title: Harmonization of reimbursement and regulatory approval processes: a systematic review of international experiences.
abstract: A considerable degree of overlap exists between reimbursement and regulatory approval of health technologies, and harmonization of certain aspects is both possible and feasible. Various models to harmonization have been suggested in which a number of practical attempts have been drawn from. Based on a review of the literature, approaches can be categorized into those focused on reducing uncertainty and developing economies of scale in the evidentiary requirements; and/or aligning timeframes and logistical aspects of the review process. These strategies can further be classified based on the expected level of structural and organizational change required to implement them into the existing processes. Passive processes require less modification, whereas active processes are associated with greater restructuring. Attempts so far at harmonization have raised numerous legal and practical issues and these must be considered when introducing a more harmonized framework into the existing regulatory and reimbursement arrangements.
authors: Programs for Assessment of Technology in Health Research Institute, St. Joseph's Healthcare, Hamilton, Ontario, Canada.
authors: Bernice
authors: B
authors: Tsoi
authors: Lisa
authors: L
authors: Masucci
authors: Kaitryn
authors: K
authors: Campbell
authors: Michael
authors: M
authors: Drummond
authors: Daria
authors: D
authors: O'Reilly
authors: Ron
authors: R
authors: Goeree
mesh_terms: D003299:Cooperative Behavior; D018795:Device Approval / Q000331:legislation & jurisprudence; D017277:Drug Approval / Q000191:economics* / Q000331:legislation & jurisprudence; D004608:Eligibility Determination / Q000191:economics; D033161:Government Regulation; D017048:Health Care Costs / Q000331:legislation & jurisprudence; D006291:Health Policy / Q000191:economics* / Q000331:legislation & jurisprudence; D006801:Humans; D019458:Insurance Coverage / Q000191:economics; D007349:Insurance, Health, Reimbursement / Q000191:economics* / Q000331:legislation & jurisprudence; D033183:Interdisciplinary Communication; D007373:Interinstitutional Relations; D018803:Models, Economic; D015233:Models, Statistical; D011050:Policy Making; D013673:Technology Assessment, Biomedical / Q000191:economics* / Q000331:legislation & jurisprudence; D035501:Uncertainty