New Medicines Landscape in Canada & Abroad: PMPRB Outlines Trends in Pharmaceutical Approvals, Sales and Drug Pricing
On May 5, 2022, the Patented Medicine Prices Review Board (“PMPRB”) presented an Overview of the New Medicines Landscape in Canada. The presentation outlined trends in pharmaceutical approvals, sales and drug pricing internationally and in Canada, as recently reported in the sixth edition of the PMPRB’s Meds Entry Watch Report.
Below we summarize the key takeaways from the Board’s presentation and report:
- New medicine approvals trending upwards
- An average of 45 new medicines received first-time market approval through the FDA, EMA and/or Health Canada annually between 2015 and 2020.
- 50 new medicines received market approval from Canada, Europe and the U.S. in 2020 (up from 47 in 2019).
- Oncology and orphan drug therapies dominate new drug approvals
- Almost half of new medicines approved in Canada in 2019 were indicated to treat cancer.
- New medicines that received market approval from Canada, Europe and the U.S. in 2020 included greater shares of orphan and oncology treatments:
- ~58% of new approvals received an orphan designation from the FDA and/or EMA (up from 40% in 2019)
- ~34% of new approvals were for the treatment of cancer (up from 23% in 2019)
- Of the new medicines, 75% had treatment costs exceeding 10,000 per year or $5,000 per 28-day course (up from ~60% in Q4 2019).
- Trends in drug pricing for new patented medicines
- Canadian drug prices were ~9% higher than median prices among the PMPRB 11 comparator countries in the last quarter of 2019, and ~170% lower than prices for the same medicines in the United States.
- Of the 2019 new medicines reviewed by the Canadian Agency for Drugs and Technologies in Health (“CADTH”), none were determined to be cost-effective at the submitted price. Recommended price reductions ranged from 5% to over 90% of the submitted price.
The PMPRB has also released its 2021 Meds Pipeline Monitor Report, which contains an overview of new medicines in the development pipeline and analyses of new medicines with the potential to significantly impact drug spending. Other highlights include discussion of emerging Covid-19 therapies currently under review by Health Canada.
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 Australia, Belgium, France, Germany, Italy, Japan, the Netherlands, Norway, Spain, Sweden, and the United Kingdom.