Pathology Interviews for launching a new device

Interviews with experts on launching a new cardiovascular device

1. © 2002 EAC Enterprise Analysis Corporation
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Canary
Pathology
Interviews
A Confidential Report
Prepared for Ortho-Clinical Diagnostics
EAC, Enterprise Analysis Corp.
Stamford, Connecticut
October 21, 2002

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©2002 EAC
2Table of ContentsTable of Contents
•Executive Summary
•Objectives, Methodology and Scope
–Participants
•Value of Ischemia Marker
•Possible Applications
•Adoption Process
•Barriers to Adoption
•Current Testing Protocols
Appendix
A.Interview Guide
B.Call Write-Ups

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©2002 EAC
3Executive SummaryExecutive Summary
•A good Ischemia marker would be of value
–Value will be dependent on the medical and economic
outcomes of the clinical trials
•Primary applications would be both “rule-in” and
“rule-out” for MI and possibly for use in
conjunction with a stress test
•Time horizon for adoption would be 2 to 5 years
–2 years if the marker is a “breakthrough”
•Low current levels of POC testing in the ED
–Will have to fit workflow of the ED and pass all lab
requirements
–Some barriers may be overcome with highly sensitive and
specific, 90 second, whole blood test, in “connected” solution,
that does “invisible QC” and can be done in three simple steps
(or less)

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©2002 EAC
4ObjectivesObjectives
•Support Ortho in the development of a Canary
instrument design that will be acceptable for use
in the Emergency Department
•Validate and explore additional applications for
Canary
•Detail common adoption processes for new
markers

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©2002 EAC
5Methodology and ScopeMethodology and Scope
•EAC identified, recruited and conducted
interviews with 18 pathologists representing
institutions considered peer leaders, secondary
adopters and hospital networks
•An honoraria was paid to each participant
•Participants spent 45 – 60 minutes in responding
to a questions developed jointly by OCD and EAC
(Questionnaire is in Appendix)
•Criteria used in screening participants included
–Number of Emergency Department visits
–Experience in introducing Troponin
–Decision authority for the introduction of new tests
•Individual call Write-ups are included in Appendix

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©2002 EAC
6ParticipantsParticipants
•Completed interviews
–Dr. John Boyle, St. Johns Episcopal Hospital, Far Rockaway, NY
–Dr. Michael Bissell, Ohio State University Med Ctr, Columbus,
OH
–Dr. Jerry McHan, DeKalb Medical Center, Decatur, GA
–Dr. Kent Lewandrowski, Mass General, Boston, MA
–Dr. James Wolfe, Mercy Anderson, Cincinnati, OH
–Dr. Robert Christianson, University of Maryland, Baltimore, MD
–Dr. Bruce Jones, St. John Hospital & Med. Center, Detroit, MI
–Dr. Gordon Edward, Duke University, Durham, NC
–Dr. I. Argani, Westchester Medical Center, Valhalla, NY
–Dr. Mitchell Scott, Barnes-Jewish Hospital, St. Louis, MO

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©2002 EAC
7Participants (cont)Participants (cont)
•Completed interviews
–Dr. Saad Ghosn, Veterans Administration, Cincinnati, OH
–Dr. Mark Lifshitz, NYU, Medical Center, NY, NY
–Dr. Daniel Fink, NY Presbyterian, NY, NY
–Dr. Richard Lent, NY Hospital, NY, NY
–Dr. Edward Friedlander, University Health System, Kansas City,
MO
–Dr. Mark Linder, University of Louisville, Louisville, KY
–Dr. Larry Brace, University of Illinois, Chicago, IL
–Dr. James Faix, Stanford University Med. Center, Palo Alto, CA
–Dr. Gary Utz, University Hospital, Cincinnati, OH

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©2002 EAC
8
Value of an Ischemia MarkerValue of an Ischemia Marker

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©2002 EAC
9Value of Ischemia MarkerValue of Ischemia Marker
•Good conceptual agreement that an ischemia
marker would be of considerable value to the
current ED practices if it is as sensitive and
specific as postulated
•Good conceptual agreement that a “faster
Troponin” would be valuable: an earlier
confirmatory or an earlier positive predictor
–Potential for much earlier intervention for patients with
normal EKGs and a negative Troponin
–Should speed flow through the ED and that is desirable
–May cut down repetition of Troponin and CK – though not
likely to eliminate
•As an Ischemia marker to “rule-out” MI is also
seen as valuable
–Will move patients more quickly to non-cardiac protocols
–Potential for earlier discharge
–Less likely to incur “unnecessary” CCU admissions

