PAGE 56 IMS HEALTH REAL-WORLD EVIDENCE SOLUTIONS

INSIGHTS RWE PLATFORM DEVELOPERS

The authors

Ian Bonzani, PHD, BSC is Principal, RWE Solutions, IMS HealthIbonzani@imshealth.com

Marla Kessler, MBA is Vice President,RWE Solutions, IMS HealthMkessler@imshealth.com

Frances Milnes, MBA is Patient Access Head,Global Retina Franchise,Novartisf.milnes@novartis.com

Building innovative, effective real-world evidence platforms

As more pharmaceutical companies pursue RWE as a corecapability in their organization, they have been increasing theirinvestment in integrated evidence platforms. With a uniqueand objective market perspective, supported by Novartis clientobservations from their VERO platforms in multiple sclerosis(mS), retina and heart failure, we consider the lessons learnedand the key drivers behind successful implementation.

ACCESSPOINT • VOLUME 5 • ISSUE 10 PAGE 57

Four ‘secrets’ to successful implementationOver the past five years, pharmaceuticalcompanies have been significantly increasingtheir investment in RWE platforms as theylook to make RWE a core capability.Integrated evidence platforms are systemsthat access and identify fit-for-purpose RWDsources, use IT solutions to host, integrateand enable access to those sources, andprovide front-end user access andinterrogation tools and service models toaddress varied internal and external evidenceneeds across a number of stakeholders.

During this time, IMS Health has had the unique opportunity

to work with more than 10 pharmaceutical organizations to

collaboratively scope, build and run a number of evidence

platforms across a variety of geographies, therapeutic areas

(TAs), data sources and applications. This article reflects that

experience, including assessments made during numerous

benchmarking exercises.

Varied approaches but common themesCompanies have developed enterprise RWE solutions in a

variety of ways once they have made the commitment to

move beyond ad-hoc studies. Some platform builders have

kept them almost exclusively as scientific research

platforms, even separating out commercial functions from

use. Others have developed fully integrated, cross-

functional capabilities. A few have tried to build the

platform across the entire business while others have

looked to support specific therapy area/franchise evidence

needs. Although many platforms have been built as a

reaction to a brand crisis or a slower-moving portfolio

threat, there are clear signs of a market shift to more

systematic and proactive RWE development.

Based on objective observations of these varied approaches,

it is possible to identify common themes in terms of what

makes these platforms successful. This is based on a

quantitative and qualitative blend of their ability to improve

not only internal performance but also engagement efforts

with a variety of external customers (eg, regulators, payers,

providers and patients).

Novartis, with its publicized VERO platform (Value and

Evidence from the Real wOrld, meaning: in truth, to be

sure), is one exciting and very successful example of a

technology-enabled evidence platform. VERO integrates and

allows analytical access to a number of TA-specific and

fit-for-purpose datasets from existing sources (eg, IMS RWD

Claims, IMS RWD LRx) and new sources (eg, clinic EMR) in

MS, retina and, most recently, heart failure. Once

platformed, analytic users can translate that data into

meaningful insights in a fast, reproducible and credible way

to fulfill a range of franchise requests for evidence.

Observations from Novartis are included in this article to

illustrate and contextualize the common themes and enable

others to gain from their experience.

Four key learnings for successful evidence platforms

SECRET #1: It’s all about the therapy area

One of the key pitfalls is to view all RWE as the same,

regardless of application. While it can make sense to look at

RWE at the enterprise level across the entire portfolio – and

many decisions such as IT programs and governance

structures can be consistent across the organization – the

need to match RWD requirements and RWE efforts to the

way the evidence will be used, quickly becomes dependent

on the medical area and competitive dynamics.

Success is achieved when the RWE approach meets the core

evidence needs of a brand or franchise, requiring a TA focus

to ensure that what is to be created will generate immediate

and lasting value. In this way, the type of evidence required

as well as the thresholds become much clearer, revealing

the specific applications needed (eg, commercial insights to

plan brand strategies; value dossiers with unique value

propositions; phase IV trials to prove ongoing value).

A TA approach also enables RWE to rapidly become a core

part of ‘business as usual’ functions and decision making

processes for a key brand or franchise because it solves

their immediate challenges. In order to gain traction, it

must be useful to them. If experience can be leveraged

across franchises, then movement to enterprise solutions

can be exploited. Thus, the TA solution can often empower a

movement to enterprise solutions, as in the case of VERO.

