The Plan

members with certain types of knee pain may be eligible for treatment with hyaluronic acid injections to improve function and decrease pain.

Osteoarthritis

is an inflammatory-mediated joint condition that often affects one or both knee joints, with increasing prevalence in older adults. It can present as tenderness, stiffness, swelling, and/or instability.

Many patients will improve with conservative measures such as physical therapy, exercise, weight loss, oral medications such as acetaminophen and nonsteroidal anti-inflammatory drugs (e.g., ibuprofen, naproxen, meloxicam, nabumetone), topical medications (e.g., capsaicin cream and diclofenac 1% gel), and/or intra-articular corticosteroid injections. Some patients with more severe symptoms or those who do not improve with conservative therapy may require further treatment. Surgery with total knee replacement is the standard of care for refractory osteoarthritis of the knee. However, some patients may benefit from a non-surgical treatment called viscosupplementation, which is an injection of a lubricating agent called hyaluronic acid to improve function and decrease pain.

This guideline will provide criteria and exclusions for viscosupplementation with hyaluronic acid derivatives.

Table 1. Intra-articular Hyaluronic Acid Products

• Brand Name - Dosing Guidelines / Injection Series (per 6-month period)
• Durolane® (hyaluronic acid) - 60 mg (3 mL) x 1 dose
• Euflexxa® (1% sodium hyaluronate) - 20 mg once weekly x 3 doses
• Gel-One® (cross-linked hyaluronate) - 30 mg (3 mL) x 1 dose
• Gelsyn-3™ (sodium hyaluronate 0.84%) - 16.8 mg (2 mL) once weekly x 3 doses
• GenVisc® 850 (sodium hyaluronate) - 25 mg once weekly x 3-5 doses
• Hyalgan® (sodium hyaluronate) - 20 mg once weekly x 5 doses
• Hymovis® (high molecular weight viscoelastic hyaluronan)
• Monovisc® (high molecular weight hyaluronan)
• Orthovisc® (high molecular weight hyaluronan)
• Supartz™ (sodium hyaluronate)
• Supartz FX ™ (sodium hyaluronate)
• Synojoynt (sodium hyaluronate) - 20 mg (2 mL) once weekly x 3 doses
• Synvisc® (hylan G-F 20) - 16 mg once weekly x 3 doses
• Synvisc-One® (hylan G-F 20) - 48 mg x 1 dose
• Triluron™ (sodium hyaluronate) - 20 mg (2 mL) once weekly x 3 doses
• TriVisc™ (sodium hyaluronate) - 25 mg (2.5 mL) once weekly x 3 doses
• Visco-3™ (sodium hyaluronate) - 2.5 mL once weekly x 3 doses

Sources: Prescribing Information (See here)

NOTE: The Plan may require that preferred products be used first. Please review the applicable Plan Clinical Guideline for a full list of our preferred and non-preferred products:

• Commercial Preferred Physician-Administered Specialty Drugs (CG052)
• Medicare B Step Therapy Preferred Physician-Administered Specialty Drugs (CG066)

Definitions

• Hyaluronan or Sodium hyaluronate or Hyaluronic acid is a thick fluid similar to the fluid naturally inside the joint. When injected into the knee joint in a process known as "viscosupplementation", it can act as a lubricant and shock absorber in an effort to decrease symptoms and improve function.
• Osteoarthritis is a joint disease caused by inflammation where the protective cartilage of the joint wears down over time resulting in bone-on-bone contact. This can cause pain, swelling, decreased mobility, and stiffness.
• Viscosupplementation is a procedure where hyaluronic acid is injected into the joint space.

Medical Necessity Criteria for Initial Authorization

The Plan considers initial requests for viscosupplement injections medically necessary when ALL of the following criteria are met:

1. Diagnosis of osteoarthritis (OA) of the knee AND ALL of the following:
   • Radiologic evidence (e.g. x-ray or MRI) confirming OA of the knee, characterized by features such as joint space narrowing, subchondral sclerosis, osteophytes, and subchondral cysts; and
   • Persistent pain in the affected knee, significantly interfering with functional activities such as walking, standing for prolonged periods, or sleeping; and
   • Other forms of joint disease to which the pain may be attributed have been ruled out;
2. The member is unable to use, or have failed to respond adequately (e.g. decrease pain or improve function) to at least a 3-month trial of ALL of the following:
   • Nonpharmacologic therapy (e.g. low-impact exercise, aquatic exercise); and
   • Dietary weight management as part of a healthy lifestyle regimen for individuals presenting with body mass index ≥30 kg/m2; and
   • Oral or topical pharmacologic therapy (e.g. nonsteroidal anti-inflammatory drugs (NSAIDs), capsaicin, acetaminophen, duloxetine, tramadol); and
   • Intra-articular corticosteroid injection therapy; AND
3. The member meets BOTH of the following:
   • Is not a candidate for surgery (e.g. high risk, contraindication) OR surgery is not expected within 6 months of the injection series (e.g., member being considered for knee arthroplasty (replacement) to treat arthritis or arthroscopy to treat a meniscal tear); and
   • Has no contraindications to injection per FDA label (e.g. infections or skin diseases in the area of the injection site) OR as listed below under Experimental or Investigational / Not Medically Necessary.

If the above prior authorization criteria is met, the requested product will be approved for one injection series lasting up to six (6) months to determine effectiveness.

Medical Necessity Criteria for Reauthorization (i.e., Continuing Treatment Post Initial Trial)

The Plan considers subsequent requests for viscosupplement injections medically necessary when ALL of the following criteria are met:

1. The above “Initial Authorization” criteria continue to be met; and
2. A minimum of 6 months have elapsed since the last injection series, with no more than one injection series performed in a 6-month period; and
3. The patient demonstrated improvement in overall pain and function from the prior injection series, as evidenced by ALL the following:
   • Documented reduction in pain demonstrated through objective measures such as increased range of motion, decreased tenderness upon examination, or reduction in the amount and/or frequency of medication use; and
   • Documented enhancement in the ability to perform daily activities, such as walking, standing for extended periods, and improved quality of sleep.

Experimental or Investigational / Not Medically Necessary

The use of viscosupplementation for knee osteoarthritis where the above criteria are not met is considered not medically necessary. Viscosupplements for any other indication is considered not medically necessary or experimental or investigational.

Non-covered indications include, but are not limited to, the following:

• Acute injury (e.g., sprain, fracture)
• Adhesive capsulitis of shoulder (frozen shoulder)
• Chondromalacia patellae
• Edema of the bone
• Infectious arthritis
• Knee joint infections
• Osteoarthritis for any joints other than the knee (e.g., shoulder, elbow, carpometacarpal, thumb, hip, ankle, metatarsophalangeal)
• Psoriatic arthritis for any joints including the knee
• Rheumatoid arthritis for any joints including the knee
• Skin disease or infections in the area of injection site
• Temporomandibular joint disorders
• Tendinopathy
• Trigger finger
• Viscosupplementation in combination with intra-articular corticosteroid, mesenchymal stem cell, amniotic product, or platelet rich plasma (PRP) injection