Transcript Technology Assessment in Kaiser Permanente NAIC Health

Technology Assessment
in Kaiser Permanente
NAIC Health Innovations (B) WG
May 30, 2008
Brent Barnhart
Senior Counsel
Kaiser Permanente
About Kaiser Permanente
Nationwide
Description: Nation’s largest nonprofit
health plan
WA
OR
Integrated health care
delivery system
CO
CA
OH
VA
GA
HI
MD
DC
People: 8.5 million members
14,000+ physicians
140,000+ employees
Facilities: 8 regions in 9 states and D.C.
32 hospitals and med centers
430+ medical offices
Revenue: $37 billion annually
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A Prepaid Integrated Delivery System
With Aligned Incentives
 Social Purpose
 Quality Driven
 Shared Accountability
for Program Success
 Integration along
Multiple Dimensions
 Prevention & Care
Management
Focus
Kaiser
Foundation
Hospitals
Permanente
Medical
Group
The
Permanente
Federation
Health Plan
Members
Kaiser
Foundation
Health Plan
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Comparative Effectiveness
New
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Medical Technology
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Assessment
Entirely new technology
New applications of existing technology
Drugs
Biologics
Devices, Equipment and Supplies
Medical and Surgical Procedures
Support Systems, Organizational and
Managerial Systems including IT
Systematic and comprehensive
evaluation of the medical (safety,
efficacy, and effectiveness), social,
ethical and economic implications of
development, diffusion, and use of health
technology
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Comparative Effectiveness
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Within Kaiser Permanente, the Interregional New Technologies
Committee (INTC) is one of a group of national committees that
review new technologies, products and pharmaceuticals:
• INTC
• National Product Council
• Pharmacy and Therapeutics Committee
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Kaiser Permanente is also helping to fund a new Institute for
Comparative Effectiveness Research (ICER) that will
disseminate information to patients, clinicians, and insurers.
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INTC
Interregional New Technologies
Committee
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Monitors and evaluates new, and new applications of
existing, medical and behavioral technologies
Evaluates the medical appropriateness based on
demonstrated safety, efficacy and comparative utility
Tracks and analyzes emerging technologies as
evidence becomes available.
Compares the new technology to existing alternative
technologies
Recommendations, not coverage decisions; never
patient-specific
Under The Permanente Federation – the national physician
arm of Kaiser Permanente
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Establishment of the INTC
Charge to develop an explicit process for evaluating new medical technologies. The goal is to evaluate
available scientific evidence, determine if a new technology is safe and effective, and make
recommendations to the KP Regions.
The Executive
Medical Directors
chartered the INTC
Early
1980s
New recommendation language employed
KP hires David Eddy MD, PhD
1990
Two court cases
Involving IVF and
Infant Liver Transplant
1993
2004
2007
KP enters
collaboration with
BCBSA TEC
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INTC
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18 members, all regions represented
Inter-regional
Inter-entity
10/18 members are physicians
Quarterly meetings with approx. 8 topics each
Internal and external evidence reviews
PMG experts as clinical guests for select topics
PMG expert opinion gathered for all topics
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FDA and INTC Scope Compared
FDA’s Scope
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Safety
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Efficacy
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INTC Scope
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Intermediate, short-term
outcomes
Effectiveness
•
Benefit of using a technology
for a particular health
problem in ideal conditions
Substantial equivalence or
comparison to placebo
Everything in the left
column plus
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Benefit of using a
technology for a
particular health problem
in general or routine
conditions
Comparisons to standard
of care and experience
relevant to members
Long-term health
outcomes
Operational impact
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FDA: Medical Devices
Class I
Class II
Class III
Low Risk
Moderate Risk
High Risk
Scalpels, tongue depressors
Aerosol holding chambers, oxygen
generators
Implantable electric urinary continence devices
General Controls
General Controls
General Controls
Special Controls
Premarket Application (PMA)
General controls sufficient
to provide reasonable
assurance of safety and
efficacy
510(k) process results in
determination of whether a
device is substantially
equivalent (SE) to a predicate
device. If not SE, risk
determines if process is PMA
or 510(k).
