Meds Entry Watch 9th Edition
Table of Contents
- Executive Summary
- Introduction
- Methods
- Limitations
- A: Trends in New Medicine Approvals, 2018–2023
- B: New Medicine Approvals and Sales, 2022
- C: New Medicine Approvals and Sales, 2023
- D: Spotlight on Canada
- References
- Appendix A: Medicines approved in Canada that have met EDRD criteria* (through Q4-2024)
ISSN: 2560-6204
Cat. No.: H79-12E-PDF
June 2025
Figures
- Figure A1: New medicines approved by the US FDA, the EMA, and/or Health Canada, 2018 to 2023
- Figure A2: New medicine cumulative share of all brand-name medicine sales by year of approval (2018 to 2022), Canada and the PMPRB11*
- Figure A3: Share of new medicines* from 2018 to 2022 with available sales and their respective share of OECD sales, by country, Q4-2023
- Figure A4: Health Canada review status of new active substances with an international approval between 2018 and 2022
- Figure B1: Number of 2022 new medicines with approval as of Q4-2022 and Q4-2023
- Figure B2: Number of 2022 new medicines with available sales and their respective share of OECD sales, by country, Q4-2023
- Figure B3: Distribution of 2022 new approvals for specialty medicines
- Figure B4: Distribution of new medicines approved in 2022 by treatment cost
- Figure C1: Number of 2023 medicines with approval as of Q4-2023 and Q3-2024
- Figure C2: Distribution of 2023 new approvals for specialty medicines
- Figure D1: Annual approvals for expensive drugs for rare diseases (EDRDs) and other new medicines in Canada, 2019 to 2023
Tables
- Table B1: New medicines approved in 2022, availability, share of sales, prices, and treatment costs, ranked by therapeutic class share of sales, Q4-2023
- Table B2: Assessments, recommendations, and reimbursement decisions for 2022 new medicines approved in Canada by Q3-2024
- Table B3: Summary of Reimbursement Review assessments for 2022 new medicines approved in Canada by Q3-2024
- Table C1: New medicines approved in 2023, availability, prices, and treatment costs, Q4-2023
- Table D1: Medicines first approved in Canada in 2022, availability, sales, and prices as of Q4-2023
- Appendix A: Medicines approved in Canada that have met EDRD criteria* (through Q4-2024)
About the PMPRB
The Patented Medicine Prices Review Board (PMPRB) protects and informs Canadian consumers by reviewing the prices of patented medicines sold in Canada, and by reporting on pharmaceutical trends. The PMPRB is an independent quasi-judicial body that is part of the Health portfolio, and operates at arm’s-length from the Minister of Health.
The NPDUIS Initiative
The National Prescription Drug Utilization Information System (NPDUIS) research initiative was established by federal, provincial, and territorial Ministers of Health in September 2001. It is a partnership between the PMPRB and the Canadian Institute for Health Information (CIHI).
Pursuant to section 90 of the Patent Act, the PMPRB has the mandate to conduct analysis that provides decision makers with critical information and intelligence on price, utilization, and cost trends so that Canada’s health care system has more comprehensive and accurate information on how medicines are being used and on sources of cost pressures.
The specific research priorities and methodologies for the NPDUIS research initiative are established with the guidance of the NPDUIS Advisory Committee and reflect the priorities of the participating jurisdictions, as identified in the NPDUIS Research Initiative Agenda. The Advisory Committee is composed of representatives from public drug plans in British Columbia, Alberta, Saskatchewan, Manitoba, Ontario, New Brunswick, Nova Scotia, Prince Edward Island, Newfoundland and Labrador, Yukon, the Non-Insured Health Benefits Program (NIHB), and Health Canada. It also includes observers from CIHI, Canada’s Drug Agency (CDA-AMC), the Ministère de la Santé et des Services sociaux du Québec (MSSS), and the pan-Canadian Pharmaceutical Alliance (pCPA) Office.
Acknowledgements
This report was prepared by the Patented Medicine Prices Review Board (PMPRB) as part of the National Prescription Drug Utilization Information System (NPDUIS) research initiative.
The PMPRB wishes to acknowledge and thank the members of the NPDUIS Advisory Committee for their expert oversight and guidance in the preparation of this report. Please note that the statements, findings, and conclusions do not necessarily reflect those of the members or their organizations.
Appreciation goes to Blake Wladyka for leading this project, and to Dianne Breau, Dr. Étienne Gaudette, and Brian O’Shea for their oversight and contributions to the report. The PMPRB also wishes to acknowledge the scientific contributions of Adam Fenwick and the editorial contributions of Shirin Paynter.
Disclaimer
The NPDUIS research initiative operates independently of the regulatory activities of the Board of the PMPRB. The research priorities, data, statements, and opinions expressed or reflected in NPDUIS reports do not represent the position of the PMPRB with respect to any regulatory matter. NPDUIS reports do not contain information that is confidential or privileged under sections 87 and 88 of the Patent Act, and the mention of a medicine in an NPDUIS report is not and should not be understood as an admission or denial that the medicine is subject to filings under sections 80, 81, or 82 of the Patent Act or that its price is or is not excessive under section 85 of the Patent Act.
Although this information is based in part on data obtained under license from the MIDAS® database proprietary to IQVIA Solutions Canada Inc. and/or its affiliates (“IQVIA”), the statements, findings, conclusions, views, and opinions expressed in this report are exclusively those of the PMPRB and are not attributable to IQVIA.
Contact Information
Patented Medicine Prices Review Board
Standard Life Centre
Box L40
333 Laurier Avenue West
Suite 1400
Ottawa, ON K1P 1C1
Tel.: 1-877-861-2350
TTY 613-288-9654
Email: PMPRB.Information-Renseignements.CEPMB@pmprb-cepmb.gc.ca
Web: https://www.canada.ca/en/patented-medicine-prices-review.html
Suggested Citation
Patented Medicine Prices Review Board. (2025). Meds Entry Watch, 9th edition. Ottawa: PMPRB.
Executive Summary
This is the ninth edition of the Meds Entry Watch report, which explores the market entry of new medicines in Canada and other countries. Prior to sale, medicines must be approved by the appropriate national or regional health authority. Building on a retrospective analysis of trends since 2018, this report focuses on medicines that received first-time approval from the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and/or Health Canada in 2022 and 2023, and analyzes their uptake, pricing, sales, and availability as of the last quarter of 2023 (Q4-2023).
In addition to the international analysis, a Canadian-focused section provides sales and pricing information on medicines that received their first Health Canada approval in 2022, as well as a retrospective review of approvals from 2019 to 2023.
This publication informs decision makers, researchers, and patients of the evolving market dynamics of emerging therapies in Canadian and international pharmaceutical markets.
The IQVIA MIDAS® database was the primary source for the sales and list prices of new medicines in Canadian and international markets, as well as for the quantity sold.
International markets examined include the Organisation for Economic Co-operation and Development (OECD) members, with a focus on Australia, Belgium, France, Germany, Italy, Japan, the Netherlands, Norway, Spain, Sweden, and the United Kingdom (UK), which comprise the PMPRB11 comparator countries. Where appropriate, the United States (US) is included to provide additional context.
Key Findings
- Trends in New Medicine Approvals, 2018 to 2023
- From 2018 to 2023, an average of 52 new medicines were approved internationally each year. Half of these medicines received an orphan designation from the FDA or EMA.
- In Q4-2023, 80% of total OECD 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. Canada ranked fourth among OECD countries for this metric.
- 2022 New Medicine Approvals and Sales
- In 2022, 48 new medicines were approved by the FDA, the EMA, and/or Health Canada. Of those, 28 (58%) received an orphan designation, including 12 of 13 (92%) oncology medicines. Of the 37 medicines for which a treatment cost was available, 17 (46%) were identified as expensive drugs for rare diseases (orphan-designated therapies exceeding $100,000 in annual treatment costs, or $7,500 per 28-day cycle for oncology).
- Canada ranked seventh among OECD countries in terms of new medicines with sales, despite fewer 2022 new medicines being approved in Canada than in the US and Europe.
- Diabetes medicine tirzepatide was the highest-selling new medicine of 2022, accounting for 63% of Q4-2023 sales.
- 2023 New Medicine Approvals and Sales
- In 2023, 63 medicines received first-time market approval through the FDA, the EMA, and/or Health Canada. Of those, 40 (63%) received an orphan designation from the FDA and/or the EMA, and 17 (27%) were oncology treatments.
- Of the new medicines approved in 2023, 16 (25%) recorded sales in PMPRB11 countries and/or Canada by Q4-2023.
- Spotlight on Canada
- Between 2019 and 2023, Health Canada approved 40 new medicines each year on average, of which 14 (35%) were expensive drugs for rare diseases.
- As of Q4-2023, faricimab was the highest-selling among Canada’s 2022 newly approved medicines with 30% of new-to-Canada sales.
Introduction
Meds Entry Watch is an annual publication that explores the dynamics of new medicines entering Canadian and international markets, providing information on their availability, sales, and prices.
This report builds on the eight previous editions to provide a broad analysis of medicines that have received market approval since 2018, with a special focus on medicines approved in 2022 and 2023. New medicines are identified for each year based on the date of their first market authorization by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and/or Health Canada. Prior to being sold in Canada, a medicine must receive a Notice of Compliance from Health Canada. Public drug plans may require further steps before adding the medicine to their formularies, including a cost-effectiveness review and price negotiations with manufacturers.
The report consists of four main sections: Section A provides an overview of trends from 2018 to 2023; Section B focuses on new medicines that received international market approval in 2022; Section C presents a preliminary analysis of the new medicines approved internationally in 2023; and Section D spotlights Health Canada approvals in 2022.
This publication informs decision makers, researchers, and patients of emerging therapies in Canadian and international pharmaceutical markets.
Methods
New medicines that received first-time market approval from the FDA, the EMA, and/or Health Canada since 2018 were analyzed, with a focus on those approved in 2022 and 2023. A new medicine was selected for analysis if it received market authorization from any of these regulatory bodies during the calendar year for the first time, even if it was not yet listed for reimbursement or if there were no recorded sales in the available source data. For the purposes of this analysis, new medicines were identified at the medicinal ingredient level. The approval of these medicines in Canadian and international markets was assessed as of the third quarter of 2024 (Q3-2024).
The selection of medicines featured in the analysis of the Canadian market in Section D differed from the previous sections. Medicines analyzed in Section D included new and previously marketed medicinal ingredients that received their first Canadian market authorization through Health Canada between 2019 and 2023, with a focus on those authorized in 2022. The latter included several medicines in the 2022 analysis in Section B, but also encompassed medicines that received initial approval through the FDA or EMA in previous years but were first approved for the Canadian market in 2022. Marketed status for Canadian approvals was sourced from Health Canada’s Drug Product Database.
The international markets examined included the Organisation for Economic Co-operation and Development (OECD) countries, with a focus on Australia, Belgium, France, Germany, Italy, Japan, the Netherlands, Norway, Spain, Sweden, and the United Kingdom (UK), which comprise the 11 PMPRB Schedule Countries (“PMPRB11”) specified in the amended Patented Medicines Regulations, which came into force July 1, 2022. Results for the United States (US) were also included for comparison purposes.
The IQVIA MIDAS® database (all rights reserved) was the main data source for the sales and list prices of new medicines in Canadian and international markets, as well as the volume of units sold. MIDAS® data reflects the national retail and hospital sectors for each country, including all sales (public, private, and out-of-pocket). Sales and volume data encompass all versions of a medicine available in a particular country, produced by any manufacturer in any strength and form. For more information on MIDAS® and other NPDUIS source materials, see the Resources section of the NPDUIS Analytical Studies webpage.
Canadian prices were based on MIDAS® data, if available; otherwise, they were obtained from publicly available results of the Reimbursement Review reports published by Canada’s Drug Agency (CDA-AMC). Treatment costs were calculated using Canadian list prices where possible; if not, the foreign median price was used. Information on dosing regimens was taken from the product monographs published by Health Canada, or if not available, from the FDA or EMA. Al medicines were reviewed as of Q3-2024.
