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6 plenary 2 j shin cadth adaptive pathways
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Transcript of 6 plenary 2 j shin cadth adaptive pathways
Gwendolyn Ryals, Look at MeArtwork from The Creative Center
Janey Shin, Director, Real World EvidenceGovernment Affairs and Market Access
CADTH SymposiumApril 2016
Adaptive Pathways: A New Option for Canada? A Perspective from Industry
2
International Landscape: Keeping pace with scientific innovation while addressing health system and societal needs
NEWDIGsFDA (Sentinel, MDEpiNet, UDI)
EMA (MAPP)IMI (ADAPT SMART, GetReal)
Timely access to new medicines and technology for patients
Key opportunity for industry to engage with regulators, HTAs, payers, patients, HCPs
Increasing use of RWE to better understand benefit and risk
MARS EXCITE
3
Leveraging RWE to Support Adaptive Pathways
Sources of Real World Data:
EMRs/EHRs Registries
Observational Studies
Chart Audits PROs
Randomized Pragmatic Studies Administrative
Claims Data
4
Managed Entry Agreements: Managing uncertainty with evidence not just with dollars
Adaptive Pathways provides a mechanism for Access with Evidence schemes (such as, Coverage with Evidence Development and Performance-based Risk Sharing)To build successful schemes we must acknowledge:
Innovative products and related services delivering important and cost-effective outcomes
Different approaches to different kinds of drugs (e.g. oncology, first in class, drugs for rare diseases, biologics)
Generating meaningful data that can inform the healthcare system
Driving appropriate prescribing, utilization and compliance
5
Challenges Assessment of Value Acceptability of evidence outside of RCTs Managing uncertainty
Generating and Accessing RWD/RWE Allocation of resources, cost, and timely
development of registries Ability to link databases; inter-provincial data
sharing Timely access to robust secondary data
(EMRs/EHRs)
Implementation and Resources Innovative Product Listing Agreements Infrastructure and Monitoring of outcomes
How will Adaptive Pathways be successful within the current Canadian context of various legislative frameworks: PMPRB,
Health Canada, HTA, pCPA, formulary decisions by payers?
Opportunities and Benefits Early access for patients to novel
medicines Ability for patients to engage in
adaptive process Engagement and robust discussions with
all stakeholders Building trust: Collaboration with
industry, payers, HTA, regulators, system leaders, health care providers, patients, data custodians
Public/private partnerships Improve understanding of outcomes in
real-world settings Advanced analytics and methodology Increase efficiency of knowledge
generation
Taking and sharing risk
Current regulatory, HTA assessment, reimbursement, and pricing environment needs to align with evolving, innovative science: engagement and flexibility from all stakeholders is critical
Generating evidence that focuses on value for the whole health system
Onus on industry to bring solutions to the table – onus on all to resource and execute those solutions