Adherence – the bridge between clinical and real world outcomes

Aji Barot

Atlantis Healthcare

Aji Barot proposes that market access as a function of pharma is absolutely critical to the commercial success of a medicine. This involves engaging the relevant stakeholders, not just payers, at the right time with the right message. A well designed adherence programme can assist with this by adding value for patients, healthcare professionals and payers.

Whilst the term ‘market access’ is well used within pharma, it does mean different things to different people. Historically, its focus has been on the payer and negotiating the right drug price to secure reimbursement, but modern market access is actually about an integrated approach to dealing with multiple stakeholders including payers, healthcare professionals and patients. Despite each of these stakeholder groups having very different concerns and priorities – the common goal is a positive outcome for the patient.

The Department of Health in England is close to defining the value-based pricing (VBP) approach to reimbursement based on outcomes, not cost – and they are not alone. All around the world, from the USA to Japan, payers are starting to think about value in a different light, and the focus is on real-world outcomes.

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“…payers are starting to think about value in a different light, and the focus is on real-world outcomes.”

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With outcomes playing such a key role in defining value, it becomes apparent that pharma’s job does not cease once the prescription has been exchanged for pills – it is in the industry’s interest to ensure those pills live up to the expectations set in clinical trials. We often hear of the discrepancy between trial data and real world observation and non-adherence is widely acknowledged to play a part in this shortfall.

Supporting adherent behaviour is central to maximising value for all stakeholders

Non-adherence is driven by practical barriers as well as complex personal beliefs. To provide a comprehensive review of the factors and challenges involved is beyond the scope of this article, but the overriding point is that there is a responsibility (and an incentive) for all healthcare stakeholders to ensure that they are getting the most out of their medications.

Time and time again, we see traditional models to tackle patient engagement fail – clearly, information alone is not enough to change behaviour.1 If you want proof , just stand outside the ASCO cancer congress and see how many oncologists you see smoking – all (hopefully) well informed as to the risks of smoking. There is often a conflict between the information being presented (i.e. smoking is a risky behaviour) and the beliefs of the individual (I just want to have a good time and live in the moment), which must be addressed.

The starting point is to understand what an adherent patient looks like. In my experience, they possess the following characteristics:

1. They are well informed, not just on their medication’s side effects, but also on disease progression and how they should monitor therapeutic progress.

2. They possess the correct practical and emotional tools.

3. Appropriate focus and support is paid to non-pharmacological recommendations.

In effect, what we have defined above are the requirements for a successful patient support framework and a series of critical success factors to achieve optimal outcomes.

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“…any good adherence programme starts with understanding the beliefs of the patient and the practical barriers to adherence.”

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It’s all about the beliefs…

Our understanding of adherence has come a long way in the past two decades, and not only are we are acutely aware of the scale of the problem, but we also have experience of solving it. The key is to understand the relationship between the patient, the therapy and the healthcare professional – and we must be cautious not to make assumptions on how patients will act after experiencing a health threat.

We see patients with breast cancer missing chemo, and recent victims of heart attack not making appropriate lifestyle choices. Even with life-threatening conditions, unhelpful beliefs can be powerful enough to make patients risk their lives. So any good adherence programme starts with understanding the beliefs of the patient and the practical barriers to adherence. Once these beliefs are understood they can be modified, and from there, long-term positive behaviour change can be achieved. However, each patient holds their own individual beliefs about their illness and treatment, so a personalised intervention is essential.

We live in a world where we information is consumed from beautifully produced TV, achingly cool magazines and trendy online blogs all competing for our attention. We demand engaging, accessible content that speaks to us as individuals – but have you seen a patient website recently? When you consider how voracious the appetite for information becomes when we are ill, I am frequently disappointed by the quality of patient information available. If we, as an industry are serious about supporting patients, we need to create environments which are thoughtfully designed with the patient in mind.

Address adherence and reduce the cost to the payer

If the patient and the HCP work together on adherence, the payer also reaps the rewards. To qualify this benefit in value terms, just consider the multitude of ways in which non-adherence has an impact from the payer perspective:

Wastage – costly medicines go unused / are disposed of. In the UK NICE estimated that around £4 billion of medicines supplied on prescription through the NHS are not used correctly and a total of 4.6% of global total health expenditure (THE) or $269bn worldwide, can be avoided from adherence medicines.2,3

Secondary care costs – increased hospitalisation due to non-adherence significantly impacts on the disease burden.

