Comparative Effectiveness Research in Ontario, Canada

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Comparative Effectiveness Research in Ontario,
Canada

• Sean Tunis MD, MSc
• July 30, 2008

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Study Team

• Danielle Whicher (CMTP)
• Kalipso Chalkidou (CMTP, JHU, NICE)
• Irfan Dhalla (Univ of Toronto, NICE)
• With extensive help from
• Les Levin (Ontario Ministry of Health)
• Ron Goeree (McMaster, PATH)
• Murray Krahn (University of Toronto, THETA)

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Purpose

• Extract lessons from a well-developed
  international example of a health system trying
  to solve problems similar to those driving the
  current comparative effectiveness discussion in
  the US
• Focus evidence-based policy making for non-drug
  health technologies in Ontario, Canada.

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Background

• Single payer healthcare system with primary
  provincial role (Canada Health Act).
• Ontario population 12 million, public health
  spending 40B.
• Healthcare administered by Ministry of Health
  and Long Term Care (MOHLTC)
• Provincial government sets annual health
  budget
• Drug and non-drug technology policy handled
  by separate groups
• Issues driving development of HTA/CER capacity
• Rising costs
• Rapid diffusion of technology
• Demand from hospitals, clinicians, patients

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Technology Review Process
Only used for NON-DRUG health technologies
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OHTAC / MAS Partnership

• MAS prepares systematic review
• Prioritizes requests from MoH, hospitals, etc
• 16 week systematic reviews
• Staff of about 15, plus consultants
• Reports to OHTAC using GRADE guidelines

• OHTAC Policy Recommendation to MOHLTC
• If evidence is insufficient, may request
  Conditionally Funded Field Evaluation (CFFE)

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Conditionally Funded-Field Evaluations

• Conducted by 2 academic centers with core funding
  provided by the MOH
• Appropriate study design is determined by program
  staff in collaboration with experts
• Focus on evidence needs of OHTAC ongoing
  dialogue take place
• All include cost-effectiveness analysis
• Technologies are covered for study participants
  (usually from MoH budget)

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PATH

• Program for the Assessment of Technology in
  Health (PATH)
• 20 staff Directed by Ron Goeree
• 4-5 per field evaluation plus consultants
• Located at McMaster University and St. Josephs
  Healthcare Centre
• Example Comparative Effectiveness of
  Drug-Eluting Stents vs Bare-Metal Stents
• Prospective observational study that used
  existing province-wide registries
• Outcome was revascularization rates within 2
  years of treatment
• Showed benefit of DES only for patients at high
  risk for restenosis
• N-21,000 published in NEJM
• OHTAC recommended that DES only be covered for
  high risk patients
• Impact 20 million annual savings ? Reduced
  thrombosis, mortality

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THETA

• Toronto Health Economics and Technology
  Assessment Collaboration (THETA)
• 28 Investigators and 6 Staff
• Directed by Murray Krahn
• Located at the University of Toronto
• Example Deep Brain Stimulation for Resistant
  Depression
• Randomized Control Trial
• Outcomes are effect on depressive symptoms,
  physical / mental health functioning, work /
  social adjustment
• To be completed in 2011

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Programs for CFFEs Usability Laboratories

• University Health Network Usability Labs
• 15 staff including human factors analysts and
  engineers
• Safety related field evaluations
• Ease of use
• Qualifications necessary to manage the technology
• Risk to hospital staff or patients
• Example Safety Issues related to CT radiation,
  MRI, and smart infusion pumps

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ICES

• Institute for Clinical Evaluative Science
• Receives core funding from Ministry of Health
• Annual budget 14 million (loonies)
• 75 faculty members and 194 staff
• Primarily involved in health services research
• Sets up and links registries and large datasets
  to monitor patterns of use and quality of care
• Provide information to PATH / THETA / MAS for
  initial HTA
• Example Positron Emission Tomography (PET)
  Registries
• Registries are supporting three ongoing trials
  and two studies that have completed patient
  accrual

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CFFE Overview

• 10 completed studies 9 with direct impact on MOH
  decisions
• 24 ongoing studies
• Budget of 8-10 million per year
• Leverages existing data infrastructure, clinical
  staff, research staff
• Conducted by independent academic centers
  ongoing collaboration with policy makers

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Take Home Points

• A case study of well-developed, coherent program
  not comprehensive CER
• Great efficiency possible using existing
  infrastructure, workforce, delivery system
• Recurring challenge of validity vs. feasibility
  in study design
• You can get a lot done with modest resources,
  talented folks and some vision

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Potential for Collaboration

• Drug-eluting coronary stent registry (N21,000)
• Implantable defibrillators (RCT N1000)
• Coronary CT angiography (N1000)
• PET RCTs (lung cancer, breast)
• PET registry (with clinical outcomes)
• Laser therapy for BPH
• Surgery for urinary incontinence
• Negative pressure wound therapy

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Linking Evidence Development and Decision Making

• Ontario has set up independent research function
  with ongoing links to policy makers
• May be critical to keeping evidence development
  coordinated with policy needs
• Need to carefully construct globalize evidence,
  localize decisions framework

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Contact Info

• sean.tunis_at_cmtpnet.org
• www.cmptnet.org
• 410-963-8876