Early phase value scan for biotechnology innovation

Abstract

Abstract The registration of a medicinal product by EMA or FDA used to be the main driving critical success factor for the future sales of a new medicinal product. The current additional important criteria for reimbursement decisions are cost-effectiveness and budgetary impact, which are taken into consideration in order to make a value for money decision. In order to maximize the chances of obtaining reimbursement at a maximum price, it is very important to have a well thought through strategy at the early onset of the development program in order to proactively cope with the emerging reimbursement hurdles. This paper aims to provide a pricing, market access and reimbursement strategy, which is based on a strategic scan, sales forecast model, pricing model, and cost-effectiveness model. These models are interacted and linked with a discounted cash flow model in order to optimize the economic value of the company.