Prices and foreign-to-Canadian price ratios were reported for the highest-selling form and strength of each medicine in Canada, or in the PMPRB11 if no Canadian sales were available at the time of the analysis. The foreign-to-Canadian price ratios presented in this report were expressed as an index with the Canadian price set to a value of one and the international median reported relative to this value. For more details on how foreign-to-Canadian price ratios are calculated, see the Resources section of the NPDUIS Analytical Studies webpage.
Prices and sales in foreign currencies were converted into Canadian dollars using the 12-month or 3-month average exchange rate for the year or quarter, respectively.
Limitations
New medicines reported in Sections A, B, and C are selected for analysis based on their date of market approval by the FDA, the EMA, and/or Health Canada. Some of the medicines reported may have earlier approval dates in other countries, such as Australia and Japan, which are governed by other regulatory bodies. Likewise, the medicines included in this analysis do not necessarily represent all of those introduced in 2022 and 2023, as other national regulatory bodies not examined in this report may have approved additional medicines. Nevertheless, as the FDA and EMA represent significant international markets, this is expected to have little effect on the overall results.
Market approval does not necessarily mean that the medicine is available for sale in the country or countries represented by the regulatory body granting approval. The availability of a new medicine in each country at any point in time is influenced by a variety of factors including the manufacturer’s business decision to launch, as well as the timing of that decision; the regulatory approval process in place; and the existing market dynamics. The assessment of medicine availability in Canada does not consider non-marketed medicines available through exceptional programs such as the Special Access Program (SAP) for drugs in Canada. Because this report describes the initial market penetration of new medicines, availability and uptake are expected to increase in subsequent years.
Canadian and international sales and prices are based on manufacturer list prices as reported in MIDAS®, and do not capture price rebates, managed entry agreements (also known as product listing agreements), dispensing fees, or patient access schemes. The methodology used by MIDAS® for estimating sales volumes and revenue, which are used to calculate unit prices, varies by country and data availability.
Some medicines with sales may not be reported in IQVIA MIDAS®, and thus, the sales of new medicines may be under-reported. However, as the effect is expected to be approximately consistent across all markets, this should not have an impact on the overall findings.
Aggregated international sales and pricing data are skewed towards the United States because it approved more drugs than other countries and had a larger market size. As a result, the ranking of medicines by international sales generally reflects the order of sales in the US.
Publicly available prices from Canada’s Drug Agency (CDA-AMC) are based on the manufacturers’ submitted list prices, which may differ from list prices upon market entry.
While vaccines are included in the report, their sales and pricing data are not included due to inconsistent information from data sources because an important portion of sales occur through government purchasing agreements.
A: Trends in New Medicine Approvals, 2018–2023
This section presents a five-year retrospective review of new medicine approvals and sales. It reports on the number of new medicines approved from 2018 to 2023 and tracks the progress of those approved from 2018 to 2022 through the end of 2023. Sales and pricing information is reported as of Q4-2023.
Specialty medicines such as orphan and oncology treatments made up an important share of the new medicines approved over the period. Canada ranked ninth among the PMPRB11 countries and thirteenth in the OECD in terms of the number of new medicines approved and sold domestically. By the end of 2023, 8% of all brand-name sales in Canada were for medicines first approved by the US FDA, the EMA, or Health Canada between 2018 and 2022.
An average of 52 new medicines received first-time market approval through the FDA, the EMA, and/or Health Canada annually between 2018 and 2023 (Figure A1). In 2022, 48 new medicines were approved, of which 28 (58%) received an orphan designation for at least one indication from the FDA and/or EMA, and 13 (27%) were indicated to treat cancer.
An additional 63 new medicines were approved in 2023, including a higher share of orphan treatments and an unchanged share of oncology treatments: orphan medicines accounted for 63% of new approvals while oncology medicines represented 27%.
Figure A1: New medicines approved by the US FDA, the EMA, and/or Health Canada, 2018 to 2023
Figure A1 – Text version
2018 | 2019 | 2020 | 2021 | 2022 | 2023 | |
---|---|---|---|---|---|---|
Number of new medicines | 51 | 46 | 50 | 55 | 48 | 63 |
2018‑2023 Average | 52 | |||||
Share of oncology medicines | 31% | 23% | 34% | 27% | 27% | 27% |
Share of orphan medicines | 59% | 38% | 58% | 42% | 58% | 63% |
Data source: US Food and Drug Administration, European Medicines Agency, and Health Canada databases.
Figure A2 illustrates the year-over-year uptake in sales for medicines first approved between 2018 and 2022. By Q4-2023, these medicines collectively accounted for 8.9% of the total brand-name pharmaceutical market in Canada and internationally (Figure A2). Medicines that were approved in 2022 represented 0.8% of all branded pharmaceutical sales in Canada and the PMPRB11.
In any given year, the impact of new medicines on pharmaceutical sales depends on their number, therapeutic relevance, and treatment costs. Relative to the previous edition of this report, the share of new medicines among Canadian branded pharmaceutical sales dropped by almost half (from 15.7% to 8.2%), due to the 2017 blockbuster diabetes drug semaglutide exiting the basket of new medicines. Canadian Q4-2023 sales of new medicines were led by bictegravir, an HIV medicine introduced in 2018, and risankizumab, a medicine for the treatment of plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis introduced in 2019.
Figure A2: New medicine cumulative share of all brand-name medicine sales by year of approval (2018 to 2022), Canada and the PMPRB11Footnote *
Figure A2a: Canada and the PMPRB11
Figure A2a – Text version
- | Revenue year | |||||
---|---|---|---|---|---|---|
Year of approval | 2019 | 2020 | 2019 | 2022 | 2023 | Q4‑2023 |
2018 | 0.6% | 1.2% | 1.7% | 2.2% | 2.7% | 2.8% |
2019 | 0.1% | 0.5% | 1.1% | 2.0% | 2.8% | 3.0% |
2020 | 0.0% | 0.1% | 0.4% | 1.2% | 1.4% | 1.5% |
2021 | 0.0% | 0.0% | 0.0% | 0.2% | 0.6% | 0.7% |
2022 | 0.0% | 0.0% | 0.0% | 0.2% | 0.6% | 0.8% |
New medicine shares of sales | 0.7% | 1.8% | 3.3% | 5.8% | 8.0% | 8.9% |
Figure A2b: Canada
Figure A2b – Text version
- | Revenue year | |||||
---|---|---|---|---|---|---|
Year of approval | 2019 | 2020 | 2021 | 2022 | 2023 | Q4‑2023 |
2018 | 0.4% | 1.1% | 1.7% | 2.2% | 2.5% | 2.5% |
2019 | 0.1% | 0.4% | 0.9% | 1.8% | 3.1% | 3.5% |
2020 | 0.0% | 0.0% | 0.2% | 0.7% | 0.9% | 1.3% |
2021 | 0.0% | 0.0% | 0.0% | 0.0% | 0.4% | 0.5% |
2022 | 0.0% | 0.0% | 0.0% | 0.0% | 0.2% | 0.4% |
New medicine shares of sales | 0.5% | 1.6% | 2.8% | 4.7% | 7.0% | 8.2% |
Data source: IQVIA MIDAS® Database, 2023 (all rights reserved).
Of the 250 medicines approved from 2018 to 2022, 85 (34%) had sales in Canada by Q4-2023 (Figure A3). While Canada’s proportion of new medicines with sales was higher than the OECD median of 32%, it ranked below eight of the PMPRB11 countries, many of which have lower average list prices for patented medicines than Canada (PMPRB, 2024).
The new medicines with sales in Canada included those with higher sales across OECD countries. For example, in Q4-2023, 80% of total OECD sales of new medicines were for the 85 medicines that had sales in Canada, as shown on the right side of Figure A3. This indicates that most international spending on new medicines was concentrated in the subset available in Canada. This was the fourth-highest share in the OECD and above the median of 67%. Similar results have also been found in targeted analyses of the expensive drugs for rare diseases and oncology market segments (PMPRB 2020; 2022).
Figure A3: Share of new medicinesFootnote * from 2018 to 2022 with available sales and their respective share of OECD sales, by country, Q4‑2023
Figure A3 – Text version
Country | Share of new medicines with sales | Share of total Organisation for Economic Co-operation and Development new medicine sales |
---|---|---|
United States | 76% | 99% |
Germany | 56% | 89% |
Italy | 50% | 76% |
United Kingdom | 48% | 89% |
Austria | 48% | 73% |
France | 42% | 73% |
Sweden | 38% | 71% |
Japan | 38% | 72% |
Spain | 36% | 67% |
Portugal | 36% | 66% |
Norway | 35% | 72% |
Czechia | 35% | 72% |
Canada | 34% | 80% |
Poland | 33% | 64% |
Finland | 33% | 67% |
Switzerland | 32% | 74% |
Belgium | 31% | 68% |
Slovenia | 26% | 54% |
Australia | 24% | 74% |
Slovakia | 24% | 47% |
Korea | 22% | 51% |
Hungary | 22% | 58% |
Netherlands | 16% | 45% |
Mexico | 16% | 53% |
Ireland | 15% | 48% |
Luxembourg | 12% | 44% |
Estonia | 12% | 36% |
Türkiye | 9% | 37% |
Greece | 6% | 25% |
Chile | 6% | 36% |
New Zealand | 4% | 37% |
OECD median | 32% | 67% |
Note: Sales are based on manufacturer list prices and include sales for all OECD countries.
Data source: IQVIA MIDAS®, 2023 (all rights reserved).
A retrospective analysis of the Health Canada submission status of the new medicines approved internationally from 2018 to 2022 is presented in Figure A4. Of 250 new active substances, 169 (68%) had been submitted for Health Canada review by September 2024. Of those, 153 received a Notice of Compliance (NOC), 8 were still under review, and 8 had an unsuccessful review process. The remaining 81 medicines (32%) had not yet been submitted for review. The difference between the 153 new active substances which received a NOC and the 85 which recorded sales in Q4-2023 (Figure A3) may reflect the time needed for medicines to launch after receiving a NOC and, in some cases, Canadian sales of low-volume new medicines not showing in the sales data.
Figure A4: Health Canada review status of new active substances with an international approval between 2018 and 2022
Figure A4 – Text version
New active substances approved internationally between 2018 and 2022 | |||
---|---|---|---|
250 | |||
Submitted to Health Canada for approval | Not submitted to Health Canada | ||
169 | 81 | ||
Received a Notice of Compliance | Currently under review | No Notice of Compliance granted | |
153 | 9 | 8 |
Note: Review statuses were last updated on September 9, 2024.
Data source: Health Canada’s Notice of Compliance database; Health Canada’s New Drug Submissions Completed website; and Health Canada’s New Drug Submissions Under Review website.
B: New Medicine Approvals and Sales, 2022
This section reports on new medicines approved in 2022 and tracks their international sales through the calendar year following approval. Sales and pricing data are provided as of Q4-2023, while assessments, recommendations, and reimbursement decisions are reported as of Q3-2024. Tirzepatide dominated new medicine sales as of Q4-2023, accounting for 63% of revenues for drugs approved in 2022.
Forty-eight new medicines received their first market approval from Canada, Europe, and the US in 2022. By the end of 2023, 41 of these medicines had been approved by the US FDA, 32 by the EMA, and 21 by Health Canada (Figure B1).
Figure B1: Number of 2022 new medicines with market approval as of Q4‑2022 and Q4‑2023
Figure B1 – Text version
US Food and Drug Administration | European Medicines Agency | Health Canada | |
---|---|---|---|
Total approved in 2022 | 48 | ||
Approved as of Q4‑2022 | 37 | 24 | 11 |
Approved as of Q4‑2023 | 41 | 32 | 21 |
Data source: US Food and Drug Administration (FDA), European Medicines Agency (EMA), and Health Canada databases.
Of the 21 medicines approved in Canada, 10 had sales data available in MIDAS® by Q4-2023 (Figure B2). This placed Canada seventh in the OECD and fifth in the PMPRB11 in terms of the number of new medicines sold. Tirzepatide accounted for 63% of OECD new medicine sales in Q4-2023 and was sold by only 6 countries, including Canada. This explains the large discrepancy between countries visible on the right side of the figure, where Canada ranked third across the PMPRB11 and fifth in the OECD. Of the PMPRB11, only Germany and the UK had higher shares of total new medicine sales.
