Transcript Changing the Course of Disease

CLINICAL LABORATORY TESTING :
PROVIDING CRITICAL EVIDENCE FOR
DIAGNOSIS AND TREATMENT
Kenneth Sisco, MD, PhD, FCAP
Medical Director
Quest Diagnostics
February 11, 2013
WHAT ARE CLINICAL LABORATORY TESTS?
 Types of Tests
 Cholesterol
 Pap
 Complete blood count
 Serum albumin
 HIV
 Leukemia
 Clinical Role
 Detect
 Diagnose
 Prevent
 Monitor progress
 Determine treatment
 Inform physicians in
medical decisions
Clinical lab tests guide health care decisions
2
A CRITICAL DISTINCTION
Clinical lab
tests
Medical imaging
tests
3
CLINICAL LABORATORY PROFILE
Annual Test Volume, 2010
 7 billion tests
Independ
Labs
33%
Other Labs
4%
Hospital
Labs
54%
 5,346 labs
 In all 50 states
Physician
Office Labs
9%
Clinical lab tests constitute only 1.6% ($8.9B) of total
Medicare spending
4
HOW LAB TESTING WORKS
5
HOW LABS ARE REGULATED
Laboratory
Reagents,
Equipment
Laboratory
Personnel
Know-How
FDA regulates
individual
components
Lab personnel
pass CAP
proficiency tests
LaboratoryDeveloped
Test
CLIA regulations
State regulations
CAP accreditation
6
WHAT ARE THE RESULTS OF LAB TESTING ?
Disease
Lab Test
Results
Cervical cancer
Pap Test
75% drop in cervical cancer mortality
Kidney Disease
eGFR
Early detection helps prevent kidney
failure
Diabetes
Glucose, HbA1c
Appropriate glucose level…
• Lowers eye disease risk 78%
• Lowers nerve disease risk 60%
• Adds 5 more years of life
Heart Disease
Cholesterol, lipids
Guide doctors in prescribing drugs that cut
heart attacks and strokes
Leukemia
Genetic Test
Cure rate in childhood leukemia exceeds
80% vs 4% in ‘60s
Colon Cancer
Fecal Occult Blood Test
Reduces death rates
7
RISING HEALTH COSTS IN THE U . S …
Total Health Expenditures, 1970 - 2011
3000
2500
$ Billions
2000
1500
1000
Chronic Disease =
75% Health Costs
500
0
1970 1980 1990 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011
Source: CMS, CDC
8
SO WHAT DO WE DO ABOUT IT?
“Although chronic diseases are
among the most common and costly
health problems, they are also
among the most preventable.”
Centers for Disease Control and Prevention
9
LAB TESTS HELP STOP DIABETES
 Diabetes is a killer
Diabetes control
vs
Diabetes complications
 Blindness, kidney failure, heart
disease
$53,659
 With lab tests, diabetes can
be…
 Controlled, managed,
prevented
 Controlling blood sugar levels
through lab tests…
 5 more years of life
 8 more years of eyesight
 6 more years without kidney
disease
$26,894
$27,630
$5,955
$1,852
Source: Diabetes Care, 1998, 2003; Journal
of Managed Care Pharmacy, 2005; Journal of
American Med Assn, 1998
10
WHY HBA1C TEST IS IMPORTANT IN DIABETES
 A simple blood test
 Measures blood sugar over 6-12
weeks
 Shows how well diabetes is being
managed over time
 Now also recommended by ADA
as effective diagnostic tool
 Advantages:
 Consumer friendly: no fasting
 Accurately reflects blood sugar
levels
 Less affected by factors as stress
or illness
 Why important?
 Enables proper management
 Key to preventing onset of serious
complications
 Including eye, heart and kidney
disease; nerve damage; stroke
11
LAB TESTS HELP PREVENT CERVICAL CANCER
 Pap tests detect precancerous cells
 Early detection,
prevention, treatment
mean:
Deaths per 100,000 Pop.
Cervical Cancer Mortality Rate, 1969-2004
9
8
7
6
5
4
3
2
1
0
 Lives saved
 Money saved
 Costs
 Test = $31
 Surgery = $37,000
Source: National Cancer Institute
Pap Test
$31
Treatment for abnormal findings
$1,281
Treatment for early stage cervical
cancer
$20,255
Treatment for late-stage cervical
cancer
$36,912
Source: National Business Group on Health
12
LAB TESTS HAVE TRANSFORMED HIV
HIV Death Rates, 1987 - 2003
 HIV test + HIV drugs =
“one-two” punch…
 Lab tests tell docs which
drug combo will work best
 Tests let docs adjust drugs
to combat fast-morphing
virus
 HIV lab tests cost-effective
18
16
Deaths per 100,000
 Dramatic decline in deaths
 Patients live normal lives
20
14
12
10
8
6
4
2
0
Source: Journal of American Medical Association, 2006; New
England Journal of Medicine, 1998; Centers for Disease Control
and Prevention
13
LAB TESTS ENABLE BETTER UTILIZATION
 KRAS gene mutation
 40% of metastatic colon
cancer patients do NOT
benefit from drug
Cost of drug per patient: $62,000
 Genetic test
 Avoid ineffective treatment
 Reduce adverse events
 $ Savings
 One estimate: $100 million
 Savings annually if test is
done before prescribing
Cost of test per patient: $452
Source: Shankaran, V, et al, ”Economic Implications of KRAS
testing in metastatic colorectal cancer,” Paper presentation,
ASCO, 2009; Manci, Am J Health-Syst Pharm., 2009
14
GENETIC TEST TAILORS BREAST CANCER CARE
 Analyzes patient’s tumor at
molecular level
Cost, Savings from Testing 60K
Patients, $Millions
 Estimates likelihood of recurrence
within 10 years
 Predicts likelihood of chemo benefit
 Gives critical info to decide chemo
vs no chemo
$372M
$238.5M
 Average chemo efficacy = 25%
 Each year, 60,000 tests…
 30% changed treatment decision
 25% avoided toxicity of unneeded
chemo
 5% will add chemo
Cost of Test
Savings from less
chemo
15
HOW MUCH DOES THIS MATTER?
1.6% of Medicare
Health care decisions
16
RESOURCES
 American Clinical Laboratory Association
 Alan Mertz, President
 Francesca Fierro O’Reilly, Legislative Affairs
 202-637-9466
 acla.com
 Results for Life
 labresultsforlife.org
17