RISK FACTORS 4 Future insurance coverage and reimbursement status of our reimbursement of products are mostly governed by national product candidates is uncertain. states and governmental entities. In many countries, the prices of medical products are subject to varying price control mechanisms We expect the cost of a single administration of our products as part of national health systems. In general, the prices of candidates to be substantial, when and if they achieve regulatory medicines under such systems are substantially lower than in the approval. We expect that coverage and reimbursement by United States. Other countries allow companies to fix their own government and private payors will be essential for most patients prices for medical products, but monitor and control company to be able to afford these treatments. Accordingly, sales of our profits. Additional other price controls or other changes in pricing product candidates will depend substantially, in the United States regulation could restrict the amount that we are able to charge and the European Union in particular, on the extent to which for our product candidates. Accordingly, in many markets outside the costs of our product candidates will be paid or reimbursed the United States, the reimbursement for our products may be by government authorities, private health coverage insurers reduced compared to the United States and may be insufficient to and other third-party payors. The marketability of any products generate commercially reasonable product revenues. for which we receive regulatory approval for commercial sale may suffer if the government and third-party payors fail In the United States, third-party payors, including government to provide adequate coverage and reimbursement. There payors such as the Medicare and Medicaid programs, play an can be no assurance that any country that has price controls important role in determining the extent to which new drugs or reimbursement limitations for pharmaceutical products will and biologics wil l be covered and reimbursed. The Medicare al low favorable reimbursement and pricing arrangements for and Medicaid programs increasingly are used as models for how any of our product candidates. Even if favorable coverage and private payors and government payors develop their coverage reimbursement status is attained for one or more products for and reimbursement policies. A number of gene therapy products which we receive regulatory approval, less favorable coverage have been approved over the past year by the FDA. Although the policies and reimbursement rates may be implemented in the Center for Medicare and Medicaid Services, or CMS, subsequently future. approved its first method of coverage and reimbursement for one Coverage and reimbursement by a third-party payor may such product, the methodology has been subject to challenge by depend upon several factors, including the third- party payor’s members of Congress. Further, CMS’s decision as to coverage determination that use of a product is: and reimbursement for one product does not mean that al l similar products wil l be eligible for analogous coverage and • a covered benefit under its health plan; reimbursement. As there is no uniform policy for coverage and • safe, effective and medically necessary; reimbursement amongst third-party payors in the United States, • appropriate for the specific patient; even if CMS approves coverage and reimbursement for any of our • cost-effective; and product candidates, it is unclear what affect, if any, such a decision wil l have on our ability to obtain and maintain coverage and • neither experimental nor investigational. adequate reimbursement from other private payors. Moreover, Obtaining coverage and reimbursement for a product from third- reimbursement agencies in the European Union may be more party payors is a time-consuming and costly process that could conservative than CMS. For example, several cancer drugs have require us to provide to the payor supporting scientific, clinical been approved for reimbursement in the United States and have and cost-effectiveness data. We may not be able to provide not been approved for reimbursement in certain EU Member data sufficient to gain acceptance with respect to coverage States. It is difficult to predict what third-party payors will decide and reimbursement. If coverage and reimbursement are not with respect to the coverage and reimbursement for our product available, or are available only at limited levels, we may not be able candidates. to successful ly commercialize our product candidates. Even if coverage is provided, the approved reimbursement amount may Increasing efforts by government and third-party payors in not be adequate to realize a sufficient return on our investment. the United States, the Europe Union and elsewhere to cap or reduce healthcare costs may cause such organizations to limit There is significant uncertainty related to third-party coverage both coverage and the level of reimbursement for new products and reimbursement of newly approved products. In many approved and, as a result, they may not cover or provide adequate countries outside the United States, product sales general ly payment for our product candidates. Payors increasingly are are subject to extensive government price controls and other considering new metrics as the basis for reimbursement rates, market regulations. In both the European Union and Canada such as average sales price, average manufacturer price and actual there is an increasing emphasis on cost-containment initiatives, acquisition cost. The existing data for reimbursement based on which may put pricing pressure on us. In the European Union, some of these metrics is relatively limited, although certain states GENSIGHT BIOLOGICS – 2017 Registration Document– 35