PMA approval is based on a
determination that there is
sufficient valid scientific
evidence to reasonably assure
that the device is safe and
effective for its intended use.
Exempt from 510(k)
except…
510(k) required except…
PMA required except …
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Guiding Principles
By Applying Principles of Evidence-based Medicine
Base clinical and policy decisions on evidence of effectiveness &
benefit. David Eddy, MD, PhD
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Evidence of benefit
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Evidence of no benefit/harm
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Insufficient evidence
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Do it
Don’t do it
Be conservative
Use discretion
If it is new, recommend only within well designed trials
Do things that work, don’t do things that don’t,
use resources wisely.
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Topic Selection
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Needs and ideas from INTC members
Feedback on meeting minutes
Feedback from regions as they make operational decisions
Inquiry line database
Internal and external assessment topics
New evidence: medical journals and professional meetings
FDA approvals, panel meetings, minutes, reviews
Member and physician demand
Open agenda planning calls including non-KP colleagues
Strict criteria are NOT used to select topics.
Generous input and judgment are used to
determine topic priority.
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Topic Selection
2007 INTC Topics
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Surgery for morbid obesity
CT colonography
Wearable cardiodefibrillator vest
CAD Mammography
Artificial cervical discs
Hip resurfacing
Remote electronic telemonitoring for CHF
Robot-assisted laparoscopic prostatectomy
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Preparing a Topic
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Determine interest level in new technology
Gauge potential operational impact and demand
Raise relevant benefit, media, legal and ethical issues
Learn how the technology might fit into PMG practice
Gather PMG input
Determine source of assessment
• Consider internal and external resources, public and private
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Supplement most current assessment, as needed
Select a speaker and prepare a presentation
Assist speaker in drafting a recommendation
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Anatomy of a Technology
Assessment
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Background
Problem Formulation
Literature Search Strategy
Evidence Summary/Tables
Regulatory Information including FDA
External assessments, all sectors
Conclusion/Rationale
Bibliography
Supplemented with PMG expert opinion and professional societies
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Sources of Information
Internal Assessments
Primarily SCPMG
Also TPMG, TPF
The Permanente
Federation
(TPF)
INTC
Inquiry Line
External Assessments
ECRI
Hayes
BCBSA
TEC
FDA
AHRQ
EPCs
NICE
Cochrane CCOHTA
Others: Advisory
Board, HTC, etc.
Internal Input:
Regional
Initiatives
Interregional
Initiatives
Inter-entity
Permanente Medical
Groups
The INTC manages the national agenda for
new medical technology assessment with the input of numerous
collaborators and resources.
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New Technology Inquiry Line
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Supports the needs of PMG physicians throughout all KP
regions for evidence-based information on new technologies
Volume of Inquiries . . .
• Total inquiries (1999-2006) – 4,531
• In 2006, the average number inquiries per day was 2.2
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In 2006, clients used the inquiry line for . . .
• Patient-specific inquiry – 44%
• General technology inquiry – 46%
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INTC Website
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The BCBSA TEC/KP Collaboration
TEC's collaborative relationship with Kaiser Permanente began in 1993.
This relationship has given TEC staff ready access to Kaiser's clinical
experts on a wide range of topics. As a result of TEC's collaboration
with Kaiser, David M. Eddy, M.D., Ph.D., Senior Advisor for Health
Policy and Management, served for over 10 years as TEC's Scientific
Advisor, until his retirement from the position in 2004. In addition, one
Permanente physician, Jed Weissberg, M.D., is a voting member of
TEC's Medical Advisory Panel.
TEC Assessments and other publications are provided to Kaiser Permanente staff as drafts.
