Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: A patient has requested authorization and coverage for Orthovisc three (syringes) 2 mL each. The Health Plan has denied this request indicating that the requested medication is not medically necessary for treatment of the patients unilateral primary osteoarthritis, left knee. The submitted documentation supports the medical necessity of the requested medication. There is significant evidence supporting the requested medication in the presence of unilateral primary osteoarthritis of the knees with failed non-operative treatment, and in the presence of patients who have shown significant benefit from prior injections. Based on the current medical evidence, the requested use of viscosupplementation is medically necessary for the patients medical condition of unilateral primary osteoarthritis, left knee, which did not respond to non-operative treatment. The European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis treatment algorithm recommends intra-articular hyaluronic acid for management of knee osteoarthritis as second-line treatment in patients who remain symptomatic, or have failed the use of non-steroidal anti-inflammatory drugs. Further evidence shows that intra-articular hyaluronic acid injections reduce pain and increase function in knee osteoarthritis with long-lasting benefits as compared with intra-articular corticosteroids. Evidence from real-life studies show that repeat courses of intra-articular hyaluronic acid demonstrate an improvement in pain or function lasting up to 40 months, which is 12 months after the last injection cycle and a reduction in the use of concomitant analgesia by up to 50 percent. This suggests that there may be a delay in the need for total knee replacement of approximately two years. The clinical benefit of intra-articular hyaluronic acid on knee osteoarthritis may be two-fold. First, mechanical viscosupplementation of the joint allows lubrication and shock absorption and second, the re-establishment of joint homeostasis through induction of endogenous hyaluronic acid production, which continues long after the exogenous injection has left the joint. Campbell and colleagues conducted a systematic review of overlapping meta-analyses, which compared viscosupplementation with other non-operative treatment modalities for knee osteoarthritis. In sum, this shows current evidence suggests that intra-articular hyaluronic acid is a viable option for knee osteoarthritis and the benefits can persist for up to 26 weeks. Viscosupplementation has a good safety profile, and its use should be considered in patients with knee osteoarthritis. As such, the requested Orthovisc three (syringes) 2 mL each is reasonable, appropriate, and medically necessary for the treatment of this patient.Final Result: The reviewer determined that the requested medication is medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned. Credentials/Qualifications: The reviewer is board certified in orthopedic surgery and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.