Pharmaceutical Regulatory Affairs and IPR

The purpose of this study is to describe the evolution of convergence drivers between global regulatory science and reimbursement paradigms, outline the similarities and differences between 'safety and efficacy' and 'reasonable and necessary and to explain how cost effectiveness variables can be considered during evaluation of drug approval applications. In the European Union, specifically the UK and Germany, regulatory approval and reimbursement determination for biomedical products goes hand in hand. But few biomedical product companies in the US have taken advantage of the pilot programs that enable, for example, the parallel pursuit of both FDA approval and CMS national coverage determinations. These are

intended to alleviate some of the process heavy FDA and CMS requirements that the industry often views as hampering innovation. At the same time, pursuing both approvals to market and universal coverage with Medicare in parallel can seem daunting to biomedical product developers. It calls for smarter study design that matches the expectations of the FDA, CMS and private payers. That means not only focusing on clinical endpoints that prove the products to be safe and effective, but also demonstrating that the product is reasonable and necessary, and superior to others in its category. This presentation will outline both the benefits to the parallel review pilot program on the device side and the key factors device developers need to consider when pursuing a joint approval, including: Advocate for more transparency in the process – medical device

companies often shy away from opening the door to a conversation with the FDA, but in this case, dialog and gathering as much information as possible is key; establish guiding principles – timelines and expectations for both the FDA and CMS need to be clearly defined before trials begin; know when to call it quits–device developers can withdraw from the process at any time and need to see and interpret signs for decoupling the pursuit of both milestones. Through better design of the clinical development process, biomedical product manufacturers can address both regulatory science as well as payer standards during the commercialization process.