How Canadians Access Drugs for Rare Disorders Health ：加拿大人如何访问罕见疾病的保健药物.pptVIP

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2018-06-24 发布于四川
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How Canadians Access Drugs for Rare Disorders Health ：加拿大人如何访问罕见疾病的保健药物.ppt

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How Canadians Access Drugs for Rare Disorders Health ：加拿大人如何访问罕见疾病的保健药物

Access to Drugs Canada Access to Drugs Canada Access to Drugs Canada Access to Drugs Canada Access to Drugs Canada Access to Drugs Canada Access to Drugs Canada Access to Drugs Canada Access to Drugs Canada Access to Drugs Canada Access to Drugs in Canada—Overview Durhane Wong-Rieger, PhD May 2010 May 2010 * Access to Drugs Canada 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 May 2010 Access to Drugs Canada * 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 May 2010 Access to Drugs Canada * 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? May 2010 Access to Drugs Canada * 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 s