A medicine adoption model for assessing the expected effects of additional real-world evidence (RWE) at product launch

Abstract

Abstract Introduction The optimal launch and adoption of novel medicines require effective navigation of the commercial and regulatory landscape, including three key gatekeeper groups: regulators, payors, and prescribers. Traditionally, despite lacking generalisability, the pharmaceutical industry provides Phase III randomized controlled trial evidence to gatekeepers. Despite additional real-world evidence (RWE) improving the generalisability of evidence, the provision of RWE remains in its infancy. The industry may use a multiple stakeholder approach to RWE generation to address each group s priorities and expectations effectively. Methods The Jandhyala Method observed a consensus of expert opinion on the expected effects of supplementing randomised controlled trial evidence (RCTE) with RWE on the depth and time to maximal adoption. The study recruited participants from two of the three gatekeeper stakeholder groups (prescribers and payors) and their four aligned industry stakeholder groups (market access, commercial, medical affairs, and regulatory affairs) groups involved in the approval or adoption of investigational medicines. Results The observed consensus predicted a shortened time to maximal adoption by 22% and increased maximal adoption by 31% of a new medicine with additional RWE at launch. The suggested rationales for these effects varied across stakeholder groups and between specific effects. The results found the prescriber gatekeeper to be dominant in driving the predicted shortening of adoption. No such dominant subsystem was identified for the expected increase in adoption depth, although a potential rationale was the broader population observed in the supplementary RWE. Conclusions The proposed model provides an intuitive temporal framework within which subsystem logic can be further researched to identify and address stakeholder groups’ needs and weigh those needs. Preliminary results appear to support adopting a multiple stakeholder approach to RWE for augmenting the uptake of novel medicines.