Spotlight on New Oncology Drugs: Access, Costs, and Use
Read compelling analyses of 5-year trends and projected changes in the oncology clinical drug pipeline, selected from the IMS Institute for Healthcare Informatics’ recent “Global Oncology Trend Report.”
Slides republished with permission from the IMS Institute for Healthcare Informatics. Visit theimsinstitute.org to view the full publication, “Global Oncology Trend Report: A Review of 2015 and Outlook to 2020.”
The oncology drug clinical pipeline has expanded by more than 60% in the past decade, and almost 90% of the focus is on targeted agents. More than 500 diverse companies across the globe are actively pursuing oncology drug development for over 600 indications, mainly for nonâsmall-cell lung cancer, breast, prostate, ovarian, and colorectal cancers. In the United States, initiatives including Breakthrough Therapy designation, introduced in 2012, may have contributed to the shortened time to approval seen in recent years; indeed, between 2013 and 2015, the median time to approval of new oncology drugs by the US Food and Drug Administration was reduced by about 8 months (from 10.25 years to 9.5 years). However, the complexity and duration of the drug regulatory process vary widely from country to country, and the availability of a particular drug depends on where the manufacturer files for registration. Of 49 new active substances launched in oncology from 2010 through 2014, only 6 countries (the United States, Germany, the United Kingdom, Italy, France, and Canada) have more than half of these agents available, and even less are reimbursed under public insurance programs. Emerging trends include growth in the availability and use of targeted therapies, particularly oral ones. These and other compelling analyses of the global oncology market- highlighting 5-year trends and projected changes in oncology drug access, costs, and use-are discussed in the June 2016 “Global Oncology Trend Report: A Review of 2015 and Outlook to 2020.” The report is available from the IMS Institute for Healthcare Informatics, a global health and technology information services company. This slide show presents some highlights of the report, with a focus on the deepened and broadened use of targeted therapy in oncology.
The late-phase oncology pipeline includes 270 biologic therapies; among these are 16 gene therapies, 86 new monoclonal antibodies, and 15 biosimilars of existing monoclonal antibodies. A total of 17 potential vaccine therapies are also in development. Immunotherapies are the fastest-growing segment of oncology drug research and development, and are expected to represent a larger proportion of the pipeline in 2020. In its June 2016 report on the oncology market prognosis through 2020, the IMS Institute for Healthcare Informatics notes that higher costs will be driven by wider usage of new agents, particularly immunotherapies, in developed markets such as the United States and the five major European countries (France, Germany, Italy, Spain, and the United Kingdom).
According to MIDAS Q4 2015 data from IMS Health, released in May 2016, a total of 49 new active cancer medicines were launched worldwide between 2010 and 2014. (The data do not include agents used in supportive care.) However, the discrepancy in access was significant: While patients in the United States had access to 41 of the 49 new agents, patients in Vietnam and Tunisia had access to only 1 new drug. In 2015, just half (25) of the new drugs were available in 20 or more countries, and about one-third (17) of the drugs were only available in 10 or fewer countries.
According to MIDAS Q4 2015 data from the IMS Institute for Healthcare Informatics, released in May 2016, the majority (82%) of new active substances (NAS) in oncology launched globally from 2010â2014 were targeted small molecules (27), followed by targeted biologics (11). Two targeted immunotherapies (the programmed death 1 inhibitors pembrolizumab and nivolumab) were also launched in this period. Availability of NAS for targeted cancer therapy varies widely by country and region, however-from highest availability in the United States and Canada; to low availability in China, Kazakhstan, India, Indonesia, New Zealand, and South Africa; to no availability in Tunisia and Vietnam.
Although patients in all European Union (EU) and Eastern European countries have access to some of the newly launched targeted biologics, small molecules, and hormonal therapies for cancer treatment, access is significantly better in the EU. By the end of 2015, more than three-fourths (78%) of new oncology medicines (new active substances, or NAS) launched from 2010â2014 were available in the EU countries. In contrast, just one-third of the former Eastern Bloc countries have access to one of the NAS targeted immunotherapies. Of six European countries that gained access to NAS in all six categories shown in the map key (targeted immunotherapies, targeted biologics, targeted small molecules, cytotoxics, hormonals, and radiotherapy ), three were EU countries.
Use of newer targeted oncologic agents launched globally in the last 5 years is highest in the United States, at about one-third of total volumes, compared with about one-fourth of total volumes in the top five European countries (France, Germany, Italy, Spain, and the United Kingdom) and Japan. However, oncology drug costs, as a proportion of overall drug cost, are lower in the United States, compared with Japan and these EU5 countries. NAS = new active substances; ROW = rest of world.
Wider use of immunotherapies and other new products in the United States and the five major European countries (France, Germany, Italy, Spain, and the United Kingdom) will result in higher oncology costs worldwide through 2020. Costs will also increase due to improved survival benefits translating into longer treatment durations with newer therapies. Other factors contributing to the projected increase in oncology costs include anticipated growth in the numbers of new candidate therapeutic agents.
This figure shows the proportion of global oncology and supportive care costs (in billions of US dollars) attributed to the United States, the EU5 (Germany, France, Italy, Spain, and the United Kingdom), Japan, the “pharmerging markets,” and the rest of the world. The “pharmerging” markets are defined by IMS as countries with greater than $1 billion absolute spending growth over 2012â2016 and gross domestic product per capita of less than $25,000 at purchasing power parity. Based on these criteria, China is classified as a Tier-1 country; Brazil, Russia, and India are Tier-2 countries; and Mexico, Turkey, Poland, Venezuela, Argentina, Indonesia, South Africa, Thailand, Romania, Egypt, Ukraine, Pakistan, and Vietnam are Tier-3 countries. China dominated the market during 2015, with a market share of 45%. Nearly half (46%) of the global oncology costs between 2011 and 2015 are attributed to the cost growth in the United States and the strengthening of the US dollar during this time. In the United States, non-discounted costs of cancer and supportive care medicines increased from 2% in 2011 to 13.9% in 2015, at constant exchange rates. CAGR = compound annual growth rate.
Targeted therapies have contributed the most to overall oncologic growth in recent years. The segment grew by 18% compound annual growth rate (CAGR) from 2011â2015. In the same 5-year period, the share of spending on oral forms of targeted oncologics rose from 26% to 39%. From 2005â2015, it doubled, from 19% to 39%. Newer hormonal medicines, particularly for prostate cancer, have contributed to increased spending on oral hormonal agents; the availability of new hormonals offset patent expirations that had contributed to reduced spending on oral hormonal treatment from 2005â2015, slowing overall hormonal treatment growth to 6% CAGR from 2005â2015. Similarly, while spending on cytotoxic drugs has declined by an average 3% over the past 5 years, the share of spending on oral cytotoxicshas increased by five share points.