These results are representative of the initial market penetration of new medicines. The longer-term availability and uptake in sales for these new medicines are expected to increase in subsequent years.
Figure B2: Number of 2022 new medicines with available sales and their respective share of OECD sales, by country, Q4‑2023
Figure B2 – Text version
Country | Number of new medicines with available sales | Corresponding share of total Organisation for Economic Co-operation and Development sales for new medicines |
---|---|---|
United States | 32% | 99% |
Germany | 19% | 94% |
United Kingdom | 13% | 87% |
Austria | 13% | 29% |
Japan | 12% | 84% |
Italy | 12% | 24% |
Canada | 10% | 86% |
France | 9% | 25% |
Switzerland | 8% | 84% |
Sweden | 8% | 21% |
Spain | 7% | 22% |
Portugal | 7% | 7% |
Norway | 7% | 21% |
Belgium | 7% | 22% |
Australia | 6% | 81% |
Finland | 6% | 23% |
Czechia | 6% | 21% |
Netherlands | 5% | 80% |
Korea | 5% | 16% |
Hungary | 4% | 18% |
Poland | 4% | 2% |
New Zealand | 3% | 67% |
Slovakia | 3% | 15% |
Estonia | 2% | 17% |
Slovenia | 2% | 15% |
Mexico | 2% | 13% |
Luxembourg | 2% | 4% |
Chile | 1% | 1% |
Ireland | 1% | 13% |
OECD median | 6% | 21% |
Note: Based on medicines that received market approval through the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and/or Health Canada in 2022 with recorded sales data as of Q4-2023.
Sales are based on manufacturer list prices and include sales for the selected new medicines in all OECD countries. The following countries did not register sales for any new medicines and have been omitted in the graph: Greece and Türkiye. All countries were used to calculate the OECD median.
Data source: IQVIA MIDAS®, 2023 (all rights reserved); US Food and Drug Administration, European Medicines Agency, and Health Canada databases.
Table B1 provides detailed information on the new medicines approved in 2022. For each medicine, the country with the first reported sales is given, along with the availability in Canada, the share of sales in Q4-2023, and the prices and corresponding treatment costs.Footnote 1 Prices are reported for the highest-selling form and strength of each medicine at the time of the analysis.
In total, the list of 2022 new medicines spanned 22 therapeutic classes. The highest-selling therapeutic class, diabetes drugs, accounted for 63% of new medicine sales in OECD countries and was comprised of two medicines: tirzepatide and teplizumab. The GLP-1 receptor agonist tirzepatide, sold under the brand name Mounjaro, was responsible for almost all of the class’s sales and was the highest-selling new medicine of 2022.
Ophthalmologicals ranked second in therapeutic class sales and counted two new medicines. Faricimab led the class with 13% of new medicine sales. Faricimab is sold under the brand name Vabysmo and is indicated for neovascular age-related macular degeneration. Faricimab is one of only two new medicines that were sold in Canada, the US and all PMPRB-11 countries by Q4-2023.
Antineoplastics, the third highest-selling therapeutic class in Q4-2023 with 9% of all new medicine sales, had the greatest number of new medicines in 2022, with 13 medicines approved. Of the antineoplastics which recorded sales, relatlimab in combination with nivolumab was the greatest contributor with 3% of new medicine sales, making it the fourth highest-selling new medicine overall. It is sold under the brand name Opdualag and Health Canada has approved it for the treatment of metastatic melanoma.
Combined, the top three therapeutic classes accounted for 85% of all 2022 new medicine sales across the OECD in Q4-2023. Of the 2022 medicines, 24% (11) had no sales reported in OECD countries; these included a vaccine, diagnostic agents and gene therapies.
Table B1: New medicines approved in 2022, availability, share of sales, prices, and treatment costs, ranked by therapeutic class share of sales, Q4‑2023
Rank | Therapeutic classFootnote * | Medicine (trade name, form, strength, volume) | Availability | Share of new medicine Sales | Number of PMPRB11 countries with salesFootnote ‡ | Canadian price (CAD) | PMPRB11 price (CAD) | US price (CAD) | Treatment costFootnote § | ||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
First sale in Canada, US, or PMPRB11Footnote † | First sale in Canada | Medicine | Therapeutic class | Min. | Median | Max. | Treatment cost (CAD) | Annual / Course | |||||||
1 |
A10-Drugs used in diabetes |
Tirzepatide (Mounjaro, vial sc, 5 mg/ml, 0.5 ml) |
US |
Jun-22 |
Oct-23 |
63% |
63% |
7 |
79 |
59 |
66 |
72 |
– |
4,107 |
Annual |
2 |
Teplizumab (Tzield, infus. vial/bottle, |
US |
Dec-22 |
– |
0% |
1 |
– |
– |
– |
– |
18,233 |
109,395 |
14-day treatment |
||
3 |
S01-Ophthalmologicals |
Faricimab (Vabysmo, ophth. vial, 120 mg/ml, 0.24 ml)B |
US |
Feb-22 |
Jul-22 |
13% |
13% |
13 |
1,366 |
637 |
1,047 |
1,313 |
– |
8,100 / 4,050 |
First / subsequent years |
4 |
Omidenepag (Eybelis, eye drops, 20 mcg/ml, 2.5 ml) |
JPN |
Nov-18 |
– |
0% |
1 |
– |
<1 |
<1 |
<1 |
– |
2 |
Annual |
||
5 |
L1-Antineoplastics |
Relatlimab/nivolumab (Opdualag, infus. |
US |
Mar-22 |
– |
3% |
9% |
1 |
– |
– |
– |
– |
17,169 |
446,383 |
Annual |
6 |
Teclistamab (Tecvayli, vial sc, 90 mg/ml, |
FRA |
Sep-22 |
– |
2% |
8 |
– |
5,714 |
6,229 |
7,687 |
10,568 |
404,057 |
Annual |
||
7 |
Tebentafusp (Kimmtrak, infus. vial/bottle, |
US |
Feb-22 |
Dec-23 |
2% |
6 |
18,148 |
14,657 |
16,352 |
27,202 |
23,774 |
74,260 |
28–day cycle |
||
8 |
Tremelimumab (Imjudo, infus. vial/bottle, |
US |
Nov-22 |
Oct-23 |
1% |
5 |
34,117 |
16,743 |
24,672 |
32,601 |
47,093 |
34,117 |
One–time |
||
9 |
Mirvetuximab soravtansine (Elahere, infus. vial/bottle, |
US |
Mar-23 |
– |
1% |
1 |
– |
– |
– |
– |
7,490 |
37,448 |
21–day cycle |
||
10 |
Ciltacabtagene autoleucel (Carvykti, infus. bag)B,C,O |
GER |
Feb-23 |
– |
0% |
1 |
– |
615,580 |
615,580 |
615,580 |
– |
632,455 |
One–time |
||
11 |
Mosunetuzumab (Lunsumio, infus. |
SWE |
Jun-22 |
– |
0% |
5 |
– |
9,200 |
9,767 |
10,107 |
21,672 |
9,726 to 19,451 |
21–day cycle |
||
12 |
Futibatinib (Lytgobi, film-ctd tab, 20 mg)C,O |
US |
Mar-23 |
– |
0% |
2 |
– |
– |
– |
– |
207 |
4,349 |
21-day cycle |
||
13 |
Pacritinib (Vonjo, capsule, 100 mg)C,O |
US |
Mar-22 |
– |
0% |
1 |
– |
– |
– |
– |
276 |
403,372 |
Annual |
||
14 |
Olutasidenib (Rezlidhia, capsule, 150 mg)C,O |
US |
Dec-22 |
– |
0% |
1 |
– |
– |
– |
– |
630 |
459,858 |
Annual |
||
15 |
Adagrasib (Krazati, |
US |
Dec-22 |
– |
0% |
1 |
– |
– |
– |
– |
138 |
151,270 |
Annual |
||
16 |
J5-Antivirals for systemic use |
Nirmatrelvir (Paxlovid, film-ctd tab, 150 mg + 100 mg) |
US |
Dec-21 |
Jan-22 |
4% |
4% |
13 |
1 |
1 |
15 |
44 |
– |
10 |
5-day course |
17 |
Lenacapavir (Sunlenca, vial sc ret, 309 mg/ml, 1.5 ml) |
SWE |
Aug-22 |
– |
0% |
4 |
– |
13,374 |
14,204 |
15,035 |
11,861 |
28,409 |
Annual |
||
18 |
A2-Antacids, antiflatulents and anti-ulcerants |
Vonoprazan (Voquezna, film-ctd tabs 20 mg) |
JPN |
Feb-15 |
– |
3% |
3% |
2 |
– |
4 |
4 |
4 |
24 |
1,168 |
8-month treatment |
19 |
N7-Other central nervous system drugs |
Vutrisiran (Amvuttra, prefill syrng sc, |
US |
Jul-22 |
– |
2% |
2% |
6 |
– |
56,570 |
141,739 |
159,335 |
130,007 |
566,954 |
Annual |
20 |
Ublituximab (Briumvi, infus. vial/bottle., |
US |
Jan-23 |
– |
0% |
1 |
– |
– |
– |
– |
12,332 |
86,321 |
Annual |
||
21 |
Ursodoxicoltaurine (Albrioza/Relyvrio, |
US |
Dec-22 |
– |
0% |
– |
– |
– |
– |
– |
230 |
168,052 |
Annual |
||
22 |
D5-Nonsteroidal products for inflammatory skin disorders |
Tapinarof (Vtama, cream, 1%, 60 g) |
US |
May-22 |
– |
1% |
2% |
1 |
– |
– |
– |
– |
28 |
172 |
Annual |
23 |
Deucravacitinib (Sotyktu, film-ctd tab, 6 mg) |
US |
Sep-22 |
Jul-23 |
1% |
9 |
39 |
20 |
36 |
47 |
260 |
14,409 |
Annual |
||
24 |
Spesolimab (Spevigo, infus. vial/bottle., |
US |
Sep-22 |
May-23 |
0% |
6 |
10,885 |
11,527 |
12,092 |
14,144 |
34,660 |
21,771 |
One-time |
||
25 |
J7-Vaccines |
Vaccine, dengue fever (Qdenga, vial dry)B |
SWE |
Dec-22 |
– |
1% |
1% |
7 |
– |
102 |
114 |
127 |
– |
114 |
One-time |
26 |
C1-Cardiac therapy |
Mavacamten (Camzyos, capsule, 5 mg)O |
US |
Jun-22 |
Aug-23 |
1% |
1% |
5 |
69 |
57 |
73 |
89 |
335 |
22,484 |
Annual |
27 |
J6-Sera and |
Nirsevimab (Beyfortus, prefill IM 100 mg/ml, 0.5 ml)B |
ESP |
Sep-23 |
– |
1% |
1% |
4 |
– |
4 |
1,109 |
1,552 |
639 |
4,437 |
One-time |
28 |
Tixagevimab (Evusheld, vial IM, 100 mg/ml + 100 mg/ml)B |
FRA |
Dec-21 |
May-22 |
0% |
6 |
– |
2,917 |
2,917 |
2,917 |
– |
11,667 |
Annual |
||
29 |
A16-Other alimentary tract and metabolism products |
Olipudase alfa (Xenpozyme, infus. dry bottle, 20 mg)B,O |
FRA |
May-22 |
– |
0% |
<1% |
5 |
– |
4,040 |
4,538 |
5,350 |
8,706 |
1,297,808 |
Annual (maintenance phase) |
30 |
L3-Immunostimulating agents |
Eflapegrastim (Rolvedon, prefill |
US |
Oct-22 |
– |
0% |
<1% |
1 |
– |
– |
– |
– |
5,209 |
5,209 |
21-day cycle |
31 |
N5-Psycholeptics |
Daridorexant (Quviviq, film-ctd tab, 50 mg) |
US |
Apr-22 |
Nov-23 |
0% |
<1% |
6 |
2 |
2 |
3 |
7 |
20 |
1,102 |
Annual |
32 |
B3-Haematinics, iron and all combinations |
Sutimlimab (Enjaymo, vial IV, 50 mg/ml, |
US |
Feb-22 |
– |
0% |
<1% |
3 |
– |
– |
– |
– |
2,356 |
417,635 |
Annual |
33 |
H4-Other hormones |
Terlipressin (Terlivaz, vial dry, 850 mcg)O |
US |
Oct-22 |
– |
0% |
<1% |
1 |
– |
– |
– |
– |
1,227 |
63,900 |
14-day treatment |
34 |
M5-Musculo-skeletal system |
Palovarotene (Sohonos, capsule, 10 mg)O |
US |
Nov-23 |
– |
0% |
<1% |
1 |
– |
– |
– |
– |
4,084 |
1,022,894 |
Annual |
35 |
G1-Gynaecological anti-infectives |
Oteseconazole (Vivjoa, capsule, 150 mg) |
US |
Aug-22 |
– |
0% |
<1% |
1 |
– |
– |
– |
– |
208 |
3,735 |
12-week course |
Not assigned as of Q4-2024 |
DaxibotulinumtoxinA (Daxxify)B |
FDA |
Sep-22 |
No sales data in MIDAS® as of Q4-2023 – date of approval by FDA, EMA, and/or Health Canada. |
– |
– |
|||||||||
N7-Other central nervous system drugs |
Eladocagene exuparvovec |
EMA |
May-22 |
– |
– |
||||||||||
B02-Antihemorrhagics |
Etranacogene dezaparvovec (Hemgenix)B,G,O |
FDA |
Nov-22 |
4,690,000 |
One-time |
||||||||||
A7-Intestinal disorder products |
Fecal microbiota (live) (Rebyota)B,O |
FDA |
Nov-22 |
– |
– |
||||||||||
N3-Anti-epileptics |
Ganaxolone (Ztalmy)O |
FDA |
Mar-22 |
– |
– |
||||||||||
V3-All other therapeutic products |
Lutetium Lu 177 vipivotide tetraxetan (Pluvicto)C |
FDA |
Mar-22 |
27,000 |
1-week cycle |
||||||||||
B06-Other hematological agents |
Mitapivat (Pyrukynd)O |
FDA |
Feb-22 |
– |
– |
||||||||||
L01-Antineoplastics |
Nadofaragene firadenovec (Adstiladrin)B,C,G,O |
FDA |
Dec-22 |
– |
– |
||||||||||
L1-Antineoplastics |
Tabelecleucel |
EMA |
Dec-22 |
– |
– |
||||||||||
J7-Vaccines |
Vaccine, Sars-Cov-2 Subunit (Nuvaxovid)B |
HC |
Feb-22 |
– |
– |
||||||||||
B02-Antihemorrhagics |
Valoctocogene Roxaparvovec (Roctavian)B,G,O |
EMA |
Aug-22 |
– |
– |
Note: A medicine was considered to be new in 2022 if it received initial market authorization through the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and/or Health Canada during the calendar year.
