This blog was developed with the input from the Cardiovascular, Metabolism & Venous Diseases Therapeutic Area, Research & Development, and the General Medical & Patient Affairs teams at Servier Group.

A narrow definition of unmet medical need overlooks the potential of existing medicines to improve outcomes for patients.

What comes to mind when you think of medical innovation? Perhaps it’s a novel therapy for a condition that is currently untreated? Or a new class of medicines that turns the latest science into solutions for patients. Maybe you’d think of a product that improves significantly on existing treatment options?  

Yes, these are transforming medicine innovations, each addressing the unmet medical needs for patients. But that is not the full picture. We must also address a critical aspect of managing chronic diseases effectively and therapeutic adherence is equally transformative as it plays a crucial role in achieving optimal health outcomes for patients. This can be achieved by unlocking the potential of therapeutic adherence, the extent to which patients follow their prescribed treatment regimens.

While it may attract less attention than headline-making scientific breakthroughs or blockbuster medicines, adherence is central to patient-centric care – providing a meaningful opportunity to deliver better outcomes for patients while helping our healthcare systems to manage rising rates of lifetime chronic diseases in patients.

Low adherence costs lives

More than two decades ago, the World Health Organization (WHO) identified low adherence as a ‘worldwide problem of striking magnitude’. Despite this recognition, and the growing impact of lifetime chronic diseases, healthcare systems and policymakers have given too little attention to adherence.

This comes at a cost. It creates a gap between the expected benefit of medication based on clinical trial results, and their real-life impact on patients.

In Europe, 200,000 lives are lost every year due to poor adherence (Agh et al 2023). According to WHO data, mortality from cardiovascular diseases is more than twice as high as that from cancer (World Health Organization 2022). *Invisible numbers). In the European Union this represents an additional burden on economies and health systems: avoidable hospitalisation costs €125 billion per year, includes costs related to increased hospitalizations, emergency room visits, and additional treatments due to complications arising from poor adherence  (European Commission/Medi-Voice 2011). Medicines are effective when taken as advised. Yet an estimated 31% of patients never fill their prescriptions and half of all patients do not take their treatments as directed and one third of patients stop their treatment earlier than recommended.

Heart health: a case in point

The adherence challenge is particularly problematic among people with chronic lifetime conditions who may be advised to take medicines for a prolonged period. Think of medicines that control blood pressure, heart failure, glycemia or cholesterol, for example.

Cardiovascular disease is responsible for 37% of deaths in Europe, as well as adding to the burden of healthcare, informal care and lost productivity (WHO, 2022). Yet one in two patients with cardiovascular disease are neither adherent nor controlled. Each of these patients represents a missed opportunity to intervene with proven therapies.

The causes of poor adherence in cardiovascular disease, as in other disease areas, are many. They include healthcare system barriers, such as complex procedures for collecting prescriptions; therapy-related issues, including treatment complexity; patient factors, ranging from literacy to forgetfulness; and socio-economic factors which can include a lack of social support and pill burden.

While addressing multifactorial challenges requires investment and multi-stakeholder collaboration, the benefits of getting it right are real. In Cardiovascular disease, correct use of prescribed medicines would deliver fewer strokes and heart attacks. 

Solving problems together  This is a major unmet medical need (UMN) in chronic lifetime conditions: we must find innovative ways to enhance adherence. The common barriers to adherence (Kvarnström K, et al 2018) are complex medication regimens that can be challenging to manage for patients in daily life, some adverse effects of medications may discourage patients from continuing treatment, lack of understanding by the patient about the disease and its treatment, psychosocial factors, economic hurdles like medication costs and sustain availability, transportation barriers to attend follow-up appointments, and lack of access to healthcare resource, and lack of social support, can impede adherence.

Patients, healthcare professionals, scientific societies, and pharmaceutical industry are ‘working together’ to unlock the potential of the medications by simplifying treatment, prescribing once-daily medications or combination pills can make adherence easier, by developing patient support program and the integration of digital technology we have today, while remaining committed to identifying the solutions of tomorrow.

Together, stakeholders have devised practical policy recommendations designed to address low adherence. From training for healthcare professionals and the involvement of patient advocates, to making adherence a performance metric for healthcare systems and exploring ways to reduce the medication burden on patients, we can begin to address this problem immediately – if this issue is prioritised by all.

The industry is dedicated to addressing the pill burden by developing long-acting formulations and combination products, such as single-pill combinations. These innovations aim to simplify medication regimens, reducing the need for multiple doses throughout the day while also supporting physicians in overcoming inertia by facilitating dose titration). Digital tools, including mobile health interventions, e-prescribing and telemonitoring also have a role to play and should be co-created with patients.

An inclusive definition of unmet needPolicymakers will also have a part. While the President of the European Commission, Ursula von der Leyen, has acknowledged the need for Europe to work on ‘longevity and adherence’, it is vital that this thinking is translated into our shared definition of UMN.

The narrow definition used in the General Pharmaceutical Legislation overlooks the value of addressing adherence. This definition will shape future priorities of research and innovation. That is why we are calling for a holistic view of UMN.

The development of groundbreaking new medicines can continue to extend and improve people’s lives in future decades. In tandem, we must immediately unlock the proven benefits of the therapies we have today. A key step is a shared recognition that this is an urgent UMN.

A call for action We must adopt a multifaceted approach to combat chronic cardiovascular diseases by addressing the critical unmet need of therapeutic adherence. We need to embrace the recognition of real-world evidence (RWE) methodologies, facilitate access to innovative pharmaceutical formulations like Single Pill Combinations, holistic digital adherence solutions combined with economic and societal commitments of medical education for healthcare providers and patients. By recognizing the value each of these activities bring we can foster a more effective, sustainable, and patient-centred healthcare system. Together, we can improve adherence rates, support the on-going fight against therapeutic non-adherence, and ultimately achieve better health outcomes for patients living with chronic cardiovascular disease.

Join us in this fight!

References

• European Commission/Medi-Voice (2011). MEDI-VOICE Report Summary. Project ID: 17893. European Union/European Commission.
• Kvarnström K, et al. Barriers and facilitators to medication adherence: a qualitative study with general practitioners. BMJ Open. 2018
• WHO, 2022, Global Health Observatory, World Health Organization, Geneva, Switzerland (https://www.who.int/data/gho)
• Agh T, van Boven J F, Kardas P. Europe’s cost of living crisis jeopardises medication adherence BMJ 2023; 380 :p747 doi:10.1136/bmj.p747