Most new medicines come to market with high treatment costs, while specialty medicines including biologic, orphan and cancer treatments continuing to make up a growing share of the new drug landscape, according to the 10th edition of the Patented Medicine Prices Review Board (PMPRB) annual Meds Entry Watch report.
The report focuses on medicines approved by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and Health Canada between 2021 and 2025. The report provides an analysis of uptake, pricing, sales and availability, as of the last quarter of 2024.
“In Q4-2024, 77 per cent of total OECD (Organisation for Economic Co-operation and Development) sales of new medicines were for medicines that had sales in Canada, indicating that Canada continues to approve and sell the highest-selling medicines approved internationally,” they write.
On average, Health Canada granted market authorization to 41 new medicines each year during the study period. On average, 14 of those drugs, 34 per cent, were expensive drugs for rare diseases.
“Expensive drugs for rare diseases are therapies with an orphan designation from the FDA or EMA and treatment costs exceeding $100,000 annually per patient. For oncology drugs, the threshold used is $7,500 per 28-day cycle. High-cost drugs are those with an average annual cost of $10,000 or more per patient,” the report states.
The report’s findings include that, over the past five years, most new medicine approvals have been for biologic, oncology or orphan-designated medicines, they add. (Orphan medicines are those for treating rare diseases.) “Combined, specialty medicines make between 70 per cent and 80 per cent of approvals in each of the past five years.”