Availability and sales information refer to all forms and strengths of the medicine, while pricing and treatment costs are based on the highest-selling form and strength indicated. Sales are based on manufacturer list prices.
Specialty medicines are indicated using the following abbreviations: B: biologic; C: cancer; G: gene therapy; O: orphan.
Data source: IQVIA MIDAS®, 2023 (all rights reserved); US Food and Drug Administration Novel Drugs; European Medicines Agency Human Medicines Highlights; Health Canada.
A large share of the medicines approved in 2022 were specialty medicines. A proportion of 58% (28) received an orphan designation from the FDA and/or the EMA, 27% (13) were for the treatment of cancer, and 52% (25) were biologics. As shown in Figure B3, the greatest overlap between these categories was between cancer and orphan medicines, with 92% (12 of 13) of new cancer medicines having received an orphan designation from either the FDA or EMA. In total, cancer medicines accounted for 43% of new orphan designations despite representing roughly 27% of new medicine approvals. Four new gene therapies were approved in 2022, two of which were indicated for the treatment of hemophilia.
Figure B3: Distribution of 2021 new approvals for specialty medicines
Figure B3 – Text version
Category of speciality medicine | Number of 2022 new approvals |
---|---|
Biologics only | 9 |
Orphan only | 8 |
Cancer only | 1 |
Cancer and orphan only | 4 |
Biologics and cancer only | 0 |
Biologics and orphan only | 8 |
Biologics, cancer and orphan | 8 |
Data source: US Food and Drug Administration, European Medicines Agency, and Health Canada databases.
Of the 37 new medicines with available treatment costs, 24 (65%) cost over $10,000 per year or $5,000 per 28-day cycle for oncology. Of 12 new oncology medicines, 10 were identified as expensive drugs for rare diseases (EDRDs)—orphan-designated therapies with treatment costs exceeding $100,000 annually or $7,500 per 28-day cycle for oncology.
Only one oncology medicine did not meet the “high-cost” criterion. Thirteen of 25 non-oncology medicines were categorized as high-cost and 7 of these were identified as EDRDs. In total, the 17 EDRDs approved in 2022 accounted for 12% of new medicine sales in Q4-2023.
Figure B4: Distribution of new medicines approved in 2022 by treatment cost
Figure B4 – Text version
High‑cost medicines: Expensive drugs for rare diseasesFootnote † | High‑cost medicinesFootnote *, Other than EDRDs | Other | Total | |
---|---|---|---|---|
Oncology medicines | 10 | 1 | 1 | 12 |
Non‑oncology medicines | 7 | 6 | 12 | 25 |
Note: This analysis considers the 37 new medicines approved in 2022 with treatment costs available as of Q3-2024.
Data source: IQVIA MIDAS®, 2023 (all rights reserved); Canada’s Drug Agency (CDA-AMC) reports.
Prior to being marketed in Canada, medicines must be reviewed and authorized by Health Canada. However, to be considered for listing on the formulary of public insurers, medicines must also be assessed and recommended for listing by Canada’s Drug Agency (CDA-AMC), an independent, not-for-profit health technology assessment organization. This process may also rely on health technology assessments by the Institut national d’excellence en santé et en services sociaux (INESSS) in Quebec. Depending on the results of these assessments, the pan-Canadian Pharmaceutical Alliance (pCPA)—an alliance of public drug plans that conducts joint negotiations for brand-name and generic drugs in Canada—may then choose to enter price negotiations with pharmaceutical manufacturers prior to the drugs being considered for listing on public formularies.
Table B2 provides an overview of the CDA-AMC recommendation and pCPA negotiation status for the 22 medicines approved in Canada by Q3-2024, as well as information on whether these medicines have recorded sales through private drug plans in Canada. Of this group, 15 had completed CDA-AMC’s Reimbursement Review process, with 14 receiving a recommendation to “reimburse with conditions” and the remaining receiving a “do not reimburse” recommendation. Eight of the 22 new medicines approved in Canada had completed pCPA negotiations by Q3-2024 and six others had negotiations underway. The remaining eight medicines had no record of negotiation.
A review of private drug plan data shows that 10 of the 22 new medicines had been reimbursed by a private drug plan in Canada by Q3-2024. These are early results and the rates of reimbursement for new medicines can be expected to increase in the coming years.
Table B3 provides further details on the pharmacoeconomic assessments conducted by CDA-AMC including the indications assessed, the recommended condition for reimbursement, the primary evaluation, the incremental cost-effectiveness ratios (ICER) reported, and the price reduction required for the medicine to achieve an ICER of $50,000 per quality-adjusted life year (QALY). The assessments suggest that none of the new medicines reviewed by CDA-AMC were cost-effective at the submitted price. Fourteen of the 16 assessments (87%) resulted in recommendations to be approved on the condition that their price be reduced, one medicine was not recommended for reimbursement, and the blockbuster tirzepatide’s submission was not accepted for review. Price reductions needed to reach the $50,000/QALY level were estimated in 11 of the 15 completed reports, ranging from approximately 50% to over 99% of the submitted price. Of the four remaining reports, two medicines were dominated by comparators that were deemed less costly and more effective. The remaining two medicines reviewed were found to be dominant. ICER values ranged from $201,901/QALY to $3M/QALY.
Table B2: Assessments, recommendations, and reimbursement decisions for 2022 new medicines approved in Canada by Q3-2024
Therapeutic classFootnote * | Medicine (trade name)Footnote † | Health Canada approval | CDA-AMC recommendationFootnote ‡ | pCPA negotiation statusFootnote § | Private plans | |||||
---|---|---|---|---|---|---|---|---|---|---|
Notice of Compliance | Reimburse | Reimburse with conditions | Do not reimburse | Active | Completed and closed | Concluded without agreement | No negotiations | Covered | ||
L1-Antineoplastics |
Ciltacabtagene autoleucel (Carvykti)B,C,O |
2023-02-09 |
X |
X |
||||||
N5-Psycholeptics |
Daridorexant (Quviviq) |
2023-04-28 |
X |
|||||||
D5-Nonsteroidal products for inflammatory skin disorders |
Deucravacitinib (Sotyktu) |
2022-11-24 |
X |
X |
X |
|||||
B02-Antihemorrhagics* |
Etranacogene dezaparvovec (Hemgenix)B,G,O |
2023-10-23 |
X |
X |
||||||
S01-Ophthalmologicals |
Faricimab (Vabysmo)B |
2022-05-27 |
X |
X |
X |
|||||
J5-Antivirals for systemic use |
Lenacapavir (Sunlenca) |
2022-11-02 |
||||||||
V3-All other therapeutic products |
Lutetium Lu 177 vipivotide tetraxetan (Pluvicto)C |
2022-08-25 |
X |
X |
X |
|||||
C1-Cardiac therapy |
Mavacamten (Camzyos)O |
2022-11-08 |
X |
X |
X |
|||||
J5-Antivirals for systemic use |
Nirmatrelvir (Paxlovid) |
2022-01-17 |
X |
X |
X |
|||||
J6-Sera and gamma-globulin |
Nirsevimab (Beyfortus)B |
2023-04-19 |
||||||||
A16-Other alimentary tract and metabolism products |
Olipudase alfa (Xenpozyme)B,O |
2024-02-28 |
||||||||
M5-Musculo-skeletal system |
Palovarotene (Sohonos)O |
2022-01-21 |
X |
X |
||||||
L1-Antineoplastics |
Relatlimab (Opdualag)B,C,O |
2023-09-13 |
X |
X |
||||||
D5-Nonsteroidal products for inflammatory skin disorders |
Spesolimab (Spevigo)B,O |
2023-03-22 |
X |
X |
||||||
L1-Antineoplastics |
Tebentafusp (Kimmtrak)B,C,O |
2022-06-07 |
X |
X |
X |
|||||
L1-Antineoplastics |
Teclistamab (Tecvayli)B,C,O |
2023-07-26 |
X |
X |
||||||
A10-Drugs used in diabetes |
Tirzepatide (Mounjaro) |
2022-11-24 |
X |
|||||||
J6-Sera and gamma-globulin |
Tixagevimab (Evusheld)B |
2022-04-14 |
||||||||
L1-Antineoplastics |
Tremelimumab (Imjudo)B,C,O |
2023-08-31 |
X |
X |
||||||
N7-Other central nervous system drugs |
Ursodoxicoltaurine (Albrioza/Relyvrio)O |
2022-06-10 |
X |
X |
X |
|||||
J7-Vaccines |
Vaccine, SARS-CoV-2 subunit (Nuvaxovid)B |
2022-02-17 |
||||||||
N7-Other central nervous system drugs |
Vutrisiran (Amvuttra)O |
2023-10-18 |
X |
X |
Note: Medicines were assessed through Canada’s Drug Agency (CDA-AMC)’s Reimbursement Review process.
Data source: IQVIA Private Drug Plan database; Health Canada Notice of Compliance database; Canada’s Drug Agency Reimbursement Review reports; pan-Canadian Pharmaceutical Alliance (pCPA) reports; and IQVIA MIDAS®, 2023 (all rights reserved).
