Meds Entry Watch 2018

Acknowledgements

This report was prepared by the Patented Medicine Prices Review Board (PMPRB) as part of the National Prescription Drug Utilization Information System (NPDUIS) 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 analytical project, as well as to Tanya Potashnik and Jeffrey Menzies for their oversight in the development of the report. The PMPRB also wishes to acknowledge the contribution of the analytical staff Jared Berger, Patrick McConnell, and Lokanadha Cheruvu; and the contribution of the editorial staff Carol McKinley, Sarah Parker, and Shirin Paynter.

Disclaimer

NPDUIS 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 a 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 provided under license from the IQVIA MIDAS® Database, 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
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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

Executive Summary

This is the fourth edition of the PMPRB’s Meds Entry Watch report, which explores the market entry of new medicines in Canada and other countries. Building on the retrospective analysis of trends since 2009, this report focuses on medicines that received first-time market approval through the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and/or Health Canada in 2017 and 2018, and analyzes their uptake, pricing, sales, and availability as of the last quarter of 2018 (Q4-2018). This edition includes a new Canadian section with information on medicines that received their first Health Canada approval in 2017, as well as those that were approved for new indications.

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 the seven countries the PMPRB currently considers in reviewing the prices of patented medicines (PMPRB7): France, Germany, Italy, Sweden, Switzerland, the United Kingdom (UK), and the United States (US).

Key Findings

A) Trends in New Medicine Approvals, 2009 to 2017

Although the market impact of new medicine approvals has varied from year to year since 2009, the landscape has been characterized by a continued rise in the number of specialized treatments.

B) 2017 New Medicine Approvals

More new medicines were approved in 2017 than in previous years, with a significant increase in the number of high-cost orphan and oncology medicines entering the market.

Fewer medicines were approved in Canada than in the US and Europe in 2017, although Canada compared favourably to the OECD in terms of the corresponding share of sales.

Antivirals and central nervous system medicines accounted for the majority of 2017 new medicine sales in the last quarter of 2018.

C) 2018 New Medicine Approvals

The relatively high rate of new medicine approvals in 2017 was sustained through 2018, as the number of new high-cost specialty therapies continued to rise.

D) Spotlight on Canada

A number of medicines received their first Canadian approval in 2017, though new indications approved for existing medicines had a greater impact on sales.

The next edition of Meds Entry Watch will build on this analysis to provide further insight into the medicines introduced in 2018 and a preliminary look at those approved in 2019, as well as a retrospective review of trends in new medicines over the past five years.

Introduction

Meds Entry Watch is an annual PMPRB 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 three previous editions to provide a broader retrospective analysis of medicines that have entered the market since 2009, and offers a detailed analysis of the new medicines approved in 2017 along with a preliminary examination of those approved in 2018. New medicines are identified for each year based on the date of their first market authorization through the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and/or Health Canada.

This edition also features a new section focused on medicines that received their first Canadian approval in 2017. In addition to reporting the prices of new medicines approved in Canada in comparison with international markets, this analysis monitors the sales of existing medicines that received approvals for new indications in the same year.

The report consists of four main parts: Part A provides an overview of longer-term trends from 2009 to 2017; Part B focuses on new medicines that received market approval in 2017; Part C presents a preliminary analysis of the new medicines approved in 2018; and Part D spotlights Health Canada approvals in 2017.

This publication informs decision makers, researchers, and patients of emerging therapies in Canadian and international pharmaceutical markets.

Methods

This report analyzes new medicines that received initial market approval through the FDA, the EMA, and/or Health Canada in 2017 and 2018. For the purpose of this study, new medicines were identified at the medicinal ingredient level. A new medicine was selected for analysis if it received first-time market authorization from any of these regulatory bodies during the calendar year, even if it was not yet listed for reimbursement or if there were no recorded sales in the available data. Using these criteria, 52 new medicines were identified for the 2017 analysis in Section B and 51 were identified for the preliminary analysis of 2018 medicines in Section C. The approval of these medicines in Canadian and international markets was assessed as of the end of 2018.

The selection of medicines featured in the analysis of the Canadian market in Section D differs from the previous sections. Medicines analyzed in Section D include new and previously marketed medicinal ingredients that received their first Canadian market authorization through Health Canada in 2017. This includes a number of the medicines in the 2017 analysis in Section B, but also encompasses additional medicines that may have received initial approval through the FDA or EMA in previous years and were approved for the Canadian market in 2017. Section D also reports on the sales of medicines previously marketed in Canada that received authorization for additional or extended indications in 2017.

International markets examined include the Organisation for Economic Co-operation and Development (OECD) members, with a focus on the seven countries the PMPRB currently considers in reviewing the prices of patented medicines (PMPRB7): France, Germany, Italy, Sweden, Switzerland, the United Kingdom (UK), and the United States (US).

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 number of units sold. MIDAS data reflects the national retail and hospital sectors of each country, including payers in all market segments (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 the MIDAS Database and other NPDUIS source materials, see the Reference Documents section of the Analytical Studies page on the PMPRB website.

Canadian prices were based on MIDAS data, if available; otherwise, they were taken from publicly available results of the Common Drug Review (CDR) or pan-Canadian Oncology Drug Review (pCODR) processes published by the Canadian Agency for Drugs and Technologies in Health (CADTH). 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. All medicines were reviewed as of Q3-2019, unless otherwise specified.

Prices and foreign-to-Canadian price ratios were reported for the highest-selling form and strength of each medicine in Canada, or in the PMPRB7 if no Canadian sales were available at the time of the analysis. The foreign-to-Canadian price ratios presented in this report are 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 Reference Documents section of the Analytical Studies page on the PMPRB website.

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.

Historical results for the period from 2009 to 2014 were based on the methodology employed in the first issue of Meds Entry Watch, which identified new medicines based on the date of first recorded sales in the MIDAS Database. This change in methodology is not expected to have a meaningful impact on the overall results.

Limitations

New medicines reported in Sections B and C were selected for analysis based on their date of market approval by the FDA, the EMA, and/or Health Canada; however, some may have an earlier approval date in other international markets. Likewise, the medicines included in this analysis do not necessarily represent all of those introduced in 2017 and 2018, as other national regulatory bodies not examined in this report may have approved additional medicines. Nevertheless, this should have a very limited effect on the results, as the FDA and EMA are major regulatory bodies representing large international markets and have regulatory approaches similar to those in Canada.

This report reflects the initial market penetration of these new medicines, and their availability and uptake are expected to increase in subsequent years. The availability of a new medicine in a given country at any point in time is influenced by a variety of factors including the manufacturer’s decision to launch, as well as the timing of that decision; the regulatory approval process in place; and the existing market dynamics.

Market approval through the EMA does not necessarily mean that the medicine is available in any given European country. Likewise, medicines approved through the FDA or Health Canada may not necessarily be reimbursed and/or have any recorded sales.

Some medicines with sales may not be reported in the IQVIA MIDAS® Database, and thus, the sales of new medicines in any given country may be slightly under-reported. However, as the effect is expected to be relatively consistent across all markets, this should have only a minimal impact on the overall findings.

Canadian and international sales and prices are based on manufacturer list prices as reported in the MIDAS Database, and do not capture price rebates, managed entry agreements (also known as product listing agreements), or patient access schemes. The methodology used by MIDAS for estimating medicine prices varies by country, depending on data availability, and may include assumed regulated margins and/or markups.

Publicly available prices from the Canadian Agency for Drugs and Technologies in Health (CADTH) are based on the manufacturers’ submitted prices, which may differ upon market entry.

Aggregated international sales and pricing data are heavily skewed towards the United States due to its relatively large population, and as a result, the ranking of medicines by international sales generally reflects the order of sales in the US.

The assessment of medicine availability in Canada does not consider non-marketed medicines available through programs that authorize the sale of medicines in exceptional circumstances, such as the Special Access Programme in Canada (SAP).

A. Trends in New Medicine Approvals, 2009–2017

A greater number of new medicines have been approved in recent years, including a rising share of new specialty treatments. Medicines first approved between 2009 and 2017 accounted for over one third of all brand-name sales by the end of 2018. Nearly half of these had recorded Canadian sales by Q4-2018, placing Canada 10th in the OECD and behind most PMPRB7 countries. Despite this, Canada ranked fourth in terms of the share of total new medicine sales, which suggests that the top-selling medicines were among those approved.

In 2017, 52 new medicines received first-time market approval through the FDA, the EMA, and/or Health Canada, a considerable increase from the 31 approved the year before and the annual average of 35 reported from 2009 to 2014 (Figure A1). Almost half (24) of these medicines received an orphan designation from the FDA and/or EMA, representing a sustained rise over the 33% average share from 2009 to 2014.

An additional 51 new medicines were approved in 2018, of which nearly 60% (30) received an orphan designation and close to one third (15) were approved to treat cancer.

New medicines continued to be concentrated in a few therapeutic areas, mostly notably among antineoplastic agents and antivirals. The number of approvals increased in 2017 for central nervous system medicines, ophthalmologicals, and non-steroidal products for inflammatory skin disorders. Additionally, a number of new migraine treatments were approved in 2018.

