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

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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

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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

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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

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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