Dr. Weissberg participates actively in the MAP discussions, sharing clinical opinion from
Permanente physicians on the draft TEC products. TEC staff works with Kaiser
Permanente's Technology Assessment staff to obtain input on topic selection and to gain
access to Permanente's physician experts on a wide range of topics. Permanente clinical
expertise may be used to help shape the actual research questions in TEC Assessments. In
many cases, these are the same physicians that either chair or sit on committees that are
responsible for developing practice guidelines at Kaiser Permanente.
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More on BCBSA TEC
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Founded in 1985 and pioneered the development of scientific criteria for
assessing medical technologies through comprehensive reviews of clinical
evidence.
TEC provides comprehensive evaluation of the clinical effectiveness and
appropriateness of a given medical procedure, device or drug, averaging 20 to
25 assessments a year. TEC serves a wide range of clients in both the
private and public sectors, including KP and CMS.
TEC Assessments are scientific opinions, provided solely for informational
purposes and should not be construed to suggest that BCBSA, KP or the TEC
Program recommends, advocates, requires, encourages, or discourages any
particular treatment, procedure, or service; any particular course of treatment,
procedure, or service; or the payment or non-payment of the technology or
technologies evaluated.
TEC is headed by Executive Director, Naomi Aronson, Ph.D. Its core staff of
research scientists consists of experienced physicians and doctorate-level
scientists with a history of academic and primary research affiliations.
A Medical Advisory Panel, comprising independent, nationally recognized
experts in technology assessment, clinical research and medical specialties,
has scientific accountability for all TEC assessments.
BCBSA TEC content is available at:
http://www.bcbs.com/betterknowledge/tec/
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BCBSA TEC Criteria
TEC Assessments routinely use the five TEC criteria to
evaluate whether drugs, devices, procedures and
biological products improve health outcomes such as
length of life, quality of life and functional ability.
1. The technology must have final approval from the appropriate
governmental regulatory bodies.
2. The scientific evidence must permit conclusions concerning the
effect of the technology on health outcomes.
3. The technology must improve the net health outcome.
4. The technology must be as beneficial as any established
alternatives.
5. The improvement must be attainable outside the investigational
settings.
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An Assessment Example:
Hip Resurfacing — At a Glance —
3/02
AHFMR
2002
1/04
ECRI
Tech Forecast
2004
1/04
Hayes
3/05
CCOHTA
Issue 65
2/06
Ontario
4/06
Hayes
7/06
Hayes
C
C
B
D
2005
2/05
TPMG
4/05
SCPMG
2006
2/07
ECRI
Target #907
2/07
BCBSA TEC
+
2007
2a
-
2a
8/05
INTC
6/06
SCPMG
8/06
INTC
6/07
INTC
In May 2006, the FDA conditionally approved the Birmingham System and requested Smith & Nephew conduct two post-approval studies.
In Feb 2007, the FDA voted in favor of approval with conditions for Corin’s Cormet 2000 hip resurfacing system and requested a postmarket study
No coverage.
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What the INTC Produces
The INTC Recommendations:
1.
2.
3.
There is sufficient evidence to determine that the technology is
medically appropriate (or is a medically appropriate
treatment/diagnostic option) for select patients.
There is insufficient evidence to determine whether the technology
is medically appropriate for any patient. OR There is insufficient
evidence to determine whether the technology is a medically
appropriate treatment/diagnostic option for any patient.
a) no evidence
Further describe
characteristics of
b) insufficient quantity and/or insufficient quality
the evidence
c) conflicting or inconsistent
There is sufficient evidence to determine that the technology is
generally not medically appropriate (or is not a medically
appropriate treatment/diagnostic option) for any patients.
What the INTC Does Not Do:
Cost-effectiveness studies
Clinical practice guidelines
Consultation for individual patient cases
Operational decisions
Coverage policies
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Current Example: Cervical Arthroplasty
Anterior Cervical Discectomy with Fusion (ACDF)
The goal is to decompress the disc space and stabilize the
vertebrae, relieving pressure on the nerve to reduce back,
neck and shoulder pain.
