Genzyme Corporation (CAMBRIDGE, Mass), one of the world's leading biotechnology companies, announced that it will work with the Centers for Medicare and Medicaid Services (CMS), government officials and, if necessary, through legal channels to dispute a CMS decision to group all viscosupplementation products into a single reimbursement code. This decision specifically impacts Synvisc® (hylan G-F 20), which is manufactured and marketed by the Genzyme Biosurgery division of Genzyme, and has had its own reimbursement code since 1999. Synvisc is currently approved in the US for treatment of pain due to osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and simple analgesics. According to Genzyme, if unchanged, the effect of CMS's decision will be to reduce the reimbursement rate for Synvisc below its current market price, thereby discouraging doctors and patients from using this product.

Genzyme officials stated that there are clear clinical benefits of Synvisc that are not shared by other viscosupplementation products, such as 6months of pain relief with only three injections, and a longer residence time in the joint. Genzyme will argue that the CMS decision is likely to result in the creation of  financial incentives for physicians to use products that require a greater number of treatment injections, or result in shorter periods of pain relief, which would not be in the best interest of patients and will ultimately be more costly to the Medicare system. Genzyme says that it plans to pursue this issue directly with CMS and other government officials and will take legal action if necessary.

Synvisc reimbursement coding, coverage and payment will remain the same until January of 2007.

In January 2005, Genzyme reacquired from Wyeth the full sales and marketing rights to Synvisc in the US, as well as Germany, Poland, Greece, Portugal, and the Czech Republic in exchange for an initial payment of $121 million in cash, acquisition costs payments, and a series of additional contingent payments to Wyeth based on the volume of Synvisc sales in the covered territories. Synvisc is marketed in more than 60 countries and has been used to treat more than 3 million people. Synvisc revenues reached $219 million in 2005, and $117 million for the first half of 2006.

Synvisc is injected directly into the knee joint three times, 7 days apart, over a 15-day period (days 1, 8, and 15). Completion of the full three-injection treatment course is necessary to achieve the greatest benefit. Most patients feel the greatest pain relief 8 to 12 weeks after beginning treatment. Genzyme is pursuing a label expansion in the US that would include the hip indication.

Genzyme is conducting pivotal trials of Synvisc 2 (2 or fewer injections for at least 6 months pain relief) and hylastan SGL-80 (a microbial formulation), potential next-generation viscosupplementation products under development for the treatment of OA pain. Enrollment has been completed in the trial of Synvisc 2, and Genzyme is planning for product launch in 2007 in Europe and the US, and a US launch of hylastan in 2008. Genzyme also expects to launch Synvisc in the US for use in the hip during the first half of 2007.

—A Techman

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