Early insight into new medicine launches in Canadian and international markets

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New medicines represent an increasingly important segment of the global pharmaceutical market. Over the last two years, a greater than average number of new medicines were approved, the majority of which were high-cost specialty therapies. While some of these medicines may play a key role in addressing unmet needs or offer significant therapeutic benefit to patients, rising numbers of new high-cost treatments have placed increasing pressure on payers in Canada and internationally.

This analysis explores the market dynamics of new 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 analyzes their uptake, pricing, sales, and availability as of the last quarter of 2018 (Q4-2018). It also provides a preliminary examination of new medicines approved in 2018, as well as trends in the new medicine market since 2009. These results will be published in the upcoming edition of the PMPRB’s Meds Entry Watch report.

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

1. A greater number of medicines were approved in 2017 and 2018, as the share of specialty therapies continued to rise

Fifty-two new medicines received first-time approval through the FDA, the EMA, and/or Health Canada in 2017 and 51 were approved in 2018. This follows a total of 31 approvals in 2016 and represents a steep rise from the annual average of 36 between 2009 and 2016.

Three quarters of the market entrants in 2017 were orphan, biologic, or oncology medicines. Over the past three years, an increasingly significant proportion of new therapies have had an orphan designation from the FDA or EMA, including more than half of all new medicines in 2018. Many orphan therapies are used to treat cancer, contributing to the near one-third share of oncology treatments among new medicines. While biologics make up a smaller portion of the growing market, the number of new biologic medicines approved continues to be significant. There is notable overlap among these designations, as illustrated in the Venn diagram below, which means that a single medicine may be counted in multiple specialty categories.

New medicines approved in Canada and the PMPRB7*, 2016 to 2018 Section 1
  2016 2017 2018
Orphan medicines 13 (42%) 23 (44%) 30 (60%)
Oncology medicines 5 (16%) 17 (33%) 15 (29%)
Biologic medicines 13 (42%) 18 (35%) 14 (27%)
Total specialty medicines 20 (65%) 39 (75%) 37 (73%)
Figure description

This bar graph depicts the number of new medicines launched in Canada and the PMPRB7 from 2016 to 2018. A table shows the number and share of orphan, oncology, and biologic medicines for each annual total.

  2016 2017 2018
Total number of new medicines 31 52 51
Number of orphan medicines 13 23 30
Share of orphan medicines 42% 44% 60%
Number of oncology medicines 5 17 15
Share of oncology medicines 16% 33% 29%
Number of biologic medicines 13 18 14
Share of biologic medicines 42% 35% 27%
Total number of specialty medicines 20 39 37
Total share of specialty medicines 65% 75% 73%
Distribution of 2017 new medicines by orphan, cancer, and biologic designation Section 1
Figure description

A Venn diagram illustrates the overlap between orphan, biologic, and oncology medicines among the 2017 new medicines: nine medicines were biologic, eight had an orphan designation, and six were cancer medicines. Five were both biologic and orphan, one was both biologic and oncological, seven were both orphan and oncological, and three were biologic cancer medicines that also received an orphan designation.

2. Medicines approved between 2009 and 2017 accounted for approximately one third of total pharmaceutical sales by Q4-2018

The year-over-year increase in the new medicine share of the total pharmaceutical market depends on the number and therapeutic relevance of the medicines approved. For example, between 2014 and 2016, the new medicine share of sales increased sharply by 13.5% as a result of the introduction of the direct-acting antiviral (DAA) drugs for hepatitis C. From 2016 to 2018, the uptake of new medicines slowed to a more modest 6.1%, with 2016 and 2017 approvals accounting for 2.3% and 2.8% of all new medicine sales by Q4-2018, respectively.

Cumulative new medicine share of all brand-name medicine sales by year of first approval (2009 to 2017), Canada and the PMPRB7 Section 2
Figure description

This is an area graph depicting the new medicine cumulative share of total brand-name medicine sales by launch year for Canada and the seven PMPRB comparator countries. It tracks the percentage of new medicine launches in annual sales up to the fourth quarter of 2018. The total new medicine share of sales for each year is also marked.