Figure A1 New medicines approved in Canada and the PMPRB7*, 2009 to 2018 Figure A1
Figure description

This bar graph depicts the number of new medicines launched in Canada and the PMPRB7 from 2009 to 2018. The number of medicines introduced between 2009 and 2014 is averaged from a cumulative total of 212. A table shows the share of orphan and oncology medicines for each annual total.

  Average 2009‒2014 2015 2016 2017 2018
Number of new medicines 35 41 31 52 51
Share of orphan medicines 33% 54% 42% 46% 59%
Share of oncology medicines 20% 34% 16% 33% 29%

Note: New medicines reported between 2009 and 2014 were identified based on the date of first recorded sales, while those reported for 2015 onward were determined based on the date of first-time market approval by the US Food and Drug Administration, the European Medicines Agency, and/or Health Canada.
* France, Germany, Italy, Sweden, Switzerland, the United Kingdom, and the United States.
Data source: IQVIA MIDAS® Database, 2009 to 2014 (all rights reserved); US Food and Drug Administration, European Medicines Agency, and Health Canada databases.

Following a period of steep year-over-year uptake in the sales of new medicines, recent entrants have held a relatively modest share of the market. Despite a significant number of approvals in 2017, these new medicines accounted for 2.8% of all brand-name pharmaceutical sales by Q4-2018. New medicines approved between 2009 and 2017 collectively made up one third of the total market in Canada and comparator countries (Figure A2).

Notably, new medicines accounted for a slightly larger share of the Canadian market than their corresponding share of the market in Canada and the PMPRB7. Driving this difference was a marked difference between the influence of the 2016 new medicines in Canada and internationally; whereas the 2016 medicines held only a 2.3% share across the PMPRB7 by Q4-2018, they represented 4.7% of all sales in Canada. This may be due, in part, to a greater impact from the hepatitis C treatment Epclusa (sofosbuvir/velpatasvir), which accounted for 0.6% of total pharmaceutical sales in the PMPRB7 and 2.2% of Canadian sales in Q4-2018.

In any given year, the impact of new medicines on pharmaceutical sales depends on their number, therapeutic relevance, and treatment costs. For example, the entry of new direct-acting antivirals (DAAs) for hepatitis C in 2014 continues to have a high impact on sales, accounting for one fifth of the new medicine share of the brand-name pharmaceutical market by Q4-2018.

Figure A2 New medicine cumulative share of all brand-name medicine sales by year of approval* (2009 to 2017), Canada and the PMPRB7† Figure A2
Figure description

This figure consists of two area graphs depicting the new medicine cumulative share of total brand-name medicine sales by year of approval. It tracks the percentage of new medicines in yearly sales up to the fourth quarter of 2018. New medicine share of sales for each year are also marked. The first graph is for both Canada and the seven PMPRB comparator countries and the second is for Canada alone.

(a) Canada and PMPRB7

Year of approval 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 Q4-2018
2009 0.1% 0.6% 1.4% 2.2% 2.7% 3.1% 3.8% 4.1% 4.1% 4.2% 4.3%
2010   0.1% 0.5% 0.9% 1.2% 1.4% 1.7% 1.8% 1.8% 1.9% 1.8%
2011     0.5% 1.4% 1.9% 2.3% 3.0% 3.8% 3.9% 4.1% 4.2%
2012       0.1% 0.7% 1.5% 2.6% 3.6% 3.5% 3.7% 3.8%
2013         0.2% 4.1% 3.4% 4.2% 3.6% 3.1% 3.1%
2014           0.2% 5.8% 6.4% 6.0% 6.3% 6.7%
2015             0.3% 2.1% 3.8% 4.3% 4.6%
2016                 1.9% 2.3% 2.3%
2017                   2.3% 2.8%
New medicine share of sales 0.1% 0.7% 2.4% 4.6% 6.8% 12.6% 20.6% 26.1% 28.7% 32.2% 33.5%

(b) Canada

Year of approval 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 Q4-2018
2009 0.1% 0.4% 1.1% 2.1% 3.0% 3.8% 4.4% 5.1% 5.4% 5.2% 5.3%
2010   <0.1% 0.1% 0.5% 0.9% 1.3% 1.5% 1.7% 1.7% 1.7% 1.8%
2011     <0.1% 0.8% 1.6% 2.2% 3.0% 4.2% 4.9% 5.7% 5.9%
2012       <0.1% 0.2% 0.9% 1.6% 2.5% 2.7% 2.5% 2.7%
2013         <0.1% 1.5% 2.5% 3.9% 3.6% 3.2% 3.4%
2014           0.2% 4.2% 4.0% 4.5% 5.3% 5.6%
2015             0.1% 0.6% 1.9% 2.7% 3.0%
2016                 3.2% 4.9% 4.7%
2017                   1.7% 2.4%
New medicine share of sales 0.1% 0.4% 1.3% 3.4% 5.8% 9.8% 17.3% 22.0% 27.8% 32.9% 34.8%

* New medicines introduced between 2009 and 2014 were identified based on the date of first reported sales, while those reported for 2015 onward were determined based on the date of first-time market approval by the US Food and Drug Administration, the European Medicines Agency, and/or Health Canada.
† France, Germany, Italy, Sweden, Switzerland, the United Kingdom, and the United States.
Data source: IQVIA MIDAS® Database, 2009 to 2018. All rights reserved.

Of the 336 medicines approved in Canada and the PMPRB7 from 2009 to 2017, 48% had recorded sales in Canada by Q4-2018 (Figure A3). While this represents a greater share than the OECD median of 40%, it ranks below most PMPRB7 countries, many of which have lower average list prices for patented medicines (PMPRB). The new medicines sold in Canada accounted for 94% of the OECD sales for all new medicines analyzed, representing the fourth highest share in the OECD, well above the median of 82%. This suggests that although fewer new medicines were approved in Canada, the higher-selling new medicines were among those sold, which may have been partially influenced by Canada’s proximity to the US market.

Figure A3 Share of new medicines approved* in Canada and the PMPRB7† from 2009 to 2017 with available sales, and their respective share of OECD sales, by country, Q4-2018 Figure A3
Figure description

This is a split bar graph. For each country in the Organisation for Economic Co-operation and Development, one side of the graph gives the market share of the new medicines launched in Canada and its seven PMPRB comparator countries from 2009 to 2017. The other side gives the respective share of the Organisation for Economic Co-operation and Development sales in the fourth quarter of 2018. The Organisation for Economic Co-operation and Development median is shown for each side of the graph.

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 61% 91%
Italy 61% 95%
United Kingdom 60% 94%
Austria 59% 93%
Sweden 58% 95%
Spain 55% 90%
Norway 52% 90%
France 50% 81%
Canada 48% 94%
Finland 48% 91%
Belgium 48% 88%
Switzerland 48% 92%
Japan 45% 84%
Portugal 45% 85%
Hungary 40% 81%
Australia 39% 82%
Slovakia 39% 77%
Slovenia 39% 83%
South Korea 38% 80%
Ireland 38% 81%
Mexico 34% 80%
Poland 32% 77%
Czech Republic 31% 56%
Netherlands 30% 57%
Turkey 26% 67%
Luxembourg 19% 48%
New Zealand 19% 47%
Chile 18% 58%
Greece 16% 38%
Estonia 15% 38%
OECD median 40% 82%

Note: Sales are based on manufacturer list prices and include sales for all OECD countries.
* New medicines introduced between 2009 and 2014 were identified based on the date of first reported sales, while those reported for 2015 onward were determined based on the date of first-time market approval by the US Food and Drug Administration, the European Medicines Agency, and/or Health Canada.
† France, Germany, Italy, Sweden, Switzerland, the United Kingdom, and the United States.
Data source: IQVIA MIDAS® Database, 2018. All rights reserved.

B: New Medicine Approvals, 2017

A greater than average number of new medicines were approved in Canada, Europe, and the US in 2017, nearly half of which had an orphan designation. While relatively few of these medicines had sales in Canada by the end of 2018, those sold accounted for the majority of all new medicine sales.

Fifty-two new medicines were approved internationally in 2017, representing a considerable increase from the 31 medicines approved the year before. Nearly two thirds of these new medicines were high-cost, coming with treatment costs over $10,000 per year, or $5,000 per 28-day cycle for oncology medicines. Five new non-oncology medicines were identified as expensive drugs for rare diseases (EDRDs)—orphan-designated therapies exceeding $100,000 in annual treatment costs—while ten new oncology medicines qualified as EDRDs at over $7,500 per 28-day cycle.

By the end of 2018, just over half (27) of the 2017 new medicines had been approved in Canada. Both the FDA and the EMA, which represent two of the largest international markets, approved more new medicines than Canada at 49 and 34, respectively (Figure B1).

