title: Health economics and outcomes research within drug development: challenges and opportunities for reimbursement and market access within biopharma research.
abstract: Healthcare decision makers who determine funding for new medical technologies depend on manufacturers to provide evidence of the technology's efficacy, safety and cost-effectiveness. Constrained budgets and increasing reliance on formal health technology assessment (HTA) have created an abundance of external hurdles that manufacturers must navigate to ensure successful product commercialization. These demands have pushed pharmaceutical companies to adjust their internal structures to coordinate generation of appropriate evidence. In this article we summarize internal and external opportunities for manufacturers to establish a foundation of evidence for successful market access, starting in Phase I of development and continuing throughout the post-approval product lifecycle.
authors.affiliation: United BioSource Corporation, Hammersmith, London, UK. floortje.vannooten@unitedbiosource.com
authors.forename: Floortje
authors.initials: F
authors.lastname: van Nooten
authors.forename: Stefan
authors.initials: S
authors.lastname: Holmstrom
authors.forename: Julia
authors.initials: J
authors.lastname: Green
authors.forename: Ingela
authors.initials: I
authors.lastname: Wiklund
authors.forename: Isaac A O
authors.initials: IA
authors.lastname: Odeyemi
authors.forename: Teresa K
authors.initials: TK
authors.lastname: Wilcox
mesh_terms: D001702:Biopharmaceutics / Q000191:economics*; D057186:Comparative Effectiveness Research; D003362:Cost-Benefit Analysis; D055808:Drug Discovery / Q000191:economics*; D006801:Humans; D007349:Insurance, Health, Reimbursement; D040541:Marketing / Q000191:economics*; D017063:Outcome Assessment, Health Care / Q000191:economics*; D016032:Randomized Controlled Trials as Topic; D013673:Technology Assessment, Biomedical / Q000191:economics*