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Access to Drugs in Canada—Overview

Access to Drugs in Canada—Overview. Durhane Wong-Rieger, PhD May 2010. Key Steps to Drug Access. Health Canada: Approval to Sell Common Drug Review: Cost-Effectiveness Provincial Drug Plans: Impact on Drug Budgets and Comparative Costs. Role of Health Canada. Two review bodies

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Access to Drugs in Canada—Overview

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  1. Access to Drugs in Canada—Overview Durhane Wong-Rieger, PhD May 2010 Access to Drugs Canada

  2. Key Steps to Drug Access • Health Canada: Approval to Sell • Common Drug Review: Cost-Effectiveness • Provincial Drug Plans: Impact on Drug Budgets and Comparative Costs Access to Drugs Canada

  3. Role of Health Canada • Two review bodies • Therapeutic Products Directorate: Reviews chemical entities and compounds • Biologic and Genetic Therapeutics Directorate: Reviews biologically based drugs, vaccines, and stem cell therapies • Manufacturer Must Make Application • Company decides to “sell” drug in Canada • Company applies for specific indications • Company pays “application fee” • Drug is assigned a file number and committee Access to Drugs Canada

  4. Health Canada: Safety and Efficacy • Company submits evidence from clinical trials • Is Drug Safe? • Does it cause serious harm? • What are side effects? • Does drug work? • Does it reduce symptoms, improve outcomes, or cure? • Is it more effective for some people? • How long have the benefits been studied? • Do benefits outweigh harms? • Is this a life-threatening or serious disease? • What are other treatments available? • What is long-term evidence of benefit versus harm? Access to Drugs Canada

  5. Health Canada Decisions • Notice of Compliance (NOC): Approval to market drug in Canada • Approval for specified conditions • Reality: physicians make prescribe for anyone • Notice of Compliance with Conditions (NOC/c): Approval to market with specific conditions attached • “Breakthrough” drugs usually for conditions where no drug is presently available or offers significant advantage • May lack direct evidence of disease impact but evidence on “surrogate” markers that represent disease impact • Often required to do follow-up studies • Notice of Noncompliance: May not market in Canada Access to Drugs Canada

  6. Access to Drugs Canada

  7. CDR Recommends to Drug Plans Regulatory Authority approves drugs for sale in Canada based on safety & efficacy CDR established in 2003 to assess if drugs should be reimbursed by publicly funded drug plans Common Drug Review Health Canada Canadian Expert Drug Advisory Committee (CEDAC) 11 Experts Federal Drug Programs (NIHB, VAC, RCMP) BC AB MB SK ON NB NS PE NL QC Does Not Participate in CDR Patients & Health Professionals Access to Drugs Canada

  8. How Drugs are Funded in Québec • Manufacturer submits • Conseil du médicament conducts review • Clinical perspective • Financial perspective • Recommendation to Minister of Health • Minister of Health gives decision • Provincial formulary listing (updated 3 times a year) Access to Drugs Canada

  9. Therapeutic Product Directorate Commun Drug Review (CDR /CADTH) Patented Medicines Prices Review Board (PMPRB) Conseil du médicament + Ministre de la santé Provincial Expert Cmttes + ADM/MOH Decision Making to Access Drugs in Quebec vs. Other Provinces Access to Drugs Canada

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