Table B3: Summary of Reimbursement Review assessments for 2022 new medicines approved in Canada by Q3‑2024
Medicine (trade name)Footnote * | Date of recommendationFootnote † | Indication(s) | Conditional on priceFootnote ‡ | Type of evaluation (primary) | Incremental cost-effectiveness ratio (ICER) ($ per QALY)Footnote § |
---|---|---|---|---|---|
Ciltacabtagene autoleucel (Carvykti)B,C,O |
01-May-23 |
Relapsed or refractory |
Yes |
CUA |
$201,901 |
Deucravacitinib (Sotyktu) |
08-Aug-23 |
Psoriasis, Moderate |
N/A |
CUA |
Dominated |
Etranacogene dezaparvovec |
19-Apr-24 |
Hemophilia B |
Yes |
CUA |
Dominant |
Faricimab (Vabysmo)B |
14-Oct-22 |
Diabetic macular edema |
Yes |
CUA |
Dominant |
Lutetium Lu 177 vipivotide tetraxetan (Pluvicto)C |
03-Mar-23 |
Metastatic castration-resistant prostate cancer |
Yes |
CUA |
Dominated |
Mavacamten (Camzyos)O |
14-Apr-23 |
Obstructive hypertrophic cardiomyopathy |
Yes |
CUA |
$576,295 |
Nirmatrelvir (Paxlovid) |
11-Apr-24 |
Mild-to-moderate |
Yes |
CUA |
$442,082 |
Palovarotene (Sohonos)O |
11-May-23 |
Fibrodysplasia |
Yes |
CUA |
$2,979,324 |
Relatlimab (Opdualag)B,C,O |
02-Feb-24 |
Unresectable or |
Yes |
CUA |
$408,364 |
Spesolimab (Spevigo)B,O |
Active |
Generalized pustular |
Yes |
CUA |
$431,569 |
Tebentafusp (Kimmtrak)B,C,O |
04-Jan-23 |
Unresectable or metastatic uveal melanoma |
Yes |
CUA |
$728,513 |
Teclistamab (Tecvayli)B,C,O |
08-Apr-24 |
Relapsed or refractory |
Yes |
CUA |
$506,518 |
Tirzepatide (Mounjaro) |
Cancelled project |
– |
– |
– |
– |
Tremelimumab (Imjudo)B,C,O |
03-Nov-23 |
Unresectable |
Yes |
CUA |
$265,036 |
Ursodoxicoltaurine (Albrioza/Relyvrio)O |
21-Jul-22 |
Amyotrophic lateral |
Yes |
CUA |
$2,086,658 |
Vutrisiran (Amvuttra)O |
29-Jan-24 |
Hereditary transthyretin mediated amyloidosis |
Yes |
CUA |
$2,811,102 |
Note: The type of evaluation and the incremental cost-effectiveness ratio (ICER) are based on the Reimbursement Review reports. The table reports the low-bound and high-bound range estimated for all comparators and conditions analyzed. Cost-utility analysis (CUA) evaluations are provided as a range per quality-adjusted life year (QALY). Additional information can be accessed at https://www.cda-amc.ca.
Data source: Canada’s Drug Agency (CDA-AMC) Reimbursement Review reports.
C: New Medicine Approvals and Sales, 2023
This section provides an analysis of the new medicines approved internationally in 2023, including information on approval status as of Q3-2024 and pricing as of Q4-2023. Sixty-three new medicines were approved in 2023 and over half of these met the high-cost criteria.
In 2023, 63 medicines received first-time market approval through the FDA, the EMA, and/or Health Canada. As of the third quarter of 2024, the US FDA had approved 60 of these new medicines, the EMA had approved 37 and Health Canada had approved 14 (Figure C1). Manufacturers may choose to submit new medicines for approval in the US, Europe, and Canada at different times, which can affect the number of medicines approved by each regulator.
Figure C1: Number of 2023 medicines with approval as of Q4-2023 and Q3-2024
Figure C1 – Text version
US Food and Drug Administration | European Medicines Agency | Health Canada | |
---|---|---|---|
Total approved in 2024 | 63 | ||
Approved as of Q4‑2023 | 55 | 22 | 8 |
Approved as of Q3‑2024 | 60 | 37 | 14 |
Note: Based on medicines that received market approval through the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and/or Health Canada in 2023.
Data source: US Food and Drug Administration, European Medicines Agency, and Health Canada databases.
Table C1 provides a full list of the 63 new medicines approved in 2023 along with the country with first reported sales, availability in Canada, and price and treatment cost where availableFootnote 2. Prices were reported for the highest-selling form and strength of each medicine. Similarly to Table B1, prices for COVID-19 vaccines have been omitted from Table C1. It should be noted that this information reflects the early availability and uptake of these medicines in the markets analyzed.
As of Q4-2023, 23 (37%) of the drugs with a first approval in 2023 had not recorded sales in any country and an additional 23 had only recorded sales in the US. Four medicines reported sales in more than three countries and Canada recorded sales for three of them, including the respiratory syncytial virus (RSV) vaccine Abrysvo. As of Q4-2023, Abrysvo was the widestselling new medicine recording sales in Canada, the US and eight PMPRB11 countries. Approximately three quarters (31) of the medicines that recorded sales in Canada, the US, and/or the PMPRB11 had treatment costs exceeding $10,000 per year or $5,000 per 28-day course for oncology medicines, placing them in the high-cost category. Of these medicines, 20 had treatment costs over $100,000 per year.
Table C1: New medicines approved in 2023, availability, prices, and treatment costs, Q4-2023
Medicine (trade name, form, strength, volume) | Therapeutic classFootnote * | Availability | Number of PMPRB11 countries with salesFootnote ‡ | Canadian price (CAD)Footnote § | PMPRB11 price (CAD) | US price (CAD) | Treatment costFootnote ** | |||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
First sale in Canada, US, or PMPRB11Footnote † | First Sale in Canada | Min. | Median | Max. | Treatment cost (CAD) | Annual/Course | ||||||
Apadamtase alfa (Adzynma, vial dry)B,G,O |
B1-Antithrombotic agents |
US |
Dec-23 |
– |
1 |
– |
– |
– |
– |
2,153 |
111,948 |
Annual |
Avacincaptad pegol (Izervay, ophth. vial, 20 mg/ml, 0.1 ml) |
S1-Ophthalmologicals |
US |
Sep-23 |
– |
1 |
– |
– |
– |
– |
2,808 |
3,650 |
Annual |
Beremagene geperpavec (Vyjuvek, gel/sol top., 2.5 ml)B,G,O |
D3-Wound healing agents |
US |
Dec-23 |
– |
1 |
– |
– |
– |
– |
11,105 |
577,480 |
Annual |
Capivasertib (Truqap, film-ctd tab, 200 mg)C |
L1-Antineoplastics |
US |
Dec-23 |
– |
1 |
148Footnote i |
– |
– |
– |
463 |
9,446 |
28-day cycle |
Cipaglucosidase alfa (Pombiliti, infus. dry bottle, 105 mg)C,O |
A16-Other alimentary tract and metabolism products |
PRT |
Mar-23 |
– |
3 |
– |
1,460 |
1,741 |
2,022 |
1,835 |
646,585 |
Annual |
Daprodustat (Duvroq, film-ctd tab, 4 mg) |
B3-Anti-anaemic preparations |
JPN |
Aug-20 |
– |
2 |
– |
2 |
2 |
2 |
– |
4,815 |
Annual |
Durlobactam (Xacduro, infus. dry bottle, 1 g + 1 g) |
J1-Systemic antibacterials |
US |
Sep-23 |
– |
1 |
– |
– |
– |
– |
213 |
5,960 |
14-day treatment |
Efanesoctocog alfa (Altuviiio, infus. dry bottle, 4 IU)B,G,O |
B2-Blood coagulation system products |
US |
Apr-23 |
– |
2 |
– |
5,741 |
5,741 |
5,741 |
27 |
279,875 |
Annual |
Elacestrant (Orserdu, film-ctd tab, 345 mg)C |
L2-Cytostatic hormone therapy |
US |
Mar-23 |
– |
2 |
– |
445 |
445 |
445 |
892 |
162,373 |
Annual |
Elranatamab (Elrexfio, vial sc, 40 mg/ml, 1.9 ml)B,C,O |
L1-Antineoplastics |
SVN |
Mar-23 |
– |
1 |
4,053Footnote i |
– |
– |
– |
16,713 |
28,000 |
21-day cycle |
Epcoritamab (Epkinly, vial sc, 60 mg/ml, 0.8 ml)B,C,O |
L1-Antineoplastics |
SWE |
Sep-23 |
– |
5 |
6,609Footnote i |
11,554 |
11,554 |
11,554 |
20,918 |
14,320 |
28-day cycle |
Etrasimod (Velsipity, film-ctd tab, 2 mg) |
A7-Intestinal disorder products |
US |
Dec-23 |
– |
1 |
– |
– |
– |
263 |
15,742 |
Annual |
|
Fecal microbiota spores, live (Vowst, capsule)B,O |
A7-Intestinal disorder products |
US |
Jun-23 |
– |
1 |
– |
– |
– |
– |
1,962 |
23,547 |
3-day treatment |
Fezolinetant (Veozah, film-ctd tab, 45 mg) |
G2-Other gynaecologicals |
US |
May-23 |
– |
1 |
– |
– |
– |
– |
24 |
8,695 |
Annual |
Fruquintinib (Fruzaqla, capsule, 5 mg)C |
L1-Antineoplastics |
US |
Nov-23 |
– |
1 |
– |
– |
– |
1,548 |
6,321 |
28-day cycle |
|
Gefapixant (Lyfnua, film-ctd tab, 45 mg) |
R5-Cough and cold preparations |
JPN |
Apr-22 |
– |
1 |
– |
1 |
1 |
1 |
– |
1,014 |
Annual |
Glofitamab (Columvi, infus. vial/bottle, 1 mg/ml, 10 ml)B,C,O |
L1-Antineoplastics |
PRT |
Apr-21 |
Sep–23 |
5 |
4,300 |
<1 |
2,784 |
5,569 |
12,436 |
12,480 |
21-day cycle |
Lebrikizumab (Ebglyss, prefill autoinj, 125 mg/ml, 2 ml)B |
D5-Nonsteroidal products for inflammatory skin disorders |
GER |
Dec-23 |
– |
1 |
1,877Footnote i |
1,297 |
1,297 |
1,297 |
– |
24,397 |
Annual |
Lecanemab (Leqembi, infus. vial/bottle, 100 mg/ml, 5 ml)B |
N7-Other central nervous system drugs |
US |
Jan-23 |
– |
2 |
– |
829 |
829 |
829 |
803 |
32,327 |
Annual |
Leniolisib (Joenja, film-ctd tab, 70 mg)O |
L3-Immunostimulating agents |
US |
Mar-23 |
– |
0 |
– |
– |
– |
– |
– |
– |
– |
Lotilaner (Xdemvy, eye drops, 0.25%, 10 ml) |
S1-Ophthalmologicals |
US |
Sep-23 |
– |
1 |
– |
– |
– |
– |
12 |
12 |
6-week treatment |
Mirikizumab (Omvoh, infus. vial/bottle, 20 mg/ml, 15 ml)B,O |
A7-Intestinaldisorder products |
JPN |
Jun-23 |
Oct-23 |
5 |
2,361 |
1,393 |
1,888 |
3,033 |
12,912 |
30,977 |
Annual |
Momelotinib (Ojjaara, film-ctd tab, 200 mg)C,O |
L1-Antineoplastics |
USA |
Apr-23 |
– |
1 |
231Footnote i |
– |
– |
– |
1,100 |
6,464 |
28-day cycle |
Motixafortide (Aphexda, vial dry, 62 mg)C,O |
L3-Immunostimulating agents |
US |
Nov-23 |
– |
1 |
– |
– |
– |
– |
7,639 |
11,535 |
One-time |
Nirogacestat (Ogsiveo, film-ctd tab, 50 mg)C,O |
L1-Antineoplastics |
US |
Dec-23 |
– |
1 |
– |
– |
– |
– |
194 |
10,808 |
28-day course |
