ENTRY WATCH 2016 Published by the Patented Medicine Prices Review Board June 2018 Meds Entry Watch, 2016 Is Available in Electronic Format on the PMPRB Website
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MEDS ENTRY WATCH 2016 Published by the Patented Medicine Prices Review Board June 2018 Meds Entry Watch, 2016 is available in electronic format on the PMPRB website. Une traduction de ce document est également disponible en français sous le titre : Veille des médicaments mis en marché, 2016 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: [email protected] Web: www.pmprb-cepmb.gc.ca ISSN 2560-6204 Cat. No.: H79-12E-PDF © Her Majesty the Queen in Right of Canada, as represented by the NPDUIS initiative of the Patented Medicine Prices Review Board, 2018 MEDS ENTRY WATCH 2016 About the PMPRB Acknowledgements The Patented Medicine Prices Review Board This report was prepared by the Patented (PMPRB) is a respected public agency that makes Medicine Prices Review Board (PMPRB) a unique and valued contribution to sustainable as part of the National Prescription Drug spending on pharmaceuticals in Canada by: Utilization Information System (NPDUIS). ~ providing stakeholders with price, cost and The PMPRB would like to acknowledge the utilization information to help them make timely contributions of and knowledgeable drug pricing, purchasing and ~ The members of the NPDUIS Advisory reimbursement decisions; and Committee for their expert oversight and ~ acting as an effective check on the patent rights guidance in the preparation of this report. of pharmaceutical manufacturers through the ~ PMPRB NPDUIS staff for their contribution responsible and efficient use of its consumer to the analytical content of the report: protection powers. y Karine Landry – Senior Economic Analyst The NPDUIS Initiative y Tanya Potashnik – Director, Policy and Economic Analysis The National Prescription Drug Utilization Information y Elena Lungu – Manager, NPDUIS System (NPDUIS) is a research initiative established by federal, provincial, and territorial Ministers y Nevzeta Bosnic – Senior Economic Analyst of Health in September 2001. It is a partnership y Jared Berger – Policy Analyst between the PMPRB and the Canadian Institute y Linda Klassen – Scientific Officer for Health Information (CIHI). y Ai Chau – SAS Analyst Pursuant to section 90 of the Patent Act, the PMPRB has the mandate to generate analysis that provides y Dan Roumelis – SAS Analyst policy makers and public drug plan managers with y Carol McKinley – Publications Advisor critical information and intelligence on price, utilization and cost trends so that Canada’s health care system y Sarah Parker – Junior Communications Officer has more comprehensive and accurate information on how patented and non-patented prescription drugs Disclaimer are being used and on sources of cost pressures. NPDUIS operates independently of the regulatory The specific research topics and methodologies for activities of the Board of the PMPRB. The research the NPDUIS reports are established with the guidance priorities, data, statements and opinions expressed of the NPDUIS Advisory Committee, and the NPDUIS or reflected in NPDUIS reports do not represent Research Agenda posted on the PMPRB website the position of the PMPRB with respect to any reflects the analytical requirements of the participat- regulatory matter. NPDUIS reports do not contain ing members. The Advisory Committee is composed information that is confidential or privileged under of representatives from public drug plans in British sections 87 and 88 of the Patent Act, and the men- Columbia, Alberta, Saskatchewan, Manitoba, Ontario, tion of a drug in a NPDUIS report is not and should New Brunswick, Nova Scotia, Prince Edward Island, not be understood as an admission or denial that Newfoundland and Labrador, the Yukon, and Health the drug is subject to filings under sections 80, 81 Canada. It also includes observers from CIHI, the or 82 of the Patent Act or that its price is or is not Canadian Agency for Drugs and Technologies in excessive under section 85 of the Patent Act. Health (CADTH), the Ministère de la Santé et des Services sociaux du Quebec (MSSS), and the pan- Canadian Pharmaceutical Alliance (pCPA) Office. Although based in part on data provided under license by the QuintilesIMS MIDAS™ Database, the statements, findings, conclusions, views and opinions expressed in this report are exclusively those of the PMPRB and are not attributable to QuintilesIMS. PATENTED MEDICINE PRICES REVIEW BOARD i NATIONAL PRESCRIPTION DRUG UTILIZATION INFORMATION SYSTEM MEDS ENTRY WATCH 2016 EXECUTIVE SUMMARY The PMPRB’s Meds Entry Watch explores the market entry dynamics of new drugs in Canadian and international markets. Building on the retrospective analysis included in the first edition, this report focuses on new active substances (NASs) that received market approval through the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and/or Health Canada