Euflexxa denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: A 62-year-old female enrollee has requested authorization and coverage for Euflexxa shots series of three for the left knee every six months. In the current peer-reviewed medical literature, the authors conducted a systematic review on the efficacy and safety of repeat courses of hyaluronan therapy in patients with osteoarthritis of the knee. The authors concluded that repeat courses of the hyaluronans were safe and effective in the treatment of pain associated with osteoarthritis of the knee. Further, the researchers found that repeated cycles of intra-articular sodium hyaluronate in patients with knee osteoarthritis was found efficacious during a 54-month follow-up period.

Nature of Statutory Criteria/Case Summary: An enrollee has requested Euflexxa injections for treatment of the enrollee’s osteoarthritis. Findings: The physician reviewer found that the evidence based medical peer-reviewed literature supports the use of repeat series of viscosupplementation injections for the treatment of pain in patients with osteoarthritis of the knee. Bannuru and colleagues concluded that hyaluronic acid was the best pharmacologic intervention for knee osteoarthritis in their meta-analysis of 137 studies with 33,243 participants. Hyaluronic acid was found to be better than injected placebo or injected corticosteroids.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested Euflexxa injections for treatment of her osteoarthritis. Findings: The physician reviewer found that the evidence based medical guidelines and peer-reviewed literature does not support the use of hyaluronic acid injections, such as Euflexxa, for osteoarthritis in the knees. Its use for treatment of osteoarthritis of the knee remains the subject of debate because the use of hyaluronan is not consistently supported by evidence based literature. The rationale for the use of hyaluronan includes the concept that proinflammatory mediators and metalloproteinases (MMPs) that stimulate chondrocytes to syntheses endogenous hyaluronic acid and proteoglycans will be affected positively by the injection of hyaluronic acid.

Nature of Statutory Criteria/Case Summary: An enrollee has requested Euflexxa injections for treatment of his medical condition. Findings: The physician reviewer found that evidence based peer-reviewed literature and clinical practice guidelines have indicated that intraarticular steroid injections are a first line pharmacological intervention consideration in the treatment of knee arthritis, while intraarticular hyaluronan injections like Euflexxa are a second line consideration (Cheng, et al; 2012; Henrotin, et al; and Hochberg, et al). Jevsevar and colleagues performed a systematic review of the published evidence and concluded that, “Meta-analysis of only the double-blinded, sham-controlled trials with at least sixty patients did not show clinically important differences of HA treatment over placebo.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving Euflexxa, then check the rights and deadlines that apply to your plan.