Figure B1 Number of 2017 new medicines with market approval as of Q4-2017 and Q4-2018 Figure B1
Figure description

This is a bar graph with the number of 2017 new medicines approved by Health Canada, the European Medicines Agency, and the Food and Drug Administration in the United States as of the fourth quarter of 2017 and as of the fourth quarter of 2018. The total number of new medicines in 2017 was 52.

  US Food and Drug Administration European Medicines Agency Health Canada
Q4-2017 49 19 13
Q4-2018 49 34 27

Data source: US Food and Drug Administration (FDA), European Medicines Agency (EMA), and Health Canada databases.

Of the 27 medicines approved in Canada, 18 had sales data available in MIDAS by Q4-2018. This placed Canada sixth in the OECD in terms of the number of new medicines sold and third in terms of the corresponding OECD sales of these new medicines at 88%, marking an increase over 2016 results. The US market, which ranked first among all OECD countries, recorded sales for 43 of the medicines approved in 2017, representing over 99% of OECD sales.

These results reflect the initial market penetration, and the availability and uptake in sales for these new medicines are expected to increase in subsequent years.

Figure B2 Number of 2017 new medicines with market approval and their share of OECD sales as of Q4-2018 Figure B2
Figure description

This is a split bar graph showing the number of new medicines approved and with available sales as of the fourth quarter of 2018 and the corresponding share of 2018 fourth quarter sales in 31 Organisation for Economic Co-operation and Development countries. A median is given for each side of the graph.

Country Number of new medicines with sales Share of total Organisation for Economic Co-operation and Development sales for new medicines
United States 43 >99%
Germany 26 88%
Sweden 23 86%
Austria 22 81%
United Kingdom 19 84%
Canada 18 88%
Italy 17 72%
Japan 16 58%
France 16 70%
Norway 14 69%
Finland 13 66%
Switzerland 13 70%
Slovenia 12 75%
Belgium 11 42%
Netherlands 11 72%
Hungary 10 38%
Ireland 7 40%
Australia 7 50%
South Korea 6 41%
Poland 6 32%
Luxembourg 4 15%
Mexico 4 46%
Czech Republic 3 30%
Slovakia 3 29%
Turkey 2 18%
Chile 1 17%
Estonia 1 26%
Portugal 1 <1%
Spain 1 <1%
Greece 1 2%
New Zealand 0 <1%
OECD median 10 46%

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 2017 with recorded sales data as of Q4-2018.
Sales are based on manufacturer list prices and include sales for the selected new medicines in all OECD countries.
Data source: IQVIA MIDAS® Database, 2018 (all rights reserved); US Food and Drug Administration, European Medicines Agency, and Health Canada databases.

Although new medicines approved in Canada and the PMPRB7 in 2017 covered a wide range of therapeutic classes, their sales were highly concentrated. The top four ATC classes by sales represented half of the 2017 new medicines and over 80% of all new medicine sales in Canada and the PMPRB7 by Q4-2018. Two medicines, glecaprevir/pibrentasvir and ocrelizumab, together accounted for 45% of sales and represented the top two therapeutic classes, antivirals and central nervous system drugs, respectively. Antineoplastics ranked as the third top-selling ATC class, with oncology treatments accounting for 12 of the 52 new medicines and 15% of sales.

As illustrated, a significant number of new medicines fell into multiple specialty categories. Most notably, 11 of the new oncology medicines and nine of the new biologic therapies were also orphan-designated, four of which belonged to all three groups. In total, 46% (24) of the 2017 new medicines received an orphan designation from the FDA and/or the EMA. The share of oncology medicines rose to 33%, and 35% of new medicines were biologics.

Venn Diagram
Figure description

Venn diagram

This is a Venn diagram illustrating the overlap between orphan, biologic, and oncology medicines among the 2017 new medicines: 18 medicines were biologic, 24 had an orphan designation, and 17 were cancer medicines. Nine were both biologic and orphan, five were both biologic and oncological, 11 were both orphan and oncological, and four were biologic cancer medicines that also received an orphan designation.

Data source: US Food and Drug Administration, European Medicines Agency, and Health Canada databases.

Table B1 lists the new medicines approved in 2017. For each medicine, the country with the first reported sales is given, along with the availability in Canada, the share of sales in Q4-2018, 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.

Table B1 New medicines approved in 2017, availability, share of sales, prices, and treatment costs, ranked by therapeutic class share of sales, Q4-2018

