Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Bilateral knee osteoarthritis
Treatment: Zilretta 32 milligrams (mg) injection 
The insurer denied Zilretta 32 mg injection.
The denial is overturned. 

This is a male who was diagnosed with bilateral knee osteoarthritis. The patient is recommended Zilretta 32 milligrams (mg) injection (inj). The health plan has denied the request as there was no documentation of treatment failure to Triamcinolone acetonide, methylprednisolone, and betamethasone injections. There is a clinical note, documenting a visit with the patient's provider. The patient had been seen and underwent a cortisone injection bilaterally (methylprednisolone) with relief for the left knee; however, there was persistent right knee pain. The comorbidities include high cholesterol. The medication list includes naproxen and prednisone. Objectively, there was range of motion bilaterally 0-130 (degrees) and no objective deficits noted. The treatment plan included Euflexxa. A letter of medical necessity stated that the patient has tried activity modification, weight loss, and nonsteroidal anti-inflammatory drugs (NSAIDs) without improvement. A Zilretta injection was recommended to avoid the need for surgery.

At issue is the medical necessity of Zilretta 32 mg inj.

The health plan's determination of medical necessity is overturned in whole.

The requested health service/treatment of Zilretta 32 mg inj is medically necessary for this patient.

The randomized controlled trial from the Journal of Bone and Joint Surgery concludes the extended-release formulation of triamcinolone acetonide (Zilretta) provides a clinically relevant improvement in pain relief in patients with knee osteoarthritis relative to immediate release triamcinolone. The randomized controlled trial from Advances in Therapy indicates extended-release triamcinolone (Zilretta) provided 5-6 months pain relief that consistently exceeded placebo and standard release triamcinolone. As noted in the article from Drugs, in a randomized phase 3 clinical trial, triamcinolone acetonide extended-release (Zilretta) significantly improved mean average daily pain intensity in patients with knee osteoarthritis relative to placebo, and pain, stiffness, and physical function relative to placebo and immediate-release triamcinolone acetonide.

The patient has an established diagnosis of bilateral knee osteoarthritis, and the intent is to avoid the need for surgical intervention. The prior treatment has included activity modification, weight loss, NSAIDs, and methylprednisolone steroid injections bilaterally with temporary relief for the left knee and insufficient relief for the right knee. As appropriate conservative interventions have been exhausted, proceeding with an extended-release steroid injection would be appropriate, particularly when noting the supportive literature for this exact indication. As Zilretta has been proven to provide 5-6 months of pain relief that consistently exceeded standard release triamcinolone, authorization of Zilretta would be appropriate in this case even though there is no documented treatment with Triamcinolone acetonide and betamethasone injections. Based on the available information, Zilretta is medically necessary for this patient.

Therefore, the requested health service/treatment of Zilretta 32 mg inj is medically necessary.