Gwendolyn Ryals, Look at MeArtwork from The Creative Center

Julia Brown, Vice PresidentGovernment Affairs and Market Access

CADTH SymposiumApril 2015

RWE is the New Black: A Perspective from Industry

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What is Real World Evidence (RWE)?

Generated using data from usual care setting in a range of non-interventional (observational) studies, including:

Primary data collections

Analyses of secondary data

RWE can be generated using so called “pragmatic” randomized trials that are conducted in more usual care settings that employ broad patient inclusion criteria and that investigate effectiveness (rather than efficacy) of different treatments.

A working definition of RWE…

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Growing demand and increasing data availability moving RWE close to tipping point

RWE is growing in importance and relevance at accelerated pace

Growing demand – Focus on value and transparency

Increasing supply – Easier availability of data/analytics

Societal trends (e.g., reform, aging population, emerging middle class) increasing utilization

Markets becoming increasingly demanding as health care systems seek meaningful innovation, value and transparency

Substantial economic / pricing pressure; increased legal, regulatory, and business scrutiny

More data from new data sources, e.g., sensors, self-reported data

Better insights from structured and unstructured data

Governments (e.g., US, UK, Denmark) playing an active role making health data liquid

Engaged patients – more involved in care, sharing and generating data

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RWE is becoming increasingly important

IMS Health

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Stakeholders responding globally

Regulators

▪ Mainly focused on pharmacovigilance

▪ Adaptive licensing concepts and corresponding use of RWE data

Payors

▪ Selected payers use RWE for formulary decisions (US) or cost/quality analyses (GER)

▪ Emerging outcomes based/risk-sharing contracts

Providers/clinicians

▪ Usage of internal RWE datasets for cost/quality monitoring and physician incentives

▪ Creating registries to generate RWE

HTA bodies

▪ Broad variation of use, some systematic (e.g, UK, Italy) others more research focused (e.g., US)

Patients

▪ Interest in real-world evidence mixed with questions on data privacy

▪ Starting to “create” real-world data via forums

Academia

▪ Broad use of RWE as source of insight to medical research

▪ Partnerships with other stakeholders

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But there are significant geographic variations

RWE used for national market access and general reimburse-ment

RWE mainly used for utilization/ safety or formularies (e.g., payer/reg-ional/hos-pital)

Sporadic use Frequent use

▪ Limited RWE use for benefit assessments and reimbursement negotiations – RWE has low weight vs. clinical data

▪ Some payors using cost-benefit assessment (e.g., WellPoint)

▪ Major investments in RWE analytics

Use of RWE by stakeholders in health system

Main

ap

plicati

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of

RW

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ata

France

Germany

ItalyUK

USSpain

RWE data used for conditio-ned reimbursement and ma-naged entry agreements (especially for high cost innovative drugs)

▪ RWE mainly used to identify potential post-marketing safety concerns

Japan

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Going forward, RWE use will increase – albeit at different speeds

RWE used for national market access and general reimburse-ment

RWE mainly used for utilization/ safety or formularies (e.g., payer/reg-ional/hos-pital)

Sporadic use Frequent use

▪ Slower - RWE likely to play a somewhat larger role during drug re-evaluations post launch

▪ Faster - Higher number of payers and providers conducting HTA-type assessments (driven by data availability)

Use of RWE by stakeholders in health system

Main

ap

plicati

on

of

RW

E d

ata

▪ Faster - RWE expected to play significantly larger role during drug evaluations (3-5 yrs post launch)

Faster - RWE likely to be used more frequently at national level for access and during re-evaluations at regional level

▪ Faster - RWE use likely to increase due to increasing data availability

▪ Slower – role of HTA and RWE for market access and reimbur-sement likely to increase slowly

Outlook: At what speed will RWE usage increase?

France

Germany

ItalyUK

USSpain

Japan

▪ Slower - opportunity to increase use of RWE via Public Know-ledge Assessment process

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What do we need to do in Canada to catch up?

From… …To

Mindset ▪ Systematic and proactive; earlier and patient-centric

▪ Ad hoc and reactive; post-launch and product-centric

Capabilities ▪ Broad awareness, collaboration and information sharing

▪ Low awareness, variable capabilities and no framework for incorporation into decision-making

Process ▪ Iterative and strategic use of RCT and RWE

▪ Fragmented and serial lacking cohesive approach

Data/infra-structure ▪ Greater access, coordination ▪ Limited access and

coordination

Partnerships▪ Coordinated and integrated

partnerships▪ One-off collaborations

Funding ▪ Limited funding ▪ Pre-planned and coordinated

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In Summary

Engagement and collaboration from all stakeholders:

– Patients, HTA bodies, payers, healthcare professionals, academia, industry…

Framework for RWE generation and incorporation into HTA reviews, public policy and formulary decision-making

Generation of data that balances commercial and public interests

Appropriate allocation of resources and willingness to risk-share

Prioritization of patient outcomes over short-term cost-containment