Rank Therapeutic class* Medicine (trade name, form, strength, volume)† Availability Share of new medicine sales (%)  No. of countries with sales Canadian price§ (CAD) PMPRB7‡ price (CAD) Treatment cost**
First sale in Canada or PMPRB7 First sale in Canada Medicine Therapeutic class  Min Median  Max Treatment cost (CAD) Annual / Course
1 J5-Antivirals Glecaprevir, pibrentasvir (Maviret, film-ctd tab, 100 mg + 40 mg) US Aug-17 Sept-17 25.7% 29.0% 8 236 187 230 251 79,240 16-week treatment
2 Voxilaprevir (Vosevi, film-ctd tab, 400 mg + 100 mg + 100 mg) US Jul-17 Sept-17 2.6% 7 699 684 854 1,020 58,752 12-week treatment
3 Letermovir (Prevymis, film-ctd tab, 480 mg)O US/CAN Dec-17 Dec-17 0.7% 4 245 452 477 501 24,450 100-day treatment
4 N7-Other central nervous system drugs Ocrelizumab (Ocrevus, infus. vial/bottle, 30 mg/ml, 10 ml)B US Sept-17 Sept-17 17.0% 20.1% 8 8,446 7,124 8,955 18,885 33,786 Annual
5 Deutetrabenazine (Austedo, ctd tab, 12 mg)O US Jun-17 1.7% 1 108 108 108 19,760 / 158,100 Annual (6 mg / 48 mg)
6 Edaravone (Radicava, infus. bag, 300 mcg/ml, 100 ml)O US Aug-17 1.2% 1 712 661 661 661 190,880 / 185,182 First year / subsequent years
7 Cerliponase alfa (Brineura, infus. vial/bottle, 30 mg/ml, 5 ml)B,O SWE May-17 0.2% 4 16,190i 15,569 30,478 346,556 841,900 Annual
8 Valbenazine (Ingrezza, capsule, 80 mg)O US Mar-17 0.1% 1 265 265 265 96,900 Annual
9 L1-Antineoplastics Durvalumab (Imfinzi, infus. vial/bottle, 50 mg/ml, 10 ml)B,C US May-17 Nov-17 6.1% 14.5% 7 4,028 3,180 3,698 4,093 11,280 28-day cycle
10 Ribociclib (Kisqali, film-ctd tab, 200 mg)C US Mar-17 Apr-18 1.9% 7 101 68 92 236 6,340 28-day cycle
11 Abemaciclib (Verzenio, tab or film-ctd tab, 150 mg)C US Oct-17 1.8% 3 95ii 72 75 239 5,300 28-day cycle
12 Niraparib (Zejula, capsule, 100 mg)C,O US Apr-17 1.1% 7 119 158 247   13,300 28-day cycle
13 Midostaurin (Rydapt, capsule, 25 mg)C,O FRA Oct-16 Sept-17 0.9% 8 166 150 167 193   9,270 28-day cycle
14 Inotuzumab ozogamicin (Besponsa, infus. dry bottle, 0.9 mg-1 mg)B,C,O FRA Apr-17 May-18 0.8% 8 14,256 15,759 15,775 21,645 48,490 / 40,375 21-day cycle / subsequent 28-day cycle
15 Avelumab (Bavencio, infus. vial/bottle, 20 mg/ml, 10 ml)B,C,O US Mar-17 Dec-17 0.6% 8 1,391 1,143 1,350 1,850 9,738 28-day cycle
16 Acalabrutinib (Calquence, capsule, 100 mg)C,O US Nov-17 0.6% 1 283 283 283 15,840 28-day cycle
17 Enasidenib (Idhifa, film-ctd tab, 100 mg)C,O US Jul-17 0.3% 1 972 972 972 27,227 28-day cycle
18 Brigatinib (Alunbrig, film-ctd tab, 180 mg)C,O US May-17 0.1% 3 337ii 236 416 596 9,435 28-day cycle
19 Tisagenlecleucel (Kymriah, infus. bag)B,C,O,G GER Aug-17 0.1% 1 482,549 482,549 482,549 482,549 One-time treatment
20 Neratinib (Nerlynx, film-ctd tab, 40 mg)C US Jul-17 0.1% 1 74 74 74 12,538 28-day cycle
21 Copanlisib (Aliqopa, inf. dry bottle, 60 mg)C,O US Sept-17 0.1% 1 5,393 5,393 5,393 16,200 28-day cycle
22 Tivozanib (Fotivda, capsule, 1.34 mg)C GER Nov-17 0.1% 2 145 194 242 4,070 28-day cycle
23 D5-Nonsteroidal products for inflammatory skin disorders Dupilumab (Dupixent, prefill syrng sc, 150 mg/ml, 2 ml)B US Mar-17 Feb-18 8.1% 12.7% 7 1,068 780 1,013 1,801 29,386 / 27,800 First year / subsequent years
24 Guselkumab (Tremfya, prefill syrng sc, 100 mg/ml, 1 ml)B US Aug-17 Nov-17 4.1% 7 3,139 2,984 3,543 12,430 22,100 / 20,500 First year / subsequent years
25 Brodalumab (Siliq/Kyntheum, prefill syrng sc, 140 mg/ml, 1.5 ml)B SWE Jul-17 Jul-18 0.6% 6 627 670 896 2,164 17,230 / 16,300 First year / subsequent years
26 J7-Vaccines Herpes zoster vaccine [recombinant, adjuvanted] (Shingrix Vaccine, vial im, 100 mcg/ml, 0.5 ml)B US Dec-17 Jan-18 6.8% 6.8% 3 119 122 148 174 240 Treatment (2 doses)
27 A10-Diabetes Semaglutide (Ozempic, prefill pen, 1.34 mg/ml, 1.5 ml) US Jan-18 Feb-18 5.2% 5.7% 5 132 113 378 643 1,720 to 3,440 Annual
28 Ertugliflozin (Steglaro, film-ctd tab, 5 mg) US Jan-18 May-17 0.5% 3 2i 2 7 11 894 Annual
29 R3-Anti-asthma and COPD products Benralizumab (Fasenra, prefill syrng sc, 30 mg/ml, 1 ml)B US Dec-17 Mar-18 3.0% 3.0% 7 3,770 2,908 3,299 5,880 30,160 / 24,500 First year / subsequent years
30 M1-Anti-inflammatory and anti-rheumatic products Baricitinib (Olumiant, film-ctd tab, 2 mg)O UK Apr-17 Sept-18 1.8% 2.8% 8 50 34 43 85 18,270 Annual
31 Sarilumab (Kevzara, prefill syrng/autoinj, 175 mg/ml, 1.14 ml)B CAN Feb-17 Feb-17 1.0% 8 718 564 769 1,941 50,500 Annual
32 B2-Blood coagulation system, other products Emicizumab (Hemlibra, vial sc, 150 mg/ml, 1 ml)B,O US Nov-17 2.5% 2.5% 6 15,980 17,446 18,537 683,900 / 635,000 First year / subsequent years
33 Coagulation Factor IX [recombinant], glycoPEGylated (Rebinyn, vial dry, 2000 IU)B SWE Jun-17 0.1% 2 4 4 4  8 to 13 Dose
34 H4-Other hormones Abaloparatide (Tymlos, prefill pen, 2 mg/ml, 1.56 ml) US Jun-17 0.9% 1.0% 1 2,131 2,131 2,131 25,500 Annual
35 Angiotensin II (Giapreza, infus. vial/bottle, 2.5 mg/ml, 1 ml) US Feb-18 <0.1% 1 1,915 1,915 1,915 550 / 320 Max titration / maintenance per hour
36 S1-Ophthalmologicals
Netarsudil (Rhopressa, eye drops, 0.02%, 2.5 ml) US Apr-18 0.5% 0.7% 1 6 6 6 2,175 Annual (per eye)
37 Latanoprostene bunod (Vyzulta, eye drops, 0.02%, 2.5 ml) US Dec-17 0.2% 1 4 4 4 1,626 Annual (per eye)
38 Cenegermin (Oxervate, eye drops, 20 mcg/ml, 1 ml)B,O GER Nov-17 <0.1% 2 23 23 23 7,690 8-week treatment (per eye)
39 Voretigene neparvovec (Luxturna)B,O,G US Feb-18 <0.1% 1 23,567 23,567 23,567 561,595 One-time treatment (per eye)
40 A3-Functional gastro-intestinal disorder drugs Plecanatide (Trulance, tab, 3 mg) US Mar-17 0.6% 0.6% 1 16 16 16 5,900 Annual
41 A6-Drugs for constipation and bowel cleansers Naldemedine (Symproic, film-ctd tab, 200 mcg) US Oct-17 0.2% 0.2% 1 13 13 13 4,800 Annual
42 A7-Intestinal disorder products Telotristat ethyl (Xermelo, film-ctd tab, 250 mg)O US Mar-17 0.2% 0.2% 5 85i 16 19 81 92,199 Annual
43 J1-Systemic antibacterials Delafloxacin (Baxdela, tab, 450 mg) US Jan-18 0.1% 0.1% 1 87 87 87 870 / 2,450 5-day / 14-day treatment
44 Vaborbactam (Vabomere, inf. dry bottle, 1 g + 1 g) US Aug-17 0.1% 1 197 197 197 16,590 14-day treatment
45 D10-Anti-acne prepararations Ozenoxacin (Ozanex, cream, 1%, 10 g) CAN Jan-18 Jan-18 0.1% 0.1% 1 2 NA NA NA NA Topical use
46 A16-Other alimentary tract and metabolism products Vestronidase alfa (Mepsevii, infus. vial/bottle, 2 mg/ml, 5 ml)B,O US Dec-17 <0.1% <0.1% 1 2,630 2,630 2,630 683,900 Annual (25kg)
47 V3-All other therapeutic products Lutetium Lu 177 dotatate (Lutathera, infus. vial/bottle, 370 mg/ml, 30 ml)C,O FRA Apr-15†† <0.1% <0.1% 1 23,567 23,567 23,567 140,000 32-week treatment
48 T2-Diagnostic tests Macimorelin (Macrilen, oral u-d powdr, 0.05%, 120 ml)O US Jul-18 <0.1% <0.1% 1 5,605 5,605 5,605 NA Topical use
49 B1-Antithrombotic agents Betrixaban (Bevyxxa, capsule, 80 mg) US Jan-18 <0.1% <0.1% 1 15 15 15 540 to 640 35- to 42-day treatment

Medicines without sales data in MIDAS® as of Q4-2018

Rank Therapeutic class* Medicine (trade name, form, strength, volume)† First approval by FDA, EMA, and/or Health Canada First approval in Canada
50 L03-Immunostimulants Axicabtagene ciloleucel (Yescarta)B,C,O,G FDA Oct-17 Feb-19‡‡
51 P01-Antiprotozoals Benznidazole (Benznidazole)O FDA Aug-17
52 L01-Antineoplastic agents Padeliporfin (Tookad)C EMA Nov-17

Note: A medicine was considered to be new in 2017 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.
* Level 2 of the Anatomical Classification of Pharmaceutical Products, as reported in MIDAS, except for the new medicines without sales data in MIDAS, for which the reporting is based on the Anatomic Therapeutic Chemical (ATC) Classification System maintained by the World Health Organization (WHO).
† B: biologic; C: cancer; O: orphan medicines; G: gene therapies.
‡ France, Germany, Italy, Sweden, Switzerland, the United Kingdom, and the United States.
§ Canadian unit prices were retrieved from IQVIA MIDAS® Database, where available; otherwise, they were taken from:
i CADTH's Canadian Drug Expert Committee Recommendation report.
ii pCODR Expert Review Committee (pERC) Recommendation report.
** Treatment costs were calculated using Canadian list prices if available; otherwise, the foreign median price or available foreign price was used. Information on dosing regimens was taken from the product monograph provided by Health Canada, or the FDA or EMA if unavailable though Health Canada.
†† Lutetium Lu 177 dotatate has been added to the list of 2017 new medicines reported in the previous edition of Meds Entry Watch. Despite being approved individually in France in 2015, it received its first market authorization from the EMA in 2017.
‡‡ Notice of Compliance issued as of Q3-2019.
Data source: IQVIA MIDAS® Database, 2018 (all rights reserved); US Food and Drug Administration Novel Drugs 2017; European Medicines Agency Human Medicines Highlights 2017; Health Canada databases.

Many of the 2017 new medicines came with a high treatment cost: 14 oncology medicines had costs exceeding $5,000 for a 28-day regimen; and 20 non-oncology medicines had annual costs exceeding $10,000. Ten oncology and five non-oncology orphan medicines qualified as expensive drugs for rare diseases with treatments costs over $7,500 per 28-day cycle or $100,000 annually, respectively.

Figure B3 Number of high-cost new medicines approved in 2017, Q4-2018 Figure B3
Figure description

This stacked bar graph gives the distribution of 2017 new medicines with available treatment costs by high-cost bracket. The first bar shows the distribution of new oncology medicines, while the second gives the totals for non-oncology medicines. Each bar is broken down into the number of new medicines that are expensive drugs for rare diseases (EDRDs), those that are high-cost but do not qualify as EDRDs, and all other non-high-cost medicines. High-cost medicines exceed $10,000 in annual treatment costs for non-oncology medicines or $5,000 per 28-day cycle for oncology medicines. Expensive drugs for rare diseases are defined as having treatment costs in excess of $100,000 annually for non-oncology or $7,500 per 28-day cycle for oncology medicines, as well as an orphan designation from either the US Food and Drug Administration or the European Medicines Agency.

