Health Canada approval rate for medicines edges above five-year average

The latest annual Meds Entry Watch report from the Patented Medicine Prices Review Board (PMPRB) has found that between 2017 and 2022, an average of 50 new medicines were approved each year internationally. Among these drugs, 81 per cent reported new medicine sales in Canada.

They say migraine medicine atogepant was the highest-selling new medicine of 2021, accounting for 17 per cent of sales in the fourth quarter of 2022. In Canada, sales of semaglutide generated over $1-billion in revenue, over a quarter of new medicine revenues in 2022. As of the fourth quarter of 2022, trastuzumab deruxtecan and risdiplam were the highest-selling among Canada’s 2021 newly approved medicines with 37 per cent and 26 per cent of new-to-Canada sales, respectively, the report states.

Speciality medicines 

“Most new medicines come to market with high treatment costs,” the PMPRB states in an announcement about the publication’s release. “Speciality medicines such as biologic, orphan and cancer treatments continue to make up a growing share of the new drug landscape.” 

The analysis of drug trends includes a look at 55 medicines that received first time market approval in 2021 and provides a preliminary analysis of the 48 medicines approved in 2022. Using the PMPRB’s criteria, 254 new medicines were identified as new approvals between 2017 and 2022. In 2022, orphaned medicines – those developed to treat rare conditions that are not profitable to produce without assistance – accounted for 56 per cent of new approvals, while oncology medicines represented 27 per cent.

The report goes on to rank the new medicines approved, including their availability, share of sales, prices and treatment costs. Until the end of the third quarter in 2023 it also looks at assessments, recommendations and reimbursement decisions for 2021 new medicines approved in Canada. 

High-cost drugs 

“Of the 42 new medicines with available treatment costs, 36 (85 per cent) cost over $10,000 per year or $5,000 per 28-day cycle for oncology. Of 13 new oncology medicines, six fell into this high-cost category and the remaining seven were identified as expensive drugs for rare diseases (EDRDs)— orphan-designated therapies exceeding $100,000 in annual treatment costs, or $7,500 per 28-day cycle for oncology,” the report states. “Every single oncology medicine fell into one of these two high-cost categories. Sixteen of 29 non-oncology medicines were categorized as high-cost and an additional seven were identified as EDRDs. In total, 14 EDRDs accounted for 28 per cent of new medicine sales in Q4-2022.” 

In Canada, Health Canada approved 43 new medicines in 2021 and 46 in 2022, both above the five-year average of 40.