Embracing real-world evidence is driving a new world for pharma

Following Adelphi's Renaissance thought leadership forum on real-world evidence, Stuart Cooper, chairing the meeting, is optimistic that the pharma industry will rise to the challenges and emerge re-energised and better placed to demonstrate and deliver positive health outcomes for patients on the front line.

In his recent piece on pharmaphorum after attending our Renaissance forum earlier this year, Paul Tunnah drew an interesting analogy between F1 motorsport and the pharmaceutical industry, stressing that pharma cannot allow itself to become irrelevant to the faster moving healthcare challenges of the real world.

The observation is valid, but my sense from the discussion exploring the impact real-world evidence (RWE) is having on the industry is that it recognises, and is rising to, these challenges. There is much to do though, and one clear conclusion from hearing many different perspectives on the issue was that the decision-making framework around assessing the value of new medicines has dramatically shifted.

Far from being regarded as an additional hurdle to overcome, our speakers stressed payers must now be recognised and embraced as one of the key stakeholders operating on the front line of medicine. They are present at every level of the decision process around whether healthcare systems will utilise new medicines, they are becoming more closely aligned with the regulators and providers, and when it comes to collecting, understanding and interpreting RWE they are arguably one step ahead of the industry.

The concomitant realignment within the industry to address this shift is in recognition that RWE is now integral to everything it does and the required solutions are multi-faceted. Within the scope of this article it is impossible to cover every detail that emerged, with expert speakers representing views from the industry, payers and external analysts, but the following four high-level themes emerged as areas to focus on.

1. Closing the gap between RCT / HEOR and RWE

Clinical studies, in the form of randomised controlled trials (RCTs) and, more latterly, health economics and outcomes research (HEOR) have always been the focus for securing initial access to the market via regulators and overarching payers, increasingly in the guise of health technology appraisal organisations such as Germany's IQWiG.

While the regulators continue to hold the initial key to the market, providers of new treatments could find the door is later closed in the absence of supportive RWE, with multiple payer groups conducting more frequent, ongoing assessment of whether medicines are delivering cost-effectiveness within their own real, segmented patient populations, rather than the theoretical 'hyper-unreal' RCT ones. Governments, payers and healthcare providers are moving very quickly in their capability to do so, even in markets currently regarded as 'price insensitive' like the US. To hear one major US healthcare insurer present on how they have developed an oncology registry that is providing near real-time assessment of medical benefit by combining multiple RWE data sources, including electronic medical records, together was an eye opener for all the attendees.

The message is clear – the US is no longer a bastion of free pricing and pharma must be able to provide evidence that it can deliver on the initial promise made by RCT / HEOR data by following through with RWE. In addition, healthcare stakeholders expect the industry to have 'skin in the game' by sharing the ongoing risks as well as rewards.

2. Personalising messages to different payers

While there is a suggestion that national payer organisations may start to come together in terms of the way they assess the cost-effectiveness of new and existing medicines, the reality is that this will take a long time. In addition, even within individual markets, payers are present at many different levels and with differing challenges and incentives. Consider Spain, for example, where a national HTA process is further scrutinised by regional bodies or the UK, where this multi-tiered approach is visible from NICE at the top, through over 200 local CCGs and onto every individual hospital formulary.

Our industry has long since learned that when it comes to 'traditional' sales and marketing to a very diverse prescriber audience the approach of one message fits all is inefficient. Here, new technologies and approaches have sprung up around multi-channel marketing and closed-loop marketing to better understand each and every prescriber and deliver exactly the information they need in an appropriate way. Evidence-based content, and how it is communicated, is now king.

This approach must also be adopted when it comes to presenting RWE to different payer stakeholders. Pharmaceutical companies must form a better understanding of, and build trust with, each 'payer archetype' to be successful, rather than talking to a fictional, homogenised payer that is not representative.

3. Utilising technology as part of the solution

Real-world evidence can be procured via multiple different routes, such as highly specialised investigation into patient-reported outcomes or large objective patient surveys, claims data, patient registries, electronic medical records and many others. The industry does not need to 'own' all this data, but must be able to integrate and interpret it in an efficient manner if it is to partner with the payers and providers, who are investing heavily in this space. Efficient data warehousing and modelling are the keys to success here.

In doing so, it is vital that we all move to become more tech savvy to unlock the potential of this area of 'big data' in both positioning new medicines appropriately and ensuring the value of those already on the market can be demonstrated. Indeed, a presentation by one of the market access leaders for a top ten pharma company would have been equally at home at a technology conference, as he explained how they are tackling the challenges of integrating, validating and utilising multiple RWE data sources.

The industry has significant commercial expertise that can be brought to bear on these technology challenges, bringing the opportunity to become a strategic partner to healthcare systems also grappling to tackle them.

4. Structuring pharma organisations around RWE

Real-world evidence and outcomes touches on so many different functions within pharma companies, all the way from R&D, through medical affairs / pharmacovigilance and onto sales, marketing and market access. Delivering on all the above solutions therefore depends on having the right desire, objectives, people and structures in place organisationally.

Currently, this challenge is being approached in many different ways. Within the space of only a few hours one pharma company presented on how they were implementing rigorous internal training programs for all relevant personnel on the importance of RWE, whilst another outlined how they are developing an ever-growing RWE function to work with all of these other internal stakeholders. It is probably too early to say whether there is a best direction here, but it is clear that some companies are significantly upskilling with regards to RWE, and quickly.

The above may paint a picture of a challenging time for the pharma industry over the next few years – and I have no doubt there will be some ups and downs. But if it embraces these challenges, a new world will emerge for pharma that could revolutionise its activities.

By getting to grips with RWE, working with the right partners and adapting its business operations appropriately, our industry can emerge even stronger and ensure it is seen as a valuable player in delivering optimised and informed healthcare solutions in the real world.

For more information about Adelphi's recent Renaissance thought leadership forum on real-world evidence, or if you wish to comment/contact Adelphi, please visit:

http://www.adelphigroup.com/adelphi_system/renaissanceseries2013/index.html

About the author:

Stuart Cooper is CEO of Adelphi Group and has led the organisation to its current unique position in the world of pharmaceutical consultancy and service provision. With over 40 different real-world and outcomes programmes of its own, Adelphi Group and its expertise is at the leading edge of this change in pharma across all disciplines.

Adelphi Group has a presence in the US, Europe and Asia and over 700 personnel worldwide, with its offerings spanning the lifecycle of pharmaceutical development, with comprehensive services in Strategic Product Development Consultancy, Health Economics and Outcomes Research, Real World Disease Understanding, Marketing Research, Medical Communications and Post-meeting Brand Support Services.

To contact Adelphi, please visit:

http://www.adelphigroup.com/index.php/contact

Closing thought: What opportunities for pharma does RWE present?