When assessing new drugs and treatments, health authorities and insurers or ‘payers’ are often required to make the difficult decision of whether to reimburse costly pharmacological therapies and provide access for patients while taking into account their limited resources. Following regulatory approval, manufacturers are often required to propose patient access schemes or value-based pricing agreements to payers in order to allow both the payers and manufacturers to share the ‘risk' or ‘uncertainty’ of administering new therapies beyond clinical studies to a wider patient population. Unfortunately, most healthcare providers or payers around the world lack the relevant infrastructure to track and implement outcomes-based pricing agreements, and so are shy in adopting such innovative pricing contracts and policies. This results in innovative pharmacological therapies being denied to patients who are most at need, an opportunity missed to decrease the long term economic and disease burden on health systems and a barrier to reimbursement for manufacturers.
Real world evidence (RWE) is playing an increasingly influential role in informing decision making within the healthcare industry and is crucial to informing value-based healthcare. Yet the delay of RWE outputs, the expenses of data access and the current methods of data collection negate many of the benefits of utilising these rich data resources. The lack of easily accessible and comprehensive RWE currently prevents stakeholders in healthcare to evaluate the real time performance and value provided by therapy in real life clinical practice as part of a value-based healthcare delivery system.