Conference overview: Real world data Europe 2014

Jacky Law provides an overview of the recent event 'Real world data Europe 2014' and shares why she thinks that real-world data needs real-world perspective.

Payers, regulators and pharma representatives attending eyeforpharma's recent Real World Data Europe conference in London may have had very different perspectives about how data from the real world can be used in healthcare decision-making. But they were all on the same steep learning curve. Their common struggles centre on, among other things, the quality of the data, the lack of linkage between datasets, the tools and methodologies to make sense of them, data privacy issues and the place of observational research in evidence hierarchies.

Pharma companies have further organisational and educational challenges in terms of efficiently accessing real-world data, making sure they get to everyone who needs them and building bridges between the R&D and commercial sides of the company so they can be used to build the kind of evidence that is now required by payers and regulators.

And as fast as initiatives are taken to create the infrastructures to work effectively with RWD so new challenges emerge. Attendees heard from Richard Barker, director of the regulatory consultancy, CASMI, about the new mindset emerging from European regulators to introduce adaptive licensing, a step-wise collaborative approach involving many more stakeholders and the promise of earlier access to new medicines. "We now have a more flexible blueprint involving exploratory and confirmatory trials," he said adding that the inclusion of HTA agencies, payers, regulators and patients to customise the exploratory trials should increase the efficiency of the process. "If the findings are justified via pharmacovigilance and pharmacoeconomics data, licensing continues." In keeping with the heterogeneous nature of Europe, not all countries agree. Meriem Bouslouk, a desk officer at Germany's HTA body, the GBA, confirmed her employer's doubts about the quality of evidence implicit in the adaptive approach.

It is not only the thinking on evidence that separates Europe's markets. Detlev Parow, head of the Department of Care Management Development at Germany's third largest insurer, DAK Gesundheit, spoke about how strict data privacy laws seriously inhibit their claims data being used except internally and, like many other speakers, about the difficulties of making sense of what is available. To overcome some of these difficulties, he mentioned how a national registry tracking medical data on a cohort of 200,000 people for 20 years had been started this year.

In the more cash-strapped countries of southern Europe, the thinking was more punitive. In Italy, Thomas Schael, CEO and commissioner of the health authority in Naples, spoke of huge disparities between hospitals in the use of premium-priced medicines and how the Italian pricing and reimbursement authority (AIFA) may increase its use of registries in facilitating managed entry agreements to ensure the money spent on expensive drugs can be justified. Under these patients must be entered into a registry for reimbursement and if they don't improve, reimbursement is stopped or curtailed.

In Spain, Antonio Sarria-Santamera, director of the Spanish national HTA body, AETS, mentioned how one of the 17 autonomous regions, Catalonia, will be requiring all new drugs to enter into risk-sharing agreements from 2015 and how more registries are being compiled to help know what happens in the real world.

In the UK, a few speakers focussed on the complexities of local decision-making and the challenges presented to pharma companies in meeting their requirements. Omar Ali, formulary development pharmacist at Surrey & Sussex Healthcare NHS Trust, said he had recently been presented with data showing non-inferiority between a £2 pill for Parkinson's disease and a £60 patch on the grounds that patients shake and can't easily take pills. He wondered how they were any better at putting on the more expensive patch and said he would rather risk wasting money on the pills. "This is an example of a non-inferiority study but not a non-inferiority price".

Conference attendees were also given a glimpse of what the leading pharma players in this space are doing with RWD. James Harnett, senior director of RWD and Analytics at Pfizer, gave an impressive talk outlining partnerships with health insurer Humana, which gives access to the anonymised data on around 30 million patients, and with analytics company, Humedica, which helps make sense of the data via, among other things, cutting-edge technologies such as natural language processing. The company has systems to distribute data internally and to take queries from across the organisation as well as a number of tools to create data reports, facilitate rapid cycle learning, integrate data and evaluate the software being used in other industries such as financial services. For all these capabilities, Harnett said the greatest returns of investment come from early research to ensure further trials can be conducted more efficiently by better patient profiling, discovery of new mechanisms of actions and knowing what questions to ask.

At the other end of the spectrum Simon Hammett, CEO of Monitor Deloitte Europe, said there were companies that, with so much still to do on solidifying RWD infrastructures in healthcare systems, had taken a conscious decision to 'wait and see'. For these companies in particular, it may have been with some relief to learn that any discussion on RWD should be framed in a much longer perspective. "We are substantially underestimating the impact of RWD on whole health economies," said Hammett. "We hide behind products and how they are assessed but there is a huge amount still to learn about patient care and that is where most money is spent. The technology platforms are there but we should be thinking in a 20-30 year time frame."

About the author:

Jacky has been writing about pharmaceuticals since joining Scrip Magazine in 1998, before becoming a regular columnist for Pharmaceutical Executive. From 2010 to 2013 she wrote industry reports for FirstWord.

At pharmaphorum Jacky is leading on the production of unique and insightful research reports covering the key issues impacting the global pharmaceutical industry.

You can follow her on Twitter here.

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