  Expensive drugs for rare diseases† High-cost medicines*, other than EDRDs Other Total
Oncology medicines 10 4 1 15
Non-oncology medicines 5 15 12 32

Note: This analysis considers the 47 new medicines approved in 2017 with treatment costs available as of Q4-2018.
* High-cost medicines have treatment costs exceeding $5,000 per 28-day cycle for oncology or $10,000 annually for non-oncology.
† Expensive drugs for rare diseases (EDRDs) have an orphan designation through the FDA or EMA and treatment costs exceeding $7,500 per 28-day cycle for oncology medicines or $100,000 annually for non-oncology.
Data source: IQVIA MIDAS® Database, 2018. All rights reserved.

Twenty-seven of the medicines first approved in 2017 were authorized for market in Canada by the end of 2018. Of these, 24 had been reviewed by the PMPRB’s Human Drug Advisory Panel (HDAP) as of the third quarter of 2019. The HDAP scientific review found that 75% of the new medicines assessed demonstrated slight or no improvement over their therapeutic comparators.Footnote 2

Table B2 provides an overview of the recommendations and negotiation status for the 27 approved medicines, while Table B3 provides further details on the pharmacoeconomic assessments conducted by CADTH through the Common Drug Review (CDR) and the pan-Canadian Oncology Drug Review (pCODR).

By the third quarter of 2019, 24 new medicines had been reviewed by CADTH for public reimbursement, of which 11 had completed pan-Canadian Pharmaceutical Alliance (pCPA) negotiations and five others had negotiations underway. Thirteen non-oncology medicines reviewed by the CDR received a recommendation to reimburse with clinical criteria and/or conditions while four received a recommendation not to reimburse. Of the oncology medicines reviewed by pCODR, five were recommended for funding on the condition that their cost effectiveness be improved to an acceptable level and one was recommended not to reimburse. One orphan oncology medicine, midostaurin (Rydapt), received a recommendation to reimburse without conditions.

A review of private drug plan data found that over two thirds (19) of the 27 new medicines were reimbursed by at least one private drug plan by the end of 2018. However, these are preliminary results, and their interpretation is limited. For example, if the approval date in Canada was near the end of the 2018 calendar year, the uptake in private plans may only have occurred in 2019 and would not be reflected in these results.

Table B2 Recommendations, negotiation status, and reimbursement decisions for 2017 new medicines approved in Canada by Q4-2018

ATC* Medicine (trade name)† Health Canada approval CADTH recommendation‡ pCPA negotiation status§ Private plans
Notice of Compliance Reimburse Reimburse with clinical criteria and/or conditions Do not reimburse Active Completed and closed No negotiations Reimbursed
L1 Avelumab (Bavencio)B,C,O Dec-17   X     X   X
M1 Baricitinib (Olumiant)O Aug-18   X         X
R3 Benralizumab (Fasenra)B Feb-18   X     X   X
L1 Brigatinib (Alunbrig) C,O Jul-18     X       X
D5 Brodalumab (Siliq/Kyntheum)B Mar-18   X         X
N7 Cerliponase alfa (Brineura)B,O Dec-18   X   X      
B2 Coagulation Factor IX [recombinant], glycoPEGylated (Rebinyn)B Nov-17              
D5 Dupilumab (Dupixent)B Nov-17     X X     X
L1 Durvalumab (Imfinzi)B,C May-18   X     X   X
N7 Edaravone (Radicava)O Oct-18   X          
B2 Emicizumab (Hemlibra)B,O Aug-18              
A10 Ertugliflozin (Steglatro) May-18     X X     X
J5 Glecaprevir, pibrentasvir  (Maviret) Aug-17   X     X   X
D5 Guselkumab (Tremfya)B Nov-17   X         X
J7 Herpes zoster vaccine [recombinant, adjuvanted] (Shingrix Vaccine)B Oct-17             X
L1 Inotuzumab ozogamicin  (Besponsa)B,C,O Mar-18   X     X    
S1 Latanoprostene bunod (Vyzulta) Dec-18   X   X      
J5 Letermovir (Prevymis)O Nov-17   X   X     X
L1 Midostaurin (Rydapt)C,O Jul-17 X       X   X
N7 Ocrelizumab (Ocrevus)B Feb-18   X     X   X
D10 Ozenoxacin (Ozanex) Jan-17     X     X X
L1 Ribociclib (Kisqali)C Mar-18   X     X   X
M1 Sarilumab (Kevzara)B Jan-17   X     X   X
A10 Semaglutide (Ozempic) Jan-18   X     X   X
A7 Telotristat ethyl (Xermelo)O Oct-18     X        
L1 Tisagenlecleucel (Kymriah)B,C,O,G Sep-18   X          
J5 Voxilaprevir (Vosevi) Aug-17   X     X   X

Note: Non-oncology medicines were assessed through CADTH’s Common Drug Review process, while oncology medicines were assessed through the pan-Canadian Oncology Drug Review (pCODR) process.
* Level 2 of the Anatomical Classification of Pharmaceutical Products, as reported in MIDAS®.
† B: biologic; C: cancer; O: orphan medicines; G: gene therapies.
‡ Initial or final recommendation issued as of Q3-2019.
§ As of Q3-2019.
Data source: IQVIA Private Drug Plan database, 2018; Health Canada Notice of Compliance Database; Canadian Agency for Drugs and Technologies in Health (CADTH) reports; pan-Canadian Pharmaceutical Alliance (pCPA) reports.

Table B3 reports information related to the results of the health technology assessments for the new medicines, including the indications assessed; the recommended condition for reimbursement; the primary evaluation; the range of reported 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 results suggest that most new medicines sold in Canada were not cost-effective at the submitted price, and the vast majority of these medicines were approved on the condition that their price be reduced. At the high end of the reported range, the price of some medicines would need to be decreased by more than 99% in order to achieve an ICER of $50,000 per QALY. Brodalumab, midostaurin, and voxilaprevir were the only medicines to fall within the $50,000/QALY threshold.

Table B3 Summary of Common Drug Review and pan-Canadian Oncology Drug Review assessments for 2017 new medicines approved in Canada, Q2-2019

Medicine (trade name)* Date of recommendation† Indication(s) Conditional on price‡ Type of evaluation (primary)§ Incremental cost-effectiveness ratio (ICER) ($ per QALY) Price reduction range ($50,000 per QALY)
Avelumab (Bavencio)B,C,O Mar-18 Metastatic Merkel cell carcinoma Yes CUA 84,000 to 126,000
Benralizumab (Fasenra)B Aug-18 Severe eosinophilic asthma Yes CUA 62,000 to 1,534,803 15% to 95%
Brigatinib (Alunbrig)C,O Aug-19 Non-small cell lung cancer Do not reimburse CUA/CEA 117,763 to 163,603
Brodalumab (Siliq/Kyntheum)B Jun-18 Psoriasis, moderate to severe plaque Yes CUA 43,000
Cerliponase alfa (Brineura)B,O May-19 Neuronal ceroid lipofuscinosis type 2 Yes CUA 1,718,976 >99%
Dupilumab (Dupixent)B Jun-18 Atopic dermatitis Do not reimburse CUA 579,672 84%
Durvalumab (Imfinzi)B,C May-19 Non-small cell lung cancer Yes CUA/CEA 162,670
Edaravone (Radicava)O Mar-19 Amyotrophic lateral sclerosis Yes CUA 1,441,000 to 3,152,000 >99%
Ertugliflozin (Steglatro/Segluromet) Jan-19 Diabetes mellitus, type 2 Do not reimburse CCA -
Glecaprevir, pibrentasvir (Maviret) Jan-18 Hepatitis C, chronic Yes CUA 69,000 to Dominated** 3% to 12%
Guselkumab (Tremfya)B Feb-18 Psoriasis, moderate to severe plaque Yes CUA 1,606,003 to Dominated**
Inotuzumab ozogamicin (Besponsa)B,C,O Jul-18 Acute lymphoblastic leukemia Yes CUA/CEA/CCA Dominant** to 200,597
Letermovir (Prevymis)O Jun-18 Cytomegalovirus infection, prophylaxis Yes CUA 51,052 0.1%
Midostaurin (Rydapt)C,O Dec-17 Acute myeloid leukemia No CUA/CEA 22,579
Ocrelizumab (Ocrevus)B Nov-17 Multiple sclerosis, relapsing Yes CUA 214,504 to Dominated** 50%
Apr-18 Primary progressive multiple sclerosis 588,143 82%
Ozenoxacin (Ozanex) Oct-18 Impetigo Do not reimburse CUA 171,907 to 244,184 28% to 51%
Ribociclib (Kisqali)C Apr-18 Advanced or metastatic breast cancer Yes CUA/CEA 175,827 to 204,805
Sarilumab (Kevzara)B Apr-17 Arthritis, rheumatoid Yes CCA
Semaglutide (Ozempic) May-19 Diabetes mellitus, type 2 Yes CUA --
Tisagenlecleucel (Kymriah)B,C,O,G Jan-19 Relapsed or refractory B-cell acute lymphoblastic leukemia No CUA 211,870 65%
Voxilaprevir (Vosevi) Jan-18 Hepatitis C, chronic Yes CUA 923 to 16,864

Note: The type of evaluation and the incremental cost-effectiveness ratio (ICER) are based on the CDR estimate (base case) and the pCODR Economic Guidance Panel (EGP) evaluations. The table reports the low-bound and high-bound range estimated for all comparators and conditions analyzed. Cost-utility analysis (CUA) and cost-effectiveness analysis (CEA) evaluations are provided as a range per quality-adjusted life year (QALY). Additional information can be accessed at https://www.cadth.ca.
* B: biologic; C: cancer; O: orphan medicines; G: gene therapies.
† Initial or final recommendation issued as of Q2-2019.
‡ Price was explicitly defined as a condition for reimbursement.
§ CUA: cost-utility analysis; CEA: cost-effectiveness analysis; CCA: cost comparison analysis.
** Dominated indicates that a high-bound ICER value cannot be calculated as the product is more costly and less effective than comparator products. Dominant refers to a negative low-bound ICER value, which indicates that the product is less costly and more effective than comparators.
Data source: Canadian Agency for Drugs and Technologies in Health (CADTH) reports.

