Insight into Approvals, Marketing, and Pricing of New Medicines 2018 to 2022
Author(s)
Blake Wladyka, MBA, MS;
Patented Medicine Prices Review Board, Economist, Ottawa, ON, Canada
Patented Medicine Prices Review Board, Economist, Ottawa, ON, Canada
OBJECTIVES: The price of new medicines in Canada and around the world continues to grow. High-cost specialty medicines, which include biologics, orphan drugs, and cancer products, are increasingly dominating the landscape. Many of these medicines have treatment costs in tens or hundreds of thousands of dollars per year, yet many have limited evidence of therapeutic benefit. The objective of this presentation is to provide an overview of new medicine characteristics, access and pricing.
METHODS: This study explores the market entry dynamics of new medicines approved in Canada and internationally from 2018 to 2022. The analysis explores the availability, pricing and sales of medicines within a time frame of one calendar year following the year of first international approval and monitors how these metrics compare year over year.
RESULTS: On average, 52 new medicines have been approved each year internationally between 2018 and 2022. These medicines accounted for approximately 9% of pharmaceutical sales. Approximately two thirds of new medicines were submitted to Health Canada for approval by the time of this study, with a 90% success rate. Canada marketed approximately one third of new medicines by the end of 2023, ranking 14th out of 31 Organisation for Economic Co-operation and Development (OECD) countries. Medicines marketed in Canada accounted for the majority of new medicine sales internationally. In the last three years, over half of the new medicines approved internationally had treatment costs in excess of ten thousand Canadian dollars with many of those reaching over one million. Most received an orphan designation from at least one international approval body.
CONCLUSIONS: The number of new medicines approved internationally is stable with orphan designations and treatment costs increasing every year. Canadian access to new medicines ranks in the middle of the OECD.
METHODS: This study explores the market entry dynamics of new medicines approved in Canada and internationally from 2018 to 2022. The analysis explores the availability, pricing and sales of medicines within a time frame of one calendar year following the year of first international approval and monitors how these metrics compare year over year.
RESULTS: On average, 52 new medicines have been approved each year internationally between 2018 and 2022. These medicines accounted for approximately 9% of pharmaceutical sales. Approximately two thirds of new medicines were submitted to Health Canada for approval by the time of this study, with a 90% success rate. Canada marketed approximately one third of new medicines by the end of 2023, ranking 14th out of 31 Organisation for Economic Co-operation and Development (OECD) countries. Medicines marketed in Canada accounted for the majority of new medicine sales internationally. In the last three years, over half of the new medicines approved internationally had treatment costs in excess of ten thousand Canadian dollars with many of those reaching over one million. Most received an orphan designation from at least one international approval body.
CONCLUSIONS: The number of new medicines approved internationally is stable with orphan designations and treatment costs increasing every year. Canadian access to new medicines ranks in the middle of the OECD.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
HPR5
Topic
Health Policy & Regulatory
Topic Subcategory
Approval & Labeling, Pricing Policy & Schemes, Public Spending & National Health Expenditures, Reimbursement & Access Policy
Disease
No Additional Disease & Conditions/Specialized Treatment Areas