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 (C)</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 (B)</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 (D)</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 (A)</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 (B)</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 (A)</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) (D)</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 (A)</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 (A)</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 (C)</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 (C)</p> Signup and view all the answers

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

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

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

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

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

<p>Patient Affordability (B)</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. (A)</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 (A)</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 (B)</p> Signup and view all the answers

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