Diagnosis: Bilateral knee degenerative joint disease (DJD)

Treatment: Euflexxa injections

The insurer denied coverage for Euflexxa injections. The denial was upheld.

This patient is a female patient with a medical history of cervical spondylosis, lumbar degenerative disc disease with intermittent right L5-S1 radiculopathy, left carpal tunnel syndrome and bilateral knee degenerative joint disease (DJD) mostly affecting the patella-femoral joints. She was prescribed Euflexxa knee injections to treat her progressive knee pain. She was prescribed Euflexxa knee injections in the past which provided pain relief. She reported that the pain is currently more prominent in the right knee than in the left knee.

The health plan has denied coverage for the requested bilateral Euflexxa injections as not medically necessary.

In the patients' appeal, she states the following:

1) The injections are necessary and effectively treat her medical condition. 2) She has pain with bending and kneeling which is required for her work.

The literature summarizing the hyaluronic acid injections is well documented in the American Academy of Orthopaedic Surgery (AAOS) guidelines. In general, the use of hyaluronic acid is not supported due to the fact that most studies show that it does not show superiority over other treatments, including placebo. Even in their studies that show some patients reached a statistical improvement, it usually did not meet minimally clinically important difference (MCID) in their studies. The patient's physician claims that since steroids injections did not work, then they are a candidate for Synvisc-one. However, this is not something that has been borne out in literature and while it is discussed as a treatment in people who failed steroid treatment, it is not evidence that hyaluronic acid injections would work.

The American Academy of Orthopaedic Surgery, in their guidelines, recommends against use of hyaluronic acid injections. In their recommendations, they state that the evidence is strong based on multiple studies with consistent findings for recommendations against the use of hyaluronic acid injections (AAOS Clinical Use Guidelines, 2015). In a thorough review of the literature, they feel that although there is often a small statistical improvement, meta-analyses of WOMAC pain, function, and stiffness subscales scores all found statistically significant treatment effects; none of the improvements met the minimum clinically important improvement thresholds. Whereas the 2008 guidelines were relatively inconclusive, the current literature supports the updated guidelines where the available evidence suggests there is strong evidence against the use of hyaluronic acid injections.

Therefore, while the authors do correctly conclude that HA injections are beneficial, it does not show that there is a great benefit over other treatments. Jaysevar et al (JAAOS 2018) demonstrated that all treatments showed significance over oral placebo, with corticosteroids having the largest magnitude of effect and significant difference only over IA placebo. They found that for function, no IA treatments showed significance compared with either placebo, or naproxen was the only treatment showing clinical significance compared with oral placebo. They concluded that cumulative probabilities showed naproxen to be the most effective individual treatment, and when combined with IA corticosteroids, it is the most probable to improve pain and function.

Thus, evidence does support the AAOS guidelines that suggest the evidence is strong that HA injections do not provide a clinically meaningful improvement in knee pain and function in a majority of clinical trials. The health plan acted reasonably with sound medical judgment in the best interest of the patient.

Based on the above, the medical necessity for the bilateral knee Euflexxa injections is not substantiated. The insurer's denial is upheld.