robot-assisted surgeries...• shorter length of stay after robot-assisted radical prostatectomy...
TRANSCRIPT
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Robot-Assisted Surgeries A Project for CADTH, a Decision for Jurisdictions
2012 CADTH Symposium Panel Discussion
Dr. Janice Mann
Mr. Michel Boucher Dr. Nina Buscemi
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“We NEED this!”
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What is a Surgical Robot?
The da Vinci® Surgical System
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The da Vinci® Surgical System
• Surgeon Console
• Patient-side cart with 4 arms
• 3D HD vision system
• Miniaturized wristed instruments
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Why Surgical Robotics?
• Less pain
• Less blood loss
• Shorter hospital stay
• Fewer complications
• Excellent cancer control
• Faster return to work
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Why Surgical Robotics?
• Less surgeon fatigue
• Less repetitive strain
• Physician retention
• Physician recruitment
• Resident training
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Why NOT Surgical Robotics?
• Significant costs – capital and operating
• Limited budgets
• Limited evidence
• Cost/benefit uncertain
Item $ (US)
da Vinci Si Surgical System 2,600,000
Start-up reusable equipment and accessories 200,000
Disposables and consumables (per procedure) 2,500
Training of surgeons† (each) 6,000
Training of other personnel Nursing and CPD in-
service at no charge
Annual maintenance (after first year warranty) 175,000
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How to Choose?
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Captain CADTH to the Rescue!
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The Real Captain CADTH?
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The Real CADTH…
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Canadian Agency for Drugs and Technologies in Health (CADTH)
Founded in 1989 by
Canada’s federal, provincial,
and territorial Ministers of
Health
Independent, not-for-profit
Funded by Health Canada,
the provinces, and territories
145 employees, $22.5M
budget
CADTH supports informed
decisions by providing impartial,
evidence-based research and
advice on drugs, medical devices,
and other health technologies.
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CADTH’s Customers and Users
Government policy- and decision-makers
Public drug plan managers
Regional health authorities
Hospitals and other health care facilities
Health professionals
Patients
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CADTH’s Products and Services
CADTH conducts health technology assessments on drugs, non-drug technologies, and procedures
Environmental Scans
Rapid Response Service
Drug Formulary Recommendations
Therapeutic Reviews
Optimal Use Advice, Recommendations, and Tools
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How CADTH Helps
CADTH provides the EVIDENCE piece
to the decision-making puzzle
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Project Background
In 2009/10, robot-assisted surgical programs were progressively developing in Canada due to the availability of the Da-Vinci Surgical
System (Intuitive Surgical Inc.)
↓
Robot-assisted surgery may offer benefits to patients and surgeons, but the costs to acquire, maintain, and operate the system are
significant
↓
Information needed to inform decisions about the acquisition of the technology, its use or expanded use
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Project Background
Need for CADTH work:
One RHA submitted a request for CADTH to undertake an HTA → decision about expanding the RHA robot-assisted surgery pilot project
to include procedures other than prostatectomy
+
Two provinces expressed interest in CADTH undertaking an evaluation of robot-assisted surgery to inform policy development
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Project Background
Alberta Health and Wellness
↓
Develop provincial policy on robot-assisted surgery
↓
CADTH HTA report = source of the technical
information (clinical and economic effectiveness) for
Alberta policy development framework
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Project Background
• CADTH Advisory Committee initially prioritized this topic for HTA work for urology and cardiac procedures
• Through topic refinement activities, and in order to meet CADTH client needs, the HTA project was expanded to include the following indications: gynaecological, urological, renal, and cardiology procedures including but not limited to:
• Hysterectomy
• Prostatectomy
• Nephrectomy (partial nephrectomy)
• Cardiac surgery (atrial septal defect repair, mitral valve repair, CABG)
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Methods
• Clinical assessment:
• Systematic review with meta-analyses to compare the clinical
effectiveness between robot-assisted, open, and laparoscopic
surgeries
• Economic assessment:
• Systematic review of economic studies
• Primary economic evaluation (cost-minimization analysis) to
compare the relative costs of robot-assisted radical prostatectomy
with open and laparoscopic radical prostatectomy
• Budget impact analysis
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Challenges
• No randomized clinical trials → observational studies
(many retrospective) + heterogeneity → lower quality
evidence
• Limited clinical data for cardiac surgery and total
nephrectomy
• Limited Canadian economic evaluations
• Scarcity of data on long-term outcomes (e.g. survival
rates, quality of life, time to return to work) → cost-
minimization analysis
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Key Findings – Clinical
• Shorter length of hospital stay versus:
• Open and laparoscopic prostatectomy
• Open and laparoscopic hysterectomy
• Laparoscopic partial nephrectomy
• Reduced blood loss and transfusion rates versus:
• Open and laparoscopic prostatectomy
• Open hysterectomy
• Reduced positive margin rates (cancer left after surgery)
versus open prostatectomy in patients with stage II
prostate cancer (tumor confined to prostate)
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Key Findings – Clinical
• Reduced post-operative complication rates (e.g. wound
infection, blood clots, …) versus open and laparoscopic
hysterectomy
• Operative time:
• Reduced versus laparoscopic prostatectomy
• Increased versus open prostatectomy and open
hysterectomy
• Cardiac surgery (mitral valve repair):
• Data suggest shorter length of hospital stay
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Key Findings – Economic
• Shorter length of stay after robot-assisted radical
prostatectomy reduced hospitalization costs versus open
and laparoscopic radical prostatectomy
BUT
• High acquisition, operating, and maintenance costs of
the surgical robot system
↓
Higher per patient cost
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Key Findings – Economic
