Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Osteoarthritis; Bilateral knee pain

Treatment: Zilretta 32mg injections

The insurer denied coverage for Zilretta 32mg injections.

The denial is overturned.

This female patient has a history of arthritis and had 2 right knee arthroscopic surgeries and 1 left knee arthroscopic surgery.  The patient was seen at an office visit with complaints of bilateral knee pain and the office note states that the patient reported longstanding history of bilateral knee pain, left worse than right. The patient has had bilateral knee arthroscopies with partial meniscectomies with good effect, but reported that her knee pain has gotten progressively worse since then.  The patient has had cortisone injection every three months over her recent history and multiple Euflexxa injections with good effect.  The patient presented with no complaints at the time because the injections gave her significant relief.  The office visit note documented an impression of moderate to advance bilateral knee tri-compartmental degenerative joint disease with diminished medial joint spaces, no other bony abnormalities with no gross evidence of malalignment, range of motion defects, joint instability or muscle tone abnormalities that suggest an acute injury to other extremities. Treatment options discussed included operative and non-operative options.  The patient elected to continue non-operative management.  The patient reported her previous knee Euflexxa injections have lasted six months to one year with good effect. The patient was given home exercise program. The patient was instructed to return to the office to receive another round of injection with discussion on total knee arthroplasty.  Per follow-up treatment records, the patient received Euflexxa injections of bilateral knees and injection of Zilretta of bilateral knees.  

Based on the review of the medical record, this patient has a diagnosis of end stage osteoarthritis to both knees. The patient has consistency of subjective complaint, physical findings and imaging for her condition.  The patient had received a full course of conservative management including corticosteroid injections, pharmacological and non-pharmacological treatment.  The patient also received the long-acting cortisone Zilretta.

Based on the review of the medical literature, recent studies have reported a change in the FDA recommendation for use. There have been findings that support the safety and efficacy of repeated use of Zilretta (triamcinolone-acetonide extended release). According to Spitzer et al (2019), "repeat administration of triamcinolone acetonide extended-release (TA-ER) using a flexible dosing schedule timed to patient response was well tolerated, with no radiographic evidence of cartilage impact...[and has shown] improvements in [osteoarthritis (OA)] symptoms across a broad spectrum of disease severity reflective of that seen in clinical practice". Paik et al (2019) study also supports that "findings from a single-arm phase IIIb study indicated that a repeat administration of triamcinolone acetonide ER may be similarly efficacious to an initial injection without having deleterious effects on cartilage or other aspects of joint structure. Thus, triamcinolone acetonide ER expands the treatment options available for the management of OA pain of the knee."

Based upon the review of this patient's clinical condition, new FDA policy and recent literature, the repeated use of Zilretta is considered medically necessary for this patient.

The health plan did not act reasonably with sound medical judgment, and in the best interest of the patient.

The carrier's denial of coverage for Zilretta 32mg injections should be overturned.  The medical necessity is substantiated.