Disadvantages:
 complications associated with grafting
 loss of cervical mobility
 growing evidence that fusion may contribute to
adjacent-level degenerative disease
versus
Cervical Arthroplasty
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Uses the same anterior surgical approach as cervical fusion
Eliminates need for donor bone
Aims to maintain motion of cervical vertebrae hoping to reduce
future problems and not hasten DDD in adjacent discs
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Implanted Bryan Disc
Cervical Discs and the FDA
Prestige-ST® by Medtronic
On July 17, 2007, the FDA approved the Prestige-ST® for the treatment in
skeletally mature patients for reconstruction of the disc from C3-C7 following
single-level discectomy for intractable radiculopathy and or myelopathy.
Intractable radiculopathy and or myelopathy should be present with at least
one of the following items producing symptomatic nerve root and/or spinal cord
compression which is documented by patient history (e.g., pain [neck and/or
arm], functional deficit, and/or neurological deficit), and radiographic studies
(e.g., CT, MRI, x-rays, etc.): 1) herniated disc, and/or 2) osteophyte formation.
The Prestige® is implanted via an open anterior approach.
The FDA’s Panel recommended Medtronic be barred from claiming
preservation of ROM could protect adjacent discs.
The FDA recommended a post-approval study of a min. of 200 pts.
with data collection at 5 and 7 years post-op.
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Cervical Discs and the FDA
Bryan by Medtronic
On July 17, 2006, the Orthopaedic and Rehabilitation Devices Panel of the
FDA recommended approval of the Bryan Cervical Disc but has not received
final marketing approval at this time. The Bryan disc is indicated for use in
patients similar to those for whom the Prestige device is indicated.
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Cervical Artificial Disc Replacement
—At a Glance—
6/06
ECRI
Forecast
11/05
NICE
TEC draft
soon
expected
7/07
10/07
ECRI
ECRI Target
Forecast
Expected
9/06
HAYES
Outlook
T
B
D
2004
2005
2006
-
7/03
INTC
11/04
INTC
2007
2008
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T
B
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11/06
INTC
12/07
INTC
There is currently not a policy on artificial cervical discs.
In July of 2007, the FDA approved the Prestige® Cervical Disc System. At the same time, the FDA's Orthopaedic and Rehabilitation
Devices Panel recommended approval of Byran® Cervical Disc System.
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Selective Evidence by Disc Type
Lind (2007), Bryan, n=11,
Sears (2007and 2007b), Bryan, n=67
Shim (2006), Bryan, n=61
Coric (2006), Bryan, n=33, RCT
Lafuente (2005), Bryan, n=46, prosp. series
Hacker (2005), Bryan, n=46, RCT
Goffin (2002, 2003), Bryan, n=146, prosp. series
Duggal (2004), Bryan, n=26, prosp. Series
Bertagnoli (2005), ProDisc-C, n=27, prosp. Series
Pimenta (2004), PCM, n=53, prosp. Series
Mummaneni (2007), Prestige, n=541, RCT
Porchet (2004), Prestige II, n=55, RCT
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Even More Selective:
RCTs by Disc Type
Coric (2006), Bryan, n=33, RCT
Hacker (2005), Bryan, n=46, RCT
(2005), Bryan, n=550 (not published)
Mummaneni (2007), Prestige, n=541, RCT
Sawin (2005), Prestige ST, n=118, RCT (not publ.)
Porchet (2004), Prestige II, n=55, RCT
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Mummaneni et al - Prestige IDE Trial
• 28% of surgeons (20/72) had financial interest in Medtronic and
contributed a total of 187 of 541 patients with all centers contributing 1-49
patients each.
• A fixed non-inferiority margin of 10% was agreed upon in advance by
Medtronic and the FDA (Hypothesis: The success rate of Prestige is not
lower than control by 10%.)
• The interim Bayesian statistical analysis was planned when all patients
reach 12-months and 250 pts. reach 24 mos. Primary endpoint is a
composite of pain and functional disability, neurological status, adverse
events, secondary surgical interventions and a radiographic functional
spinal unit (FSU) height determination.
