Aiming for Health Equity

The following is a guest article by Hakim Yadi, PhD OBE, Co-Founder and CEO at Closed Loop Medicine

Healthcare has historically taken a ‘one size fits all’ approach, which misses the ability to treat all patients as effectively and equitably as possible. Consequently, personalized medicine where treatments are better tailored to a patient has become an aspiration of the modern healthcare system. However, when we look at existing medicines used today, drug therapy is rarely dose optimized for the individual, with most therapies and medical devices approved based on overall safety and efficacy investigated in large-scale clinical trials. These factors not only vary between individuals of different races, gender, age etc., but also in the same person over time. Yet, from 2013-2017, 78% of the drugs approved by the FDA had only one dose regimen and of the drugs considered to be amenable to response-guided treatment, only 39% provided relevant dose instructions. As a result, patient outcomes are affected, not only increasing side effects, medication non-compliance and chronic illness mismanagement, but also higher payor healthcare costs and lost pharma revenue. This perpetuates an ongoing negative care cycle. 

Until now, personalized medicine has only been applied to a handful of conditions and is often regarded as the domain of expensive oncological drugs. However, emerging software based medical devices (SaMD) that enable real-time and remote patient monitoring are creating a huge opportunity to link optimized dosing with outcome improvements, and bringing these capabilities into the hands of any patient. By flipping data collection from the generalized population to an individual level, drug plus software combination products can become more socially representative. Key healthcare stakeholders, such as physicians, providers, payors, and critically patients, are realizing the potential of these combination platforms to facilitate tailored treatment options. There is a clear increasing demand, particularly by younger people, to have regular access to their health data, and consequently inform and empower care decisions. By facilitating digital companions to be prescribed alongside traditional (and new) therapeutics, smartphone technology holds massive potential to provide a huge proportion of the global population access to personalized medicine, regardless of their access level to healthcare. It is estimated 86.3% of the global population owns a smartphone, equivalent to 6.9 billion users, and expected to increase to 7.3 billion in 2025.

Patient facing software based medical technologies hold the ability to level the healthcare playing field, providing broader access to the highest quality care, usually only available to the few. The WHO’s recognizes this potential in its Global Strategy on Digital Health 2020-2025 report, “…the strategic and innovative use of digital and cutting-edge information and communications technologies will be an essential enabling factor towards ensuring that 1 billion more people benefit from universal health coverage, 1 billion more people are better protected from health emergencies, and 1 billion more people enjoy better health and well-being.” Challenging the historical disease- symptom- management paradigm, these platforms offer necessary support to time-poor providers, whilst enabling an extended engagement window with patients; integrating real-world monitoring between appointments, remote check-ins, ongoing treatment review and optimization, and generally increasing trust. Digital healthcare services can reach a broader range of people than traditional models ever could, for example those that have limited access to treatment and in-person consultations, a challenge that has been exposed and exacerbated by the COVID-19 pandemic. By incorporating digitalization, access to high quality, bespoke care can be maximized, becoming a democratized system for all.

Data surrounding the impact of software on global health is growing. Hypertension, for example, is the leading preventable cause of morbidity and premature death worldwide; impacting a third of the US adult population and disproportionately those of lower socio-economic standing. Improved standards of care for patients could prevent 91,900 heart attacks, 139,000 strokes and 115,400 cardiovascular deaths in the US in 5 years. Breakthrough data published in 2022 in the Journal of the American College of Cardiology, demonstrated how a drug plus software-as-a-medical-device (SaMD) combination product can facilitate personalized dose optimization by integrating real-time patient feedback and closed loop models of care with a first-line anti-hypertensive drug. The findings evidence that a degree of personalization can lead to better patient outcomes by identifying the balance between efficacy and unwanted effects, ensuring maintenance of blood pressure control. Final findings from the trial are expected imminently. 

Effective and accessible dose optimization not only holds the potential to improve patient health outcomes, but it could also avoid unnecessary financial losses; the annual cost of drug-related morbidity and mortality resulting from non-optimized medication in the US was $528.4 billion in 2016, 16% of healthcare expenditures. Health equity is not only a humanitarian necessity; it has economic benefits – in Texas alone, it is estimated that racial health disparities have resulted in 452,000 life years lost due to premature deaths, $2.7 billion in excess medical spending and $5 billion in lost productivity since 2016. Using the example of hypertension, the disease costs $131 – $198 billion annually – as aforementioned, improved delivery of care could significantly impact patients’ quality of life, and also save hundreds of millions of dollars every year. Partnerships between healthcare technology companies and payers have the potential to dramatically improve outcomes for patients, saving funds that can be invested elsewhere in the healthcare system. 

Digitization doesn’t just provide access via technology, but by addressing the waste that stems from impersonal and imprecise medication, it offers a complete reimagination of what is possible for healthcare. To be effective in supporting health equity, driving adoption of combination tools in clinical practice is key. These must be designed with both the patient and provider at the forefront, to fully consider the practical and realistic challenges faced, such as administrative concerns, ease of integration and value-added. Furthermore, a detailed understanding of the complex relationship between drug efficacy and side effects is needed, requiring fine tuning to bring key data points together. Many elements must coordinate to deliver this: quality systems, technical, regulatory and commercial, with input and advocating from key opinion leaders across the field. The growing intersection between science and technology, drug and digital, is evident and provides a unique opportunity to challenge the health inequality observed globally. By harnessing these tools, we can envision a future where personalized medicine can become a universal reality. Considered to be both essential, and seemingly expected, this progression towards a truly inclusive and agile system will benefit us all. 

Author Hakim Yadi

Hakim Yadi, PhD OBE, is the CEO and Co-Founder of Closed Loop Medicine, a TechBio company developing combination prescription drug plus software products to support personalized dose optimization, through integration of drugs and devices with patient-led digital experiences. This closed loop approach has the potential to provide bespoke universal healthcare access and improve outcomes for patients with chronic diseases by enabling precision treatment decisions at an individual patient level. Hakim was awarded an OBE in 2017 for his services to Healthcare Technology and the Economy. 

   

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