biosimilars - can we do without them? dr paul cornes, consultant oncologist, bristol haematology...
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Biosimilars - Can we do without them?
Dr Paul Cornes, Consultant Oncologist, Bristol Haematology & Oncology Centre
Biosimilars - Can we do without them?
Dr Paul Cornes, Consultant Oncologist, Bristol Haematology & Oncology Centre
Comparative Outcomes Group
Pharmaceutical medicine moves fast!
1984 Nobel Prize for Medicine
1984 Nobel Prize for Medicine
awarded jointly to Niels K. Jerne, Georges J.F.
Köhler and César Milstein
awarded jointly to Niels K. Jerne, Georges J.F.
Köhler and César Milstein
"for the discovery of the principle for production of monoclonal antibodies".
"for the discovery of the principle for production of monoclonal antibodies".
Yet only 27 years later
We have developed a whole range of new treatments - 1984 to 2012 Monoclonal antibody therapy
http://en.wikipedia.org/wiki/File:Da_Vinci_Vitruve_Luc_Viatour.jpg
Breast Cancer
Head and Neck Cancer
Bowel Cancer
Leukaemia
Lymphoma
Ovary cancer
Secondary bone cancer
Melanoma skin cancer
Macular Degeneration
Multiple sclerosis
Asthma
Heart disease
Transplant rejection
Inflammatory bowel disease
Psoriasis
Arthritis
Yet only 27 years later
Monoclonals in Cancer - Lymphoma• Rituximab
– Halves Lymphoma Relapse
– Prima Trial reviewed at http://www.medscape.com/viewarticle/722470
http://www.jnccn.org/content/8/Suppl_6/S-1/F3.large.jpg
Monoclonals in Breast Cancer
• Trastuzumab– Halves the chance of
relapse– Reduces death by 33%
Romond EH, et al. NEJM. 2005;353:1673-1684
71% reduction in disability in Multiple sclerosis
http://users.ox.ac.uk/~path0116/tig/new1/mstrialfig.jpg
Campath-H1 vs interferon
Controlling type 1 diabetes
http://users.ox.ac.uk/~path0116/tig/new1/t1dtrial.jpg
Anti-CD3 vs placebo
Controlling Rheumatoid Arthritis
http://users.ox.ac.uk/~path0116/tig/new1/thefg.gif
Thermal imaging of hand and elbow joints before……
..and after Mab therapy
Controlling painful skin diseases – Efalizumab for psoriasis
1. Sylvia Marecki & Peter Kirkpatrick. Efalizumab. Nature Reviews Drug Discovery 2004;3:473-474 2. http://www.epgpatientdirect.org/send_article.cfm/page/355/title/Biologicals
All demonstrations of the power of
“Biologic or Targeted therapy”
I am very fortunate to work with international colleagues
Comparative Outcomes Group
We know - there is a cost to cancer
83 million years of “healthy life” lost due to death and disability from cancer in 2008.
The total economic impact of premature death and disability from cancer worldwide was $895 billion in 2008.
16.7 percent of all 'healthy' years lost in the European Union
Cancer causes the highest economic loss of all of the 15 leading causes of death worldwide
cancer has the most devastating economic impact of any cause of death in the world.
www.usatoday.com/news/health/2008-12-09-cancer_N.htmhttp://www.cancer.org/acs/groups/content/@internationalaffairs/documents/document/acspc-026203.pdf
WHO: Cancer world's top killer since 2010
We know - there is a cost to cancer care
http://www.bloomberg.com/news/2011-06-20/global-rise-in-cancer-cost-300-billion-in-2010-harvard-economist-says.html File:David E. Bloom at the World Economic Forum Summit on the Global Agenda 2008.jpg
“Think about health spending as not consumption but investment”
David E. Bloom, professor of economics and demography at Harvard
…but “cost” may be the wrong word to use – try “investment” instead
Payback on our “investment” is plain to see - Good news for cancer
treatment
Vaccines
Immunostimulants
Gene therapy
Supportive care
Novel approaches
Hormonals
Cytotoxics
• Cancer death rates are falling– Jemal A, Ward E, Thun M (2010). Declining death rates reflect progress against cancer.
PLoS ONE 5(3): e9584. doi:10.1371/journal.pone.0009584
• Novel approaches dominate drug development
– Timbs O, Cancer World, 2004; Sept-Oct p.12
Good news for cancer treatment
The costly war on cancer. The Economist. 2011 May 26. http://www.economist.com/node/18743951
Drugs in development, 2010
Drugs in development, 2010
900 drugs in development are for cancer
900 drugs in development are for cancer
But it is not all good news – Bad news for cancer treatment
• There will be more cancer to treat
• World population growth and ageing imply a progressive increase in the cancer burden – 15 million new cases,10 million new deaths are expected in 2020,
even if current rates remain unchanged• D Maxwell Parkin. Global cancer statistics in the year 2000. Lancet. 2001;2(9) 01 September
– New cancer cases will likely increase to 27 million annually by 2030, with deaths hitting 17 million
• http://www.usatoday.com/news/health/2008-12-09-cancer_N.htm
Bad news for cancer treatment• Innovative drug development is slow and
expensive
• From 5000 - 10000 compounds in pre-clinical trials: – only 0.1% reach clinical trial stage– of these, only 10-20% are finally approved
• It takes 15 years from the target discovery to the market at 800 million $/drug
• Adams CP et al: Estimating the cost of new drug development: Is it really 802 million dollars? Health Aff (Millwood) 2006;25:420-428
ASCO 2009 Meeting emphasis: individualised care and cost-
effectivenessUSA Medical insurance costs are rising faster than earnings and general inflation
Ward E. CA Cancer J, 2008;58:9-31
Medical care is becoming
unaffordable
Cost of USA cancer care 1963 to 2004
Cancer treatment spending, in billions
US$
$1.3$13.1
$27.5
$72.1
Cancer is a key driver for increasing
costs