Genzyme Corp (CAMBRIDGE, Massachusetts) and Anika Therapeutics, Inc (WOBURN, Massachusetts) independently announced that Synvisc® (hylan G-F 20) and Orthovisc®, their respective hyaluronic acid (HA) viscosupplement products used to treat pain caused by osteoarthritis (OA) of the knee, will maintain separate reimbursement codes and rates for 2007, according to a decision made by the Centers for Medicare and Medicaid Services (CMS). The CMS reversed a decision made earlier this fall that would have placed all viscosupplement products in the same reimbursement code for billing next year. As a result of the CMS decision, effective January 1, 2007, the Medicare payment rate for both products will continue to be 106% of the average selling price calculated from data submitted to CMS. In addition, Q-codes have replaced the J-codes for viscosupplementation products. Like J-codes, Q-codes are unique identifiers for drugs and biologics.
This decision by the CMS, which recognizes the differences between marketed HA products, is viewed also as good news for those companies developing next-generation viscosupplement products.
Synvisc, currently approved in the US for treatment of pain caused by OA of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and simple analgesics, has had its own reimbursement code since 1999. According to Genzyme, if unchanged, the effect of CMS's decision would have been to reduce the reimbursement rate for Synvisc below its current market price, thereby discouraging doctors and patients from using the product. Genzyme recently announced preliminary results from a study conducted in Europe that indicate that patients treated with a single dose of Synvisc achieved a statistically significant improvement in pain from OA of the knee over 26 weeks compared with those using placebo. Currently, Synvisc is delivered through three intra-articular administrations given at one-week intervals. Synvisc is registered in more than 70 countries and has been used to treat more than 3 million people. Synvisc, is manufactured and marketed by the Genzyme Biosurgery division of Genzyme.
Like Synvisc, Orthovisc is indicated in the treatment of OA of the knee in patients who do not get adequate pain relief from conservative nonpharmacologic therapy and to simple analgesics (eg, acetaminophen). Orthovisc, with a 30 mg dose of HA, contains the highest concentration of HA, which may offer improved pain relief at early, mid, and late time points with only three injections. Orthovisc is the only injection made from ultra-pure natural hyaluronan and contains no buffers or preservatives. In addition to its effectiveness, Orthovisc has the highest safety profile of all HA products on the market; there are no published reports of pseudoseptic reactions reported in over 1,000,000 injections. Orthovisc is available internationally and marketed in the US by DePuy Mitek, Inc, a subsidiary of Johnson & Johnson.
—A. Techman
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