We have talked before about the importance of outcomes audits as part of an integrated market access strategy. Outcomes audits give biopharma highly detailed insight into how a care pathway for a specific patient population is functioning in the real world, and we believe that along with simulation modeling, health informatics and specialist market access services, outcomes audits are an essential tool for biopharma.

By combining centralized analysis of national data sets with hugely detailed local data, information can inform an action plan that can help identify and bridge gaps in a pathway, discover where stronger messaging needs to reach clinicians, and where adherence could be improved by providing additional patient support.

DiagramWhat makes outcomes audits so powerful is that they are so much more than merely data analysis. One way to carry out an audit is to use software and aim to discover insight through algorithms. This approach can be done anywhere, although it can often mean coldly manipulating data in a remote office. Instead, a first-hand approach is recommended – allowing for a more reliable analysis of real-world data with added context and room for flexibility.

The importance of being in the right place at the right time

Quintiles does have analysts working off-site, but much key work is done by in-the-field nurses working within a specific hospital or other healthcare unit. These nurses are highly qualified, have years of experience working in the NHS, and are now working with Quintiles in that same environment. This hands-on approach is what really sets the outcomes audit apart.

This is because it allows us to see what the clinical pathway looks like in reality and witness first-hand how patients journey through the system. We know that there are often significant variations in the way treatments are deployed through treatment pathways, and that patients and clinicians behave differently across the country.

Rather than simply channeling aggregated data into computer programs after a patient’s episode has finished, the nurses get their insight directly from the clinicians and patients’ records. Gathering data direct from patient notes to see what is being measured, recorded, and observed in real time will reveal subtleties that you simply cannot see from data that is aggregated in an automated fashion. It allows you to draw conclusions and decipher clinic-level information in a way you could never achieve from just looking at cold data sets after the event.

Part of the reason why this is so important is that the most valuable audit is one that analyzes and interprets data in the local context. Because the nurses are onsite, they can speak directly to clinicians – and sometimes even patients – and can go deeper than face value. Is there a reason why the data is throwing up a major anomaly? For example, does it really reflect unique patient behavior never seen outside this geography, or after speaking to clinicians; is it apparent that the variation was actually caused by inconsistent recording processes? Having this observational resource on the ground gives real depth to an audit, and I believe is invaluable if you want to truly understand how clinicians and patients are using a product.

How this fits into a wider market access strategy

So if in-the-field nurses help ensure exceptional quality data and insights from outcomes audits, how do the action plans they produce help maximize patient outcomes? By carrying out audits in a number of different centers in a number of different geographies, you can discover where patient care is being optimized by your drug. But equally, it will highlight were this isn't happening, showing you where a pathway needs to be strengthened or redesigned to bridge gaps that are acting as a barrier to uptake or adherence.

The action plans will also allow biopharma to align the rest of their market access strategy to what's really happening on the ground. It helps them ensure that patient support services they offer – or are planning to offer – will actually address the challenges they are designed to solve.

And of course, if biopharma truly understands where pathways need to be redesigned and where extra 'wrap-around' services are needed, this paves the way for joint-working with the NHS. Working in partnership is both cost effective, and helps built up a relationship of trust between the stakeholders, which is vital for a successful long term market access strategy.


To learn more about outcomes audits, including why this collaboration between biopharma and the NHS is so integral to improving real-world patient outcomes, you can: 

Topics in this blog post: Biopharma, Evidence, Commercialization, EMA, EU, Market Access, NHS