C: New Medicine Approvals, 2018

The notable rate of approvals in 2017 was sustained through 2018, with a comparable number of new medicines authorized for market. More than half of the new medicines approved received an orphan designation, including many new oncology medicines, while a quarter were biologic therapies. Almost all new cancer treatments were high-cost, and one non-oncology orphan medicine was introduced at over $3.5 million per year.

In 2018, 51 new medicines received first-time market approval through the FDA, the EMA, and/or Health Canada. As of the third quarter of 2019, Canada had approved 19 of these new medicines, trailing behind the EMA (29) and the FDA (50) (Figure C1).

Figure C1 Number of 2018 medicines with market approval as of Q4-2018 and Q3-2019 Figure C1
Figure description

This is a bar graph with the number of 2018 new medicines approved by Health Canada, the European Medicines Agency, and the Food and Drug Administration in the United States as of the fourth quarter of 2018 and as of the third quarter of 2019. The total number of new medicines in 2018 was 51.

  US Food and Drug Administration European Medicines Agency Health Canada
Q4-2018 50 18 10
Q3-2019 50 29 19

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 2018.
Data source: US Food and Drug Administration, European Medicines Agency, and Health Canada databases.

By Q4-2018, 40 new medicines had available sales in Canada, the US, and/or Europe. Over two thirds (28) of these came with treatment costs exceeding $10,000 per year or $5,000 per 28-day course. Table C1 provides a full list of the 51 new medicines approved in 2018 along with the country with first reported sales, the availability in Canada, and the prices and treatment costs where available.Footnote 3 Note that this information reflects the early availability and uptake of these medicines in the markets analyzed. Prices are reported for the highest-selling form and strength of each medicine.

Table C1 New medicines approved in 2018, availability, prices, and treatment costs, Q4-2018

Medicine (trade name, form, strength, volume)* Therapeutic class† Availability No. of countries with sales Canadian price§ (CAD) PMPRB7‡ price (CAD) Treatment cost**
First sale in Canada or PMPRB7 First sale in Canada Min Median Max Treatment cost (CAD) Annual / Course
Andexanet alfa (Andexxa, vial dry, 100 mg) B2-Blood coagulation system, other products US Sept-18 1 3,594 3,594 3,594 31,629 Dose
Apalutamide (Erleada, film-ctd tab, 60 mg)C L2-Cytostatic hormone therapy US Feb-18 Jul-18 3 29 111 111 111 3,259 28-day cycle
Avatrombopag (Doptelet, film-ctd tab, 20 mg)O B2-Blood coagulation system, other products US Jun-18 1 1,124 1,124 1,124 11,244/ 16,867 5-day treatment
Bictegravir (Biktarvy, film-ctd tab, 50 mg + 200 mg + 25 mg) J5-Antivirals US Feb-18 Aug-18 6 38 32 39 115 13,840 Annual
Baloxavir marboxil (Xofluza, film-ctd tab, 20 mg) J5-Antivirals US Nov-18 1 95 95 95 191 Dose
Binimetinib (Mektovi, film-ctd tab, 15 mg)C,O L1-Antineoplastics US Jun-18 3 37 51 71 8,573 28-day cycle
Burosumab (Crysvita, vial sc, 30 mg/ml, 1 ml)B,O M5-Other drugs for disorders of the musculoskeletal system GER Apr-18 2 6,041 10,654 15,267 183,232 Annual
Caplacizumab (Cablivi, vial dry, 10 mg)O B6-All other hematological agents FRA Sept-18 2 2,057 4,475 6,894 143,206 Treatment††
Cemiplimab (Libtayo, infus. vial dry, 50 mg/ml, 7 ml)B,C L1-Antineoplastics US Oct-18 1 10,775 10,775 10,775 10,775 28-day cycle
Dacomitinib (Vizimpro, film-ctd tab, 15 mg)C,O L1-Antineoplastics US Oct-18 1 117ii 505 505 505 3,267 28-day cycle
Damoctocog alfa pegol (Jivi, vial dry ret., 2000 IU)B B2-Blood coagulation system, other products US Sept-18 1 4 4 4 422 to 592 Annual
Doravirine (Pifeltro, film-ctd tab, 100 mg) J5-Antivirals US Sept-18 Nov-18 2 16 54 54 54 5,747 Annual
Duvelisib (Copiktra, capsule, 25 mg)C,O L1-Antineoplastics US Oct-18 1 246 246 246 13,750 28-day cycle
Elagolix (Orilissa, film-ctd tab, 150 mg) H1-Pituitary and hypothalamic hormones US Aug-18 Oct-18 2 6 38 38 38 1,131 Annual
Elapegademase (Revcovi, vial im, 1.6 mg/ml, 1.5 ml)B,O A16-Other alimentary tract and metabolism products US Nov-18 1 11,795 11,795 11,795 3,577,947 Annual
Encorafenib (Bravtovi, capsule, 75 mg)C,O L1-Antineoplastics US Jun-18 3 47 51 71 8,627 28-day cycle
Eravacycline (Xerava, inf. dry bottle, 50 mg) J1-Systemic antibacterials US Oct-18 1 56 56 56 623 to 2,179 4- to 14-day treatment
Erenumab (Aimovig, prefill autoinj, 70 mg/ml, 1 ml) N2-Analgesics US May-18 Dec-18 7 554 527 622 808 6,646 Annual
Fostamatinib (Tavalisse, film-ctd tab, 100 mg)O B6-All other hematological agents US May-18 1 194 194 194 191,036 / 212,802 Fist year / subsequent years
Fremanezumab (Ajovy, prefill syrng sc, 150 mg/ml, 1.5 ml)B N2-Analgesics US Sept-18 1 724 724 724 8,685 Annual
Galcanezumab (Emgality, prefill autoinj, 120 mg/ml, 1 ml)B N2-Analgesics US Oct-18 1 723 723 723 9,400 / 10,120 First year / Subsequent years
Gilteritinib (Xospata, film-ctd tab, 40 mg)C,O L1-Antineoplastics US Dec-18 1 315 315 315 8,832 28-day cycle
Glasdegib (Daurismo, film-ctd tab, 100 mg)C,O L1-Antineoplastics US Dec-18 1 753 753 753 21,091 28-day cycle
Ibalizumab (Trogarzo, infus. vial/bottle, 150 mg/ml, 1.33 ml)B,O J5-Antivirals US Apr-18 1 1,362 1,362 1,362 149,766 / 141,597 First year / Subsequent years
Inotersen (Tegsedi, prefill syrng sc, 189 mg/ml, 1.5 ml)O N7-Other central nervous system drugs GER Oct-18 1 14,063 14,063 14,063 731,300 Annual
Ivosidenib (Tibsovo, film-ctd tab, 250 mg)C,O L1-Antineoplastics US Aug-18 1 531 531 531 29,747 28-day cycle
Lanadelumab (Takhzyro, vial sc, 150 mg/ml, 2 ml)O B6-All other hematological agents US Sept-18 2 19,422 22,934 26,446 596,288 Annual
Larotrectinib (Vitrakvi, capsule, 100 mg)C,O L1-Antineoplastics US Dec-18 1 320ii 712 712 712 39,860 28-day cycle
Lorlatinib (Lorbrena, film-ctd tab, 100 mg)C,O L1-Antineoplastics US Nov-18 1 675 675 675 18,888 28-day cycle
Lusutrombopag (Mulpleta, film-ctd tab, 3 mg) B2-Blood coagulation system, other products US Sept-18 1 1,441 1,441 1,441 10,089 7-day treatment
Mogamulizumab (Poteligeo, infus. vial/bottle, 4 mg/ml, 1 ml)B,C,O L1-Antineoplastics US Oct-18 1 4,321 4,321 4,321 120,993 / 60,496 28-day cycle
Moxetumomab pasudotox (Lumoxiti, inf. dry bottle, 1 mg)B,C,O L1-Antineoplastics US Nov-18 1 2,543 2,543 2,543 21,363 28-day cycle
Patisiran (Onpattro, infus. vial/bottle, 2 mg/ml, 5 ml)O N7-Other central nervous system drugs US Aug-18 2 12,032 12,418 12,804 452,025 Annual
Plazomicin (Zemdri, infus. vial/bottle, 50 mg/ml, 10 ml) G4-Urologicals US Jul-18 1 400 400 400 3,357 to 5,875 4- to 7-day treatment
Revefenacin (Yulperi, lung u-d liq, 175 mcg/dose, 3 ml) R3-Anti-asthma and COPD products US Dec-18 1 43 43 43 15,805 Annual
Talazoparib (Talzenna, capsule, 1 mg)C L1-Antineoplastics US Oct-18 2 611 611 611 17,096 28-day cycle
Tezacaftor (Symdeko, film-ctd tab, 150 mg + 100 mg)O R7–Other respiratory system products US Feb-18 2 294 364 435 132,944 Annual
Tildrakizumab (Ilumya, prefill syrng sc, 100 mg/ml, 1 ml)B D5-Nonsteroidal products for inflammatory skin disorders US Oct-18 2 6,218 11,458 16,698 68,748 / 49,652 First year / Subsequent years
Velmanase alfa (Lamzede, inf. dry bottle, 10 mg)O A16-Other alimentary tract and metabolism products GER Mar-18 1,379 1,830 2,282 666,297 Annual
Zirconium cyclosilicate (Lokelma, oral u-d powder, 10 g/dose) V3-All other therapeutic products SWE Mar-18 23 26 28 9,457 / 9,354 First year / Subsequent years