“VERO was built on an understanding that we as a brand team inMS had a lot individual observational studies ongoing across anumber of geographies but no ‘tied-up’ RWE strategy drivingthem. Thus VERO started by creating a global RWE plan thattargeted the integrated use of a number of accessible claims datasources in the US to efficiently address immediate evidence needs.In the background we then, through IMS, worked on expanding theplatform geographically and sourcing deeper and richer clinical

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INSIGHTS RWE PLATFORM DEVELOPERS

EMR data through targeted data-sourcing strategies. Based on thesuccesses shown in this area, the retina franchise was able torapidly obtain the buy-in and investment required to expand VEROto retina.

Through these platforms it was clear that after initial skepticismabout the data, people have bought into it when they see thepower of what it can do. Now in Novartis, RWE is a critical part offranchise planning processes – every brand strategy must have anRWE element and every franchise has to have an RWE strategy –it’s become part of doing business for us.

In Novartis this TA-centric success has created the impetus for thecreation of the recent global RWE CoE, which can function as anenterprise capability hub for the franchise spokes. At theenterprise level it is more about the hosting of the platform,creating the toolkit, having a process for the integrated productstrategy and a template for what the RWE should look like. It is amuch more centralized process but the power is still with thefranchises because they understand where the differentiation lies.The hub creates the templates, processes and relationships but thespokes are important for driving the strategy and ideas.”

Without this focus, companies often end up with a vastamount of non-specific data in a very powerful box, butwithout the use cases, awareness, capabilities or capacity toturn the data into meaningful insights. It has becomeabundantly clear that platform success is not just abouthaving big volumes of data but rather having the right dataand fit-for-purpose solutions to efficiently and crediblyturn that into insights.

A platform can therefore become a tool of the franchise toproactively support its evolving RWE strategies – which iswhere the value of platforms resides. The role of franchiseteams and the value that platforms provide directly align;hence a franchise approach is critical to success.

SECRET #2: There is no ‘I’ in platform success: Cross-team collaboration is critical in both the sell andexecution stages

Given the level of resource, time and budget investment in these platforms, it is essential to involve all parties earlyon in the scoping, business-case building and internal buy-in activities. However, strong leadership is essential todrive momentum.

The strength of evidence platforms lies in their number ofuses and users; this means identifying their potentialapplications and the insights they can deliver as early aspossible in the scoping process, which requires across-functional team in the discussion.

In addition, it is also important to determine and define therespective roles of global HQ and individual countries interms of platform users and consumers, and ensure theseare well understood. To maximize impact and ensure qualityand consistency of messaging, this should reflect globalstrategy and oversight with local execution:

• Global: Responsible for driving the investment case and

support across the franchise; developing the global

RWE strategy; ensuring that the vision and

information/use governance of the platform is

maintained; sharing cross-market insights and

learnings; and building new capabilities.

• Local: Responsible for supporting in-country data

identification, sourcing and evaluation; building

external relationships with customers through

RWE-enabled insight-based engagement and

dissemination; and leading and driving local studies

including analytic execution.

“The importance of local & global team collaboration on RWE needs

and utilization plans has been a key learning on VERO and is

something we have carried through into our new RWE team and

vision at Novartis. One of the early things that caught us off track,

particularly in the internal selling process, was not to include key local

stakeholders from some of the markets in the scoping process. Now,

every activity we do is in collaboration with the countries. The strategy

and overarching questions are led by global but discussed and refined

with local and executed in collaboration with local teams. That is

where the data sits and it is their role to plan for its capture and create

the relationships with payers, clinics and KOLs that drive impact.”

This collaborative approach also helps to overcome another

critical issue associated with RWD/RWE: awareness-

building in terms of uses and insight dissemination across

teams and geographies. Novartis found this through the

joint leadership of HEOR and P&MA and the close

involvement of brand and medical colleagues.

“Another thing that has worked well is best practice sharing –

getting the CPOs to tell us how they would or have used the data,

what they have learned, the objections they have received and

how they were countered.”

Experience shows that when the RWE efforts are ring-fenced

off as a specialized function, efforts fail to gain traction. This

usually results in under-leveraged platforms and an overall

worse ROI in terms of both insight volume and impact.

However, it is equally important that as the users and uses of

the platforms increase this occurs in a governed and

managed way – due to the inherent risks associated with

information flows around and outside of the organization.

