OBJECTIVES:

The RWE Leadership Forum (RWLF) is a group of senior RWE executives across major pharma companies, with the objective to understand and respond to RWE challenges and opportunities with a single expert voice, with the aim of improving outcomes, business efficiencies and return on investment. The RWLF propose a common framework for discussing the value and impact of RWE for companies, quantifying benefits and risks of conducting RWE studies in order to support leadership prioritise investment decisions.

METHODS:

There are numerous analyses that demonstrate that RWE can deliver significant value to the life sciences industry. An example is how RWD can be used as an external comparator (i.e. control arm) for Pfizer and Merck KGaA's Bavencio, wherein Bavencio showed superior efficacy compared to standard of care. This was critical for early regulatory approval, underpinning an expedited launch, resulting in $113m global sales in the first 1.8 years.

RESULTS:

The RWLF developed a framework that outlines potential ROI for RWE. Mapped to the stage of the development lifecycle, this framework helps assess the value and impact of RWE, support internal pharmaceutical company leadership in making informed investment prioritisation decisions, and drive the routine adoption of RWE. Designed to aid pharmaceutical leaders in quantifying the benefits and risks of conducting RWE studies, as well as the risks and downsides of not conducting RWE studies, it creates a common language for discussing the value of RWE.

CONCLUSIONS:

There is substantial external pressure for the pharmaceutical industry to continue to innovate without increasing drug prices. RWE can help companies improve efficiencies to remain ahead of the curve in an increasingly demanding healthcare system. Pharmaceutical leaders can implement the framework to demonstrate the value of up-front investments in RWE, generate evidence that meets stakeholder needs, realize efficiency savings, and evaluate the rate of return on RWE.