Harnessing vital data to inform an optimal market access strategy in the UK

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1 White paper Harnessing vital data to inform an optimal market access strategy in the UK The power of the outcomes audit Access to >61M patient lives via EHRs since 2004 Paul Sutton, BA Hons, MA (Oxon), Director of Outcomes and Value, Quintiles Commercial UK Executive summary This white paper seeks to give a comprehensive overview of outcomes audits and their place in UK market access. It will examine how real-world data can help biopharma increase adherence to their product, build better relationships with payers and providers, and inform pathway redesign that improves patient outcomes while maximizing commercial success. 195 patient registeries and observational studies since 2003 In a climate where ongoing reimbursement of a drug relies on biopharma s ability to demonstrate how it delivers value to the entire healthcare system, outcomes audits led by in-the-field nurses can be seen as one of the most important tools at their disposal. Crucially, this paper will also demonstrate the benefits an audit delivers to the NHS. Market access now demands closer collaboration between biopharma, payers and providers, so an outcomes audit can help all stakeholders pinpoint where there is need for additional patient support in a specific geography. The audit delivers detailed action plans to both biopharma and the NHS, proposing improvements to the care pathway aimed at delivering real value to the entire healthcare system.

2 Table of contents Executive summary 1 Introduction 3 Key drivers for running an outcomes audit 4 Joint working by biopharma and the NHS 5 On-site data collection: why in-the-field nurses are a vital resource 5 Moving forward: making a market access outcomes audit work 6 About the author 7

3 Introduction Biopharma companies are facing new challenges in UK market access. In order for a drug to be clinically and commercially successful, manufacturers must be able to demonstrate how it delivers value to the entire healthcare system. Not only that, but since the 2013 NHS reforms, there are hundreds of budget holders spread across the country, all with differing interpretations of what value means. One thing that is common however is the fact that payers are interested in how a medicine performs in the real world. But the real world is not homogenous different areas of the country have different therapy area priorities, specialist expertise and, most importantly, care pathways. Effective market access strategies therefore need to be informed by very locally sourced real-world data, and one of the most powerful ways to do this is through an outcomes audit. This paper will set out exactly how market access specialists carry out such an important piece of research for the benefit of the NHS as a whole, and for biopharma companies seeking to increase adherence and therefore patient outcomes in support of ongoing reimbursement of a drug. With 221 local purchasers of healthcare products and services in England alone, one-size-fits-all market access is no longer an option. The outcomes audit is a much stronger and ultimately more profitable approach. Outcomes audits are highly specialized, yet can produce actionable results within weeks, and should be seen as a cornerstone of all integrated market access strategies. Figure 1 Integrated market access services Outcomes audits are just one of a wide range of services offered as integrated market access. An audit may be stand alone, but is more likely to be part of a tailored package. 3

4 Key drivers for running an outcomes audit If demonstrating value is at the heart of what market access must achieve for biopharma, then data alone will not deliver it. It is only through analysis and informed action that an outcomes audit becomes truly valuable to biopharma, payers, providers and patients. There are many reasons for commissioning an outcomes audit. For example, it can be used to identify exactly why a product is successful in one geography, yet underachieving in another. Is the drug reaching patients at the right point in the pathway? Does it have buy-in from local clinicians? Are patients getting the follow-up support they require, or is a competitor better meeting their unique patient needs? >9M patients in observational and quality improvement programs in the last 10 years and in >100 countries The audit could reveal that key parts of the pathway are not being adhered to properly, or worse, do not exist in a particular unit at all. This insight can then inform biopharma s strategy, either by supporting the local health economy to bridge that gap, or directly providing patient support to address the problem. The latter is a further driver for carrying out an outcomes audit. If biopharma is going to fund such an initiative for example providing patient support telephone lines or outreach nurses to help with drug administration the audit can be used to verify that such investment is being utilized and is having the desired impact on outcomes. Conversely, an audit can be just as valuable if it focuses on a drug that is proving to be highly successful for a certain cohort of patients. Data analysis of high-performing products allows biopharma to better replicate the success in other geographies, while the insights gained from the audit can form the backbone of a strong brand marketing strategy. Real-world data can be used in the development of compelling case studies which can support the alignment of a therapy within new markets in relation to patient pathways, funding decisions and desired outcomes. Figure 2 The outcomes audit overview What is an outcomes audit? It is conducted using a powerful set of research tools designed to collect and interpret real-world data for a specific patient population. The word specific is crucial here, as the power of an outcomes audit comes from the fact that it is highly localized. 4