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©2002 EAC
10Value of Ischemia MarkerValue of Ischemia Marker
•Economic concerns of laboratory
–May need to eliminate other markers to meet budget
constraints
–Need to show overall ED economic benefit
•Rule–out concerns
–Could fall into the problems of Myoglobin as a “rule-out”
marker
•Miss the window
–Other causes of false negatives (e.g. age related different
normal ranges)
•Rule-in
–False positive – comes up in Ischemic stroke or becomes
elevated due to exercise or other chronic conditions
–Must be tissue specific
•General ischemia marker could create a “witch hunt” to search for the
source of the ischemia (e.g. artery in the leg occludes)

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©2002 EAC
11Product Concept - ApplicationsProduct Concept - Applications
General
Reaction
Rule In for
Ischemia
Rule Out for
AMI
With Stress
Test
Argani – Westchester ++ ++ ++
Bissell – OSU + +
Boyle - St. John’s + +
Brace - U of IL + + - +
Christenson - U of MD ++ ++ ++ ++
Edward – Duke ++ + ++
Faix – Stanford + + + ++
Fink - Columbia
Presbyterian
+ + +
Friedlander - UHS ++ ++ + +++

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©2002 EAC
12Product Concept - ApplicationsProduct Concept - Applications
General
Reaction
Rule In for
Ischemia
Rule Out
for AMI
With Stress
Test
Ghosn – VA Cincinnati + + +
Jones – St. John 0 0 0
Lent – NY Presbyterian + + 0
Lewandrowsky - Mass
General
++ ++ + +
Lifshitz – NYU + ++ +
Linder – U of Louisville++ ++ ++
McHan – DeKalb + + + ++
Scott – BJH + + ++
Utz – University
Hospital
+ + + +
Wolfe – Mercy
Anderson
++ ++ 0 0

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©2002 EAC
13
Possible ApplicationsPossible Applications

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©2002 EAC
14For use in conjunction with a stress testFor use in conjunction with a stress test
•Highest receptivity was for use as a biomarker in
conjunction with a stress test
–Overall sensitivity for EKG is 80 – 85%
•Still get inconclusive results
–Too much patient subjectivity in reporting chest pain
–Reported increase in the number of stress tests being used
–High expense involved in stress test
•POC may be more acceptable at site of stress
test administration
–Population is more focused
–Clear need for a result in the moment
•Application is dependent on speed at which the
marker rises
–Value in this application relies entirely on the very early
presence of changes in the FFa

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©2002 EAC
15Other ApplicationsOther Applications
•Other possible applications that were mentioned
as valuable were biomarker for shock or for other
measures of cardiac sufficiency
•Pathologists disagreed on value of test during an
invasive cardiac procedure, but could see value
in establishing a baseline and for post surgical
monitoring
–One pathologist indicated that Lactate was currently used as
a measure of cardiac sufficiency in many operations and that
perhaps this would be a substitute

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©2002 EAC
16
Adoption ProcessAdoption Process

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©2002 EAC
17Adoption Process For New TestsAdoption Process For New Tests
•The adoption process for new tests varies by
hospital and by individual test
–Process ranges from highly formal application procedures to
very informal procedures
•Some hospitals have formal committees to
evaluate new tests
–Lab works with clinical services to evaluate cost and benefit of
new tests
–Education process is formal (meetings, symposia)
–Adoption by clinicians tends to be very quick after test is
offered
•Majority of hospitals have a very informal adoption
process
–Respond to clinician requests
–Laboratory learns of new tests and tells clinicians about it

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©2002 EAC
18Adoption Process for New TestsAdoption Process for New Tests
•Both “push” and “pull” strategies used in adoption
of new tests
•“Push” strategy: Clinicians drive adoption
–Clinicians approach laboratory and demand test
–May be a “champion” that drives lab or hospital to evaluate
new test
•“Pull” strategy: Laboratory drives adoption
–Lab educates physicians about a new or better test
–Lab often looking to replace an existing test
•Time frame for adoption new tests varies
–Typically 2 to 5 years
–2 years if a “breakthrough” marker
–Adoption rate depends on: strength of publications, medical
evidence, specificity and sensitivity, hospital need, etc.

