Real World Data Capabilities: Benchmarking Pharma Companies

Is Real World Data giving your market access the power charge it needs?

Real World Data (RWD) and Real World Evidence (RWE) are gaining traction across the industry. The front runners are already exploring new ways to collect and use data within their market access strategies and, for some, this is proving an effective way to ‘tip the balance’ from a no to a yes with target agencies. How well is pharma leveraging the data advantage? And how should companies benchmark their own RWD activities against the best of the rest?

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Report Overview

Seven senior pharmaceutical company decision-makers currently working in Real World Data and Real World Evidence were all interviewed in depth. RWD Benchmarking Capabilities details their perspectives on the use of RWD and RWE for market access now and in the future, including opinions on who is leading the field and why.

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Executive Summary

Defining Real World Data and Real World Evidence

Real World Data (RWD) are data used for decision making that are not collected in conventional randomised controlled trials (RCTs). Real World Evidence (RWE) is the evidence generated from RWD. A linked concept is ‘Big Data,’ which is generated from combing multiple sources of RWD. At the heart of RWD and RWE is patient-centricity.

RWD can be clinical, economic and humanistic and come from diverse sources; from patient records to social media and nearly everything in between. However, this proliferation of data also poses challenges for methods and analysis. Further, companies need to keep tabs on RWD and RWE in their fields as, even if they are not generating this data, others might release findings that necessitate a company response.

Real World Data and Real World Evidence for Market Access

Interest in RWD and RWE is increasing, with various stakeholders – including companies, regulators, Health Technology Assessment (HTA) agencies, payers, providers and patients – leveraging the information to inform their decisions. This data is proving particularly relevant to some HTA agencies and payers as they focus on therapies that provide value for money.

RWD and RWE are increasingly being seen as an enabler for market access, with case studies emerging on how RWD and RWE can ‘tip the balance’ from a no to a yes with HTA agencies, including the Scottish Medicines Consortium (SMC), the National Institute for Health and Care Excellence (NICE) and the French Authority for Health (HAS). However, RWD and RWE may need to be coupled with changes in price to secure those positive recommendations. Acceptance of RWD and RWE across agencies is not universal and challenges to using RWD and RWE with payers need to be overcome to increase their influence.

For the companies themselves, meanwhile, RWD and RWE are core to outcomes-based contracts, which currently remain limited, but are expected to grow in the future. Further, RWD and RWE are helpful beyond initial market access and can be used to inform development plans and future business decisions. RWD and RWE can also help differentiate products from those of competitors.

Companies leading on Real World Data and benchmarking

The pharmaceutical industry as a whole recognises the importance of RWD and RWE, although there is significant diversity in terms of company approach. Pfizer is particularly busy – running one of the highest number of real world studies as a sole sponsor, based on analysis of data from ClinicalTrials.gov. Other big pharma companies are also gaining significant ground. For example, Astellas won the first inaugral UK Prix Galien award for RWE in 2016 based on their work on Dificlir (fidaxomin) for clostridium dificile infection in the English National Health Service (NHS). GlaxoSmithKline has been breaking new ground with the first pragmatic Phase III real world trial: the Salford Lung Study (SLS). The pay-off for this multi-million pound study in terms of market access aren’t yet known.

Those companies who are seen as leaders in RWD and RWE share several common features, including:

Centralising RWD and RWE in the organisation, whilst at the same time striving to integrate this information across the business and work cross-functionally
Implementing RWD and RWE early in the clinical development process
Investing in the infrastructure for RWD and RWE
Gathering data from a diverse set of data sources and performing varied analysis to address the unique needs of various stakeholders
Collaborating with others so as to provide access to RWD and expertise, as well as to add credibility to a company’s own RWE

Real World Data and collaboration

Companies need to collaborate with a variety of stakeholders to optimise RWD and RWE. Doing so will not only increase the insights from RWD and RWE, but also increase the acceptance and credibility of RWD and RWE by external stakeholders. Companies have a wide choice of collaborators, including Patient Powered Research Networks (PPRNs), providing a way to work with patients and access patient data.

The future for Real World Data and Real World Evidence

RWD and RWE are going to grow in importance, reflecting the increase in volume of data available, improvements in its quality and the ability to link disparate data sources. RWD and RWE will be in greater demand too, because of the trend for coverage and reimbursement decisions to be based on this information, as well as being used in outcomes-based contracts that are expected to increase in the future. Further, the types of data captured and the methods in which outcomes can be generated are also expected to evolve, with patient reported outcomes (PROs) expected to grow in importance. Beyond the pharmaceutical industry, a number of other stakeholders are expected to shape the future of RWD and RWE, with technology companies expected to emerge as a key influencer given their efforts to seek a greater presence in healthcare.

©Doctor’s Guide Publishing Limited. This executive summary is provided for commercial evaluation purposes only. It can be shared with colleagues for this purpose but cannot be reproduced, extracted or published without the express permission of the publisher.

Report Features

Overview of the definitions and types of Real World Data, who is generating it, how it is being used successfully and the challenges being overcome.
How Real World Data and Real World Evidence can improve performance within patient-centric strategies and outcomes-based contracts.
The key issues regarding the effective use of Real World Data for market access including core requirements and limitations.
Assessment of market activity including company profiles of the current Real World Data ‘movers and shakers’ as well as case studies and who to watch.
New ideas on how to benchmark Real World Data activities, effective planning and analysis, and future trends to prepare for.

