Cedar Associates LLC assists company decision makers–from regulatory, clinical, commercial, and reimbursement teams–to develop an effective strategy for commercializing a new product. Our emphasis is primarily on the economic and reimbursement strategy, and our experience reveals that it must be informed from input of other teams.

We have experience from early-to-late phase development in:
   » reviewing the economic and reimbursement landscape,
   » assessing key regulatory, clinical, commercial, and reimbursement objectives,
   » determining the deliverables that are needed to achieve objectives, and
   » generating a prioritized list of projects to complete deliverables.

Our approach stems from the core fundamentals of decision analysis (e.g., "Value-Based Thinking"  Raiffa, 1996).  We start by undertaking to fully understanding the economic and reimbursement landscape. This involves review of practice patterns, incentives of key stakeholders (e.g., patients, providers, payers), the regulatory environment, and the economic environment. We then assess with the team their key objectives, looking especially as to whether the reimbursement/economic objectives align with regulatory, clinical, and commercial objectives. The third step involves determining the deliverables that will be most needed to achieve objectives; e.g., studies that address specific knowledge gaps about burden of illness, use of existing products, quality of life, economic forecasts. We then undertake to identify all potential projects to help the team and company reach its objectives (i.e., effective brainstorming). We assess the potential for each project to achieve its goals and its feasibility and costs. (Dr. Hornberger has published on the topic of conducting cost-effective studies.) We assist in coordinating input and discussion of the pros and cons of each proposed project.

It is important to realize that not all projects have required our full involvement in each of these steps. With this process, we have found that at the end, the team and management has a well-referenced, reliable, and credible summary of strategic options and realistic expectations about the potential costs of implementing each strategy and its potential for success.

Our approach has been applied successfully in (1) influencing study design for Phase II and Phase III trials, (2) deciding on adjunctive analyses of existing trials, and (3) designing and implementing new studies that complement pivotal regulatory trials.