Meds Entry Watch 2018

This is the fourth edition of the PMPRB’s Meds Entry Watch report, which explores the market entry of new medicines in Canada and other countries. Building on the retrospective analysis of trends since 2009, this report focuses on medicines that received first-time market approval through the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and/or Health Canada in 2017 and 2018, and analyzes their uptake, pricing, sales, and availability as of the last quarter of 2018 (Q4-2018). This edition includes a new Canadian section with information on medicines that received their first Health Canada approval in 2017, as well as those that were approved for new indications.

This publication informs decision makers, researchers, and patients of the evolving market dynamics of emerging therapies in Canadian and international pharmaceutical markets.

Key findings

A. Trends in New Medicine Approvals, 2009 to 2017

• Although the market impact of new medicine approvals has varied from year to year since 2009, the landscape has been characterized by a continued rise in the number of specialized treatments.

B. 2017 New Medicine Approvals

• More new medicines were approved in 2017 than in previous years, with a significant increase in the number of high-cost orphan and oncology medicines entering the market.
• Fewer medicines were approved in Canada than in the US and Europe in 2017, although Canada compared favourably to the OECD in terms of the corresponding share of sales.
• Antivirals and central nervous system medicines accounted for the majority of 2017 new medicine sales in the last quarter of 2018.

C. 2018 New Medicine Approvals

• The relatively high rate of new medicine approvals in 2017 was sustained through 2018, as the number of new high-cost specialty therapies continued to rise.

D. Spotlight on Canada

• A number of medicines received their first Canadian approval in 2017, though new indications approved for existing medicines had a greater impact on sales.

Full report