As more pharmaceutical companies pursue RWE as a core capability in their organization, they have been increasing their investment in integrated evidence platforms.

1. PAGE 56 IMS HEALTH REAL-WORLD EVIDENCE SOLUTIONS
INSIGHTS RWE PLATFORM DEVELOPERS
The authors
Ian Bonzani, PHD, BSC
is Principal,
RWE Solutions,
IMS Health
Ibonzani@imshealth.com
Marla Kessler, MBA
is Vice President,
RWE Solutions,
IMS Health
Mkessler@imshealth.com
Frances Milnes, MBA
is Patient Access Head,
Global Retina Franchise,
Novartis
f.milnes@novartis.com
Building innovative, effective
real-world evidence platforms
As more pharmaceutical companies pursue RWE as a core
capability in their organization, they have been increasing their
investment in integrated evidence platforms. With a unique
and objective market perspective, supported by Novartis client
observations from their VERO platforms in multiple sclerosis
(mS), retina and heart failure, we consider the lessons learned
and the key drivers behind successful implementation.

2. ACCESSPOINT • VOLUME 5 • ISSUE 10 PAGE 57
Four ‘secrets’ to successful implementation
Over the past five years, pharmaceutical
companies have been significantly increasing
their investment in RWE platforms as they
look to make RWE a core capability.
Integrated evidence platforms are systems
that access and identify fit-for-purpose RWD
sources, use IT solutions to host, integrate
and enable access to those sources, and
provide front-end user access and
interrogation tools and service models to
address varied internal and external evidence
needs 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 themes
Companies 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 in
MS had a lot individual observational studies ongoing across a
number of geographies but no ‘tied-up’ RWE strategy driving
them. Thus VERO started by creating a global RWE plan that
targeted the integrated use of a number of accessible claims data
sources in the US to efficiently address immediate evidence needs.
In the background we then, through IMS, worked on expanding the
platform geographically and sourcing deeper and richer clinical
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3. PAGE 58 IMS HEALTH REAL-WORLD EVIDENCE SOLUTIONS
INSIGHTS RWE PLATFORM DEVELOPERS
EMR data through targeted data-sourcing strategies. Based on the
successes shown in this area, the retina franchise was able to
rapidly obtain the buy-in and investment required to expand VERO
to retina.
Through these platforms it was clear that after initial skepticism
about the data, people have bought into it when they see the
power of what it can do. Now in Novartis, RWE is a critical part of
franchise planning processes – every brand strategy must have an
RWE 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 the
creation of the recent global RWE CoE, which can function as an
enterprise capability hub for the franchise spokes. At the
enterprise level it is more about the hosting of the platform,
creating the toolkit, having a process for the integrated product
strategy and a template for what the RWE should look like. It is a
much more centralized process but the power is still with the
franchises because they understand where the differentiation lies.
The hub creates the templates, processes and relationships but the
spokes are important for driving the strategy and ideas.”
Without this focus, companies often end up with a vast
amount of non-specific data in a very powerful box, but
without the use cases, awareness, capabilities or capacity to
turn the data into meaningful insights. It has become
abundantly clear that platform success is not just about
having big volumes of data but rather having the right data
and fit-for-purpose solutions to efficiently and credibly
turn that into insights.
A platform can therefore become a tool of the franchise to
proactively support its evolving RWE strategies – which is
where the value of platforms resides. The role of franchise
teams 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 and
execution stages
Given the level of resource, time and budget investment
in these platforms, it is essential to involve all parties early
on in the scoping, business-case building and internal
buy-in activities. However, strong leadership is essential to
drive momentum.
The strength of evidence platforms lies in their number of
uses and users; this means identifying their potential
applications and the insights they can deliver as early as
possible in the scoping process, which requires a
cross-functional team in the discussion.
In addition, it is also important to determine and define the
respective roles of global HQ and individual countries in
terms of platform users and consumers, and ensure these
are well understood. To maximize impact and ensure quality
and consistency of messaging, this should reflect global
strategy 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.

4. 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.”
Conclusion
The 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.