Pegunigalsidase alfa (Elfabrio, infus. vial/bottle, 2 mg/ml, 10 ml)B,G |
A16-Oother alimentary tract and metabolism products |
AUT |
Sep-23 |
– |
1 |
– |
4,322 |
4,322 |
4,322 |
– |
421,382 |
Annual |
Perfluorohexyloctane (Miebo, eye drops, 1,3 ml) |
S1-Ophthalmologicals |
US |
Sep-23 |
– |
1 |
– |
– |
– |
– |
17 |
N/A |
– |
Pirtobrutinib (Jaypirca, film-ctd tab, 100 mg)C,O |
L1-Antineoplastics |
US |
Feb-23 |
– |
1 |
– |
– |
– |
– |
438 |
319,679 |
Annual |
Quizartinib (Vanflyta, film-ctd tab, 17.7 mg)C,O |
L1-Antineoplastics |
JPN |
Oct-19 |
– |
2 |
– |
145 |
145 |
145 |
700 |
107,072 |
Annual |
Repotrectinib (Augtyro, capsule, 40 mg)C,O |
L1-Antineoplastics |
US |
Dec-23 |
– |
1 |
– |
– |
– |
– |
164 |
468,941 |
Annual |
Retifanlimab (Zynyz, infus.vial/bottle, 25 mg/ml, 20 ml)B,C,O |
L1-Antineoplastics |
US |
Apr-23 |
– |
1 |
– |
– |
– |
– |
18,151 |
235,963 |
Annual |
Rezafungin (Rezzayo, infus. dry bottle, 200 mg)O |
J2-Systemic agents for fungal infections |
US |
Aug-23 |
– |
1 |
– |
– |
– |
– |
2,578 |
15,466 |
5-week treatment |
Ritlecitinib (Litfulo, capsule, 50 mg) |
D5-Nonsteroidal products for inflammatory skin disorders |
PRT |
Jul-23 |
– |
2 |
– |
42 |
42 |
42 |
172 |
15,339 |
Annual |
Rozanolixizumab (Rystiggo, infus.vial/bottle, 70 mg/ml, 2 ml)B,O |
L4-Immunosuppressants |
US |
Jul-23 |
– |
1 |
– |
– |
– |
– |
8,085 |
388,082 |
Annual |
Sparsentan (Filspari, film-ctd tab, 400 mg)O |
G4-Urologicals |
US |
Mar-23 |
– |
1 |
– |
– |
– |
– |
397 |
141,989 |
Annual |
Talquetamab (Talvey, vial sc, 40 mg/ml, 1 ml)B,C,O |
L1-Antineoplastics |
US |
Aug-23 |
– |
3 |
7,300Footnote i |
8,326 |
8,326 |
8,326 |
12,368 |
29,129 |
28-day course |
Vaccine, respiratory syncytial virus (Arexvy/Abrysvo, vial dry, 120 mcg)B |
J7-Vaccines |
NLD |
Jun-23 |
Sep-23 |
10 |
225 |
216 |
235 |
271 |
315 |
225 |
One-time |
Vadadustat (Vafseo, film-ctd tab, 300 mg) |
B3-Anti-anaemic preparations |
JPN |
Aug-20 |
– |
1 |
– |
3 |
3 |
3 |
– |
935 |
Annual |
Zavegepant (Zavzpret, u-d liq, 10 mg/dose) |
N2-Analgesics |
US |
Jun-23 |
– |
1 |
– |
– |
– |
– |
235 |
20,085 |
14-day treatment |
Zuranolone (Zurzuvae, capsule, 25 mg) |
N6-Psychoanaleptics excluding anti-obesity preparations |
US |
Dec-23 |
– |
1 |
– |
– |
– |
– |
717 |
20,000 |
14-day treatment |
Bexagliflozin (Brenzavvy) |
A10-Drugs used in diabetes |
FDA |
Jan-23 |
No sales data in MIDAS® as of Q4-2023 – date of approval by FDA, EMA, and/or Health Canada. | ||||||||
Concizumab (Alhemo)B |
B02-Antihemorrhagics |
HC |
Mar-23 |
|||||||||
Delandistrogene moxeparvovec (Elevidys)B,G,O |
M05-Drugs for treatment of bone diseases |
FDA |
Jun-23 |
|||||||||
Donislecel (Lantidra)B,O |
A10-Drugs used in diabetes |
FDA |
Jun-23 |
|||||||||
Efbemalenograstim alfa (Ryzneuta)B,C |
L03-Immunostimulants |
FDA |
Nov-23 |
|||||||||
Eplontersen (Wainua)O |
N07-Other nervous system drugs |
EMA |
Jun-24 |
|||||||||
Exagamglogene autotemcel (Casgevy)B,G,O |
B06-Other hematological agents |
FDA |
Dec-23 |
|||||||||
Fidanacogene elaparvovec (Beqvez)B,G,O |
B06-Other hematological agents |
EMA |
Dec-23 |
|||||||||
Gepirone (Exxua) |
N06-Psychoanaleptics |
FDA |
Sep-23 |
|||||||||
Iptacopan (Fabhalta)O |
L04-Immunosuppressants |
FDA |
Dec-23 |
|||||||||
Lovotibeglogene autotemcel (Lyfgenia)B,G,O |
No ATC class as of Q4-2024 |
FDA |
Dec-23 |
|||||||||
Nedosiran (Rivfloza)O |
A16-Other alimentary tract and metabolism products |
FDA |
Sep-23 |
|||||||||
Omaveloxolone (Skyclarys)O |
N07-Other nervous system drugs |
FDA |
Feb-23 |
|||||||||
Omidubicel (Omisirge)B,O |
No ATC class as of Q4-2024 |
FDA |
Apr-23 |
|||||||||
Palopegteriparatide (Yorvipath)O |
H05-Calcium homeostasis |
EMA |
Nov-23 |
|||||||||
Pegzilarginase (Loargys)B,O |
A16-Other alimentary tract and metabolism products |
EMA |
Dec-23 |
|||||||||
Pozelimab (Veopoz)B,O |
L04-Immunosuppressants |
FDA |
Aug-23 |
|||||||||
Tislelizumab (Tevimbra)B,C,O |
L01-Antineoplastic agents |
EMA |
Sep-23 |
|||||||||
Tofersen (Qalsody)O |
N7-Other central nervous system drugs |
FDA |
Apr-23 |
|||||||||
Toripalimab (Loqtorzi)B,C,O |
L01-Antineoplastic agents |
FDA |
Oct-23 |
|||||||||
Trofinetide (Daybue)O |
N07-Other nervous system drugs |
FDA |
Mar-23 |
|||||||||
Vamorolone (Agamree)O |
H02-Corticosteroids for systemic use |
FDA |
Oct-23 |
|||||||||
Zilucoplan (Zilbrysq)O |
L04-Immunosuppressants |
FDA |
Oct-23 |
Note: A medicine was considered to be new in 2023 if it received market approval through the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and/or Health Canada during the calendar year.
Availability and sales information refers to all forms and strengths of the medicine while pricing and treatment costs are based on the highest-selling form and strength indicated. Sales are based on manufacturer list prices.
Specialty medicines are indicated using the following abbreviations: B: biologic; C: cancer; G: gene therapy; O: orphan.
Data source: IQVIA MIDAS®, 2023 (all rights reserved); US Food and Drug Administration Novel Drugs; European Medicines Agency Human Medicines Highlights; Health Canada Notice of Compliance database.
Figure C2 illustrates the overlap between the number of new specialty medicines authorized for market in 2023. Of the 63 new medicines approved in that year, 63% (40) had received an orphan designation from the FDA and/or the EMA, 27% (17) were oncology treatments, and 44% (28) were biologic medicines. Orphan and oncology medicines showed an important overlap, with 13 of 17 (76%) new cancer medicines having received an orphan designation. Included in the biologics were eight gene therapies, of which all but one were given an orphan designation.
Figure C2: Distribution of 2023 new approvals for specialty medicines
Figure C2 – Text version
Category of speciality medicine | Number of 2023 new approvals |
---|---|
Biologics only | 5 |
Orphan only | 12 |
Cancer only | 3 |
Cancer and orphan only | 6 |
Biologics and cancer only | 1 |
Biologics and orphan only | 15 |
Biologics, cancer and orphan | 7 |
Data source: US Food and Drug Administration Novel Drugs 2023; European Medicines Agency Human Medicines Highlights 2023; Health Canada Notice of Compliance database.
D: Spotlight on Canada
While Sections B and C reported new medicines approved internationally, this section reports on Canadian approvals between 2019 and 2023, with a focus on the 46 medicines that received their first Canadian market authorization in 2022. As of Q4-2023, faricimab was the highest-selling among Canada’s 2022 newly approved medicines with 30% of new-to-Canada sales.
Between 2019 and 2023, Health Canada granted initial market authorization to an average of 40 new medicines each year, of which 14 (35%) were expensive drugs for rare diseases (EDRDs)—orphan-designated therapies with treatment costs exceeding $100,000 annually or $7,500 per 28-day cycle for oncology. A full list of EDRDs approved in Canada is provided in Appendix A.
Figure D1: Annual approvals for expensive drugs for rare diseases (EDRDs) and other new medicines in Canada, 2019 to 2023
Figure D1 – Text version
Annual approvals for expensive drugs for rare diseases in Canada | Annual approvals for other new medicines in Canada | |
---|---|---|
2019 | 15 | 19 |
2020 | 16 | 20 |
2021 | 11 | 32 |
2022 | 13 | 33 |
2023 | 17 | 25 |
Approval average for expensive drugs for rare diseases | 14 | |
Overall approval average | 40 |
Note: Expensive drugs for rare diseases (EDRDs) are defined as those with an orphan designation through the FDA or EMA and treatment costs exceeding $100,000 annually or $7,500 per 28-day cycle for oncology.
Data source: Health Canada Notice of Compliance database, drugs@FDA database, EMA drug database, CDA-AMC databases.
Table D1 reports on the therapeutic class, availability, sales, and pricing for the 35 of the 46 new-to-Canada medicines approved in 2022 which had recorded sales by the end of 2023. Those medicines collectively accounted for less than 1% of branded pharmaceutical sales in Canada in Q4-2023. The top-selling new-to-Canada medicine was ophthalmological faricimab, used in the treatment of agerelated macular degeneration and diabetic macular edema, which accounted for 30% of 2022 new-to-Canada medicine sales. With nirmatrelvir, faricimab was the only medicine to be sold in Canada, the US, and all PMPRB11 countries by Q4-2023. Among the new-to-Canada medicines with both Canadian and PMPRB11 sales, Canadian sales occurred on average 11 months after a first international sale.
Table D1 also provides foreign-to-Canadian price ratios, which compare the median price of medicines in the PMPRB11 countries and the US price with the Canadian price. The price of the medicine in Canada is set to a value of one and the corresponding foreign prices are reported relative to this value. The resulting ratios reflect how much more or less Canadians would have paid for a new medicine if they had paid the median international price or the US price. The median PMPRB11-to-Canadian price ratio reported across new medicines was 0.89, indicating that international prices in Q4-2023 were approximately 11% lower than Canadian prices at introduction. In contrast, the median US price ratio was 3.49, indicating that the US pays nearly 3.5 times more than Canada for the same medicines.