5 Joint-working between biopharma and the NHS Rather than being a one-sided process purely focused on the commercial success of a product, an audit delivers real insight back to the NHS to help optimally manage their patients. Following data collection and analysis, the healthcare provider receives a detailed action plan that maps out how patients are performing along the care pathway. They can see where and why patients are achieving good outcomes, and just as importantly where there are opportunities to improve adherence, increase compliance or save money. It is this dual benefit for both biopharma and provider that makes an outcomes audit such a powerful tool. Crucially, it therefore helps the biopharma company take the lead in moving towards a more collaborative systems-oriented approach. Engaging a market access specialist to carry out an outcomes audit is a strong indicator that the biopharma company is not just investing in data, but actively working to improve the environment for that cohort of patients. By providing the NHS with clinically based findings and recommendations, they are demonstrating a longer-term commitment to a pathway and contributing to its success. By providing the NHS with clinically based findings and recommendations, biopharma are demonstrating a longer-term commitment to a pathway and contributing to its success. Proactive biopharma companies may then use the information collected from the audit to identify joint-working opportunities with the NHS. By analyzing the baseline data, they may be able to immediately identify that there is a whole tranche of patients with unmet needs. They can then engage with that local health economy and offer to bridge the pathway gap, either directly, or by calling on the resources of the market access provider running the audit. This could include setting up and running nurse review clinics or carrying out deep-dive analytics into a particular part of a pathway. Again, the aim is to help improve outcomes, rather than simply sourcing data to optimize drug marketing for biopharma. On-site data collection: why in-the-field nurses are a vital resource An outcomes audit is normally delivered by a market access provider, through an in-the-field nurse and a primarily desk-based analyst, and it is this combination of working styles that is integral to the service. There is no doubt that the modern healthcare environment is now driven in large part by technological advances, and there is a huge raft of data that can be sourced remotely through complex computer software. But algorithms will only retrieve so much. A key benefit of the outcomes audit is the level of detail that only surfaces if a nurse is working directly on site. Nationally available Hospital Episode Statistics data is a solid foundation for an audit, but often the most valuable insight comes from studying patient notes and interpreting those findings. An in-the-field nurse working through case notes is by far the best way to track what could be the most valuable data, such as what is happening between review clinics, how a patient is feeling about their care, or what observations clinicians are making about their patients progress. Combined with this is the clinical expertise an on-site nurse brings to the audit. A nurse trained in the specific disease area they are analyzing means that when they work through patient notes, they have a wealth of knowledge that they can bring to the data. They are able to delve deeper, because they can make informed connections between seemingly unrelated statistical information, then know the right questions to ask clinicians so they can turn even the smallest details into actionable insight. They can witness first-hand how patients are being managed and how the pathway is operating. Rather than relying solely on an office-based analyst to make assumptions, the biopharma company can be confident that the findings emerging from the audit are based on real-world insights. Regardless of the motivations behind an audit, what s vitally important is that the emphasis is firmly on transforming data into value. On-site data collection and analysis also helps avoid the dangers of taking standardized coded data at face-value. The reality is that it is not always complete or robust and is often open to interpretation. Individual sites or health care professionals may record the same piece of data in different ways, which could ultimately skew the results of data gathered through automated processes. 5

6 However, an in-the-field nurse is able to factor these inconsistencies into any analysis because they are in a position to see the wider context. They are also able to speak directly to NHS staff to get a clear understanding of why such inconsistencies occur, and how this can be remedied. This is a clear benefit of an audit, as the nurse can make the hospital aware of these reporting inconsistencies and help them standardize their processes. Once again, this further strengthens the argument that an outcomes audit adds value for both biopharma and the NHS. Regardless of the motivations behind an audit, what s vitally important is that the emphasis is firmly on transforming data into value. An outcomes audit is not simply a reporting exercise, but the start of a process that can deliver real change for both biopharma companies, and the providers and patients they are seeking to work with. Moving forward: making a market access outcomes audit work Not all outcomes audits are the same. For a highly robust and effective audit, a number of key elements are essential: An appropriately sized patient population there is a danger that when larger-scale audits are carried out, focus will be lost. Multiple themes may emerge but divert attention from the initial intent of the project, whereas fixing an audit at site-level is often more likely to produce clear, actionable results. Highly qualified, in-the-field nurses there is no substitute for the rigor and insight of an auditor with in-depth knowledge of the disease area, based on the ground and working alongside clinicians and patients. An integrated provider an action plan clearly does not stand alone. Outcomes audits are just one part of effective market access, and it is only when an integrated provider combines them with a comprehensive suite of market access tools can biopharma make the impact they want and initiate real change. It is clear that now more than ever, biopharma companies must be able to demonstrate that their product delivers value to the entire healthcare system. The outcomes audit is therefore a vital tool for any firm when planning to maximize commercial value for their drug. It is this analysis of local real-world data and crucially the action plans that emerge from it that helps increase take-up, adherence and improve patient outcomes. 6

7 This white paper was produced by Quintiles, (NYSE: Q), a Fortune 500 company, is the world s largest provider of biopharmaceutical development and commercial outsourcing services. With a network of more than 30,000 employees conducting business in approximately 100 countries, we helped develop or commercialize all of 2013 s Top 100 best-selling drugs on the market. Quintiles applies the breadth and depth of our service offerings along with extensive therapeutic, scientific and analytics expertise to help our customers navigate an increasingly complex healthcare environment as they seek to improve efficiency and effectiveness in the delivery of better healthcare outcomes. To learn more about Quintiles, please visit >30,000 employees operating in >100 countries Quintiles outcomes audit nurses work via honorary contracts to access hugely detailed, individualized data that is not easily accessible to biopharma companies. They then collaborate with analysts who have unrivalled expertise in their field. As a market access provider, Quintiles is uniquely positioned to combine outcomes audits with a full suite of tools for maximizing clinical and commercial success of a product. About the author Paul Sutton, BA Hons, MA (Oxon) Director of Outcomes and Value at Quintiles Commercial UK Paul Sutton leads the design and implementation of health informatics, data analytics, service pathway evaluation and modeling, and patient outcome audit service: to help pharmaceutical clients (and their NHS stakeholders) understand, realize and demonstrate real-world outcomes and value for their brands at a local health economy level in the UK market. Prior to Quintiles Paul held key positions with Bupa Home Healthcare, developing value-added services for biopharma; and with Bupa Health Dialog as a senior management consultant to NHS clients. Paul worked in the NHS for 12 years, culminating in senior commissioning roles in NHS Manchester. Paul received his Bachelor of Arts and Master of Arts degrees from Oxford University. 7

8 Contact us Direct: Website: Copyright 2014 Quintiles. All rights reserved

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