in 2015 and 2016, and analyzes their uptake, pricing, sales and availability as of the last quarter of 2016 (Q4-2016). The methodology in this edition has been updated to provide a more apples-to-apples comparison The international markets examined include the of the number of drugs launched in Canada and seven countries the PMPRB considers in review- in international markets. The sales and pricing ing the prices of patented drugs (PMPRB7): data for all NASs is based on MIDAS™, as in the France, Germany, Italy, Sweden, Switzerland, the previous edition. United Kingdom and the United States. Some of This publication informs decision makers, the analyses also include other countries in the researchers and patients of the evolving Organization for Economic Co-operation and market dynamics associated with emerging Development (OECD). drug therapies in the Canadian and international pharmaceutical environment. PATENTED MEDICINE PRICES REVIEW BOARD ii NATIONAL PRESCRIPTION DRUG UTILIZATION INFORMATION SYSTEM MEDS ENTRY WATCH 2016 Key Findings (A) Trends in New Drug Launches, ~ 14 of the 20 NASs recorded sales in Canada 2009 to 2015 by the end of 2016, placing Canada tenth in the OECD, lower than most other PMPRB7 ~ Important new drugs have been launched countries but higher than Italy. since 2009, generating nearly one quarter of brand-name drug sales in Canada by 2016. ~ These drugs represented 80% of the total NAS sales for the OECD, suggesting that ~ Canada launched more new drugs than most the higher-selling drugs were approved OECD countries, but fewer than all PMPRB in Canada. comparator countries, including many with lower average patented drug prices. 3. Oncology and HIV drugs accounted for the majority of NAS sales in 2016. ~ Orphan drugs are increasingly dominating the new drug landscape, accounting for 54% of ~ Overall, sales for NASs were highly new drugs entering the market in 2015 and concentrated, with antineoplastic drugs 42% in 2016, a significant increase from the (to treat cancer) and antivirals together 33% average share between 2009 and 2014. accounting for over 65% of NAS sales in Canada and the PMPRB7 in Q4-2016. ~ Over one quarter of the new drugs in 2015 and 2016 were developed for the treatment ~ There were 14 new cancer agents launched of cancer and came with a high cost, in 2015, accounting for over one third (35%) averaging $13,000 for a 28-day treatment. of NAS sales in Canada and the PMPRB7 by Q4-2016. ~ An antiviral for HIV was the top-selling NAS (B) 2015 New Drug Launches in Q4-2016, accounting for 32% of NAS sales 1. A greater than average number of new active in Canada and the PMPRB7. substances (NASs) were launched in 2015, many of which were higher-cost specialty drugs. (C) 2016 New Drug Launches ~ 41 NASs received market approval through the FDA, the EMA and/or Health Canada in 4. 2016 was a less active year for drug launches. 2015, exceeding the average annual rate of ~ 31 NASs received market approval through 35 drugs launched from 2009 to 2014. the FDA, the EMA and/or Health Canada in ~ Many new drugs came with a high cost: 35% 2016, significantly fewer than in 2015. were oncology drugs with costs exceeding 5. As in previous years, many of the specialty $5,000 for a 28-day treatment and 30% were drugs had high treatment costs. non-oncology drugs with costs exceeding ~ Of the NASs launched in 2016, nearly half (13) $10,000 per year. Of the NASs assessed by received an orphan designation from the FDA the PMPRB, only two demonstrated more than and/or the EMA. a moderate level of therapeutic improvement. ~ Thirteen of the NASs launched in 2016 were 2. Fewer drugs were approved for market in classified as biologics, and 5 of the new Canada than in the US and Europe in 2015, launches were oncology products1. although Canada still ranked well in terms of sales. The next edition of this publication will build on ~ Approximately half (20) of the 41 NASs this analysis to provide further insight into the launched in 2015 were approved for sale drugs introduced in 2016 and identify new drugs in Canada in 2015, compared to 76% (31) approved in 2017. approved by the EMA and 98% (40) by the FDA. 1. Note that a single molecule may fall into more than one category, thus there may be some overlap in the counts. PATENTED MEDICINE PRICES REVIEW BOARD iii NATIONAL PRESCRIPTION DRUG UTILIZATION INFORMATION SYSTEM MEDS ENTRY WATCH 2016 TABLE OF CONTENTS Introduction A Trends in New Bibliography 21 Drug Launches, Appendix I: 2009–2015 Drug information for 02 new active substances approved in 2015 22 05 Appendix II: Methods Drug information for new active substances B New Drug approved in 2016 24 03 Launches, 2015 Limitations 09 04 C New Drug Launches, 2016 18 PATENTED MEDICINE PRICES REVIEW BOARD 1 NATIONAL PRESCRIPTION DRUG UTILIZATION INFORMATION SYSTEM MEDS ENTRY WATCH 2016 INTRODUCTION Meds Entry Watch is an annual PMPRB publication that explores the dynamics of new drugs entering Canadian and international markets.