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How can real world data prove useful at other ends of the value chain?

By Aidan Brain on Feb 11, 2016

eyeforpharma recently spoke to Michael Seewald, VP & Worldwide Head of Real World Evidence at Novartis, about the changing uses of real world evidence in market access, drug discovery and HTA efforts for the pharma industry. Read Michael’s answers to our questions below. 

eyeforpharma: How has pharma’s use of real world evidence, and payer’s perspectives of it, changed in the past 5 years and how do you expect it to change in the next 5? 

Michael Seewald: The importance of Real World Evidence (RWE) has significantly increased during the past 5 years driven by both demand from stakeholders and also supply of data. In the past, customers relied on pharma to bring them information about the performance of the compound. We characterized burden of disease and local standard of care for factual input into economic evaluations as well as for pharmacovigilance efforts. Now, with the abundance of data and the sophistication of health information exchange, payers and providers are building own analytic capabilities and they are beginning to demand more evidence of value extending well beyond the initial reimbursement. Pharma will need to upgrade capabilities to ensure a level playing field. And it needs to deliver to increased expectations in the quantification of value and outcomes.

How much of an asset do you believe real world evidence to be in drug development and discovery? Can it inform early phase activity? 

Already today we are looking at a lot of possibilities of using RWE to supplement and enhance drug discovery and development, i.e. from basic disease epidemiology to identifying populations of greatest unmet need, improving the efficiency of trial design and operations, replacing or supplementing placebo arms with RWE, identifying drug targets etc. For many of those, it may be just a matter of time until enough data is out there, and we can leverage these methods at scale.

How should pharma be using real world evidence at the market access stage?
 
We should recognize RWE as a key opportunity to gain an understanding of the disease and the real-world use and effectiveness of current treatments, including the value that products offer in certain subpopulations. In addition, Real World Data means patient-centric data for most of the data sources. It can enhance our understanding of the patient journey through their disease and of the overall outcomes for patients.

For many pharma companies, one of the key changes in market access is that it must now be maintained and sustained well beyond initial approval. How should the industry adapt? 

In pharma, we will need to get better in proactively planning for evidence generation and making sure that it delivers to the diverse functional needs. We should see it as an opportunity to combine our requirements to fulfil safety reporting requirements with an overall evidence generation approach that delivers to both benefit/risk assessments and also value demonstration efforts in countries. Clearly, this will require a mindset shift that monitoring the value of a product belongs to regular life-cycle activities.

Does RWE have a cross-functional use? Should it and are pharma companies doing this yet? 

The cross-functional approach is key to success. Within pharma, we should see core teams comprising of experts from Real World analytics, HEOR, medical affairs, and safety & epidemiology. Not everybody is approaching it this way, but there is a clear trend driven by a growing number of successful use cases and case studies in several of pharma’s functions.

In your opinion, is HTA in Europe moving towards a common standard? What are the outliers? 

Personally, I’d very much welcome common standards for HTA in Europe. The “rules of the game” should be clear upfront and ideally agreed across national borders. As an industry, we would be more efficient to focus on what matters for patients.

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Michael Seewald will speak more on this topic at this year’s Market Access & Real World Evidence EU Summit.