Shaping the Medicinal Landscape: An Overview of New Approvals
The landscape of new medicine approvals underwent significant changes in 2020 and 2021, as revealed in the latest edition of the Meds Entry Watch report published by the Patented Medicine Prices Review Board (PMPRB).
The report delves into trends shaping the pharmaceutical sector, examining medicines approved by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and/or Health Canada. A total of 50 new medicines secured first-time market approval in 2020, while 2021 witnessed a five-year peak of 55 new treatments entering the market.
Balancing Treatment Benefits with High Costs
Among these newly approved medicines, a substantial percentage bore high treatment costs, a factor that is increasingly relevant in healthcare decision-making.
In 2020, an astonishing 76% of the approved medicines came with treatment costs exceeding $10,000 annually or more than $5,000 per 28-day treatment cycle.
The trend persisted into 2021, where three-quarters of the new medicines also carried considerable financial implications.
Navigating Rare Diseases and Oncology
The report further highlights that 58% of the new medicines in 2020 received an orphan designation, emphasizing the industry’s commitment to addressing rare diseases. Moreover, 36% of the approved treatments in 2020 were dedicated to oncology, underscoring the persistent focus on battling cancer.
Continued Focus on Unmet Needs
The subsequent year, 2021, demonstrated a similar trend. Of the 55 medicines that achieved market approval, 42% received orphan designations, addressing unmet needs for rare conditions. Additionally, 27% of the medicines approved in 2021 were targeted toward oncology treatments.
Responding to a Global Crisis: COVID-19 Medicines
The report also emphasizes the pivotal role that the pharmaceutical industry played in responding to the COVID-19 pandemic. In 2020, two new active substances received approval for the treatment and prevention of COVID-19.
Remdesivir and mRNA COVID-19 vaccines took center stage as vital tools in the global battle against the virus. The following year, the momentum escalated, with eight new medicines being approved for COVID-19 indications, reflecting a significant increase from the previous year.
Canada’s Role in Medicine Approvals
Canada, as a critical player in the global pharmaceutical landscape, approved 36 new medicines in 2020 and 43 in 2021.
Notably, the highest-selling among Canada’s newly approved 2020 medicines were remdesivir and tafamidis, contributing 57% and 24% respectively to new-to-Canada sales by Q4-2021.
The Broader International Perspective
As the report examines the broader international context, it reveals that there was an average annual approval of 47 new medicines across the globe from 2016 to 2021.
The Meds Entry Watch report positions Canada’s new medicine launch rate as exceeding the median for Organisation for Economic Co-operation and Development (OECD) countries, yet falling below the median of the eleven PMPRB comparators.
These comparators exhibit lower average patented medicine prices, as outlined in the PMPRB’s Annual Report for 2021.
Insights from the Meds Entry Watch Report
The 7th edition of the Meds Entry Watch report, as published by the PMPRB, offers a comprehensive analysis of the evolving landscape of emerging therapies in both Canadian and international pharmaceutical markets.
Focusing on medicines approved since 2016, the report provides valuable insights into the dynamics of the new medicine market. It underscores the shift towards high treatment costs and the growth of specialty medicines, including biologics, orphan drugs, and cancer treatments.
Shaping the Future of Medicine Approvals
As decision-makers, researchers, and patients delve into the Meds Entry Watch report, they gain a deeper understanding of the evolving pharmaceutical landscape.
With insights drawn from the trends of the past five years, the report informs strategies, drives conversations, and shapes the future trajectory of medicine approvals and access.