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Key Benefits

Assess how your current data strategy stacks up: How do your Real World Data activities compare to other pharmaceutical companies? What do the data leaders have in common? How can you benchmark your market access data strategy?
Understand more about the opportunities and threats: Just how important is social media? Which data sources are others already mining? What concerns exist regarding data quality, cost, and patient protection?
Invigorate your strategy with new ideas and approaches: Avoid being overwhelmed by the enormity of the data task and gain greater clarity on the specific strategies and actions that have the most impact.
Shape your long-term plans and data investments: Gain the insight and evidence needed to build a business plan to evolve and enhance your Real World Data strategy.

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Why is Real World Data such a pressing issue today?

At the heart of the Real World Data revolution is the issue of control. Pharma companies used to be in the driving seat when it came to the data produced from trials and studies of their drugs. But now the floodgates have opened and everyone from payers to patients to your competitors can all see and comment on real world drug performance. And they are, in droves. This new data-rich environment presents significant opportunities but also threats. The key to success is finding a strategy that is sustainable, meets commercial objectives, and produces insight that is ultimately trusted enough to influence opinion.

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Key Questions Answered By This Report

Can RWD and RWE deliver results as stand-alone strategies or should they be coupled with price changes too?
What practical steps can be taken to increase acceptance of RWD and RWE amongst HTA agencies and payers?
How intrinsically linked is RWD and patient-centricity? Can it also be used to deliver against other core pharma business goals and if so, which ones?
With seemingly limitless data sources available, what can be done to ensure disparate data are linked and subsequent analysis is robust, relevant and result-oriented?
How will Real World Data evolve? Is collaboration the latest fad or should pharma be actively seeking new relationships? Which companies are the ones to watch?

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Expert Views

Each of our experts have detailed understanding of RWD and RWE and how it is being used currently. To enable them to express candid views, our experts have chosen to remain anonymous.

A Vice President with expertise in HEOR at a top 10 global pharmaceutical company.
A global market access and health economics executive previously employed at a top 30 global pharmaceutical company.
A Real Life Evidence Manager at a top 20 global pharmaceutical company.
A Vice President and Worldwide Head of Real World Evidence at a top 10 global pharmaceutical company.
A Senior Director for Health Economics and Outcomes Research (HEOR) and Real World Evidence at a top 20 global pharmaceutical company.
A Senior Director at a top 20 global pharmaceutical company.
An Associate Director working for Global Health Economics and Outcomes Research (HEOR) at a top 10 global pharmaceutical company.

3 Key Quotes

“This is really a paradigm shift. In the past, global pharmaceutical companies could define which data is generated in global trials and then follow up post-market. We had a lot of control over which kinds of studies are running and what kind of data is being generated. In the new world, using real world data, this is changing. The majority of the data is not produced by pharma companies, it’s from healthcare systems, patients using devices, patients discussing products on social media, payers collecting data to process their transactions. This is the new world.”

“Secondary data sources like registries, claims databases, social media, apps and devices and electronic medical records are the data sources I would consider exciting and providing new opportunities.”

“The patient journey is the one of the most interesting areas for RWD. [It] will allow us to be even more specific to what patients need in the future…for me, this is one of the most exciting areas.”

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Who Would Benefit from This Report?

Market access teams looking for new ways to boost the effectiveness of their RWD activity
Patient liaison specialists investigating new sources of data and patient interaction methods
Senior management planning for ongoing RWD investment, technology and resources
Health economics and outcomes research (HEOR) professionals looking for new ways to boost coverage strategies
Brand marketers concerned about competitor activity and the impact of data on market dynamics
Payer liaison departments under increasing pressure to produce Real World Evidence

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Content Highlights

Executive summary
Research objectives and methodology
Defining Real World Data and Real World Evidence

Key findings
Defining Real World Data
Types of Real World Data
Patient-centricity
Diversity in Real World Data
Growth in Real World Data availability
Enablers for Real World Data
Challenges for Real World Data
Real World Data and Real World Evidence being generated by those outside of industry

Real World Data and Real World Evidence for Market Access

Key findings
Intensifying interest in Real World Data and Real World Evidence
Desire for Real World Value
Real World Data can help overcome limitations in the evidence base
Real World Data as the ’new normal’ for bringing a new product to market
Real World Data and Real World Evidence are core requirements for outcomes-based contracts
Real World Data and Real World Evidence is useful across the business
Real World Data and Real World Evidence is relevant for all external stakeholders

Companies that are leading on Real World Data

Key findings
Variability across companies
The companies doing the most real world studies
2016 winner of the first Prix Galien Award for Real World Evidence

Company profiles on Real World Data and Real World Evidence

Key findings
The companies with the most real world studies

Pfizer
AstraZeneca
Bristol-Myers Squibb
GlaxoSmithKline
Bayer
Hoffman-La Roche

Other companies to watch

Amgen
Astellas
Merck
Novartis
Novo Nordisk
Sanofi
Shire/Baxalta

Commonalities across companies

What can companies benchmark themselves on?

Key findings
Insights from within companies

Planning: start early taking into account context
Data and analysis: no single approach dominates
Capability: More to do
Plans for the future: Increasing investment in Real World Data and Real World Evidence

Benchmarking

Real World Data and collaboration

Key findings
The need to work together

The future for RWD

Key findings
Real World Data and Real World Evidence will only get more important in the future
Industry won’t be the only influencers of Real World Data and Real World Evidence
Real World Data and Real World Evidence will become increasingly patient-centric
Real World Data and Real World Evidence will underpin greater use of outcomes—based contracting

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