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Biosimilars - Can we do without them?
Dr Paul Cornes,
Consultant Oncologist,
Bristol Haematology & Oncology Centre
Comparative Outcomes Group
[email protected]
Pharmaceutical medicine moves fast!
1984 Nobel Prize
for Medicine
"for the discovery
of the principle
for production of
monoclonal
antibodies".
awarded jointly to
Niels K. Jerne,
Georges J.F.
Köhler and César
Milstein
Yet only 27 years later
We have developed a whole range of new treatments 1984 to 2012 Monoclonal antibody therapy
Macular Degeneration
Head and Neck Cancer
Multiple sclerosis
Breast Cancer
Asthma
Bowel Cancer
Heart disease
Leukaemia
Lymphoma
Transplant rejection
Ovary cancer
Inflammatory bowel
disease
Secondary bone cancer
Psoriasis
Arthritis
Melanoma skin cancer
Yet only 27 years later
http://en.wikipedia.org/wiki/File:Da_Vinci_Vitruve_Luc_Viatour.jpg
Monoclonals in Cancer - Lymphoma
• Rituximab
– Halves Lymphoma
Relapse
– Prima Trial reviewed at
http://www.medscape.c
om/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
Campath-H1 vs interferon
http://users.ox.ac.uk/~path0116/tig/new1/mstrialfig.jpg
Controlling type 1 diabetes
Anti-CD3 vs placebo
http://users.ox.ac.uk/~path0116/tig/new1/t1dtrial.jpg
Controlling Rheumatoid Arthritis
Thermal imaging of hand and
elbow joints before……
http://users.ox.ac.uk/~path0116/tig/new1/thefg.gif
..and after Mab therapy
Controlling painful skin diseases –
Efalizumab for psoriasis
1.
2.
Sylvia Marecki & Peter Kirkpatrick. Efalizumab. Nature Reviews Drug Discovery 2004;3:473-474
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
cancer has the most
devastating economic
impact of any cause of
death in the world.
WHO: Cancer world's top
killer since 2010
The total economic
impact of premature
death and disability from
cancer worldwide was
$895 billion in 2008.
Cancer causes the highest
economic loss of all of the
15 leading causes of
death worldwide
16.7 percent of all
'healthy' years lost in the
European Union
83 million years of
“healthy life” lost due to
death and disability from
cancer in 2008.
www.usatoday.com/news/health/2008-12-09-cancer_N.htm
http://www.cancer.org/acs/groups/content/@internationalaffairs/documents/document/acspc-026203.pdf
We know - there is a cost to cancer
care
…but “cost” may be the wrong word to use –
try “investment” instead
“Think about health spending as not
consumption but investment”
David E. Bloom,
professor of economics and
demography at Harvard
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
Payback on our “investment” is
plain to see - Good news for cancer
treatment
• 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
Vaccines
Immunostimulants
development
Gene therapy
– Timbs
O, Cancer World, 2004; Sept-Oct p.12
Supportive care
Novel approaches
Hormonals
Cytotoxics
Good news for cancer treatment
Drugs in
development,
2010
900 drugs in
development
are for cancer
The costly war on cancer. The Economist. 2011 May 26. http://www.economist.com/node/18743951
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,
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
ASCO 2009 Meeting emphasis:
individualised care and costeffectiveness
USA Medical insurance costs are rising faster than earnings and general inflation
Medical care is
becoming
unaffordable
Ward E. CA Cancer J, 2008;58:9-31
Cost of USA cancer care 1963 to 2004
Cancer treatment spending, in billions
$72.1
US$
Cancer is a key driver
for increasing costs
$27.5
$13.1
$1.3