Potential impact of subsequent entry biologics in nephrology practice in Canada

Canadian Journal of Kidney Health and Disease
Daniel J MartinusenMarianna Leung

Abstract

Subsequent entry biologics may soon be a reality in Canadian nephrology practice. Along with opportunities to reduce health care costs, these agents pose unique challenges that must be met for successful implementation. Understanding the experiences around the globe in both regulatory affairs and implementation will be a valuable guide for Canadian clinicians. This report provides an executive summary of the information required to guide decisions to use or implement subsequent entry biologics by comparing Canadian regulations to other developed nations, discussing their clinical issues and predicting their impact on the Canadian market and nephrology practice. We hope that this review will assist clinicians and policy makers to navigate this complex subject and to make informed decisions in the best interest of their patients. Sources of information include published literature and reports available in the public domain including guidelines obtained from regulatory agencies and information shared by Pharmaceutical companies. Lastly, we generated information from our own focus group consisting of nephrologists, a regulatory body representative, a hospital formulary representative, a patient representative, a hospital administra...Continue Reading

References

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Citations

Oct 14, 2016·Clinical Rheumatology·Valderilio AzevedoBrian Fitzpatrick
Jan 1, 2014·Canadian Journal of Kidney Health and Disease·Judith Genevieve MarinDaniel J Martinusen

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