NEWS FROM THE NETWORK: ISSUE 4 (2017)
Newsletter Feature
THEME 4: IP and Commercialization
Theme lead: Dr Tania Bubela
On June 27th to 29th, the Network's Theme 4, in partnership with PACEOMICS, held an international workshop in the beautiful Canadian Rockies:
Risk-sharing Models to Advance Payer Paradigms for Precision Medicines. Participants - Thirty-seven experts from Canada, the United Kingdom, Australia, Japan and the United States
- Representation from regulatory agencies, reimbursement agencies, the insurance industry, health system data analytics, the biotechnology sector, investors, clinicians, research
institutions, and patient organizations.
WORKSHOP FOCUS - Key challenges for payers and developers in evaluating, funding and managing market access to Precision Health Technologies and Interventions
- Models to best align adaptive licensing frameworks for regulation and reimbursement
TOPICS - Price based solutions, such as price discounts or volume price agreements
- Research based solutions, such as only-in-research and only-with-research schemes
- The use of routine data infrastructure solutions, such as post-market surveillance infrastructure
Sessions began with a ‘Scene setting’ presentation, and were followed by comments from a multi-stakeholder expert panel. Participants explored a range of issues, including: - Risk management for developers and health systems;
- Models for managing uncertainty, investment and reimbursement;
- Funding of precision technologies and interventions within the context of high R&D investment, limited payer capacity, and pressures towards regulatory approval with decreased evidence;
- Research design challenges, including rigor and ‘real-world’ research;
- Need for Lifecycle HTA, with multiple decision and evaluation points;
- Conditional licensing, post-market surveillance & data collection following regulatory approval, and potential 'off-ramps' for approved precision technologies and interventions;
- Capacity for studying delivery of health care; and
- Differing perspectives among stakeholders
Workshop outputs and publication will be announced
here.
Theme 4, Workshop II: Data Access/Data Integration
Date: Oct 25th and 26th, 2017 Using case examples from Canadian Provinces, the goal of this workshop is to discuss best practices and pose solutions to the following questions: Are data access issues, especially with respect to data integration across multiple databases within Provinces, the result of legislative, policy, or practice (e.g., risk-benefit calculus) barriers; How can we improve the architecture of databases to inform Precision Health initiatives and Life-Cycle Health Technology Assessment; Can current data infrastructures support Precision Health initiatives and Life-Cycle Health Technology Assessment; and What are the impediments to inter-provincial data sharing?.
WHO SHOULD ATTEND - Investigators with the Genomics and Personalized Health (GAPH) projects
- Those working in the ‘omics field
- Key stakeholders
If you are interested in attending, please contact PrecisionMedPolicyNet@gmail.com for more information.
UPCOMING NETWORK ACTIVITIES August 19, 2017: SEMINAR
Precision medicine and preventing overdiagnosis: concordance or paradox?
Conference: Preventing Overdiagnosis (Aug 16-19), Quebec City, QC
Theme 3: KT and Implementation October 12 and 13, 2017: WORKSHOP
Incorporating uncertainty into economic evaluations of
Precision Medicine technologies
Theme 2: Health economics and HTA October 25 and 26, 2017: WORKSHOP
Data Access / Data Integration
Theme 4: IP & Commercialization Fall 2017 (TBA): WORKSHOP
Stakeholder engagement in KT and implementation science for personalized health
Theme 3: KT & Implementation February 2017 (TBA): Workshop
Topic: Value of Information
Theme 3: KT & Implementation
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