title: Does conditional approval for new oncology drugs in Europe lead to differences in health technology assessment decisions?
abstract: An early access pathway of conditional approval for potentially beneficial medicines is available within the European regulatory framework. However, marketing authorization does not necessarily result in recommendations for public funding by health technology assessment (HTA) agencies. As conditional approval goes along with less than complete data on benefits and risks of a treatment option for a high medical need, this raises the question how HTA decision-making is affected by these uncertainties.
authors.affiliation: Center for Innovation in Regulatory Science, Warsaw, Poland.
authors.forename: I
authors.initials: I
authors.lastname: Lipska
authors.affiliation: Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht University, Utrecht, The Netherlands.
authors.forename: J
authors.initials: J
authors.lastname: Hoekman
authors.affiliation: Center for Innovation in Regulatory Science, Warsaw, Poland.
authors.forename: N
authors.initials: N
authors.lastname: McAuslane
authors.affiliation: Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht University, Utrecht, The Netherlands.
authors.forename: H G M
authors.initials: HG
authors.lastname: Leufkens
authors.affiliation: Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht University, Utrecht, The Netherlands.
authors.forename: A M
authors.initials: AM
authors.lastname: Hövels
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use; D003657:Decision Making; D017277:Drug Approval / Q000331:legislation & jurisprudence / Q000379:methods*; D005060:Europe; D006801:Humans; D013673:Technology Assessment, Biomedical / Q000331:legislation & jurisprudence / Q000379:methods* / Q000639:trends
chemical_list: D000970:Antineoplastic Agents