Launch year 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%

3. Over half of the the 2017 medicines had approval in Canada by Q4-2018, and more than a third had sales, including most of the international top-selling new therapies

Out of the 52 medicines first approved in 2017 by either the FDA, EMA, or Health Canada, 13 (25%) were approved in Canada by Q4-2017, compared to 49 (94%) in the US, and 19 (37%) by the EMA in Europe. By Q4-2018, 28 (54%) of the 2017 new medicines were approved in Canada and 34 (65%) in Europe, substantially narrowing this gap.

Of those approved in Canada, 18 (35%) had sales by the end of 2018, placing Canada sixth among the OECD countries and in line with the PMPRB7. By comparison, Canada ranked last among the PMPRB7 and 11th in the OECD for the sales of 2016 medicines in Q4-2017. The corresponding share of sales for the 2017 new medicines sold domestically remained among the highest in the OECD at approximately 88%, suggesting that the higher selling medicines were approved in Canada.

Number of 2017 new medicines with market approval, Q4-2017 and Q4-2018 Section 3
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.

  Health Canada European Medicines Agency US Food and Drug Administration
Q4-2017 13 19 49
Q4-2018 28 34 49
Share of new medicines approved in Canada and the PMPRB7 in 2017 with sales, and their respective share of OECD sales, by country, Q4-2018 Section 3
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
United States 43 99.7%
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 0%
Spain 1 0%
Greece 1 2%
New Zealand 0 0%
OECD median 10 46.4%

4. Over two thirds of the 2017 new medicines came with high treatment costs

Fourteen of the oncology medicines approved in 2017 had costs exceeding $5,000 for a 28-day treatment regimen, and 20 non-oncology medicines had costs exceeding $10,000 annually. These high-cost medicines accounted for 68% of the 2017 new approvals with reported sales in Canada and the PMPRB7 by Q4-2018.

Of the medicines with available Canadian sales, 14 (28%) were expensive drugs for rare diseases (EDRDs): five non-oncology orphan medicines with annual treatment costs in excess of $100,000 and nine orphan medicines for cancer with 28-day treatment costs over $7,500. All 14 medicines received their orphan designations through the FDA. Of the five non-oncology EDRDs, three are indicated to treat central nervous system diseases, four are biologic medicines, and one is a gene therapy.

Number of new high-cost medicines approved in 2017, Q4-2018 Section 3
Figure description

This stacked bar graph gives the distribution of 2017 new medicines with available sales by treatment cost. 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 9 5 2 16
Non-oncology medicines 5 15 14 34

* 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.

Expensive drugs for rare diseases (EDRDs) approved in 2017 with sales, and their treatment costs, Q4-2018

Therapeutic class* Medicine (trade name, form, strength, volume)† Treatment cost‡
Treatment cost (CAD) Annual/Course
A16 – Other alimentary tract and metabolism products Vestronidase alfa (Mepsevii, infus. vial/bottle, 2 mg/ml, 5 ml)B,O $683,900 Annual (25 kg)
B02 – Antihemorrhagics Emicizumab (Hemlibra, vial sc, 150 mg/ml, 1 ml)B,O $732,753 / $680,413 First year / subsequent years
L1 – Antinoeplastics Tisagenlecleucel (Kymriah, infus. bags)B,C,G,O $482,550 One-time treatment
L1 – Antinoeplastics Avelumab (Bavencio, infus. vial/bottle, 20 mg/ml, 10 ml)B,C,O $9,738 28-days
L1 – Antinoeplastics Inotuzumab ozogamicin (Besponsa, infus. dry bottle, 0.9-1 mg) B,C,O $48,490 / $40,375 21 days / subsequent 28 days
L1 – Antinoeplastics Brigatinib (Alunbrig, film-ctd tabs, 180 mg) C,O $9,435 28 days
L1 – Antinoeplastics Copanlisib (Aliqopa, inf. dry bottle, 60 mg) C,O $16,200 28 days
L1 – Antinoeplastics Midostaurin (Rydapt, capsules, 25 mg) C,O $9,270 28 days
L1 – Antinoeplastics Enasidenib (Idhifa, film-ctd tab, 100 mg) C,O $27,227 28 days
L1 – Antinoeplastics Niraparib (Zejula, capsules, 100 mg) C,O $13,300 28 days
N7 – Other CNS drugs Deutetrabenazine (Austedo, ctd tab, 12 mg)O $19,760 / $158,100 Annual
N7 – Other CNS drugs Edaravone (Radicava, infus. bag, 300 Y/ml, 100 ml)O $190,880 / $185,182 First year / subsequent years
N7 – Other CNS drugs Cerliponase alfa (Brineura, infus. vial/bottle, 30 mg/ml, 5 ml)B,O $841,900 Annual
V3C – Radiopharmaceuticals Lutetium Lu 177 dotatate (Lutathera, infus. vial/bottle, 370 mg/ml, 30 ml)C,O $140,000 32 weeks

