Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Osteoarthritis, Right Knee

Treatment Zilretta 32 milligram (mg) injections

The insurer denied coverage for Zilretta 32 milligram injections

The denial is overturned 

The treating provider has diagnosed the patient with primary osteoarthritis of the right knee. The patient presented with pain in the right knee, associated with swelling and stiffness. The pain bothered her whilst walking up and down stairs. The patient has received corticosteroid injections and viscosupplementation, with minimal relief. She also received Zilretta 32 milligrams (mg) injections for the right knee; however, the benefit is short lived. The patient was seen and evaluated and it was noted that she was provided with triamcinolone. The treating provider recommended another injection of Zilretta, which was denied on the basis that repeat injections were not found to be beneficial. The treating provider is requesting approval for a repeat injection in the right knee of Zilretta 32 milligrams (mg).

Per New York State External Appeal Application, "The patient has had three Zilretta 32 milligrams (mg) injections for the right knee with positive effect, and would like to continue this treatment, as it has been maintaining the patient's pain relief."

Per progress note, "The patient's diagnosis is unilateral primary osteoarthritis of the right knee. The patient presents with right knee pain, swelling, and stiffness. The patient's pain is worse with activity. The patient has tried and failed anti-inflammatories, corticosteroid injections and visco-supplementation with minimal relief. The patient reports Zilretta injections have provided better relief, however, the duration of the pain relief has decreased. The patient's last injections provided only six weeks of pain relief before the pain returned. The patient now states she is walking straight-legged, due to the pain with ambulation. An X-ray of the right knee showed moderate-to-severe joint space narrowing without osteophyte formation or sclerotic joint margin with no fractures."

The health care plan acted reasonably and with sound medical judgment and in the best interest of the patient.

The patient has previously received repeated Zilretta injection with minimal relief. Zilretta 32 mg injections for the right knee are not considered medically necessary for this patient.

Synovitis is common and is associated with progression of structural characteristics of knee osteoarthritis. Intra-articular corticosteroids could reduce cartilage damage associated with synovitis but might have adverse effects on cartilage and periarticular bone.

"Current treatment guidelines for the management of OA [osteoarthritis] pain of the knee recommend the combined use of non-pharmacological interventions (such as exercises and manual therapy) with pharmacological interventions. The American College of Rheumatology (ACR) and American Academy of Orthopedic Surgeons (AAOS) guidelines recommend oral and topical non-steroidal anti-inflammatory drugs (NSAIDs) and tramadol; in addition, the ACR guidelines recommend the use of paracetamol and IA corticosteroids. Although IA (intra articular) corticosteroids are an important treatment option, their efficacy is typically short-lived, with evidence for their longer-term effectiveness inconclusive." (Paik, J. et al. 2019).

The Zilretta 32mg injections for the right knee are not considered medically necessary for this patient, as the patient has had repeated Zilretta injections, and there is a lack of documentation of non-pharmacologic therapy (exercise, physical therapy, weight loss) management.                                                         

The health plan acted reasonably with sound medical judgment in the best interest of the patient.

The insurer's denial of coverage for Zilretta 32 mg injections for the right knee is upheld. Medical Necessity is not substantiated.