SummaryThe patient perspective should be incorporated across the care spectrum, including clinical research and drug development, care decisions, outcomes measures, and how value is defined.
In this series, Avalere is identifying the top trends in health economics and outcomes research (HEOR) that are shaping the landscape in 2023 and beyond. In this Insight, Avalere experts dive into trend #5: patient-centricity across the drug development lifecycle.
Patient-centricity is considered a fundamental component of high-value health systems. To develop holistic strategies that consider all aspects of patients’ care journey, stakeholders need to establish a systematic approach to patient-centric clinical research and drug development; tactics to promote shared decision-making; metrics and track patient-reported outcomes (PROs); and (re)define value through a patient-centric lens. While many stakeholders are doing well in one of these areas, most are not addressing all four.
Clinical Research and Drug Development
Patient-centric clinical research and drug development focuses on understanding the most bothersome aspects of a condition, how patients prioritize their clinical and non-clinical needs in treatment selection, and their preferences for care. This research also identifies diagnostics and therapies that address high-priority symptoms and utilizes clinical trial endpoints that address patient-centered impacts. For pharmaceutical manufacturers, this focus has manifested most clearly in the Food & Drug Administration’s emphasis on patient centered drug development. This approach has downstream implications for adherence to treatment since patients are more likely to stick with a treatment plan that addresses their individualized needs. It also impacts the value proposition and assessment for certain therapeutics and diagnostics, as stakeholders can demonstrate with high-quality evidence their product’s impact on factors that patients value.
Opportunities also exist for incorporating patient-centricity in the drug development ecosystem by ensuring patient-informed and patient-involved treatment selection at the point of care. Shared decision-making provides a framework for constructive discussion between patients and their clinicians, so they align on patient values and preferences in treatment. It enables optimal decision-making that appropriately weighs the patient’s needs and promotes ownership over decisions, helping them to feel empowered in their care journey.
To have an effective shared decision-making process, three things are needed:
- Both the patient and the care team need to have a clear understanding of the patient’s goals, values, preferences, and concerns, which may include their concerns about treatment burdens
- They need clear, accurate, and unbiased medical evidence about their options – and the risks and benefits of each
- The communication process needs to be tailored to the learning needs of the patient and allow for open and honest dialogue within a trusting environment.
Manufacturers should consider in their evidence strategy how to ensure that patients and clinicians are equipped with the information needed to understand how a therapy could affect all aspects of the patient’s life, such as their finances, their emotional health, their ability to work and to care for their children, and their ability to socialize.
PROs also contribute to a holistic perspective of a therapy’s impact. Data for PROs are captured through surveys, patient-reported information to a clinician recorded in the electronic health record, interviews, and novel techniques like apps or consumer devices. These instruments are typically focused on measuring how a patient feels, functions, or experiences care. PROs provide important context and inform a more holistic understanding of quality and value when combined with traditional measures like clinical outcomes, claims-based utilization, and cost metrics.
Finally, patient-centered value has emerged as another framework of patient-centricity. There has been a greater push by organizations such as The Innovation and Value Initiative and patient advocacy groups to incorporate patient-centric value elements in assessments of drugs and other therapies. The most widely recognized value assessor in the US, the Institute for Clinical and Economic Review (ICER), released its updated value framework in 2019 to begin incorporating a chapter on patient perspectives in its assessment reports. ICER’s patient-centric value inputs rely on evidence from patient-centered research and patient-reported outcomes, allowing for quantified inputs within the value framework, though to date the information has largely been included qualitatively, not in the actual health benefit price benchmarks. Building patient-centric value assessments and patient-centered value propositions can shape payer, employer, regulatory, policy, and consumer decisions.
Look for future Avalere Insights on HEOR top trends, including artificial intelligence, value assessment, and health equity. To learn more about how Avalere’s evidence and strategy experts can help you stay on top of this evolving landscape and support your HEOR initiatives, connect with us.
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