indicated

Documentation Required

Required Documentation

Documentation must include radiologic confirmation of the treated knee's osteoarthritis and clear documentation of prior therapies (nonpharmacologic and pharmacologic) when required by the criteria. For repeat-course requests, include documentation that the patient responded to prior hyaluronic acid therapy and the date of the last injection to confirm the ≥6-month interval. Requests for doses or indications outside those specified in the policy will be considered on a case-by-case basis and may require review by a clinician (Medical Director or Pharmacist).

Include imaging confirming knee osteoarthritis
Document prior nonpharmacologic and pharmacologic therapies and dates (verification required when noted)
For repeat requests, document prior response and date of last hyaluronic acid injection (to verify ≥6 months)
Requests outside listed dosing/indications may require clinician review

Denial Risk

Non‑Recommended Indications

Requests for indications not listed in the Recommended Authorization Criteria (for example, joints other than the knee such as hip, hand, shoulder, TMJ, ankle, or non-osteoarthritis knee conditions) are generally not recommended and are at high risk for denial due to insufficient evidence of safety and effectiveness. Coverage is not recommended for acute ankle sprain and other non-knee osteoarthritis indications unless future published data support such use.

Not recommended: intraarticular hyaluronic acid for joints other than the knee (hip, hand, shoulder, TMJ, ankle) or knee conditions other than osteoarthritis
Not recommended: acute ankle sprain outside of clinical evidence supporting use
Criteria updated as new published data become available

Definitions and Product Notes

Course — Definition

DefinitionA treatment course consists of the product-specific number of injections administered per the dosing regimen for one knee; number of injections varies by product (ranges from one to five injections).

Dose attributionDose listed is for one knee; each knee requires its own syringe/vial (separate course per treated knee).

Typical injection countsExamples from products: one-injection, two-injection, three-injection, three-to-four injection, and five-injection regimens as specified by product.

Retreatment interval noteRetreatment data are limited; in many cases a minimum interval of 6 months elapsed before repeat course in studies.

Avian-derived products — Note

DefinitionProducts derived from rooster or chicken combs (avian-derived).

ExamplesGel-One; Hyalgan; Supartz FX; Synvisc/Synvisc-One; Triluron; Visco-3.

Clinical relevanceNon-avian alternatives exist and may be used for patients with allergies to eggs or poultry products.

Background and Clinical Rationale

Hyaluronic acid derivatives are used to treat pain related to knee osteoarthritis by attempting to restore synovial fluid viscosity and elasticity. Evidence for these products is limited overall, guideline recommendations are generally conditional, and benefit outside the knee OA population has not been established. Products vary by origin (avian‑derived versus non‑avian), dosing regimen (ranging from one to five injections per course depending on product), and retreatment data are limited with typical retreatment intervals commonly set at >=6 months in authorization guidance.