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How Timely is Canada’s Medication Review and Approval Process?

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This presentation was hosted by Gerry Jeffcott from 3Sixty Public Affairs, who was joined by two pharmaceutical policy researchers who have conducted analyses of Canada’s access performance over time and in comparison with other countries.

The session began with an overview of each of the elements of the Canadian review and approval process by our moderator. After that, the session explored each agency’s performances in terms of supporting efficient access to needed new medicines. We will also compare Canada with other similar countries to determine how we fare internationally in terms of gaining access.

The presentation includes an interactive question and answer session.

Published in: Health & Medicine
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How Timely is Canada’s Medication Review and Approval Process?

  1. 1. How Timely is Canada’s Medication Review and Approval Process? CCSN Webinar | January 24, 2019
  2. 2. Dr. Nigel Rawson PresentersModerator Gerry Jeffcott Sarah Lussier-Hoskyn President Eastlake Research Group Senior Associate 3Sixty Public Affairs Sr. Analyst, Regulatory Affairs & Market Access Innovative Medicines Canada 2
  3. 3. How New Medicines are Reviewed and Funded in Canada 3
  4. 4. Health Canada • Health Canada is responsible for protecting Canadians’ health and well- being • Its reviews ensure medicines are safe, effective and manufactured appropriately; Cost / prices are not considered • Success comes in the form of a Notice of Compliance (NoC) / Notice of Compliance with conditions (NoC/c): - Product monograph outlines indications covered and clinical claims which can be made
  5. 5. Health Technology Assessment Canadian Agency for Drugs and Technologies in Health (CADTH) • Canada’s health technology assessment agency • Charged with producing non-binding, scientifically- based, expert recommendations addressing whether a medication should be publicly reimbursed and under what circumstances • It has two relevant programs • Expert review of comparative clinical and cost-effectiveness for non-oncology medicines • It issues formulary listing recommendations to participating public drug plans • Conducts expert reviews oncology medications • It issues formulary listing recommendations to participating public drug plans and cancer agencies
  6. 6. pan-Canadian Pharmaceutical Alliance (pCPA) • A national, multi-jurisdictional negotiations mechanism • Involves all provinces and territories • One jurisdiction negotiates on behalf of all • If negotiations are successful, separate agreements are completed with each interested jurisdiction Product Listing Agreements • Confidential agreements between innovative manufacturers and public drug benefit programs to facilitate improved access • Terms intended to address limitations identified by HTA reviews • Typically involve manufacturers offering financial considerations (i.e., rebates)
  7. 7. Public Formularies & Hospitals Public Formularies • Public drug plans vary widely, but all independently determine coverage on their drug benefit plan/cancer agency formularies • Some conduct additional HTA reviews after CDR/pCODR • All consider: - Budgetary capacity - Plan characteristics - Determination of clinical criteria (if any) - Price and utilization negotiations Hospitals • Medications administered in Canadian hospitals to eligible residents are fully funded by the public health care system (Medicare)
  8. 8. Patented Medicine Prices Review Board (PMPRB) • Federal regulatory agency • PMPRB’s mandate is to ensures that prices for patented medicines sold in Canada are not “excessive” • Determines the maximum (factory-gate) prices that can be charged in Canada for patented medications • Also regulates the level of price increase manufacturers may take on an annual basis
  9. 9. Pre-marketing Regulatory Submission Studies • Animal studies • Phase 1: Testing on healthy volunteers for safety • Phase 2: Testing on patients to assess efficacy and side effects • Phase 3: Testing on patients to assess efficacy, effectiveness and safety 9
  10. 10. Regulatory Assessment • Efficacy from randomized clinical trials and other studies • Safety from randomized clinical trials and toxicology studies • Manufacturing quality and consistency • Labeling Not cost-effectiveness 10
  11. 11. Median Approval Times by Year of Approval 0 100 200 300 400 500 600 700 800 900 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 Days Health Canada European Medicines Agency Food and Drug Administration 11
  12. 12. Median Approval Times by Drug Category 0 100 200 300 400 500 600 Days Health Canada European Medicines Agency Food and Drug Administration 12
  13. 13. Ranking of Submissions in Canada relative to Europe and the United States by Years 0 10 20 30 40 50 60 70 80 90 2002-2006 2007-2011 2012-2016 Percent First Second Third 13
  14. 14. Ranking of Submissions in Canada Relative to Europe and the United States by Drug Category 0 10 20 30 40 50 60 70 80 90 Percent First Second Third 14
  15. 15. Ranking of Submissions in Canada Relative to New Zealand by Drug Category 0 10 20 30 40 50 60 70 80 90 100 Percent First Second 38
  16. 16. Median Approval Times by Drug Category in Canada and New Zealand 0 100 200 300 400 500 600 Days Health Canada Medsafe (NZ) 39
  17. 17. 40
  18. 18. Canadian Cancer Survivor Network Contact Info Canadian Cancer Survivor Network 1750 Courtwood Crescent, Suite 210 Ottawa, ON K2C 2B5 Telephone / Téléphone : 613-898-1871 E-mail jmanthorne@survivornet.ca or mforrest@survivornet.ca Web site www.survivornet.ca Instagram: @survivornet_ca Twitter: @survivornetca Facebook: www.facebook.com/CanadianSurvivorNet Pinterest: http://pinterest.com/survivornetwork/ 41

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