Inequalities in unmet need across patient groups are increasing
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A focus on:
The management of illness is structured around single diseases, but the disease profiles of patients and populations are becoming increasingly diverse. Healthcare systems have not kept pace in considering the holistic needs of individuals.
Our vision:
Create a system that coalesces around the health needs of individuals and is proportionate and targeted to those with greatest unmet need.
Looking to the future:
Restructure health systems by adapting care pathways and clinical trials to be representative of the populations they serve now and in the future.
Moving away from the single disease model
Care pathways have traditionally been established to treat a single disease and this has led to great improvements in treatments with a laboratory bench to bedside approach. However, increasing numbers of people are living with multiple conditions and in many situations we know which diseases commonly co-occur. The culture of diagnosing and prescribing along with evidence-based guidance focused on single diseases results in coexisting conditions often being overlooked, leading to growing unmet need. The situation has become starker as longevity continues to outpace gains in healthy life expectancy, leading to more years spent living in ill health, more time in which to acquire additional and more diverse morbidities, and greater exposure to multiple drug combinations. As a result, health systems globally are struggling to manage the diverse (ill) health profiles of their populations, especially in low- and middle-income countries where there are high rates of multimorbidity linked to poor living conditions and lack of health-related resource. In the first study of its kind, a multinational analysis of 14 nations exploring 12 chronic conditions reported high rates of multimorbidity (defined as two or more chronic conditions) in those over 50 years of age, alongside certain patterns of co-occurrence (e.g. cardio-respiratory clustering). However, the true extent of patient need is much greater than 12 conditions, and broader approaches are required to quantify the issue and subsequently build solutions. The ultimate aim is to move from a ‘one size fits all’ approach in siloed disease pathways to a system that is more personalised according to the totality of patient need.
Figure 1: National levels of multimorbidity by country GDP per capita
A new model for healthcare systems
More comprehensive characterisation of the variation in health profiles is needed to help move beyond the social determinants of health, along with identifying which subgroups have the highest healthcare resource utilisation and healthcare costs. For example, our own work with the National Institute for Health and Care Excellence (NICE) reported that, at the time of diagnosis of type 2 diabetes, three of the five most common comorbidities were not traditionally associated with type 2 diabetes; these were back pain, depression, and osteoarthritis. The presence of one or more of these conditions is likely to have a negative impact on a patient’s ability to engage with behavioural interventions that are intended to reduce the speed of disease progression and risk of major cardiovascular events (e.g. stroke, heart attacks), such as exercise. Such insights are valuable for understanding within-disease case mixes and where gaps in treatment and care provision exist.
When new medicines are developed, pharmaceutical companies should consider interactions between the new compounds and common existing medicines, ensuring that new treatments are suitable for all patients regardless of comorbidities. Having more long-term health conditions leads to increased use of medications. Indeed, the average 70-year-old now takes an additional two tablets each day compared to 10 years ago. This additional level of exposure increases the risk of adverse drug reactions, which may further widen the gap in health inequalities and result in additional cost burden.
Incentivising increased representation of people living with multimorbidity in phase IV studies will begin to address this, although it is important that the focus remains on safety with a broader view of effectiveness as an important secondary outcome. Clinical trials are, rightly, tightly controlled and generally have extensive exclusion criteria, which impedes assessment of the technology in a population that reflects the true characteristics of the target patient group. For example, mental health conditions – depression, dementia, and cognitive impairment – contribute to the multimorbidity burden in approximately one third of people living with four or more conditions. However, these conditions are a common exclusion criterion for clinical trials, leading to higher risk of drug-drug interactions because of untested polypharmacy along with unknown efficacy outcomes in this patient group.
Calls to action to address inequalities in unmet need
Tackling unmet clinical need is a long-term proposition and requires multidisciplinary skills along with extensive cross-sector collaboration. To help accelerate this journey, we propose three actions:
- Pharmaceutical, medical technology and service providers should know, quantify and publish the inequalities in health profiles and unmet need in their relevant therapeutic areas.
- Medicine manufacturers should minimise the risk of adverse drug reactions through systematic assessment of the risk of drug-drug interactions at compound development.
- Sponsors of clinical trials should take meaningful steps to improve representation in clinical trials and post-authorisation surveillance to reflect the health needs of target and wider populations and include those with multimorbidity.