Real World Data Europe

Apr 28, 2014 - Apr 29, 2014, London, England

Demonstrate the true effectiveness of your drugs to satisfy payers, HTAs and improve patient outcomes

Real World Data: Collaboration is Key to Success

By now everybody appreciates the relevance of real-world data. The challenge that is left is linking snapshots of fragmented information and creating a comprehensive picture of patient journey.

The importance and value of Real World Evidence is beyond question. Increasingly companies are starting to organize themselves around real world data by creating dedicated departments, positions, and platforms, as well as by adopting relevant technologies that let them interact with the real world.

 “Bidirectional flow of information is the nature of our world today, and if you don’t conduct your business this way, your company is going to be extinct in the future. Collaboration is key,” said Nigel Hughes, Global Director Marketing/Health Information Technology Strategy Leader, Janssen Diagnostics BVBA.

Quid pro quo

This is not about a one-off transaction. This is about a sustainable relationship".

”Real world evidence is not about buying data from physicians, but about setting up an exchange. There needs to be a balance between providing a service and receiving data. For example, clinicians might be collecting data, but they don’t have the resources to process it, e.g. statisticians, or they might have it in a format that is not easy to use, and here is where pharma can intervene. “The bottom line is, physicians don’t benefit from the data they’re collecting, if they’re collecting it at all. We offer a framework in which to do that,” Hughes explained, adding that data access must follow regulations from the confidentiality and security point of view. Physicians do see value from such collaboration, and they do appreciate e.g. being linked with other medical centers, which allows them to compare performance. “This is not about a one-off transaction,” Hughes emphasized. “This is about a sustainable relationship.”

While doctors are concerned with the effective use of data, patients are worried about consent. Each country approaches this issue differently, with some places requiring permission for data use, while others don’t. There are even differences between the form of consent called for by each region, whereby select locations expect patients to enter an all-inclusive agreement, while others expect it only on a per-use basis. How the data collected can be used is a subject of a big debate nowadays; unfortunately, there doesn’t seem to be one answer to those challenges. "As we carry on, more restrictions on data might be introduced, which is something many people are concerned about, because it might bring research to a halt", Hughes commented. He speculated that in the future data brokers might take over the role of consent managers. "Perhaps in the future there will be online data management options, which will allow you to consent to the studies you wish to be a part of, and opt out of the research you don’t see a benefit from. The infrastructure isn’t there yet, but it probably isn’t far off.”

Value-based pricing

Reimbursement is increasingly tied to outcomes, and it is becoming even more important to be able to reinforce what has been shown in clinical trials, with real-world evidence. “RWD is becoming a part of the evidence base, where you can see what is effective for specific patient groups,” Hughes explained. Healthcare systems are financially constrained and we need to know what treatments are the most effective for every dollar or euro spent.

Nevertheless, clinical trials remain the gold standard from the regulatory point of view, and it’s quite difficult for RWD to match that standard. Notwithstanding, there is a variety of sources of RWD, and the suitability of each depends on the question you want answered. “From the pharma point of view, it depends on how you want to use the data, and it all has its benefits and its drawbacks, but certainly technology has become a driver enabling access to things that weren’t accessible before. The main issue is to ensure that the data is robust and representative of the population you’re looking at. Trying to establish what the real-world looks like is something you cannot do in a clinical trial.”

Payers increasingly want data from the real world setting because they want to ensure that they get value for money in terms of reimbursement for drugs and devices. Additionally, pharma is making more and more post-marketing commitments whereby they provide a drug to a patient and payers get a refund if the drug is ineffective. “To do this, you need to collect data,” Hughes stated.

Patient journey

The main advantage of RWD for pharma is an opportunity for post-marketing surveillance, in terms of both treatment response, and adverse event reporting, as well as a chance to follow-up on a patient throughout his or her journey. “Increasingly, people are trying to tie up data from electronic health records in an outpatient setting, with payer data from a hospital setting, which allows us to see the entire patient journey rather than snapshots,” Hughes said, elaborating that this is important because the effectiveness of any treatment is often seen in isolation from a person’s life. “With HIV, you can do a viral load; with diabetes, you can check blood sugar level, but unless you are using other tools, you don’t know how adherent they are, what their housing situation is like, their diet, their mental well-being. Most importantly, most diseases we look at now are chronic and they take decades from someone’s life, and we need to find a way to evaluate that over a longer period of time.” According to Hughes, it is important to consider treatments from the patient’s perspective, and for that, data is key. “If we don’t have data on what a patient is experiencing, we can’t do anything,” he concluded.

While the industry is reorganizing itself around RWD, it is crucial to remember that just getting data won’t cut it. Analytics is critical and  stakeholders need to collaborate, whilst sustainable relationships must  be built for RWD to be used successfully.

Nigel Hughes will be speaking at eyeforpharma Real World Data Europe in April. For more information on his presentation, click here. 

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Real World Data Europe

Apr 28, 2014 - Apr 29, 2014, London, England

Demonstrate the true effectiveness of your drugs to satisfy payers, HTAs and improve patient outcomes