* Level 2 of the Anatomical Classification of Pharmaceutical Products, as reported in MIDAS.
† B: biologic; C: cancer; O: orphan medicines; G: gene therapies.
‡ Treatment costs were calculated using sales data from the IQVIA MIDAS® Database as of Q4-2018. Information on dosing regimens was taken from the product monograph provided by Health Canada, the FDA or EMA if unavailable through Health Canada, or from reports issued by the Canadian Agency for Drugs and Technologies in Health (CADTH).

5. The majority of 2017 new medicines assessed by CADTH received reimbursement recommendations conditional on price

Of the 52 new medicines approved in 2017, 22 were reviewed by the Canadian Agency for Drugs and Technologies in Health (CADTH) through their Common Drug Review (CDR) and pan-Canadian Oncology Drug Review (pCODR) processes as of Q4-2018. Seventeen of the reviewed medicines were given a recommendation to reimburse on the condition that their cost-effectiveness be improved to an acceptable level. Four of the remaining medicines received a recommendation not to reimburse, due to a lack of evidence of clinical benefit.

Summary of Common Drug Review and pan-Canadian Oncology Drug Review assessments for 2017 new medicines approved in Canada by Q4-2018

Medicine (trade name) Treatment cost* (CAD) Annual/Course Recommendation
Ozenoxacin (Ozanex) <$20K 5 days Do not reimburse
Ertugliflozin (Steglatro) <$20K Annual Do not reimburse
Semaglutide (Ozempic) <$20K Annual Reimburse conditional on price
Ribociclib (Kisqali) <$20K 28 days Reimburse conditional on price
Midostaurin (Rydapt) <$20K 28 days Reimburse
Brigatinib (Alunbrig) <$20K 28 days Do not reimburse
Avelumab (Bavencio) <$20K 28 days Reimburse conditional on price
Durvalumab (Imfinzi) <$20K 28 days Reimburse conditional on price
Brodalumab (Siliq) <$20K Annual Reimburse conditional on price
Guselkumab (Tremfya) $20K-$40K Annual Reimburse conditional on price
Letermovir (Prevymis) $20K-$40K 100 days Reimburse conditional on price
Dupilumab (Dupixent) $20K-$40K Annual Do not reimburse
Benralizumab (Fasenra) $20K-$40K Annual Reimburse conditional on price
Ocrelizumab (Ocrevus) $20K-$40K Annual Reimburse conditional on price
Inotuzumab (Besponsa) $40K-$60K 28 days Reimburse conditional on price
Sarilumab (Kevzara) $40K-$60K Annual Reimburse conditional on price
Voxilaprevir (Vosevi) $40K-$60K 12 weeks Reimburse conditional on price
Glecaprevir (Mavyret) $60K-$80K 16 weeks Reimburse conditional on price
Lutetium Lu 177 dotatate (Lutathera) >$100K 32 weeks Reimburse conditional on price
Edaravone (Radicava) >$100K Annual Reimburse conditional on price
Tisagenlecleucel (Kymriah) >$100K One-time treatment Reimburse conditional on price
Cerliponase alfa (Brineura) >$100K Annual Reimburse conditional on price

* Treatment costs were calculated using sales data from the IQVIA MIDAS® Database as of Q4-2018. Information on dosing regimens was taken from the product monograph provided by Health Canada, the FDA or EMA if unavailable through Health Canada, or from reports issued by the Canadian Agency for Drugs and Technologies in Health (CADTH).

Data source: IQVIA MIDAS® Database (all rights reserved), 2009 to 2018.

Limitations: Canadian and international sales and list prices available in the IQVIA MIDAS® Database are estimated manufacturer factory-gate list prices and do not reflect off-invoice price rebates and allowances, managed entry agreements, or patient access schemes.

Disclaimer: Although this information is based in part on data obtained under license from IQVIA’s MIDAS® Database, the statements, findings, conclusions, views, and opinions expressed in this study are exclusively those of the PMPRB and are not attributable to IQVIA.

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