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Expert Review of Pharmacoeconomics & Outcomes Research Volume 13, 2013 - Issue 4
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Review

Harmonization of reimbursement and regulatory approval processes: a systematic review of international experiences

Bernice Tsoi Programs for Assessment of Technology in Health (PATH) Research Institute, St. Joseph’s Healthcare, Hamilton, Ontario, Canada. [email protected]; Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada; Programs for Assessment of Technology in Health (PATH) Research Institute, St. Joseph’s Healthcare, Hamilton, Ontario, Canada. [email protected]; Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada
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Lisa Masucci Programs for Assessment of Technology in Health (PATH) Research Institute, St. Joseph’s Healthcare, Hamilton, Ontario, Canada; Programs for Assessment of Technology in Health (PATH) Research Institute, St. Joseph’s Healthcare, Hamilton, Ontario, Canada
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Kaitryn Campbell Programs for Assessment of Technology in Health (PATH) Research Institute, St. Joseph’s Healthcare, Hamilton, Ontario, Canada; Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada; Programs for Assessment of Technology in Health (PATH) Research Institute, St. Joseph’s Healthcare, Hamilton, Ontario, Canada; Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada
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Michael Drummond Centre for Health Economics, University of York, Heslington, York, UK; Centre for Health Economics, University of York, Heslington, York, UK
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Daria O’Reilly Programs for Assessment of Technology in Health (PATH) Research Institute, St. Joseph’s Healthcare, Hamilton, Ontario, Canada; Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada; Programs for Assessment of Technology in Health (PATH) Research Institute, St. Joseph’s Healthcare, Hamilton, Ontario, Canada; Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada
&
Ron Goeree Programs for Assessment of Technology in Health (PATH) Research Institute, St. Joseph’s Healthcare, Hamilton, Ontario, Canada; Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada; Programs for Assessment of Technology in Health (PATH) Research Institute, St. Joseph’s Healthcare, Hamilton, Ontario, Canada; Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada
Pages 497-511 | Published online: 09 Jan 2014

