No less than 80 per cent of the new drugs introduced between 2018 and 2023 in Organisation for Economic Co-operation and Development (OECD) member countries are available in Canada, according to the ninth annual Meds Entry Watch report published by the Patented Medicine Prices Review Board (PMPRB). Based on this metric, Canada ranks fourth among OECD countries. 

The PMPRB monitors the prices of patented medicines sold in Canada and publishes analyses on pharmaceutical trends. 

The report lists new active-substance drugs that received market approval from Health Canada, the U.S. Food and Drug Administration (FDA), or the European Medicines Agency (EMA). 

In 2023, 63 medicines received first-time market approval through the FDA, the EMA, and/or Health Canada, up from 48 the previous year. Since 2018, they have approved an average of 52 new therapies annually. 

The number of these 63 drugs ultimately approved varies depending on the relevant national or regional health authority, as shown in the following chart.

Drugs approved between 2018 and 2022 accounted for 8 per cent of total drug sales in Canada in 2023. 

Top-selling drugs 

Tirzepatide (Mounjaro), a diabetes treatment approved in 2022, was the top-selling new medication, accounting for 63 per cent of new drug sales in the fourth quarter of 2023. 

Diabetes treatments ranked first among therapeutic classes with the highest sales in 2022, followed by ophthalmological medications. 

Among the latter, faricimab (Vabysmo), used to treat age-related macular degeneration and diabetic macular edema, led 2022-approved treatments in Canadian sales, representing 30 per cent of total new drug sales in Q4 2023. 

“Canadian Q4-2023 sales of new medicines were led by bictegravir, an HIV medicine introduced in 2018, and risankizumab, a medicine for the treatment of plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis introduced in 2019,” the report also notes. 

More orphan drugs 

An average of about 40 new drugs were approved annually in Canada between 2019 and 2023. Of those, 35 per cent were high-cost treatments for rare diseases—also known as orphan drugs—according to the report. 

These treatments cost more than $100,000 per year or $7,500 per 28-day cycle in the case of oncology drugs (see page 4 of the report). 

In 2022, over half (58 per cent) of the 48 new drugs approved for sale were designated as orphan drugs by the FDA, EMA, or Health Canada. That share rose to 63 per cent in 2023. Over the past five years, the lowest share was in 2019, at 38 per cent. 

The share of new oncology drugs remained stable, at 27 per cent, for the years 2021, 2022 and 2023. 

More affordable than in the U.S. 

Drugs sold in Canada are generally less expensive than in the United States. 

A comparison table of nearly 40 drugs approved in 2022 shows U.S. prices were between 1.31 and 11.68 times higher than Canadian prices. 

Among the drugs with publicly available prices, only selumetinib was cheaper in the U.S. than in Canada, with a U.S.-to-Canada price ratio of 0.88. 

Price differences are less pronounced between Canada and Europe, with median price ratios ranging from 0.66 to 1.37. The comparison is based on the prices of patented medicines in 11 reference countries (PMPRB11): Germany, Australia, Belgium, Spain, France, Italy, Japan, Norway, the Netherlands, the United Kingdom and Sweden. 

Looking ahead 

“Of 250 new active substances, 169 (68%) had been submitted for Health Canada review by September 2024,” the PMPRB notes. 

Of those, 153 drugs were deemed eligible; eight were still under review, and another eight were rejected. The remaining 81 drugs (32 per cent) had not yet been assessed.