Transcript Health Trends Review Workshop

Diagnostics – the best kept Secret
in Healthcare
Grasping the benefits of
Diagnostics - how Government can
make it happen…
Andy Bufton
Chairman, Public and Professional Relations Steering Group, BIVDA
Director, External and Regulatory Affairs, Abbott Diagnostics
Portcullis House 13 November 2001
IVDs in Context
• 5% of Medical Sales
• Less than 1% of Healthcare expenditure
• 60 to 70% of the data on EPR
In Vitro Diagnostics – What?
• IVDs are used on the well, the sick and the treated
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To monitor therapy
To estimate risk of, or predict, changes in health status
To aid in diagnosis of the symptomatic patient
To uncover asymptomatic conditions
To determine the safety of blood products for transfusion
To determine the most efficacious therapy (theranostics)
In Vitro Diagnostics – Where?
• In the Pathology Laboratory
– Fewer, larger laboratories with high throughput platforms
• By the patient
– Self-monitoring of Diabetes therapy, Warfarin therapy
– Self testing for Pregnancy, health-risk factors
• Point-of-care
– Bedside, operating theatre, and hospital clinics
• In the Community
– Primary Care sites
– In the High Street
In Vitro Diagnostics – Why?
• 60-70% of the data on the EPR
– To monitor therapy
• Improves outcomes, reduces sequelae of condition, lowers costs
– To estimate risk of, or predict, changes in health status
• Targets preventative measures, improves health levels
– To aid in diagnosis of the symptomatic patient
• Enables correct and timely treatment, improved outcomes
– To uncover asymptomatic conditions
• Enables treatment, reduces sequelae, lowers costs
– To determine the safety of blood products for transfusion
• Minimises risk of transfusion reactions and infections
– To determine therapy (pharmacogenomics and theranostics)
• Tailors treatment to the genetic profile of the patient, improved outcomes
In Vitro Diagnostics – Trends
Site of use
• Pathology Laboratories
– Reducing in numbers, increasing in size, overall workload increasing
a few % p.a.
• Self-use
– Self monitoring for Diabetes control increasing 15% p.a.
– Small increases in other self-tests, many available on the internet
• Point-of-care
– Robust, new technologies allied with IT beginning to realise the long
heralded Point-of-Care revolution in both the Hospital environment
and in the Community
In Vitro Diagnostics – Trends
Role of Diagnostics
• Differential Diagnosis of symptomatic patients
– New, more specific tests, e.g.. Troponin, improve outcomes and reduce waste
of resources in the acute arena
• Monitoring of Therapy
– Optimising therapy such as glycaemic control in diabetes by frequent testing
• Prediction and Prevention
– Testing programmes are emerging from around the world, delivering improved
health outcomes and cost benefits
• Uncovering asymptomatic conditions
– Conditions such as Chlamydia infection have a long term impact on the health
of the individual and use of healthcare resources
In Vitro Diagnostics – Trends
New technologies and applications
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Improved IT allows Point-of-care diagnostics to overcome previous difficulties of
Quality Assurance and Continuity of Record
New, proprietary technologies are emerging, e.g.. relating to automation of cytology
screening, HPV testing, DNA sequencing for cancer susceptibility, genetic analysis
technology using FISH, risk factors for CHD, and POC technology for platelet
inhibition therapy, cardiac diagnostics and critical care
Pharmacogenomics offer the opportunity to utilise drugs which have efficacy or
toxicity according to the genetic profile of the patient, possibly releasing previously
discarded compounds for use
Theranostics are developing which link diagnostics with drug therapy, e.g.
HercepTest/Herceptin
DNA probe technologies provide for highly sensitive and specific testing for infective
agents, enabling practical testing programmes of an asymptomatic population, e.g..
Chlamydia, HPV
In Vitro Diagnostics – utilisation in the UK
• The difficulty in transferring funds across budget boundaries limits expansion of
the use of diagnostics in the Pathology Laboratory setting (costed as overhead)
resulting in the UK having a slow uptake of new tests and low usage compared
to Europe and USA
• The use of diagnostics facilitates many emerging issues in healthcare:
– Increased quality management and the impact of Clinical Governance
– Convenience to the patient and the clinician through Point-of Care testing in
Primary Care and the Community
– Recognition of the cost and health benefits of correct and timely treatment,
and reduction of the sequelae of undiagnosed conditions
– Inter-relationships of Diagnostics and Pharmaceuticals, through the study of
Pharmacogenomics, providing treatment tailored to the individual
– Improved public awareness of IVDs through the media and the internet
In Vitro Diagnostics and the NHS Plan
‘We can radically transform the NHS from a 20th Century model of Care to a 21st
Century Health service’ Alan Milburn,The Parliamentary Monitor, July 2000
The NHS Plan:
• NHS Core principle #9:
– The NHS will help keep people healthy and work to reduce health inequalities
• NHS Core principle #10:
– ...developments in science such as the new genetics offer important
possibilities for disease prevention and treatment......
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National Institute for Clinical Excellence
Modernisation Agency, created to redesign local services....
Patients..... will be able to have tests.... in Primary Care centres
....effective screening programmes.....
‘Improving health outcomes for everyone’
What should Government be doing?
• Recognising the barrier to UK healthcare aspirations,
of having the lowest per capita use of Diagnostics in
the western world
• Acting to manage the use of diagnostics as a Strategic
Health Resource, rather than buried as an overhead in
Hospital Trusts
• Asking the right questions of Health Economists
• References
– Self-monitoring of Blood Glucose Levels and Glycaemic Control, Karter et al, Amer.J.Med
2001 111 p1-9
– King's Fund Policy Institute's report ‘Counting the Cost: The Real Impact of Non Insulin
Dependant Diabetes’,1998
– Point-of-Care testing in the Community Pharmacy, Moffat.T.,The Pharmaceutical
Journal(Vol 267)2001 267.268
– Prostate Cancer Mortality after introduction of PSA mass screening in the Federal State of
Tyrol, Austria, Bartsch et al, Urology 58: 417-424 2001
– Theranostics - the influence of Diagnostics on Pharmaceutical Therapy: Anna Bromley,
PJB Publications Ltd., 2000
– Prevention of pelvic inflammatory diseases by screening for cervical chlamydial infection.
Scholes D et al, N Engl J Med 1996;334:1362-6.
– Screening for chlamydial infections and the risk of ectopic pregnancy in a county in
Sweden: ecological analysis. Egger M et al, BMJ 1998 Jun 13;316(7147):1776-80
– Acute coronary syndromes. the diagnostic role of troponins: Hamm CW, Thromb Res 2001
Sep 30;103 Suppl 1:S63-9
– Long-term experience with an accelerated protocol for diagnosis of chest pain. Caragher TE
et al, Arch Pathol Lab Med 2000 Oct;124(10):1434-9
Prepared for BIVDA and the Patients Association by Andy Bufton and Cecilia Brown : November 2001
For further information email: [email protected]