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The Bayesian Interim Analysis
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The FDA issued draft guidance on Bayesian statistics in medical device
trials in May 2006 http://www.fda.gov/cdrh/osb/guidance/1601.pdf
“Bayesian statistics is a statistical theory and approach to data analysis
that provides a coherent method for learning from evidence as it
accumulates. Traditional (frequentist) statistical methods formally use
prior information only in the design of a clinical trial. … In contrast, the
Bayesian approach uses a consistent, mathematically formal method
called Bayes’ Theorem for combining prior information with current
information on a quantity of interest. …“
“When good prior information on clinical use of a device exists, the
Bayesian approach may enable FDA to reach the same decision on a
device with a smaller-sized or shorter-duration pivotal trial.”
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Previous INTC Recommendation (11/06)
There is insufficient evidence to determine whether cervical
arthroplasty is a medically appropriate treatment option for singlelevel cervical degenerative disc disease, including disc herniation
and spondylosis.
• The existing evidence is of insufficient quantity and
quality. The published evidence literature is limited to 3 small
RCTs on two difference devices with less than 50 disc-patients
with 24-month follow-up data reported.
KP INTC Discussion 12/07
What’s Different Now?
• FDA approval and recommendation for approval
• Access to new trial data (published & unpublished)
• Additional perspectives on the evidence pending
– Internal, BCBSA TEC, ECRI Target
• Evolving PMG opinion and growing consumer interest
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Thoughts for December Discussion
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Studies suggest comparable adverse events, maintenance of ROM, patient
satisfaction and decreased pain and disability levels.
Risks appear to be small, although number of patients examined is small
Protocols for the controls are not clear and may not represent current
practice.
RCTs have not been blinded and are sponsored by device manufacturer
Significant variability in success rate by centers and many surgeons and
most authors are financially tied to the manufacturers.
In the Prestige IDE trial, only 185 patients had completed outcome
information including FSU. Inclusion of these patients without FSU into the
overall success calculations was not consistent with the planned analysis.
In the Prestige IDE trial, 36 patients in the disc group and 48 in the control
group declined surgery after randomization suggesting informed consent
was not ideal.
In the Prestige IDE trial, the device used is not the device intended for
market. Design modifications are being made in anticipation of FDA
approval.
There are some reports regarding heterotopic ossification.
Marketing to physicians and consumers is increasing along with surgeon
training programs.
The INTC’s previous recommendation regarding artificial lumbar discs may
resurface.
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Cervical Arthroplasty: The Strategy
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Early Review
Iterative Reviews
Stay in touch with PMG practice and consumer interest
Monitor ongoing trials and unpublished data
Track FDA Advisory Panel meetings
Provide Spine Surgeons with evidence
• Assists in early discussion of potential indications
• Supports product discussions
– Information regarding FDA recommendations and approvals,
products in development, differences in design, tracking of
literature and adverse events, etc.
• Informs decision makers regarding potential deployment
considerations including surgeon training and volume
expectations
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Cervical Disc Arthroplasty
In July of 2007, the FDA approved the
Prestige® Cervical Disc System. At the same
time, the FDA's Orthopaedic and
Rehabilitation Devices Panel recommended
approval of Byran® Cervical Disc System.
10/07
TEC draft soon
ECRI Target
expected
Expected
T
B
D
+
7/07
9/07
10/07
11/07
12/07
T
B
D
Immediately upon FDA approval,
Medtronic approaches KP about training
Spine
SST
Meeting
INTC
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What You Need To Make It Work
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Evidence-based culture, or the makings of one
Supportive medical group leadership
Respected source of technology assessments
Effective physician/analyst partnerships
Resources and process that enable timely and relevant
information and recommendations
Courageous physician opinion leaders
Realization that this is the grey-zone and uncertainty is the
norm and decisions have to be made
Willingness to start somewhere and be persistent
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