Quantifying the impact of real-world evidence: the sacubitril/valsartan experience

BackgroundThe impact of RWE publication on use of approved therapies--including the existence of an effect and timing of impact--is unknown. MethodsWe assessed the relationship between the cadence of RWE publications and sales of sacubitril/valsartan (Entresto(R)) following launch. Publication data were derived from a PubMed search over 7/01/2015-12/31/2023 for English-language, human subjects studies with the drug name (Entresto(R) or sacubitril) and indication (heart failure) in the title or abstract. Quarterly RWE publication data were combined with quarterly information on sacubitril/valsartan sales over the 34-quarter period spanning Q3 2015 through Q4 2023. Quarter-to-quarter change in total sales was modeled with linear regression as a function of counts of previously published RWE-related studies, adjusting for a linear time trend to control for any underlying trends in sales growth; change in total sales from the quarter prior to publication to the quarter of publication to control for recent sales changes; and the cumulative count of RWE publications from Q3 2015 through the previous quarter to control for the contribution of previous RWE publications to future sales. ResultsThe PubMed search identified 888 studies; of these, 333 (37.5%) were classified as RWE-related. An additional RWE-related publication (in quarter q) was associated with an estimated mean increase in quarterly sales of $1.8M (from quarter q to q+1 following publication), $3.5M (from q+1 to q+2), and $2.7M (from q+2 to q+3). In adjusted models, an additional RWE publication was associated with a mean gain in sales from quarter q+1 to q+2 of $2.6M (95% CI -$0.2M to $5.4M). RWE publications were not associated with an increase in sales in the quarter following publication, and the association was attenuated by third quarter following publication. ConclusionRWE studies were associated with increased use of sacubitril/valsaratan, providing preliminary evidence of RWEs ability to support therapy adoption.