SECRET #3: Advertise: Build a platform brand and target

quick wins

Critical to creating RWE use and user ‘stickiness’ is to create

a distinct brand for the platform. It has to be seen as an

asset that is delivering value for the organization. Ascribing

it a brand identity enables manufacturers to discuss it both

internally and externally as a credible and useful asset, as

well as ensuring early awareness and the ability to build a

positive support community across the organization.

ACCESSPOINT • VOLUME 5 • ISSUE 10 PAGE 59

“Branding VERO was our best decision. Before then, the talk had

always been about treatment patterns and one drug versus another.

The branding pulled everything together under one very easily

remembered name. Without it there wouldn’t have been the same

traction or recognition.”

Although not always publicized, IMS Health experience

shows that clients are increasingly using branding as a way

to translate RWE from concept into practice. However,

having a brand name is not the end; targeting the

generation of quick-win insights (either through studies or

ad-hoc pieces of exploratory analyses) is the next critical

piece for gaining traction in a number of areas:

• Justifying the large build-phase investment required for

platform set-up

• Creating strong and immediate first franchise and

organization impression

• Showing skeptics how the conceptual translates into

business value and converting these individuals into new

users and consumers of RWE

These are all ‘reasons to believe’ in the platform.

Success here lies in the ability to leverage foundational and

instantly accessible data sources to address priority

questions of the franchise. In retina, the VERO platform was

able to deliver RWD insights into treatment patterns.

“We knew the misperceptions in the market and needed to

capture very quickly the use of drugs in a real-world clinical

setting to dispel the myths.”

Trying to create or access that single ‘unicorn’ data source

or data-point before producing any insights will inevitably

result in impatience and loss of value. Novartis generated

the first piece of evidence from the platform within the

initial three months of its implementation, without slowing

down background data sourcing priorities, allowing it to

build momentum and an evidence story.

Finding these quick wins requires a core understanding of

the business needs and detailed mapping of these needs to a

data sourcing and access strategy; failure to do so will delay

the insights produced or result in the production of insights

that are not seen as a priority for the franchise – both of

which are unhelpful for platform business.

SECRET #4: The halo effort of knowledge: Elevate

evidence to elevate stakeholder engagement, going

beyond the brand

The value of RWE to the external community is in providing

a view of the world that reflects routine clinical practice and

elevating disease understanding and patient outcomes

beyond the level of a single brand. RWD and an evidence

platform are directly supportive of this but its achievement

relies on setting a vision and strategy that aim to look at

outcomes, insights and customer engagement in a different

way. This can help products at launch by better showing the

needs in the market as well as over time to demonstrate

their value.

Although this challenges pharma to move beyond a brand

focus in the short term, portfolio success is achievable

through the two-way exchange of new and credible

TA-centric insights. For example, in the USA, Integrated

Delivery Networks indicate that they are eager to use more

RWE to improve patient management and outcomes but

lack the skills and resources to achieve it.1 They are open to

working with pharma in those areas but want a non-product

approach since drugs are often only a small driver of

performance when looking at care delivery.

This may require a new way of supporting the brand or

engaging with stakeholders around the evidence generated

but ultimately it can result in owning the disease area from

an insight generation and understanding perspective.

Novartis has been able to leverage its platforms in retina

and heart failure to help stakeholders identify unmet needs

and understand treatment patterns, epidemiological

profiles, geographic differences in treatment and healthcare

use, and how these all translate into real patient outcomes.

“Payers and clinicians have been very responsive to the data

generated from VERO. In the case of retina, we opened a strong

dialogue with physicians by providing them with scientifically

credible and transparent evidence that challenged pre-existing

hypotheses of real-world treatment patterns. This led to a two-

way dialogue where physicians were feeding questions and

hypotheses back to us to be tested or explored further in the

platform. This led to a downstream analysis around ocular events

and further engagement with the clinical and research

community.”

ConclusionThe success of teams and companies to build platforms that

can create a stronger foundation of RWE to benefit the

entire organization, provides helpful guidance for others

looking to achieve their own RWE goals. If the platform is

created flexibly enough to integrate new data as the

organization’s RWE needs grow, it will become an integral

part of the development and market access processes.

However, these experiences show that platform

development has to be purposeful and nurtured with a

vision for its longer-term use, including supporting

stakeholders on issues beyond products.

1 Online survey of 70 payers and IDNs conducted by IMS Health in December 2014.