Medicines without sales data in MIDAS® as of Q4-2018

Medicine (trade name, form, strength, volume)* Therapeutic class† First approval by FDA, EMA, and/or Health Canada First approval in Canada
Calaspargase pegol (Asparlas)B,C,O Not assigned as of Q3-2019 FDA Dec-18
Emapalumab (Gamifant)B,O L04-Immunosuppressants FDA Nov-18
Moxidectin (Moxidectin)O P02-Anthelmintics FDA Jun-18
Omadacycline (Nuzyra) J01-Antibacterials for systemic use FDA Oct-18
Pegvaliase (Palynziq)B,O A16 – Other alimentary tract and metabolism products FDA May-18
Ravulizumab (Ultomiris)O L04- Immunosuppressants FDA Dec-18 Aug-19‡‡
Sarecycline (Seysara) J01- Antibacterials for systemic use FDA Oct-18
Segesterone acetate (Annovera) Not assigned as of Q3-2019 FDA Aug-18
Tafenoquine (Krintafel)O P01-Antiprotozoals FDA Jul-18
Tagraxofusp (Elzonris)O L01-Antineoplastic agents FDA Dec-18
Tecovirimat (Tpoxx)O J05-Antivirals for systemic use FDA Jul-18

Note: A medicine was considered to be new in 2018 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.
* B: biologic; C: cancer; O: orphan medicines.
† Level 2 of the Anatomical Classification of Pharmaceutical Products, as reported in MIDAS, except for the new medicines without sales data in MIDAS, for which the reporting is based on the Anatomic Therapeutic Chemical (ATC) Classification System maintained by the World Health Organization (WHO).
‡ France, Germany, Italy, Sweden, Switzerland, the United Kingdom, and the United States.
§ Canadian unit prices were retrieved from IQVIA MIDAS® Database, where available; otherwise, they were taken from:
i CADTH's Canadian Drug Expert Committee Recommendation report.
ii pCODR Expert Review Committee (pERC) Recommendation report.
** Treatment costs were calculated using Canadian list prices if available; otherwise, the foreign median price or available foreign price was used. Information on dosing regimens was taken from the product monograph provided by Health Canada, or the FDA or EMA if unavailable though Health Canada.
†† Based on assumption of one-day plasma exchange.
‡‡ Notice of Compliance issued as of Q3-2019.
Data source: IQVIA MIDAS® Database, 2018 (all rights reserved); US Food and Drug Administration Novel Drugs 2018; European Medicines Agency Human Medicines Highlights 2018; Health Canada Notice of Compliance Database.

D: Spotlight on Canada

This new section reports on sales and prices of medicines that received their first Canadian approval in 2017, and analyzes the market impact of existing medicines that received approval for additional or extended indications in the same year.

Health Canada granted initial market authorization to 36 medicines in 2017, of which 25 had sales by the end of 2018, accounting for 1.6% of the Canadian pharmaceutical market. Table D1 reports on the availability, sales, and pricing of these 36 new-to-Canada medicines as of Q4-2018. Notably, the five highest-selling medicines were also reported in the list of 2017 new medicines in Section B, indicating that they received their first international approval in the same year.

This table also provides foreign-to-Canadian price ratios for each medicine. These ratios compare the median prices in the PMPRB7 countries with those in Canada to reflect how much more or less Canadians would have paid for a new medicine if they had paid the median international price. The average price of the medicine in Canada is set to a value of one and the corresponding foreign median prices are reported relative to this value.

The average ratio reported across all new medicines was 1.58, indicating that foreign prices at Q4-2018 were 58% higher than those in Canada. However, this result is heavily skewed toward prices in the US market. For medicines with prices available in only one foreign country, typically the US, the average foreign-to-Canadian price ratio was 7.91. When medicines with fewer than two comparator countries were excluded, the average ratio dropped to 1.01, indicating that Canadian prices were on par with those internationally for medicines with established international markets. Given the differences in Canadian and international policies for price increases, this ratio is expected to decrease over time.

Table D1 Medicines first approved in Canada in 2017, availability, sales, and prices, ranked by share of sales, Q4-2018

