The Impact of Lifting Government Price Controls on Global Pharmaceutical Innovation and Population Health

Abstract

S119performance-based risk-sharing arrangements (PBRSA). Our objective was to evaluate the endpoints used in PBRSAs and their alignment with FDA approved drug labels. MethodS: The study was a retrospective database analysis of the University of Washington's Performance Based Risk Sharing (PBRS) database. Only performancelinked reimbursement arrangements of pharmaceuticals in the United States between October 1997 to October 2017 were considered for our analysis. Endpoints used to evaluate health outcomes in PBRSAs were assessed for consistency with endpoints in their respective FDA approved label. They were labeled as "covered" if they appeared in both the PBRSA and the FDA approved label, or "non-covered" if they appeared in the PBRSA but are not included on the label. Adherence was excluded as an endpoint if it was not used as an outcome measure of safety or efficacy. ReSultS: We identified 473 PBRSAs in the PBRS database with 31 arrangements fitting the inclusion criteria. 77% (n= 24) of arrangements had only covered endpoints in their agreements, while 23% (n= 7) had at least one non-covered endpoint. These arrangements used non-covered endpoints like efficacy algorithms (n= 1), associated healthcare costs (n= 3), adherence (n= 2), and hospitalizations rates (n= 1) to evaluate outcomes. ConCluSionS: Historically, PBRSAs have been conservative by using outcome measures comprising of endpoints covered in their FDA approved label. Notable exceptions using more sophisticated endpoints suggest changes enacted by the 21st Century Cures Act may increase the viability and complexity of future PBRSAs. The study was limited to only publicly available arrangements, and does not address private arrangements or other issues surrounding implementation of PBRSAs.

Regulation and Innovation in the Pharmaceutical Industry: The Case of a New Diabetes Drug

“…These findings confirm the evidence documented in the literature on the relationship between the time that the sanitary authorization and the decision of future investments takes [54,33,51,26]. However, the evidence of the analyzed drug states this relationship in the opposite way-as has also been concluded in other studies-the delay in the sanitary authorization discourages the company's innovation strategy regarding future investments in R&D activities [46,55,56,57].…”

“…Therefore, it does not benefit the development of future innovations in the long term. Also, it bears mentioning that, so far, as other studies have shown, the regulation has neither caused any positive or negative effect on the drug's novelty degree, nor on its sale price [64,65,56,66]. As suggested by the literature, the regulation was neither used to promote a relationship between actors and to benefit collaborative innovation [59,7,58].…”

Regulación e innovación: efectos en la industria farmacéutica mexicana

“…Estos hallazgos confirman la evidencia documentada en la literatura sobre la relación entre el tiempo que toma la autorización sanitaria y la decisión de futuras inversiones (Abraham & Davis, 2007;Vernon, Golec, & Nardinelli, 2009;DiMasi, Grabowski, & Hansen, 2016;Sarkissian, 2019). Sin embargo, la evidencia del medicamento analizado expone esta relación en sentido opuesto, el retraso de la autorización sanitaria desincentiva la estrategia de innovación de la empresa, en cuanto a futuras inversiones en actividades de I+D, tal como se ha concluido también en otros estudios (Katz, 2007;Lim & Suh, 2015;Schwartz, Ward, Xu, & Sullivan, 2018;Chorniy, Bailey, Civan, & Maloney, 2019).…”

“…Además, cabe señalar que la regulación no ha generó ningún efecto, ni positivo ni negativo, sobre el grado de novedad del medicamento, y tampoco sobre su precio de venta, hasta el momento, como lo han evidenciado otros estudios (González, Macho-Stadler, & Pérez-Castrillo, 2016;Schwartz, Ward, Xu, & Sullivan, 2018;Kennedy, 2019;Barros & Nunes, 2010). La regulación tampoco se empleó para promover la vinculación entre actores y favorecer la innovación colaborativa como lo sugiere la literatura (McKelvey, Orsenigo, & Pammolli, 2004;Malerba, 2004a;Samford, 2015).…”