Will Local Market Access Needs Ever Be Met by Global Evidence Packages? LiveSLR to the Rescue


Grammati Sarri, PhD, MSc, DiDS, Cytel, London, LON, UK, Maria Rizzo, MSc, Cytel, London, UK and Julia Gaebler, PhD, Cytel, Cambridge, MA, USA

With EU HTA Regulation (EU) 2021/2282, a new vehicle for standardizing HTAs, pharmaceutical sponsors will soon confront multiple sets of evidentiary requirements - for clinical review by the Joint Clinical Assessment (JCA) and for pricing and access by each of the different national bodies. To date, sponsor Global Value Dossiers (GVD) have provided a core compendium of evidence that is then tailored for national (local)-level HTA review. With JCAs coming soon, can sponsors still rely on GVDs to efficiently capture the abundance of clinical and economic data to meet the diverse and specific requirements for the JCA and for each local market?

Regularly updating evidence closer to local submissions along meeting specific population, intervention/comparator, outcomes, and study design (PICOS) requests for each local market remain significant challenges for companies preparing for multiple country submissions that may seriously compromise market access success. Furthermore, these challenges are magnified by a general push by decision-makers for faster patient access to promising health technologies that put pressure to companies to prepare submissions at higher evidentiary standards in a shorter preparation period. This is where LiveSLR® comes to the rescue; we will introduce how an online tool, LiveSLR® which uses automation and by adhering to HTA standards, can store and present the vast quantity of literature as part of a global evidence package, but can easily and transparently filter local relevant evidence based on PICOS and geography. The output from PICOS selection is an automated report with customized study selection criteria, tailored Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) flow of literature, with data visualization and graphics. By speeding up time-consuming steps in local submissions such as conducting or updating local systematic literature reviews, manufacturers can divert investment in time and resources towards stronger, value-based local market access submissions.

Sponsored by Cytel




Health Technology Assessment