Table D1: Medicines first approved in Canada in 2022, availability, sales, and prices as of Q4‑2023
Medicine (trade name, form, strength, volume) | Therapeutic classFootnote * | Availability | Number of months from international to Canadian sale | Share of Canadian new medicine sales | Number of countries with salesFootnote ‡ | Price (CAD) | ||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
First sale in the PMPRB11Footnote † | First Sale in Canada | First Sale in US | CanadaFootnote § | PMPRB11 median | US | Median PMPRB11-to-Canadian price ratio | US-to-Canadian price ratio | |||||
Abrocitinib (Cibinqo, film-ctd tab, 200 mg) |
D5-Nonsteroidal products for inflammatory skin disorders |
Oct-21 |
Sep-22 |
Mar-22 |
11 |
1% |
12 |
54 |
54 |
213 |
1.00 |
3.93 |
Amivantamab (Rybrevant, infus. vial/bottle, 50 mg/ml, 7 ml)B,C |
L1-Antineoplastics |
Sep-21 |
Apr-22 |
Jun-21 |
10 |
2% |
7 |
1,736 |
1,842 |
4,057 |
1.06 |
2.34 |
Asciminib (Scemblix, film-ctd tab, 40 mg)C,O |
L1-Antineoplastics |
Mar-22 |
Sep-22 |
Nov-21 |
10 |
5% |
11 |
85 |
98 |
413 |
1.16 |
4.88 |
Atogepant (Qulipta, tab, 60 mg) |
N2-Analgesics |
Aug-23 |
Feb-23 |
Oct-21 |
16 |
5% |
5 |
19 |
21 |
44 |
1.11 |
2.33 |
Avacopan (Tavneos, capsule, 10 mg)O |
L4-Immunosuppressants |
Feb-22 |
Nov-22 |
Oct-21 |
13 |
2% |
7 |
33 |
45 |
101 |
1.36 |
3.04 |
Belumosudil (Rholistiq/Rezurock, film-ctd tab, 200 mg)O |
L4-Immunosuppressants |
Mar-23 |
– |
Aug-21 |
– |
0% |
2 |
376Footnote i |
332 |
691 |
– |
– |
Belzutifan (Welireg, film-ctd tab, 40 mg)C,O |
L1-Antineoplastics |
Aug-22 |
Aug-22 |
Sep-21 |
11 |
3% |
3 |
280 |
186 |
410 |
0.66 |
1.46 |
Berotralstat (Orladeyo, capsule, 150 mg)O |
B6-All other haematological agents |
Mar-21 |
– |
– |
– |
0% |
7 |
850Footnote i |
539 |
– |
– |
– |
Bimekizumab (Bimzelx, prefill autoinj, 160 mg/ml, 1 ml)B |
D5-Nonsteroidal products for inflammatory skin disorders |
Aug-21 |
Mar-22 |
Nov-23 |
7 |
14% |
12 |
1,663 |
1,238 |
8,861 |
0.74 |
5.33 |
Capmatinib (Tabrecta, film-ctd tab, 200 mg)C,O |
L1-Antineoplastics |
Aug-20 |
Sep-22 |
May-20 |
28 |
1% |
9 |
89 |
90 |
239 |
1.01 |
2.70 |
Cariprazine (Vraylar, capsule, 1.5 mg) |
N5-Psycholeptics |
Jul-17 |
Jun-22 |
Mar-16 |
75 |
3% |
11 |
5 |
3 |
59 |
0.66 |
11.68 |
Deucravacitinib (Sotyktu, film-ctd tab, 6 mg) |
D5-Nonsteroidal products for inflammatory skin disorders |
Nov-22 |
Jul-23 |
Sep-22 |
10 |
1% |
9 |
39 |
36 |
260 |
0.93 |
6.68 |
Difelikefalin (Korsuva, vial IV, 50 mcg/ml, 1 ml) |
D4-Anti-pruritics |
Apr-22 |
Feb-23 |
May-22 |
10 |
0% |
8 |
27 |
51 |
– |
1.87 |
– |
Faricimab (Vabysmo, ophth. vial, 120 mg/ml, 0.24 ml)B |
S1-Ophthalmologicals |
May-22 |
Jul-22 |
Feb-22 |
5 |
30% |
13 |
1,366 |
1,047 |
– |
0.77 |
– |
Finerenone (Kerendia, film-ctd tab, 10 mg) |
C3-Diuretics |
Feb-22 |
Nov-22 |
Jul-21 |
16 |
2% |
11 |
3 |
3 |
27 |
0.76 |
7.73 |
Lenacapavir (Sunlenca, vial sc, 309 mg/ml, 1.5ml) |
J5-Antivirals for systemic use |
Aug-22 |
– |
Jan-23 |
– |
0% |
4 |
– |
14,204 |
11,861 |
– |
– |
Lisocabtagene maraleucel (Breyanzi, infus. vial/bottle)B,C,G,O |
L1-Antineoplastics |
May-21 |
– |
– |
– |
0% |
2 |
501,900Footnote i |
371,053 |
– |
– |
– |
Lumasiran (Oxlumo, vial sc)O |
G4-Urologicals |
Jan-21 |
– |
Feb-21 |
– |
0% |
6 |
96,855Footnote i |
101,669 |
– |
– |
– |
Lutetium Lu 177 vipivotide tetraxetan (Pluvicto, vial IV, 7.5 ml)C |
V3-All other therapeutic products |
Jul-23 |
– |
– |
– |
0% |
0 |
27,000Footnote i |
– |
– |
– |
– |
Maribavir (Livtencity, film-ctd tab, 200 mg)O |
J5-Antivirals for systemic use |
Nov-22 |
Jan-23 |
Dec-21 |
13 |
0% |
10 |
718 |
277 |
– |
0.39 |
– |
Mavacamten (Camzyos, capsule, 5 mg)O |
C1-Cardiac therapy |
Aug-23 |
Aug-23 |
Jun-22 |
14 |
0% |
5 |
69 |
57 |
335 |
0.83 |
4.89 |
Mogamulizumab (Poteligeo, infus. vial/bottle, 4 mg/ml, 5 ml)B,O |
L1-Antineoplastics |
May-12 |
– |
Oct-18 |
– |
0% |
9 |
2,203Footnote i |
1,952 |
5,476 |
– |
– |
Nirmatrelvir (Paxlovid, film-ctd tab, 150 mg + 100 mg) |
J5-Antivirals for systemic use |
Jan-22 |
Jan-22 |
Dec-21 |
1 |
0% |
13 |
1 |
15 |
– |
15.34 |
– |
Palovarotene (Sohonos, capsule, 10 mg)O |
M5-Other drugs for disorders of the musculo-skeletal system |
– |
– |
Nov-23 |
– |
0% |
1 |
3,242Footnote i |
– |
4,084 |
– |
– |
Pegcetacoplan (Aspaveli/Empaveli, infus. vial/bottle, 54 mg/ml, 20 ml)O |
L4-Immunosuppressants |
Feb-22 |
– |
Jul-21 |
– |
0% |
9 |
4,970Footnote i |
4,557 |
– |
– |
– |
Pegvaliase (Palynziq, prefill syrng sc, 20 mg/ml, 1 ml)B,O |
A16-Other alimentary tract and metabolism products |
Jul-19 |
– |
Jul-18 |
– |
0% |
4 |
405Footnote i |
474 |
719 |
– |
– |
Selinexor (Nexpovio/Expovio, film-ctd tab, 20 mg)C,O |
L1-Antineoplastics |
Oct-20 |
– |
Jul-19 |
– |
0% |
3 |
550Footnote i |
694 |
– |
– |
– |
Selumetinib (Koslugo, capsule, 25 mg)B,O |
L1-Antineoplastics |
Mar-21 |
Oct-23 |
Jun-20 |
39 |
0% |
7 |
311 |
272 |
273 |
0.87 |
0.88 |
Tebentafusp (Kimmtrak, infus. vial/bottle, 200 mcg/ml, 0.5 ml)B,C,O |
L1-Antineoplastics |
Apr-22 |
Dec-23 |
Feb-22 |
22 |
2% |
6 |
18,148 |
16,352 |
23,774 |
0.90 |
1.31 |
Tezepelumab (Tezspire, prefill autoinj, 110 mg/ml, 1.91 ml)B |
R3-Anti-asthma and COPD products |
Sep-22 |
Oct-22 |
Jan-22 |
9 |
16% |
10 |
1,904 |
1,327 |
5,137 |
0.70 |
2.70 |
Tirzepatide (Mounjaro, vial sc, 5 mg/ml, 0.5 ml) |
A10-Alpha-glucosidase inhibitor antidiabetics |
Sep-22 |
Oct-23 |
Jun-22 |
16 |
10% |
7 |
79 |
66 |
– |
0.83 |
– |
Ubrogepant (Ubrelvy, tab, 100 mg) |
N2-Analgesics |
Jan-00 |
Apr-23 |
Jan-20 |
– |
5% |
2 |
16 |
– |
125 |
– |
7.87 |
Ursodoxicoltaurine (Albrioza/Relyvrio, dep oral u-d pwdr, 3 g/dose + 1 g/dose)O |
N7-Other central nervous system drugs |
– |
Mar-23 |
Oct-22 |
5 |
0% |
3 |
307Footnote i |
– |
230 |
– |
– |
Vorhyaluronidase alfa (Hyqvia, infus. vial/bottle, vari str, 300 ml)B |
L1-Antineoplastics |
May-13 |
– |
Feb-07 |
– |
0% |
9 |
2,756 |
2,693 |
6,393 |
– |
– |
Cilgavimab/tixagevimab (Evusheld, vial IM, combi str)B |
J6-Sera and gamma-globulin |
Mar-22 |
Jul-22 |
Jul-22 |
4 |
0% |
10 |
– |
– |
– |
– |
– |
Ebola Zaire Vaccine (rVSV [DELTA] G-ZEBOV-GP, live) (Ervebo)B |
J07-Vaccines |
Nov-22 |
No sales data in MIDAS® as of Q4-2023 – date of approval by FDA, EMA, and/or Health Canada. |
|||||||||
Gallium (68Ga) gozetotide (Illuccix) |
V09-Diagnostic radiopharmaceuticals |
Oct-22 |
||||||||||
Gallium (68Ga) oxodotreotide (Netvision) |
V09-Diagnostic radiopharmaceuticals |
Feb-22 |
||||||||||
Vaccine, Hepatitis B surface antigen (PreHevbrio)B |
J07-Vaccines |
Dec-22 |
||||||||||
Vaccine, Pneumococcal conjugate (Prevnar 20)B |
J07-Vaccines |
May-22 |
||||||||||
Vaccine, SARS-CoV-2 mRNA (Comirnaty Original & Omicron BA.4/BA.5)B |
J07-Vaccines |
Oct-22 |
||||||||||
Vaccine, SARS-CoV-2 mRNA (Comirnaty Original/Omicron BA.1)B |
J07-Vaccines |
Oct-22 |
||||||||||
Vaccine, SARS-CoV-2 mRNA (Spikevax bivalent (Original / Omicron BA.4/5)B |
J07-Vaccines |
Nov-22 |
||||||||||
Vaccine, SARS-CoV-2 mRNA (Spikevax bivalent)B |
J07-Vaccines |
Sep-22 |
||||||||||
Virus-like particles (VLP) of SARS-CoV-2 spike protein (Covifenz)B |
J07-Vaccines |
Feb-22 |
||||||||||
SARS-CoV-2 recombinant spike protein (Nuvaxovid)B |
J07-Vaccines |
Feb-22 |
Note: Availability and sales information refer to all forms and strengths of the medicine, while pricing and treatment costs are based on the highest-selling form and strength indicated. Sales are based on manufacturer list prices.
Due to lack of sales data, only approval data is provided for all COVID-19 vaccines.
Specialty medicines are indicated using the following abbreviations: B: biologic; C: cancer; G: gene therapy; O: orphan.
Data source: IQVIA MIDAS®, 2023 (all rights reserved); Health Canada Notice of Compliance database.
References
European Medicines Agency. 2023. Human Medicines Highlights 2022.
Available: https://www.ema.europa.eu/en/news/human-medicines-highlights-2022
European Medicines Agency. 2024. Human Medicines Highlights 2023.
Available: https://www.ema.europa.eu/en/news/human-medicines-highlights-2023
Food and Drug Administration. 2023. Novel Drug Approvals for 2022.
Silver Spring, Maryland: US FDA, Center for Drug Evaluation and Research.
Available: https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2022
Food and Drug Administration. 2024. Novel Drug Approvals for 2023.
Silver Spring, Maryland: US FDA, Center for Drug Evaluation and Research.
Available: https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2023
PMPRB. 2020. Oncology Medicines in Canada: Trends and International Comparisons, 2010–2019.
Ottawa: Patented Medicine Prices Review Board.
Available: https://www.canada.ca/en/patented-medicine-prices-review/services/npduis/analytical-studies/oncology-medicines-trends-international-comparisons/intro.html
PMPRB. 2022. Expensive Drugs for Rare Diseases: Canadian Trends and International Comparisons, 2011–2020.
Ottawa: Patented Medicine Prices Review Board.
