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There was a time not so long ago when it seemed like the world of biopharma was a little less complex. On the surface, the goal was to increase prescription rates and adherence to medicines, which would lead to better patient outcomes. This would in turn support ongoing availability and reimbursement of a drug. 

But what has changed is the demand by stakeholders for robust evidence of how efforts by biopharmaceutical companies can impact and support the achievement of those outcomes in the real world. Biopharma companies need to provide decision-makers with complete confidence that their product will have the expected impact on stratified patient populations. The answer to this question lies in real-world data, and one of the most effective ways of securing this data is through an outcomes audit.

The power of an outcomes audit 

The task is deceptively simple: gather information on the use of a drug within a specific patient population, then turn that insight into action that improves outcomes. Yet anyone who has attempted to navigate the complexities of the UK healthcare system understands the numerous challenges involved. Furthermore, the NHS redesign of last year has made a difficult job considerably harder. What, then, does the outcomes audit bring to the table? 

1. Truly local insight 

An audit is highly targeted. Rather than more population-wide health informatics that are designed to consider a potentially very wide range of factors, an outcomes audit drills down specifics, for example how a single provider treats patients with a specific condition. This is particularly valuable post-2013 in the UK, with the number of budget holders having vastly increased, with NICE, NHS England, the Cancer Drug Fund and the proliferation of clinical commissioning groups all now demanding drugs that deliver demonstrable value. These CCGs need to know that a drug doesn't just treat a disease, but that it does effectively in the context of the profile of the local population, the way health care is delivered and the priorities of local budget-holders. It needs to be compatible with their unique patient pathways, supported by evidence from the real world, not a theoretical one. An outcomes audit will focus on perhaps just 200 patients with a specific condition at a specific NHS Trust, and each one has very real needs that must be met if a drug is going to be deemed successful. An outcomes audit will find out if that is happening, and if not, suggest changes to ensure it does. 

2. In-the-field research 

An outcomes audit is normally carried out through a partnership between a desk-based analyst and a specialist nurse working in-the-field. The latter is what moves the audit beyond nationally available Hospital Episode Statistics data, creating a richly detailed picture of exactly how a care pathway is functioning. A nurse working on-site can collect extremely insightful information from patient notes, clinicians and patients themselves, then combine it with their own expert knowledge of an area in a way that remote data collection simply cannot achieve. Once again, this is real-world information, direct from the clinicians and patients of a specific population. 

3. Comparisons over time 

Outcomes audits are not isolated snapshots. By collecting data to form a baseline for comparison, then carrying out a further audit perhaps six months later, biopharma can further strengthen their case for on-going reimbursement by demonstrating how their product is improving outcomes in the real world. If the follow-up audit reveals success, then this supports their position as the product of choice. If conversely it shows that a drug isn't performing as hoped, the data collected can inform improvements to get performance back on track. 

Making the data work 

It is clear then that outcomes audits can generate a vast amount of useful data, and the key word here is 'useful'. Because ultimately data is only valuable when it is applied to the real world to improve outcomes. An audit should be an essential part of any market access strategy because the insight it delivers can show where biopharma needs to improve communication with clinicians, where it needs to invest in patient support to bridge gaps in the care pathway, where exactly in that pathway adherence decreases, and what needs to be done to solve the problem. 

 

To find out more about integrating outcomes audits into effective market access strategy – and specifically how the data they gather can be used to redesign care pathways to maximize commercial and clinical success – download the Quintiles white paper "The power of the outcomes audit: harnessing the vital data to inform an optimal UK market access strategy".

 

This post is the second in an ongoing series on UK market access.

Topics in this blog post: Evidence, EMA, EU, HTA, Market Access, NHS, Payers