Incremental Costs per patient
Robot-assisted versus
open prostatectomy
Robot-assisted versus
laparoscopic prostatectomy
$3860 $4625
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Key Findings – Budget Impact Analysis
• Estimated net institutional costs for operating a surgical
robotic program using the da Vinci Si Surgical System for
7 years:
↓
$2.9 million
• Institutional costs (over 7 years) of robot-assisted
surgery program vary depending on indications:
• Cardiac surgery: $0.9 million
• Prostatectomy: $3.5 million
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Strategies to Optimize Cost-effective Use
• Maximize caseloads
• Operate the surgical robot for longer periods
• Use the surgical robot for different surgical indications
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Nina Buscemi, PhD
Clinical Advisory and Research Branch,
Alberta Health and Wellness
Alberta Health Technologies
Decision Process:
Policy Development on Surgical
Robotics
CADTH Symposium
April, 2012
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Challenges
• Health system growth
• Range of publicly funded services and benefits
• Cost escalation
• Competing priorities
• Sustainability
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Decision Process
• Explicit bridge between evidence and policy
• Provincial level implications
• 4 principles (transparency, rigor, timeliness and
flexibility)
• Uses STEP analytic framework
– STE analysis conducted by HTA partners
– P analysis conducted by AHW
– EAG advises on review
• 4 stages
STE Analysis
Post Policy
Evaluation Policy Analysis
Selection of
Technologies
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Scope of Decision Process
• Focus on high impact technologies
• Devices and procedures in scope
– Diagnosis, treatment, management
• Health Canada licensed technologies
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Alberta Advisory Committee on Health
Technologies
• Advises on:
– Decision Process
– selection of technologies for review
– findings and recommendations of reviews
• Membership:
– Alberta Health and Wellness (Chair)
– Alberta Health Services (Co-Chair)
– Alberta Medical Association
– College of Physicians and Surgeons of Alberta
– College and Association of Registered Nurses of
Alberta
– Industry (MEDEC)
– HTA partners (IHE, UofA, UofC)
– CADTH (standing guest)
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Provincial Review of Surgical Robotics
• Decision to review surgical robotics for various
indications
– CADTH report to inform policy
• Engaged a clinician and a senior administrator
from Alberta
– Advised on results and implications for policy
development
• Should surgical robotics be established as a
publicly funded health technology in Alberta?
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Key Policy Considerations
• Legislative and regulatory frameworks
• Coverage and diffusion status
• Government’s strategic direction (AHW Business Plan, 2011-2014)
• Quality assurance
• Potential effects of the decision
• Ethical, psychosocial & care considerations
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Legislative and Regulatory Frameworks
Federal Level:
• First-generation da Vinci® Surgical System
licensed as Class 4 medical device in 2001
• Third-generation da Vinci® Si approved in 2010
Provincial Level:
• No obvious legislative impediments → licensed
medical device used in 3 provincial hospitals
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Coverage and Diffusion Status
• Provinces that have surgical robots: Quebec
(4), Ontario (6) and BC (1)
– prostatectomy most frequent procedure
• Purchased through charitable donations
• Physicians bill for standard laparoscopic
procedure – no fee codes for robotic surgery
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Alberta Context
• Edmonton: – Royal Alexandra Hospital
– University of Alberta Hospital
• Calgary: – Rockyview Hospital
• Purchased through charitable donations
• 430 robot-assisted surgeries performed in 2010 (87% prostatectomy)
• AHS prostate cancer guideline lists RARP as treatment option for low risk patients
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Government’s Strategic Direction
• Goal 4 - Excellence in health care:
– Leading introduction, integration and management of
new and existing technologies
– Further implementing HTA processes to support
evidence-informed decision-making
• Robotic surgery - innovative procedure with a
number of potential applications
• Alberta in position to provide leadership
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Quality Assurance
• No training and credentialing standards for
surgeons
• Learning curve depends on procedure and prior
experience
• Must be delivered in tertiary level hospitals with
established QA processes
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Potential Effects of Decision
Impact on Patients: • Decision to establish, expand or terminate
funding would likely have little impact on patients – No difference in patient pool for different approaches
– Clinical and quality of life benefits unclear
– Geographical access issues would remain
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Potential Effects of Decision
Impact on Health System and Providers: • Decision to establish or expand funding would
require additional expenditures for robots
• Decision to establish or expand funding would likely have positive impact on physician stakeholders
• Decision to terminate provision could have negative impact on physicians’ practice patterns, and Alberta risks falling behind other jurisdictions
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Potential Effects of Decision
Impact on Technology Providers: • Decision to establish, expand or terminate
funding would have minimal impact on the manufacturer – As of September 2011, about 2000 units shipped
worldwide
– Currently, only 14 in Canada
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Ethical, Psychosocial and Care
Considerations
• HTA suggests larger centers best suited
• Tertiary care environment required
• Presents geographical access issues
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Policy Options
• Option 1: Maintain the status quo and reassess the
technology when more evidence becomes available
• Option 2: Maintain the status quo with formal data
collection and reassessment in two years
• Option 3: Establish public funding of surgical robotics—
with a commitment to ongoing capital and operating
costs—and incorporate into clinical practice guidelines
• Option 4: Expand public provision—and establish public
funding—of surgical robotics in Alberta
• Option 5: Terminate use of surgical robotics in Alberta
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Next Steps
• Policy options will be discussed with Advisory
Committee
• Review findings and options will be presented to
key stakeholders
• Recommendation will be developed for
Ministry’s senior leadership for decision