Meds Entry Watch, 5th Edition

Full report

This is the fifth edition of the PMPRB’s Meds Entry Watch report, which explores the market entry of new medicines in Canada and other countries. Building on a retrospective analysis of trends since 2015, 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 2018 and 2019, and analyzes their uptake, pricing, sales, and availability as of the last quarter of 2019 (Q4-2019).

In addition to the international analysis, a Canadian-focused section provides information on medicines that received their first Health Canada approval in 2018, as well as a retrospective review of quarterly approvals over the past five years.

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, 2015 to 2019

Approximately 50 new medicines have been approved in each of the last three years, with orphan and oncology medicines making up a significant portion of new approvals.

Across Canada, US, and Europe, just over fifty new medicines were approved in both 2017 and 2018, with 47 new approvals in 2019.
Between 2015 and 2019, the shares of new approvals for orphan and oncology medicines averaged 27% and 48%, respectively, with variations from year to year.

A considerable portion of the new medicines approved internationally between 2015 and 2018 had Canadian sales by the end of 2019.

New medicines approved between 2015 and 2018 accounted for approximately 12% of brand-name medicine sales in Canada and the PMPRB11 in Q4-2019.
Just under 40% of these medicines had sales in Canada by Q4-2019, ahead of the OECD median (32%).
New medicines approved from 2015 to 2018 with Canadian sales accounted for 87% of all new medicine sales in the OECD in Q4-2019, indicating that the higher-selling medicines continue to be among those approved and sold in Canada.

B) 2018 New Medicine Approvals

Fifty-one new medicines were approved in 2018, with a pronounced increase in the number of orphan medicines authorized for market.

51 new medicines received market approval through the FDA, the EMA, and/or Health Canada in 2018.
Over 60% of the 2018 new medicines received an orphan designation from the FDA and/or the EMA, while more than 30% were indicated for the treatment of cancer.
Over two thirds of the new medicines had high treatment costs: 13 oncology medicines had costs exceeding $5,000 per 28-day cycle and 21 non-oncology medicines had annual costs exceeding $10,000.

Fewer medicines were approved in Canada than in the US and Europe in 2018, although Canada compared favourably to the OECD in terms of the corresponding share of sales.

20 of the 51 new medicines first approved in 2018 had market authorization in Canada by Q4-2019, compared to 50 approved by the FDA and 32 by the EMA.
Of the 20 approved medicines, nine had recorded sales in Canada by the end of 2019, placing Canada ninth in the OECD and in line with the PMPRB11 countries for the number of new medicines with sales.
Although these nine medicines represent a relatively small portion of the total number of approvals in 2018, they accounted for 75% of total sales for new medicines in the OECD.

Sales for 2018 new medicines were highly concentrated, with a single antiviral medicine accounting for the majority of new medicine revenue in the last quarter of 2019.

The HIV treatment Biktarvy (bictegravir) was responsible for 52% of OECD new medicine sales in Q4-2019, making up the vast majority of the 53% total share held by the antivirals class.
Analgesics were the second highest-selling class with three migraine medicines (erenumab, galcanezumab, and fremanezumab) accounting for 15% of 2018 new medicine sales.
Respiratory disease treatments accounted for one tenth of international new medicine sales, attributable to the new medicine tezacaftor, which is used in cystic fibrosis treatments Symdeko and Trikafta.
Oncology medicines, comprised of cytostatic hormone therapy and antineoplastics, made up 8% of new medicine sales.

C) 2019 New Medicine Approvals

The rate of new medicine approvals in 2018 was sustained through 2019, bringing a number of new high-cost oncology treatments to the market.

47 new medicines received market approval through the FDA, the EMA, and/or Health Canada in 2019. Of these, 16 were approved in Canada by the third quarter of 2020.
In total, 40% (19) of the new medicines received an orphan designation from the FDA and/or the EMA. Oncology treatments accounted for 23% (11) of the 2019 new medicines, while biologics made up nearly a third (14) of the approvals.
Based on preliminary results, nine oncology medicines had treatment costs exceeding $5,000 per 28-day cycle.

D) Spotlight on Canada

The number of new medicines that received their first Canadian approval in 2018 was in line with trends observed over the past five years.

40 new-to-Canada medicines were approved for market in 2018, of which 22 had reported sales by Q4-2019, accounting for 1.6% of the total Canadian pharmaceutical market.
Four of the five internationally top-selling new medicines in 2018 received market authorization in Canada in the same year, including Biktarvy (bictegravir), which represented 21% of all Canadian 2018 new medicine sales by Q4-2019.
An analysis of the rate of new medicine approvals in Canada found a steady annual trend of approximately nine approvals per quarter over the past five years.