Real World Evidence EU Summit

Apr 25, 2017 - Apr 26, 2017, Amsterdam

Europe's Flagship Data Summit for Pharma

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Numerous barriers impede the full realization of benefit from Real World Evidence



RWE and patient outcomes are becoming a powerful currency for engagement and demonstrating product value. However, numerous barriers impede the full realization of benefit from RWE. What are the key challenges around data access and governance and what capabilities will be required to deliver on the potential of RWE?

Cost pressures and the need to demonstrate that drugs add promised value is higher than ever. According to Hanno Ronte, Partner, Deloitte the biggest discussion at the moment around RWE and data for commercial access centers around indication-based pricing and a critical barrier to assessing a drug’s value in terms of exactly who benefits, under what circumstances, and how much it is worth is access to large-population-based data. “To enable that to work on the ground, you need to know how many patients are on each indication. The next level is to say whether you actually deliver an outcome that is true to the clinical trial that you’re referencing, whether better or worse. For example, for oncology drugs you need key data around survival and this is where the difficulty arises. A lot of databases only track the patient up to a certain point and after that you’re not clear on what has happened – have they left the system?  This data is not all in the same system and this has to happen at a country level because that’s where the payer is and pharma has to work with the payer to agree what the data set is”.

Perfection the enemy of the good

We need access to comprehensive and granular information on treatments and outcome information in large populations, with a focus on outcomes that are meaningful to clinicians and patients and which can guide effective treatment. A confounder is the need for country-specific data. “Our experience is that a key challenge is that you end up in a world where the country data systems aren’t strong enough to deliver that data and there’s a sense that people want perfection especially coming from the mentality of medical affairs, R&D and clinical where the randomized control trial is the standard. And perfection is the enemy of the good here and people often underestimate the richness and value that RWE has, that is already available within the data and you may not need to do a whole lot with it”, says Ronte.

We need a wider societal debate on the benefits/risk of sharing personal data (under the right conditions), potentially via trusted third parties.

Thy Do, Head of Data Generation, Onology & IBD, Takeda also attests to the challenge of accessing country-specific data. “A lot of countries prefer their own data sets and it often comes down to understanding why countries are insisting on country-specific data and assessing the feasibility of their use of another country’s data. Germany for example is well ahead of the curve when it comes to accessing local data systems for local data needs. Accessing local data (German) for non-local data needs (ex-Germany) is an issue though.”

Too often we are constrained, though understandably, by regulations, processes, policies and procedures that impede use of RWD/RWE. “How do you create the right governance and infrastructure to respect patients privacy around medical data and use the data around medical records in an ethical and appropriate way and the question is, who does the analysis, what data do different parts of the healthcare system see – it’s often the case that different parts of the healthcare system don’t want to share information with each other because they use it as competitive data, not to mention sharing it with pharma. So getting the data infrastructure right and the governance around that data then becomes a shared responsibility”, says Ronte.

Better collaboration

In terms of collaboration and data sharing, Ronte is optimistic and is already seeing pockets of progress. “In places like the UK, we have tried to push for better collaboration and we’ve created data platforms that allow other people to syndicate into it. It hasn’t happened really yet but I think it will come. I think the key issue is that the healthcare system is the owner of the data; they need to find a way that makes that data accessible that is acceptable to the patient and that has been a critical bottleneck. The industry can’t replicate an EMR system – it’s simply not feasible. The industry will need to find a way of accessing that information on a collective basis”.

Collaboration is key according to Nigel Hughes, Scientific Director at Janssen. “There’s a lot we can do in terms of a quid pro quo or services in exchange for data access. For example, some of the third-party data custodians such as a GP network that owns the data and is looking to carry out their own research; in this instance, we can look to providing services such as further analytics and data science support and utilizing our resources so they can better analyze the data. In general, we need a wider societal debate on the benefits/risk of sharing personal data (under the right conditions), potentially via trusted third parties”.

Initiatives such as the IMI Get Real consortium consisting of pharmaceutical companies, academia, HTA agencies and regulators (e.g., NICE, HAS, EMA and ZIN), patient organizations and SMEs have been key contributors to improving access. “The IMI initiative which concluded in 2016 is an example of what can be achieved in a short frame of time on a collective basis and is a superb example of partnering in this pre-competitive space to remove barriers to access. There’s a lot that can be done collaboratively but at all times we must be open, honest and transparent in terms of intended use”.

Translation, technology, analytics

The capabilities required to realize the full potential of RWE are very different to existing capabilities within pharma. “There’s a dearth of people who really understand data, people who have good statistical and technology backgrounds who can relate to the market access challenges and the business problem that the pharma company and healthcare system are trying to solve. It becomes a  question of ‘Can this person understand and track data and the data governance arrangements around that data and manage this in a compliant way, on a consistent basis, with the same security protocols and standards required elsewhere?’. We need people that go beyond the biostatistician that analyzes RTC trials to ask good questions, that have the capability to visualize data in a very different way and make that accessible depending on the hypothesis that’s being discussed”, Ronte concludes.



Real World Evidence EU Summit

Apr 25, 2017 - Apr 26, 2017, Amsterdam

Europe's Flagship Data Summit for Pharma