22 Questions
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 number of countries where the medicine is sold
Which organization in Canada plays a role in assessing value through the Health Technology Assessment (HTA) process?
CADTH
What does INESSS stand for in the context of reviewing patented medicines in Canada?
Institut national d'excellence en santé et services sociaux
Which entity is responsible for monitoring and reporting on price trends and research & development (R&D) spending of patented medicines in Canada?
PMPRB
What is the primary objective of the Patented Medicine Prices Review Board (PMPRB) in Canada?
To ensure that prices of patented medicines are not excessive
Which legislation provides guidance on factors to be considered by the Patented Medicine Prices Review Board (PMPRB) when assessing a medicine's price?
Patent Act
What is a drug product considered to offer if it provides slight or no improvement in therapeutic effects compared to other drugs in Canada?
Slight or no improvement
What is the purpose of the Scientific Review Process in the patented medicine review?
To assess the level of therapeutic improvement of patented drug products
Which factor is NOT considered when recommending the level of therapeutic improvement for a new patented drug?
Adherence to maximum dosage in product monograph
Which entity may gather information on clinical trials and product monographs for the Scientific Review Process?
Drug Information Centre (DIC)
How is the National and Market-Specific Non-Excessive Average Price determined for existing patented drug products?
Based on the level of therapeutic improvement
What process is used to establish the Maximum Average Potential Price for a new patented drug at introduction?
Price Review Process
What is the primary process used in determining the primary indication for a new drug?
Scientific Review Process
What role do members of the Human Drug Advisory Panel (HDAP) play in the scientific review process?
Undertaking research to supplement evidence received from other sources
Which factor is given the greatest weight when recommending the level of therapeutic improvement?
Increased Efficacy
Which type of information is NOT considered during the Scientific Review Process for patented drugs?
Generic drug prices
What is the ceiling price assigned to new patented medicines based on?
Therapeutic class comparison
What is one source of scientific information used in the patented medicine review process apart from the patentee's submission?
Research by Human Drug Advisory Panel (HDAP) members
Which of the following does NOT influence the level of therapeutic improvement recommendation?
Patient Affordability
What does a drug with breakthrough improvement achieve?
Is the first to effectively treat a particular illness or indication in Canada.
What is NOT considered when determining the primary indication for a new patented drug?
Existing competitors in the market
Which factor influences the level of therapeutic improvement recommendation based on patient convenience and caregiver needs?
Compliance improvements for caregivers
Test your knowledge on the Patented Medicine Review Process, including the Scientific Review Process and Price Review Process. Learn about how drug products are assessed for therapeutic improvement and how prices are determined based on this assessment.
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