New Diagnostics Guiding Oncology Treatment Decisions
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1 Health System, Economic and Policy Perspectives March 9, 2017 New Diagnostics Guiding Oncology Treatment Decisions
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Transcript of New Diagnostics Guiding Oncology Treatment Decisions
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Health System, Economic and Policy Perspectives March 9, 2017
New Diagnostics Guiding Oncology Treatment Decisions
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What we will discuss
1. How diagnostics and precision medicines are transforming cancer care pathways for patients
2. Policy and health system initiatives related to new diagnostics and precision cancer treatments
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Speakers today
Dr. Tracy Stockley PhD, FCCMG, FACMG
Associate Professor, University Health NetworkDirector – Molecular Diagnostics, University Health Network
Rachael Manion B.Sc. (Hon.), J.D.
Senior Associate and Director of Research, 3Sixty Public Affairs
Bill Dempster B.A., LL.B., M.A.
CEO, 3Sixty Public Affairs
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1. HOW DIAGNOSTICS AND PRECISION MEDICINES ARE TRANSFORMING CANCER
CARE PATHWAYS FOR PATIENTS
Precision Medicine: Bench to Bedside for Cancer Care
Tracy Stockley, PhD, FCCMG, FACMGAssociate Director, Genome Diagnositcs, University Health Network
Associate Professor, University of TorontoToronto, Canada
Understanding Precision Medicine in Cancer Treatment
• The promise of Precision Medicine: treatment tailored to each patient based on genes or biomarkers
• Precision medicine as a treatment option
• Precision medicine clinical trials and research moving forward
Understanding Precision Medicine in Cancer Treatment
• Precision Medicine = Approach to patient care where treatment is selected based on a molecular understanding of each patient’s disease
• ‘molecular’ = genes, proteins, biomarkers
• Precision medicine can be an additional option for people with cancer, and may be used in combination with other types of treatment such as chemotherapy and radiation
The Promise of Precision Medicine
diagnosemydisease.com
The Promise of Precision Medicine
Targeted therapy: treatment chosen by test result
www.scienceofcrc.org/treat/
Targeted Cancer Therapies and Companion Diagnostics
Targeted Therapy (drug)
Companion Diagnostic for
biomarker (test)Precision Medicine = +
Basic ResearchPrototype
design/ discovery
PreclinicalPhase I, Phase
II, Phase IIIClinical Trials
Regulatory approval,
funding, launch
Drug Development
Target Selection and Validation
Identification of biomarkers
Analytical Validation
Clinical Validation and
Utility
Regulatory approval,
funding, launch
Companion Diagnostic Development
Targeted Therapies: Examples
From: Pharmaceuticals requiring companion diagnostics: CADTH; 2014 [partially updated 2016]. (Environmental scan; Issue 57).
Treatment
Companion diagnostic test for specific biomarker
Rapid Growth of Drugs with Companion Diagnostics
Jørgensen, Hersom.Ann Transl Med. 2016 Dec; 4(24): 482.
Companion Diagnostic Test Overview
Companion Diagnostic Tests for Patient Care in Canada
• Tests that are returned to patients for their care must be performed in a licensed and accredited (inspected) clinical laboratory
• Each province has licensing and lab accreditation system
Future of Precision MedicineLimitations and Solutions
Arnedos et al Nature Reviews Clinical Oncology 12, 693–704 (2015)
New sample types for testing and improved companion diagnostic tests
Increase the number of targeted therapies through clinical trials
Precision Medicine Clinical Trials and research moving forward
Building Blocks for Precision Medicine
• To maximize the potential of precision medicine requires:– Funding for drug
development and companion diagnostic test development
– Patient participation in precision medicine trials
– Support for regulatory and policy changes required
– Appropriate approval and funding for clinical use
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2. POLICY AND HEALTH SYSTEM INITIATIVES RELATED TO NEW DIAGNOSTICS AND PRECISION CANCER
TREATMENTS
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National Precision Medicine Strategy
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Provincial Precision Medicine Strategies
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Provincial Precision Medicine Strategies
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In Canada, biomarker tests follow a varied and complex path to health system adoption and patient access
Regulatory Authorization
Health Technology Assessment
Funding Decisions
Health System
Adoption / Patient Access
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Who pays for diagnostics services24
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Health Technology Assessment Performs Clinical and Cost Effectiveness Reviews• All provinces and the federal government participate
in Common Drug Review and the pan-Canadian Oncology Drug Review, except Quebec, which has its own agency (INESSS)
• Hospital pharmacy and therapeutics committees• Provincial committees (e.g., Ontario Health
Technology Assessment Committee)• Private payers also have HTA
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HTA Expert Committees• Appointed experts who review the clinical and economic evidence and
patient input• They are responsible for developing funding recommendations which are
passed on to participating plans
• A typical expert committee is comprised of… – Pharmacologists / Pharmaco-epidemiologists– Physicians– Pharmacists– Health economists– Sometimes public/lay voice or patients
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CADTH’s Proposed Process to Evaluate Companion Diagnostics
• Would be parallel to or part of drug review programs– Stakeholder feedback: 2016– Planned implementation: 2017
Clinical evidenceSubmitter• Analytic validity,
clinical validity, clinical utility
CADTH• Review evidence
submitted • Conduct Rapid
Response
Economic evidenceSubmitter• Cost-effectiveness
analysis • Budget impact
analysisCADTH • Review submitted
evidence
Patients & other inputPatients• Experience &
expectationsClinicians• Experts in pathology &
lab testingParticipating jurisdictions • Implementation issues
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Other initiatives that are coming into play…
• pan-Canadian Pharmaceutical Alliance• Canadian Association of Provincial Cancer
Agencies: Cancer Drug Funding Sustainability Initiative
• Precision Medicine Initiatives (e.g., CIHR and Personalized Medicine Working Groups)
• Genetic non-Discrimination Act
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Thank you!
William (Bill) [email protected] (direct)613.614.0283 (mobile)
Rachael [email protected]
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Canadian Cancer Survivor Network Contact Info
Canadian Cancer Survivor Network1750 Courtwood Crescent, Suite 210Ottawa, ON K2C 2B5Telephone / Téléphone : 613-898-1871
E-mail: [email protected] or [email protected]
Web site: www.survivornet.ca
Blog: http://jackiemanthornescancerblog.blogspot.com/Twitter: @survivornetca
Facebook: www.facebook.com/CanadianSurvivorNet
Pinterest: http://pinterest.com/survivornetwork/