Personnel costs – physician and consultant time is expensive.

Poor outcomes – medicines seemingly fail to deliver value. For patients with good adherence to beneficial drug therapy, the risk of mortality is about half that of patients with poor adherence.4

Studies are now also quantifying the impact adherence has on disease burden, with the impact in common areas like cardiovascular disease and diabetes being many fold (figure 1).

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Figure 1: the multiplicative financial impact of improved adherence in cardiovascular disease and diabetes.5

Up until this point, we have neglected to consider one critical stakeholder – the pharmaceutical industry. There are those who have struggled to see the ROI for investing in adherence support and see such programmes as a ‘nice to have’. In some situations (e.g. to treat acute conditions) they may be correct, but a recent study by Capgemini stated:6

“According to our analysis, the US pharmaceutical industry alone loses an estimated $188 billion annually due to medication non-adherence. This represents 59% of the $320 billion in total US pharmaceutical revenue in 2011 and 37% of the $508 billion annual potential total revenue.”

A potential revenue loss of 59% – that is staggering. Commercially, a clear argument is therefore presented around pharma supporting adherence programmes, but the impact of adherence on outcomes must also be factored in much earlier than drug approval.

Pharma must factor adherence into drug development

Value-based pricing utilises real-world evidence, not just clinical data, as a core measure of value. Consequently, pharma must adapt the role of phase IV / observational studies to measure more than just drug safety post-approval. Instead, everything that is promised in the value proposition for the drug needs to be carefully monitored – outcomes, adherence levels, quality of life, resource utilisation and so forth. This also necessitates change in the nature and type of personnel involved in these studies, with more collaboration and coordination with stakeholders such as patient groups.

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“…pharma must adapt the role of phase IV / observational studies to measure more than just drug safety post-approval.”

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More broadly across healthcare, adherence plays a major role in defining patient outcomes, and therefore for defining the value of a particular medicine to society.

Through better understanding and greater commitment to addressing the issue of medicines non-adherence we can:

• Optimise the real-world efficacy and safety of medicines.

• Increase patient retention.

• Drive differentiation in a crowded market.

• Provide the foundation for patient dialogue that can go beyond adherence and yield valuable insight.

Whilst all the time yielding greater and more consistent revenue for the pharmaceutical industry.

In an age where pharma is moving from selling drugs to providing healthcare services, non-adherence provides fertile ground for the pharmaceutical industry to add real value to healthcare systems across the world.

References:

1. Beakelman, D. (1990).

2. Prescription Pricing Authority (2008) Update on growth in prescription volume and cost in the year to March 2008. Prescription Pricing Authority.

3. IMS (2012).

4. Reference: S.H Simpson et al. (2006). “A meta-analysis of the association between adherence to drug therapy and mortality.”

5. M. Sokol et al., “Impact of Medication Adherence on Hospitalization Risk and Healthcare Cost”, Journal of Medical Care (2005).

6. Capgemini / HealthPrize, Estimated Annual Pharmaceutical Revenue Loss Due to Medication Non-Adherence (2012).

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About the author:

Atlantis Healthcare employs the latest developments in health psychology and communication technologies to address the issue of medicines non-adherence and improve health outcomes for patients.

With 15 years of experience designing and delivering innovative, award winning adherence support programmes, Atlantis Healthcare have supported over 750,000 patients around the world. They have implemented solutions across 51 different therapeutic areas spanning different cultures and markets and have won 8 global patient communication awards.

Aji Barot is the Business Development Manager for Atlantis Healthcare, working with the UK, European and Global teams. Having graduated from UCL in 2007, he worked in business development, formulating commercial strategies for a range of healthcare agencies (patient, payer and HCP focused). Before joining Atlantis Healthcare, Aji was a Research Associate for the market access arm of Grey Healthcare Group focusing on global access strategies for drugs and devices.

How can adherence support better market access?