PMPRB report reveals most new medicines come to market with high treatment costs

News release

August 22, 2023 — Ottawa, ON — Patented Medicine Prices Review Board

The Patented Medicine Prices Review Board (PMPRB) published today the 7th edition of its annual Meds Entry Watch report. The analysis finds that the number of new medicines launched in Canada is higher than the median for Organisation for Economic Co-operation and Development (OECD) countries but falls below the median of the eleven PMPRB comparators, all of which have lower average patented medicine prices according to the PMPRB’s Annual Report, 2021. Most new medicines come to market with high treatment costs, and specialty medicines such as biologic, orphan, and cancer treatments continue to make up a growing share of the new drug landscape.

The Meds Entry Watch report focuses on medicines approved by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and/or Health Canada. This edition examines trends in the market for new medicines approved since 2016, highlighting the 50 medicines that received first-time market approval in 2020 and providing a preliminary analysis of the 55 medicines approved in 2021. The report also includes a section focused on medicines that were new to Canada in 2020 with an analysis of the rate of approvals per quarter 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.

Quick facts

  • In 2020, 50 new medicines were approved by the FDA, the EMA, and/or Health Canada. Of those, 76% had high treatment costs (>$10,000 annually or >$5,000 per 28-day treatment cycle), 58% received an orphan designation, and 36% were oncology medicines.

  • In 2021, a five-year high of 55 medicines received first-time market approval through the FDA, the EMA, and/or Health Canada. Of those, three quarters had high treatment costs, 42% received an orphan designation from the FDA and/or the EMA, and 27% were oncology treatments. 

  • 2020 saw the approval of two new actives substances indicated for the treatment and prevention of COVID-19: a treatment (remdesivir) and a vaccine class (mRNA COVID-19 vaccines were considered a single medicine). 2021 saw the approval of eight new medicines indicated for COVID-19, a notable increase from 2020.

  • Canada approved 36 new medicines in 2020 and 43 in 2021. As of Q4-2021, remdesivir and tafamidis were the highest-selling among Canada’s 2020 newly approved medicines with 57% and 24% of new-to-Canada sales, respectively.

  • From 2016 to 2021, an average of 47 new medicines were approved internationally each year. 

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