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.
We Medialis Ltd are pleased to share with you the fourth of a series of updates on the principles underlying our work, the four pillars of our medical #thirty22realworldevidencestrategy.
Pillar 4, the #medicaladoptionmodel, is at the heart of our #thirty22realworldevidencestrategy.
It suggests that the generation of #realworldevidence in time for regulatory submission increases the depth of maximal adoption by 30% and reduces the time to maximal adoption by 22%.
This means that more #patients get the right drugs, more quickly.
We developed the #medicineadoptionmodel by applying #neutraltheory and the #Jandhyalamethod to #rwe generation for #clinicaltrials and #clinicalstudies.
Our #corporatesocialresponsibility programme 2022 will apply these methods to transfusion-dependent #thalassemia to fill evidence gaps and remove existing gatekeeper barriers to access to new therapies.
Contact info@medialis.co.uk to find out how the medicine adoption model can enhance real-world evidence generation and regulatory/payor submissions in your #patientgroup and new #medicine. #clinicaltrials #pharmaceuticalindustry #pharmaceuticals #medicalaffairs #clinicalresearch #rwe #orphandrugs #raredisease #neutraltheory #jandhyalamethod #thirty22RWEstrategy #medicineadoptionmodel