Available: https://www.canada.ca/en/patented-medicine-prices-review/services/npduis/analytical-studies/chartbook/expensive-drugs-rare-diseases-2011-2020.html
PMPRB. 2024. Annual Report, 2022. Ottawa: Patented Medicine Prices Review Board.
Available: https://www.canada.ca/en/patented-medicine-prices-review/services/annual-reports/annual-report-2022.html
Appendix A: Medicines approved in Canada that have met EDRD criteriaFootnote * (through Q4-2024)
Medicine (trade name) | Notice of Compliance (NOC) date |
---|---|
Zolbetuximab (Vyloy)B,C |
2024-12-13 |
Exagamglogene autotemcel (Casgevy)B,C |
2024-09-23 |
Avapritinib (Ayvakyt)C |
2024-09-18 |
Tarlatamab (Imdelltra)B,C |
2024-09-11 |
Sotatercept (Winrevair)B |
2024-08-28 |
Ivosidenib (Tibsovo)C |
2024-07-19 |
Zilucoplan sodium (Zilbrysq) |
2024-07-11 |
Eplontersen sodium (Wainua) |
2024-06-19 |
Talquetamab (Talvey)B,C |
2024-04-30 |
Metreleptin (Myalepta)B |
2024-01-17 |
Inebilizumab (Uplizna)B |
2023-12-15 |
Calaspargase pegol (Asparlas)B,C |
2023-11-08 |
Odevixibat (Bylvay) |
2023-10-30 |
Etranacogene dezaparvovec (Hemgenix)B |
2023-10-23 |
Vutrisiran (Amvuttra) |
2023-10-18 |
Epcoritamab (Epkinly/Tepkinly)B,C |
2023-10-13 |
Evinacumab (Evkeeza)B |
2023-09-22 |
Efgartigimod alfa (Vyvgart)B |
2023-09-19 |
Nivolumab/relatlimab (Opdualag)B,C |
2023-09-13 |
Tremelimumab (Imjudo)B,C |
2023-08-31 |
Teclistamab (Tecvayli)B,C |
2023-07-26 |
Maralixibat chloride (Livmarli) |
2023-07-21 |
Mirikizumab (Omvoh)B |
2023-07-20 |
Setmelanotide acetate (Imcivree) |
2023-05-05 |
Glofitamab (Columvi)B,C |
2023-03-24 |
Ciltacabtagene autoleucel (Carvykti)B,C |
2023-02-09 |
Amifampridine (Ruzurgi) |
2023-01-10 |
Pegcetacoplan (Empaveli) |
2022-12-08 |
Maribavir (Livtencity) |
2022-09-15 |
Selumetinib sulfate (Koselugo) |
2022-08-31 |
Belzutifan (Welireg)C |
2022-07-11 |
Asciminib hydrochloride (Scemblix)C |
2022-06-22 |
Tebentafusp (Kimmtrak)B,C |
2022-06-07 |
Berotralstat hydrochloride (Orladeyo) |
2022-06-02 |
Mogamulizumab (Poteligeo)B,C |
2022-06-02 |
Selinexor (Xpovio)C |
2022-05-31 |
Capmatinib (Tabrecta)C |
2022-05-26 |
Pegvaliase (Palynziq)B |
2022-03-30 |
Belumosudil mesylate (Rholistiq/Rezurock) |
2022-03-23 |
Lumasiran sodium (Oxlumo) |
2022-03-07 |
Sacituzumab govitecan (Trodelvy)B,C |
2021-09-24 |
Pemigatinib (Pemazyre)C |
2021-09-17 |
Elexacaftor/tezacaftor/ivacaftor and ivacaftor (Trikafta) |
2021-06-18 |
Selpercatinib (Retevmo)C |
2021-06-15 |
Brexucabtagene autoleucel (Tecartus)B,C |
2021-06-08 |
Idecabtagene vicleucel (Abecma)B,C |
2021-05-26 |
Daunorubicin and cytarabine (Vyxeos)C |
2021-04-29 |
Risdiplam (Evrysdi) |
2021-04-14 |
Encorafenib and binimetinib (Braftovi and Mektovi)C |
2021-03-02 |
Triheptanoin (Dojolvi) |
2021-02-15 |
Azacitidine (Onureg)C |
2021-01-05 |
Mecasermin (Increlex)B |
2020-12-17 |
Onasemnogene abeparvovec (Zolgensma)B |
2020-12-15 |
Voretigene neparvovec (Luxturna)B |
2020-10-13 |
Givosiran (Givlaari) |
2020-10-09 |
Luspatercept (Reblozyl)B |
2020-09-25 |
Atezolizumab & bevacizumab (Tecentriq & Avastin)B,C |
2020-08-07 |
Fedratinib (Inrebic)C |
2020-07-27 |
Polatuzumab vedotin (Polivy)B,C |
2020-07-09 |
Ripretinib (Qinlock)C |
2020-06-19 |
Tucatinib (Tukysa)C |
2020-06-05 |
Satralizumab (Enspryng)B |
2020-06-01 |
Isatuximab (Sarclisa)B,C |
2020-04-29 |
Glasdegib (Daurismo)C |
2020-04-28 |
Caplacizumab (Cablivi)B |
2020-02-28 |
Entrectinib (Rozlytrek)C |
2020-02-10 |
Tafamidis (Vyndaqel) |
2020-01-20 |
Gilteritinib (Xospata)C |
2019-12-23 |
Gemtuzumab ozogamicin (Mylotarg)B,C |
2019-11-28 |
Gemtuzumab ozogamicin (Mylotarg)B,C |
2019-11-28 |
Cabozantinib (Cabometyx)C |
2019-11-08 |
Ravulizumab (Ultomiris)B |
2019-08-28 |
Acalabrutinib (Calquence)C |
2019-08-23 |
Larotrectinib (Vitrakvi)C |
2019-07-10 |
Niraparib (Zejula)C |
2019-06-27 |
Tezacaftor/ivacaftor (Symdeko) |
2019-06-27 |
Patisiran (Onpattro) |
2019-06-07 |
Cemiplimab (Libtayo)B,C |
2019-04-10 |
Lorlatinib (Lorbrena)C |
2019-02-22 |
Axicabtagene ciloleucel (Yescarta)B,C |
2019-02-13 |
Enasidenib (Idhifa)C |
2019-02-06 |
Lutetium Lu 177 dotatate (Lutathera)C |
2019-01-09 |
Cerliponase alfa (Brineura)B |
2018-12-19 |
Burosumab (Crysvita)B |
2018-12-05 |
Dinutuximab (Unituxin)C |
2018-11-28 |
Pralatrexate (Folotyn)C |
2018-10-26 |
Edaravone (Radicava) |
2018-10-03 |
Inotersen (Tegsedi) |
2018-10-03 |
Lanadelumab (Takhzyro)B |
2018-09-19 |
Tisagenlecleucel (Kymriah)B,C |
2018-09-05 |
Emicizumab (Hemlibra)B |
2018-08-02 |
Brigatinib (Alunbrig)C |
2018-07-26 |
Inotuzumab ozogamicin (Besponsa)B,C |
2018-03-15 |
Avelumab (Bavencio)B,C |
2017-12-18 |
Sebelipase alfa (Kanuma)B |
2017-12-15 |
Olaratumab (Lartruvo)B,C |
2017-11-23 |
Durvalumab (Imfinzi)B,C |
2017-11-03 |
Migalastat (Galafold) |
2017-09-05 |
Midostaurin (Rydapt)C |
2017-07-21 |
Defibrotide (Defitelio)B |
2017-07-10 |
Nusinersen (Spinraza) |
2017-06-29 |
Cysteamine bitartrate (Procysbi) |
2017-06-13 |
Eliglustat (Cerdelga) |
2017-04-21 |
Nitisinone (Orfadin) |
2016-12-13 |
Nivolumab & ipilimumab (Opdivo + Yervoy)B,C |
2016-10-26 |
Venetoclax obinutuzumab (Venclexta)C |
2016-09-30 |
Alectinib (Alecensaro)C |
2016-09-29 |
Alpha-1 proteinase inhibitor [human] (Zemaira)B |
2016-09-21 |
Ixazomib (Ninlaro)C |
2016-08-04 |
Osimertinib (Tagrisso)C |
2016-07-05 |
Daratumumab (Darzalex)B,C |
2016-06-29 |
Elotuzumab (Empliciti)B,C |
2016-06-21 |
Olaparib (Lynparza)C |
2016-04-29 |
Glycerol phenylbutyrate (Ravicti) |
2016-03-18 |
Cobimetinib (Cotellic)C |
2016-02-22 |
Lumacaftor & ivacaftor (Orkambi) |
2016-01-26 |
Coagulation factor IX (recombinant), |
2016-01-26 |
Carfilzomib (Kyprolis)C |
2016-01-15 |
Blinatumomab (Blincyto)B,C |
2015-12-22 |
Nivolumab (Opdivo)B,C |
2015-09-25 |
Teduglutide (Revestive)B |
2015-09-04 |
Asfotase alfa (Strensiq)B |
2015-08-14 |
Ramucirumab (Cyramza)B,C |
2015-07-16 |
Pembrolizumab (Keytruda)B,C |
2015-05-19 |
Carglumic acid (Carbaglu) |
2015-04-10 |
Ponatinib (Iclusig)C |
2015-04-02 |
Ceritinib (Zykadia)C |
2015-03-27 |
Dabrafenib (dabrafenib mesylate) |
2015-03-06 |
Sodium phenylbutyrate (Pheburane) |
2015-01-26 |
Ibrutinib (Imbruvica)C |
2014-11-17 |
Elosulfase alfa (Vimizim)B |
2014-07-02 |
Icatibant (Firazyr) |
2014-06-04 |
Taliglucerase Alfa (Elelyso)B |
2014-05-29 |
Lomitapide (Juxtapid) |
2014-02-04 |
Pomalidomide (Pomalyst)C |
2014-01-20 |
Romidepsin (Istodax)C |
2013-10-16 |
Galsulfase (Naglazyme)B |
2013-09-16 |
Trametinib (Mekinist)C |
2013-07-18 |
Arsenic trioxide (Trisenox)C |
2013-06-07 |
Brentuximab vedotin (Adcetris)B,C |
2013-02-01 |
Ivacaftor (Kalydeco) |
2012-11-26 |
C1 esterase inhibitor [human] (Cinryze)B |
2012-10-19 |
Crizotinib (Xalkori)C |
2012-04-25 |
Vemurafenib (Zelboraf)C |
2012-02-15 |
Ipilimumab (Yervoy)B,C |
2012-02-01 |
Velaglucerase alfa (Vpriv)B |
2010-10-01 |
Trabectedin (Yondelis)C |
2010-05-13 |
Sapropterin dihydrochloride (Kuvan) |
2010-04-30 |
Canakinumab (Ilaris)B |
2010-02-26 |
Clofarabine (Clolar)C |
2009-07-16 |
Vorinostat (Zolinza)C |
2009-06-11 |
Romiplostim (Nplate)B |
2009-02-19 |
Eculizumab (Soliris)B |
2009-01-28 |
Lenalidomide (Revlimid)C |
2008-01-17 |
Nelarabine (Atriance)C |
2007-09-22 |
Idursulfase (Elaprase)B |
2007-06-13 |
Alglucosidase (Myozyme)B |
2006-08-14 |
Bevacizumab (Avastin)B,C |
2005-09-09 |
Alfa 1-proteinase inhibitor [human] (Prolastin-C)B |
2005-06-28 |
Laronidase (Aldurazyme)B |
2004-05-31 |
Miglustat (Zavesca) |
2004-03-31 |
Agalsidase alfa (Replagal)B |
2004-02-06 |
Agalsidase beta (Fabrazyme)B |
2004-01-23 |
Treprostinil Sodium (Remodulin) |
2002-10-04 |
Pegaspargase (Oncaspar)B,C |
1997-11-19 |
Imiglucerase (Cerezyme)B |
1997-02-12 |
Note: Specialty medicines are indicated using the following abbreviations: B: biologic; C: cancer; G: gene therapy; O: orphan.
Data source: Health Canada databases, drugs@FDA database, EMA drug database, CDA-AMC databases.