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©2002 EAC
19Adoption Process - ExamplesAdoption Process - Examples
•Troponin (“Pull”)
–Adoption has been driven more by the lab than by ED staff or
cardiologists
–Most institutions said that it has taken 2 – 3 years to get to the
level of use they see now
–Adoption was greatly improved after ACC published the use of
Troponin as a standard of care
•BNP (“Push”)
–Adoption of BNP has been rapid
–In most cases, the clinicians approached the laboratory
–Labs “gave in” to clinicians despite lack of availability on a lab
platform
•Some labs “holding off” until BNP is available on lab platform
–Labs “gave in” despite reimbursement levels

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©2002 EAC
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Barriers to AdoptionBarriers to Adoption

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©2002 EAC
21Adoption Barriers for Ischemia MarkerAdoption Barriers for Ischemia Marker
•Clinical utility has to be clearly demonstrated
–High sensitivity and specificity to allow for earlier diagnosis
•Can’t be one more validation mechanism
–Clearly established window for maximum benefit
•Must have substantiated clinical explanation
–“Show me the medical mechanism”
•Stringent examination of the economics
–Best if it eliminates something else
–Prove it saves $$ in the ED diagnostic and treatment process

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©2002 EAC
22Adoption Barriers for ED POC testAdoption Barriers for ED POC test
•“Will 90 seconds really make a difference in
patient care”
–Pathologists lean toward desiring everything on an existing
platform and will make the ED and Cardiology staff (and
therefore the vendor) prove that treatment will be impacted by
the speed of the result
•Test must jump through many hurdles to be
accepted for use in ED
–Self-documenting: “Nurses will not do more documentation”
–Idiot-proof: “They get pregnancy tests wrong; they leave them
around, then forget to do them, they spill things, they don’t
label things --- POC is ridiculously labor intense”
–Whole blood is a must
•Reimbursement will matter
–If test is a money loser it may still be used (BNP) but it will go
into the lab and be under tight control

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©2002 EAC
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Current Testing ProtocolsCurrent Testing Protocols

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©2002 EAC
24Cardiac Testing Protocols: TroponinCardiac Testing Protocols: Troponin
•Protocols for the use of Troponin are widely varied
–4 institutions use Troponin alone (no additional markers)
–8 use Troponin in conjunction with some version of CK, but
this varied widely
•Total CK, CPK, CK-MB
–1 institution uses Myoglobin with Troponin
–1 institution uses all three markers
•All institutions reported running at least one
cardiac marker within a few minutes of
presentation however, there was wide disparity in
the follow up protocol
–+2, +3, +4, +6 and +8 hour intervals
–There is no fixed standard of care
•3 of the institutions had been involved in clinical
trials with either Troponin T, or I or “Quick T” strips

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©2002 EAC
25Cardiac Testing Protocols: TroponinCardiac Testing Protocols: Troponin
•Redefinition of MI: one pathologist indicated that
he felt the continued use of Troponin would result
in the redefinition of MI because there is no
Troponin present in a “normal” patient and
therefore the presence of any Troponin could be
considered indicative of patient risk
–Increasing literature about the predictive value
•Still issues with inconsistency of results
–May be more interfering conditions or substances
–Variability between readings on the same specimen larger
than preferred

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©2002 EAC
26Cardiac Testing Protocols: BNPCardiac Testing Protocols: BNP
•There is a growing body of interest and an
increase in requests for the test despite the fact
that it is a money losing test
–None of the institutions interviewed was performing the test in
the ED
–6 institutions were using the Biosite instrument in the lab
–6 institutions reported that they are waiting until the test is
available on a large analyzer (e.g. Roche Elecsys or Bayer
Centaur)
–3 pathologists said that there is not enough interest currently
to bring the test on at all
•Literature supports the value of the test in CHF
diagnosis
–Validation may improve patient care beyond the ED visit, but
less dramatically in the ED since anyone presenting with
“shortness of breath” is already being treated for that symptom
–Rapid test result less critical than for myocardial infarction
markers

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©2002 EAC
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AppendixAppendix