Intra Articular Hyaluronan Injections for Treatment of Osteoarthritis of the Knee

Restricted Product(s):

• sodium hyaluronate (Durolane®) gel for intra-articular injection for administration by a healthcare professional
• sodium hyaluronate (GenVisc® 850) viscoelastic solution for intra-articular injection for administration by a healthcare professional
• sodium hyaluronate (Hyalgan®) solution for intra-articular injection for administration by a healthcare professional
• sodium hyaluronate (Supartz®) viscoelastic solution for intra-articular injection for administration by a healthcare professional
• sodium hyaluronate (Supartz FX®) solution for intra-articular injection for administration by a healthcare professional
• high molecular weight viscoelastic hyaluronan (Hymovis®) hydrogel for intra-articular injection for administration by a healthcare professional
• 1% sodium hyaluronate (Euflexxa®) viscoelastic solution for intra-articular injection for administration by a healthcare professional
• *high molecular weight hyaluronan (Orthovisc®) viscoelastic solution for intra-articular injection for administration by a healthcare professional
• *hylan G-F 20 (Synvisc®) elastoviscous high molecular weight fluid for intra-articular injection for administration by a healthcare professional
• *hylan G-F 20 (Synvisc-One®) elastoviscous high molecular weight fluid for intra-articular injection for administration by a healthcare professional
• cross-linked hyaluronate (Gel-One®) viscoelastic gel for intra-articular injection for administration by a healthcare professional
• cross-linked high molecular weight hyaluronic acid (Monovisc®) viscoelastic solution for intra-articular injection for administration by a healthcare professional
• sodium hyaluronate (Gelsyn-3®) solution for intra-articular injection for administration by a healthcare professional
• sodium hyaluronate (TriVisc™) viscoelastic solution for intra-articular injection for administration by a healthcare professional
• 1% sodium hyaluronate (Synojoynt™) viscoelastic solution for intra-articular injection for administration by a healthcare professional
• sodium hyaluronate (Triluron™) viscous solution for intra-articular injection for administration by a healthcare professional
• sodium hyaluronate (Visco-3™) solution for intra-articular injection for administration by a healthcare professional

*preferred agent(s)

FDA Approved Use:

• For 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 for Medical Necessity:

The restricted product(s) may be considered medically necessary when the following criteria are met:

Initial Criteria for Approval:

1. The patient is using the requested product for pain relief of osteoarthritis of the knee; AND
2. The patient has at least ONE of the following:
   1. Evidence of joint space narrowing, sub-chondral sclerosis, osteophytes, and/or sub-chondral cysts present on radiographs; OR
   2. Knee pain accompanied by at least 5 of the following:
      1. Crepitus (noisy, grating sound) on active motion
      2. Erythrocyte sedimentation rate (ESR) less than 40 mm/hr
      3. Bony enlargement
      4. Bony tenderness
      5. Less than 30 minutes of morning stiffness
      6. No palpable warmth of synovium
      7. Over 50 years of age
      8. Rheumatoid factor less than 1:40 titer (agglutination method)
      9. Synovial fluid signs (clear fluid of normal viscosity and white blood cells less than 2000/mm³); AND
3. The patient is NOT scheduled to undergo a total knee replacement within 6 months of starting therapy with the requested agent; AND
4. The patient has tried and had an inadequate response to conservative non-pharmacologic therapy (e.g., exercise, physical therapy, weight loss) for at least 3 months; AND
5. The patient has tried and had an inadequate response to pharmacologic therapy with simple analgesics (e.g., acetaminophen or non-steroidal anti-inflammatory drugs [NSAIDs]) for at least 3 months; OR
6. The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to conservative non-pharmacologic and pharmacologic therapy; AND
7. One of the following:
   1. The request is for a preferred product (i.e., Synvisc, Synvisc-One, or Orthovisc); OR
   2. The patient has tried and failed or has a clinical contraindication / intolerance to TWO preferred products (i.e., Synvisc or Synvisc-One AND Orthovisc) [medical record documentation required]; AND
8. The requested quantity does NOT exceed the maximum units allowed for the duration of approval (see table below).

Duration of Approval: One course of treatment per knee for 180 days (6 months)

Continuation Criteria for Approval:

1. The patient was approved through Blue Cross NC initial criteria for approval (above); OR
2. The patient would have met initial criteria for approval upon the start of therapy; AND
3. The patient has had a reduction in the required dose of analgesics/anti-inflammatory medications following the previous series of injections [medical record documentation required]; AND
4. The patient has demonstrated significant improvement in pain and functional capacity following the previous series of injections [medical record documentation required]; AND
5. At least 6 months have lapsed since the completion of the previous intra-articular hyaluronan injection treatment course for the same knee; AND
6. The requested quantity does NOT exceed the maximum units allowed for the duration of approval (see table below).

Duration of Approval: One course of treatment per knee for 180 days (6 months)