Market Access needs Real World Data…or else

Market Access needs Real World Data…or else

Originally published at the PM Society

What the $%^& is Market Access?
Market Access is a contested term, which means that if we put 5 pharma marketeers in a room we’re likely to get 6 opinions.

For me, it is a commercial strategy, in partnership with healthcare, centred on value. I have simplified it a bit having not mentioned other phrases that are commonly associated such as influence, environment or barriers but there’s no harm in being explicit about the commercial angle. The NHS knows full well that industry has its own imperative and, despite the lack of clarity around the definition, we all know what we are seeking when we speak of access and uptake so patients get the right treatment at the right time.


How to get Market Access?

Once upon a time it was enough to offer data from randomized controlled trials (RCTs) – the gold standard among experimental methods - even after regulatory approval. How times have changed!

Payers are now far less interested in arguments around efficacy (performance in ideal conditions) than they are in arguments around effectiveness (performance in real life or real world settings).

This is because they have been struggling with unprecedented funding pressures for years and this still occupies their focus to an extraordinary degree. Payers now have very little fat left to trim in their systems and drug spend is always an obvious target when an NHS Finance Director has a new target to meet.

This is why they’re not speaking of innovative treatment, in isolation of their system, in order to save themselves. They’re focused on their system as a whole. Speak to any STP, CCG, Vanguard or GP Federation and you’ll hear the same phrases. Population health, unwarranted variation, system transformation (rather than redesign i.e. tinkering), wastage, integrated care, self-care and so on. This is why there’s such interest in the Carter Review, biosimilars (biological medicines which are highly similar to another already licensed for use) and Getting if Right First Time (GIRFT).

Therefore our answers are always more likely to resonate if they focus on how interventions fit into and benefit complex systems, instead of focusing on isolated segments of the population. In short, the value of a drug in a pathway is heightened if there’s positive impact in other related areas, for example:

  • What if a diabetes drug also lowers cardiovascular risk?
  • What if a treatment for wet Age Related Macular Degeneration (AMD) has a unique posology that means patients can be treated less frequently, reducing pressure in busy outpatient clinics, reducing the need for costly locum spend and freeing up resource for other procedures that are potentially more profitable for a hospital?
  • What if a bedside arterial blood gas analyser with rapid result turnaround ensures clinical teams don’t have to continually leave a patient to analyse blood, prevents the transport of potentially infectious material around critical care areas, supports both infection control and blood conservation best practice and improves the speed of decision making in critical care?
  • What if a chemotherapy regime for diffuse large B-Cell lymphoma can now be delivered with a sub-cutaneous injection rather than an IV, with less product (i.e. a lower cost) and increased patient throughput by up to a third (which means more patients moving through the system increasing the number of chemo cycles patients are likely to receive with attendant improvements in outcomes)?
  • Making a case for access on the value of a drug in isolation from the whole system is an increasingly dangerous proposition in a complex and crowded healthcare environment. The alternative requires data.


What is real world data?

I was genuinely confused when I first heard the phrase ‘real world data (RWD)’ because in the NHS we just called it ‘data’.

RWD is typically defined as data collected outside of clinical trials; that is observational/non-interventional and represents how care is delivered in routine settings. By definition it is messy precisely because it is uncontrolled, with missing data, variation in coding, some fields acting as proxies for other data points, with a genuine requirement to understand its context due to factors that influence it such as any financial incentives for its collection. That is not to say it is to be discounted. In fact the opposite is true. How else can we uncover the prevalence or incidence of a condition, the true burden of a disease on the entire system, the cost if we change nothing (known as the ‘do-nothing scenario’), the value of an intervention, the year-on-year costs to introduce a change or the healthcare resource utilization that transpires if we don’t?

We’re incredibly fortunate to have access to so much real world data in this country. Hospital Episode Statistics (HES) and the Clinical Practice Research Datalink (CPRD) are just two examples of world leading real world data assets we all have access to. HES data offers a view of all NHS activity in secondary care direct from hospitals while CPRD offers researchers the opportunity to study patient populations using a subset of primary care data direct from GP Practices. It is even possible to link both CPRD and HES and follow cohorts of patients across pathways, across healthcare settings and study them in detail using referral patterns, admissions, prescribing, diagnoses, procedures and more. Furthermore it is possible to link this to mortality, inequality and deprivation data from the Office of National Statistics (ONS), cancer registry data from Public Health England (PHE) and prescribing data at GP Practice level from NHS.Digital. The list of datasets being published is growing. B.R.I.D.G.E. TO DATA provides a comprehensive compendium of information on population healthcare databases worldwide and the NIHR has already developed a Health Data Finder for Research for the UK, part of an explicit strategy by the British Government to present the UK as a leader in real world healthcare research. Global attention is already on us following the success of the Salford Lung Studies run by North West eHealth (NWEH) for GSK.


Now what?

Of course, we must always be careful with Information Governance (IG) around patient data but the potential is incredible; not just for healthcare quality improvement and service transformation but also for supporting Market Access for pharmaceutical innovation. What is required now is to understand how to marry the potential of real world data to the challenges most, if not all, pharmaceutical companies face. These challenges are increasingly about demonstrating the value of an intervention in a complex, interconnected healthcare system struggling with sustainability. This is further complicated by how we often have make the case for Market Access in a way that truly resonates with all actors in a health economy so that we can work in partnership with healthcare professionals and organisations to deliver the outcomes demanded by our commercial strategies.

There’s no requirement to be a data expert to achieve this. What is absolutely crucial is that we grasp that data analysis of any sort, not just in real world data, is only ever as useful as the questions as we ask. The data is clearly available and plentiful. Therefore the task for those who want to succeed in Market Access today is simply to ask the clever questions.


Hassan Chaudhury

Hassan is a Committee Member of the PM Society and is part of the PM Society Market Access Interest Group. He is Chief Commercial Officer and a co-founder at Health iQ.