News from the Network (Issue 4): Precision Medicine Policy Network.

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.

Workshop sponsors

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

The Precision Medicine Policy Network is supported and funded by
Genome Canada, Genome Alberta, and Genome Quebec.