Medicine (trade name, form, strength, volume)* Therapeutic class† Availability Share of 2017 Canadian new medicine sales No. of PMPRB7 countries with sales Price (CAD)
First ale in the PMPRB7 First sale in Canada Canada PMPRB7‡ median Foreign-to-Canadian price ratio
Dupilumab (Dupixent, prefill syrng sc, 150 mg/ml, 2 ml)B D5X0-Other nonsteroidal products for inflammatory skin disorders Mar-17 Feb-18 21.1% 6 1,069  1,013 0.95
Herpes zoster vaccine [recombinant, adjuvanted] (Shingrix Vaccine, vial im, 100 mcg/ml, 0.5 ml)B J7E2-Varicella vaccines Dec-17 Jan-18 18.1% 2  119 148 1.25
Durvalumab (Imfinzi, infus. vial/bottle, 50 mg/ml, 10 ml)B,C L1G0- Monoclonal antibody antineoplastics May-17 Nov-17 13.9% 5  4,028  3,698 0.92
Guselkumab (Tremfya, prefill syrng sc, 100 mg/ml, 1 ml)B D5B0-Systemic antipsoriasis products Jul-17 Nov-17 9.9% 6 3,139  3,450 1.10
Insulin degludec (Tresiba, prefill pen ret., 200 IU/ml 3 ml) A10C5-Human insulins and analogues, long-acting Dec-12 Sept-17 8.4% 6 44  31 0.70
Glecaprevir, pibrentasvir (Maviret, film-ctd tab, 100 mg + 40 mg) J5D3-Hepatitis C antivirals Jul-17 Sept-17 6.4% 7 236 230 0.97
Ocrelizumab (Ocrevus, infus. vial/bottle, 30 mg/ml, 10 ml)B N7A0-Multiple sclerosis products Apr-17 Sept-17 6.2% 7  8,446 8,506 1.01
Voxilaprevir (Vosevi, film-ctd tab, 400 mg + 100 mg + 100 mg) J5D3-Hepatitis C antivirals Jul-17 Sept-17 5.7% 6 699  854 1.22
Lifitegrast (Xiidra, oph u-d liq, 5%, 0.2 ml) S1K9-Dry eye products, other Jul-16 Feb-18 2.6% 1 4 11 2.99
Nusinersen (Spinraza, vial, 2.4 mg/ml, 5 ml)O N7X0-All other CNS drugs Feb-17 Aug-17 2.4% 7  120,597 113,453 0.94
Brexpiprazole (Rexulti, film-ctd tab, 1 mg) N5A1-Atypical antipsychotics Jul-15 Apr-17 1.3% 1  4  46 12.83
Sarilumab (Kevzara, prefill syrng/autoinj, 175 mg/ml, 1.14 ml)B M1C0-Specific anti-rheumatic agents May-17 Feb-17 1.0% 7  718 711 0.99
Midostaurin (Rydapt, capsule, 25 mg)C,O L1H0-Protein kinase inhibitor antineoplastics Oct-16 Sept-17 0.8% 7  166 166 1.00
Eliglustat (Cerdelga, capsule, 84 mg)O A16A0- Other alimentary tract and metabolism products Sept-14 Nov-17 0.7% 5 625 558 0.89
Eluxadoline (Viberzi, film-ctd tab, 100 mg + 40 mg) A3G0-Gastro-intestinal sensorimotor modulators Dec-15 Apr-17 0.4% 3  2 2 1.01
Letermovir (Prevymis, film-ctd tab, 480 mg)O J5B3-Herpes antivirals Dec-17 Dec-17 0.3% 2  246 249 1.01
Olaratumab (Lartruvo, infus. vial/bot., 16 mg/ml, 50 ml)B,C,O L1G0- Monoclonal antibody antineoplastics Nov-16 Dec-17 0.3% 5  2,027 1,915 0.94
Netupitant (Akynzeo, capsule, 300 mg + 500 mcg) A4A2-NK1 antagonist antiemetics/antinauseants Oct-14 Nov-17 0.2% 7  138  103 0.75
Atezolizumab (Tecentriq, infus. vial/bottle, 60 mg/ml, 20 ml)B,C L1G0-Monoclonal antibody antineoplastics May-16 May-17 0.2% 7 7,091 6,596 0.93
Avelumab (Bavencio, infus. vial/bottle, 20 mg/ml, 10 ml)B,C,O L1G0- Monoclonal antibody antineoplastics Mar-17 Dec-17 0.1% 7 1,391  1,350 0.97
Lixisenatide (Soliqua, prefill pen ret., 100 IU/ml + 33 mcg/ml, 3 ml) A10C9-Other human insulins and analogues Feb-13 Sept-17 0.1% 4  39  42 1.09
Obeticholic acid (Ocaliva, film-ctd tab, 5 mg)O A5A9-Other bile therapy and cholagogues Jun-16 Aug-17 0.1% 6 104 138 1.33
Propiverine (Mictoryl, capsule ret., 30 mg) G4D4-Urinary incontinence products Jan-81 Apr-17 0.1% 3 1 1 1.01
Ozenoxacin (Ozanex, cream, 1%, 10 g) D10A0-Topical anti-acne preparations Jan-18 <0.1% 0 2
Neisseria meningitidis B rLP2086 [subfamilies A,B] (Trumenba, prefill im, 120 mcg/ml, 0.5 ml)B J7D2-Meningococcal vaccines Nov-14 Feb-18 <0.1% 5 101  116 1.15
Anthrax immune globulin [human] (Anthrasil)B J6BB19-Anthrax immunoglobulin
Coagulation Factor IX [recombinant], glycoPEGylated (Rebinyn, vial dry, 2000 IU)B B2D2-Factors II, VII, IX and X Jun-17 1  4
Cysteamine bitartrate (Procysbi, capsule, 75 mg)O A16A0-Other alimentary tract and metabolism products Mar-98 5 28
Defibrotide (Defitelio, infus. vial/bottle, 80 mg/ml, 2.5 ml)B,O B1C4-Platelet cAMP enhancing platelet aggregation inhibitors May-86 5 556
Florbetaben [18F]§ (Neuraceq) T1G0-Radiodiagnostic agents
Ioflupane [123i] (Datscan, vial IV, 5 ml) T1G0-Radiodiagnostic agents May-05 2 1,168
Migalastat (Galafold, capsule, 123 mg)O A16A0- Other alimentary tract and metabolism products May-16 5  1,661
Necitumumab (Portrazza, infus. vial/bottle, 16 mg/ml 50 ml)B,C L1G0- Monoclonal antibody antineoplastics Dec-15 2 3,082
Peramivir (Rapivab, infus. bag, 5 mg/ml, 60 ml) J5B4-Influenza antivirals Dec-14 1  405
Sebelipase alfa (Kanuma, infus. vial/bottle, 2 mg/ml, 10 ml)B,O A16A0- Other alimentary tract and metabolism products Aug-15 4  9,142
Vernakalant (Brinavess, infus. vial/bottle, 20 mg/ml, 25 ml) C1B0-Anti-arrhythmics Sept-10 3 519

Note: Some medicines with sales may not be reported in IQVIA’s MIDAS Database; for example, although there is no Canadian sales data available in MIDAS for cysteamine bitartrate (Procysbi), it was the subject of a Notice of Hearing issued by the PMPRB in January 2019 for allegations of excessive pricing.
* B: biologic; C: cancer; O: orphan medicines.
† Level 4 of the Anatomical Classification of Pharmaceutical Products, as reported in MIDAS; if unavailable in MIDAS, the reporting is based on the Anatomical Therapeutic Chemical (ATC) Classification System maintained by the World Health Organization (WHO).
‡ France, Germany, Italy, Sweden, Switzerland, the United Kingdom, and the United States.
§ Canadian and international sales are not reported due to limitations in the available data for this medicine.
Data source: IQVIA MIDAS® Database, 2018, all rights reserved; Health Canada Notice of Compliance Database.

Thirty-four previously marketed medicines were granted new or extended indications by Health Canada in 2017. As a group, these medicines grew by 17%, or nearly $600 million, from 2017 to 2018. By comparison, the Canadian pharmaceutical market grew by 4%, or slightly over $1 billion, over the same period. As a result, existing medications with new indications accounted for 55% of total Canadian pharmaceutical sales growth from 2017 to 2018. Of these medicines, velpatasvir, pembrolizumab, and adalimumab made the greatest positive contributions to the sales growth, while ledipasvir had the greatest negative impact. For the full list of medicines with new indications, as well as their change in sales from 2017 to 2018, see Appendix I.

Table D2 Change in sales of existing medicines with new or extended indications in Canada, 2017 to 2018

  2017 sales 2018 sales Net change in sales (% change)
Existing medicines with new indications in 2017 $3.50B $4.09B $0.59B (17%)
Total Canadian market $27.43B $28.51B $1.07B (4%)

Data source: IQVIA MIDAS® Database, 2017 to 2018. All rights reserved.

References

European Medicines Agency. 2018. Human Medicines Highlights 2017. Available: https://www.ema.europa.eu/en/news/human-medicines-highlights-2017

European Medicines Agency. 2019. Human Medicines Highlights 2018. Available: https://www.ema.europa.eu/en/news/human-medicines-highlights-2018

Food and Drug Administration. 2018. Novel Drugs 2017. 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-2017

Food and Drug Administration. 2017. Novel Drugs 2018. 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-2018

Health Canada. 2019. Drug and medical device highlights 2018: Helping you maintain and improve your health. Ottawa: Health Canada. Available: https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/drug-medical-device-highlights-2018.html

PMPRB. 2018. Annual Report, 2017. Ottawa: Patented Medicine Prices Review Board. Available: http://www.pmprb-cepmb.gc.ca/view.asp?ccid=1380&lang=en

Appendices

Change in sales of existing medicines with new or extended indications approved by Health Canada in 2017, Q4-2018

Medicine Therapeutic area* Net change in sales, 2017 to 2018 (CAD)
Velpatasvir J05-Antivirals for systemic use $165,364,017
Pembrolizumab L01-Antineoplastic agents  $129,871,160
Adalimumab L04-Immunosuppressants  $82,621,593
Palbociclib L01-Antineoplastic agents  $62,768,398
Nivolumab L01-Antineoplastic agents  $55,849,340
Ibrutinib L04-Immunosuppressants  $55,121,910
Ipilimumab L01-Antineoplastic agents  $20,124,772
Omalizumab R03-Drugs for obstructive airway diseases  $18,836,248
Liraglutide A10-Drugs used in diabetes  $17,976,801
Ranibizumab S01-Ophthalmologicals  $15,493,537
Clostridium botulinum toxin type A M03-Muscle relaxants  $15,460,818
Abacavir J05-Antivirals for systemic use  $13,165,506
Dulaglutide A10-Drugs used in diabetes  $12,204,709
Leuprorelin L02-Endocrine therapy  $9,689,172
Trametinib L01-Antineoplastic agents  $6,459,854
Everolimus L01-Antineoplastic agents  $6,195,859
Tocilizumab L04-Immunosuppressants  $5,425,992
Dabrafenib L01-Antineoplastic agents  $5,407,516
Lurasidone N05-Psycholeptics  $4,975,261
Glycopyrronium R03-Drugs for obstructive airway diseases  $3,655,720
Canakinumab L04-Immunosuppressants  $3,496,843
Eltrombopag B02-Antihemorrhagics  $3,122,527
Mifepristone G03-Sex hormones and modulators of the genital system  $3,049,514
Lenvatinib L01-Antineoplastic agents  $3,007,169
Panitumumab L01-Antineoplastic agents  $2,899,708
Lacosamide N03-Antiepileptics  $2,856,104
Fulvestrant L02-Endocrine therapy  $1,964,094
Eribulin L01-Antineoplastic agents  $1,107,911
Anakinra L04-Immunosuppressants -$161,847
Aripiprazole N05-Psycholeptics -$2,254,351
Crizotinib L01-Antineoplastic agents -$4,756,882
Daratumumab L01-Antineoplastic agents -$7,148,422
Etanercept L04-Immunosuppressants -$7,417,108
Ledipasvir J05-Antivirals for systemic use -$112,198,908
Total    $594,234,535

* Level 2 of the Anatomical Therapeutic Chemical (ATC) Classification System maintained by the World Health Organization (WHO).
Data source:  IQVIA MIDAS® Database, 2017 to 2018. All rights reserved.

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