Patented Medicine Review Process Quiz
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Questions and Answers

What is one of the factors considered by the Patented Medicine Prices Review Board (PMPRB) when evaluating whether a patented medicine's price is excessive?

  • The color of the medicine packaging
  • The brand name of the medicine
  • The size of the pharmaceutical company producing the medicine
  • The number of countries where the medicine is sold (correct)
  • Which organization in Canada plays a role in assessing value through the Health Technology Assessment (HTA) process?

  • PMPRB
  • CADTH (correct)
  • pCODR
  • CDR
  • What does INESSS stand for in the context of reviewing patented medicines in Canada?

  • International Society of Pharmaceutical Evaluators
  • National Canadian Drug Evaluation Agency
  • Institut national d'excellence en santé et services sociaux (correct)
  • International Network of Health Technology Assessors
  • Which entity is responsible for monitoring and reporting on price trends and research & development (R&D) spending of patented medicines in Canada?

    <p>PMPRB</p> Signup and view all the answers

    What is the primary objective of the Patented Medicine Prices Review Board (PMPRB) in Canada?

    <p>To ensure that prices of patented medicines are not excessive</p> Signup and view all the answers

    Which legislation provides guidance on factors to be considered by the Patented Medicine Prices Review Board (PMPRB) when assessing a medicine's price?

    <p>Patent Act</p> Signup and view all the answers

    What is a drug product considered to offer if it provides slight or no improvement in therapeutic effects compared to other drugs in Canada?

    <p>Slight or no improvement</p> Signup and view all the answers

    What is the purpose of the Scientific Review Process in the patented medicine review?

    <p>To assess the level of therapeutic improvement of patented drug products</p> Signup and view all the answers

    Which factor is NOT considered when recommending the level of therapeutic improvement for a new patented drug?

    <p>Adherence to maximum dosage in product monograph</p> Signup and view all the answers

    Which entity may gather information on clinical trials and product monographs for the Scientific Review Process?

    <p>Drug Information Centre (DIC)</p> Signup and view all the answers

    How is the National and Market-Specific Non-Excessive Average Price determined for existing patented drug products?

    <p>Based on the level of therapeutic improvement</p> Signup and view all the answers

    What process is used to establish the Maximum Average Potential Price for a new patented drug at introduction?

    <p>Price Review Process</p> Signup and view all the answers

    What is the primary process used in determining the primary indication for a new drug?

    <p>Scientific Review Process</p> Signup and view all the answers

    What role do members of the Human Drug Advisory Panel (HDAP) play in the scientific review process?

    <p>Undertaking research to supplement evidence received from other sources</p> Signup and view all the answers

    Which factor is given the greatest weight when recommending the level of therapeutic improvement?

    <p>Increased Efficacy</p> Signup and view all the answers

    Which type of information is NOT considered during the Scientific Review Process for patented drugs?

    <p>Generic drug prices</p> Signup and view all the answers

    What is the ceiling price assigned to new patented medicines based on?

    <p>Therapeutic class comparison</p> Signup and view all the answers

    What is one source of scientific information used in the patented medicine review process apart from the patentee's submission?

    <p>Research by Human Drug Advisory Panel (HDAP) members</p> Signup and view all the answers

    Which of the following does NOT influence the level of therapeutic improvement recommendation?

    <p>Patient Affordability</p> Signup and view all the answers

    What does a drug with breakthrough improvement achieve?

    <p>Is the first to effectively treat a particular illness or indication in Canada.</p> Signup and view all the answers

    What is NOT considered when determining the primary indication for a new patented drug?

    <p>Existing competitors in the market</p> Signup and view all the answers

    Which factor influences the level of therapeutic improvement recommendation based on patient convenience and caregiver needs?

    <p>Compliance improvements for caregivers</p> Signup and view all the answers

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