An international pharmaceutical company was considering an expansion for its existing urology product in Europe currently used in multiple indications. The company had already completed clinical development of a low dose version of the product for a new indication area in the U.S., but getting reimbursement for the new version in Europe would require additional clinical studies. The new formulation was expected to enable treatment of a much larger patient populations. However, the client was concerned about the risks related to the expense of further studies, the chances of gaining reimbursement, and the potential loss of sales for the existing product in its established indications. The debate within the company to date had focused on whether to launch in Europe or not. They lacked a means to come to a conclusion, as the choices were in fact more complex.
Discovery & Solutions:
Strategic Decisions Group developed a decision-making framework for the client to outline all of the potential decision-points and scenarios related to the launch in Europe, weigh the benefits against risks, and estimate the value of the outcomes. A full spectrum of strategy themes, such as “aiming for the out-of-pocket market” and “conducting Phase IV instead of Phase III trials” to enable market access, and effectively exploring all the dimensions of choice, were given a consistent and thorough evaluation—not just limited to a “go/no-go” decision.
Meanwhile, a detailed examination of the regulatory and reimbursement hurdles provided a clearer definition of the requirements for success. As a result, an entirely new set of endpoints were defined for possible Phase IIIb studies that would enable a significantly higher probability of reimbursement across the main countries in Europe.
Results & Impact:
Considering a full scope of decisions under each strategy theme allowed the company to find higher value in options that were buried in a “go/no-go” frame. The assessment of market uncertainties revealed a much greater threat to the business from not launching in Europe than expected. This, taken together with the improved Phase IIIb study design, suddenly made the choice to invest and launch in Europe obvious—a remarkable outcome considering how ambivalent the company was at the outset. This work left a lasting impression in the company and a strong desire to institute a structured approach to defining and evaluating strategy alternatives for future decisions.