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Meghan Sebastianski, Donald Juzwishin, Ulrich Wolfaardt, Gary Faulkner, Kevin Osiowy, Peter Fenwick & Tracy Ruptash. (2015) Innovation and commercialization in public health care systems: a review of challenges and opportunities in Canada. Innovation and Entrepreneurship in Health 2, pages 69-80.
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Joanne M Langley, Murray Krahn, Don Husereau, John Spika, David N Fisman, Ayman Chit & Rob Van Exan. (2014) Incorporating economic evaluation into immunization decision making in Canada: a workshop. Expert Review of Vaccines 13:11, pages 1291-1296.
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Rosanna Tarricone, Aleksandra Torbica, Francesca Ferré & Mike Drummond. (2014) Generating appropriate clinical data for value assessment of medical devices: what role does regulation play?. Expert Review of Pharmacoeconomics & Outcomes Research 14:5, pages 707-718.
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Adrian Gheorghe, Derek Kyte & Melanie Calvert. (2014) The need for increased harmonisation of clinical trials and economic evaluations. Expert Review of Pharmacoeconomics & Outcomes Research 14:2, pages 171-173.
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Rebecca Trowman, Alicia Powers & Daniel A. Ollendorf. (2021) Considering and communicating uncertainty in health technology assessment. International Journal of Technology Assessment in Health Care 37:1.
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Richard Ofori-Asenso, Christine E. Hallgreen & Marie Louise De Bruin. (2020) Improving Interactions Between Health Technology Assessment Bodies and Regulatory Agencies: A Systematic Review and Cross-Sectional Survey on Processes, Progress, Outcomes, and Challenges. Frontiers in Medicine 7.
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Ashlyn Pinto, Huseyin Naci, Emilie Neez & Elias Mossialos. (2020) Association Between the Use of Surrogate Measures in Pivotal Trials and Health Technology Assessment Decisions: A Retrospective Analysis of NICE and CADTH Reviews of Cancer Drugs. Value in Health 23:3, pages 319-327.
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Maggie MacNeil, Melissa Koch, Ayse Kuspinar, Don Juzwishin, Pascale Lehoux & Paul Stolee. (2019) Enabling health technology innovation in Canada: Barriers and facilitators in policy and regulatory processes. Health Policy 123:2, pages 203-214.
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Joseph P. Castlen, David J. Cote & Marike L. D. Broekman. 2019. Ethics of Innovation in Neurosurgery. Ethics of Innovation in Neurosurgery 75 82 .
Jaclyn Beca, Don Husereau, Kelvin K. W. Chan, Neil Hawkins & Jeffrey S. Hoch. (2017) Oncology Modeling for Fun and Profit! Key Steps for Busy Analysts in Health Technology Assessment. PharmacoEconomics 36:1, pages 7-15.
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Faiez Zannad, Maria de los Angeles Alonso Garcia, Jeffrey S. Borer, Wendy Gattis Stough, Thomas Clutton-Brock, Yves Rosenberg & Milton Packer. (2017) Role of Payers in the Development of Cardiovascular Therapeutics. Journal of the American College of Cardiology 70:22, pages 2822-2830.
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Oriana Ciani, Marc Buyse, Michael Drummond, Guido Rasi, Everardo D. Saad & Rod S. Taylor. (2017) Time to Review the Role of Surrogate End Points in Health Policy: State of the Art and the Way Forward. Value in Health 20:3, pages 487-495.
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Oriana Ciani, Britni Wilcher, Anoukh van Giessen & Rod S. Taylor. (2017) Linking the Regulatory and Reimbursement Processes for Medical Devices: The Need for Integrated Assessments. Health Economics 26, pages 13-29.
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B.A. Fiedler & L.J. Greathouse. 2017. Managing Medical Devices Within a Regulatory Framework. Managing Medical Devices Within a Regulatory Framework 203 224 .
Shingo Kano. (2016) Interaction analysis between innovation and regulation: The concept of Regulatory Science as a Process (RaaP) and its applications. Interaction analysis between innovation and regulation: The concept of Regulatory Science as a Process (RaaP) and its applications.
Sarah Kleijnen, Mohammed Fathallah, Michiel W. van der Linden, Piet Vancraeynest, Bachir Dahmani, Angela Timoney, Anthonius De Boer, Hubertus G. Leufkens & Wim G. Goettsch. (2015) Can a Joint Assessment Provide Relevant Information for National/Local Relative Effectiveness Assessments? An In-Depth Comparison of Pazopanib Assessments. Value in Health 18:5, pages 663-672.
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Michael Drummond. 2015. Health Technology Assessment and Health Policy Today: A Multifaceted View of their Unstable Crossroads. Health Technology Assessment and Health Policy Today: A Multifaceted View of their Unstable Crossroads 3 14 .
Don Husereau, Chris Henshall & Jamil Jivraj. (2014) ADAPTIVE APPROACHES TO LICENSING, HEALTH TECHNOLOGY ASSESSMENT, AND INTRODUCTION OF DRUGS AND DEVICES. International Journal of Technology Assessment in Health Care 30:3, pages 241-249.
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Michael Berntgen, Anne Gourvil, Mira Pavlovic, Wim Goettsch, Hans-Georg Eichler & Finn Børlum Kristensen. (2014) Improving the Contribution of Regulatory Assessment Reports to Health Technology Assessments—A Collaboration between the European Medicines Agency and the European network for Health Technology Assessment. Value in Health 17:5, pages 634-641.
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Angela Rocchi, Shoghag Khoudigian, Rob Hopkins & Ron Goeree. (2013) Surrogate outcomes: experiences at the Common Drug Review. Cost Effectiveness and Resource Allocation 11:1, pages 31.
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