Personalized medicine is one of the emerging approaches to improving disease treatment & prevention by taking individual variability in the genes, environment, and lifestyle. This approach allows healthcare professionals and researchers to depict which treatment & prevention strategies would work for a particular disease in a particular group of people. Preventive or therapeutic interventions can then be directed to those who benefit the most from targeted intervention, maximizing benefit and minimizing cost and complications. The personalized or precision medicine medical treatment model considers individual differences in patients’ genomes, environments, and lifestyles. It allows doctors & medical researchers to customize healthcare for patients with medical decisions, practices, and products. Most organizations conducting precision medicine have been focusing on cancer. Additionally, precision medicine is being conducted in other areas, such as neurological and cardiovascular diseases.
The personalized medicine approach for patients can be challenging as it is difficult to design an effective treatment plan for a medically complex patient. Using real-world data is proven to speed up the transition to precision medicine. It enables researchers to go beyond the scope of traditional clinical trials with real-world data while obtaining insights from the information collected in routine clinical care. Researchers can use RWD to determine which medications are best suited for specific patients, resulting in more personalized therapy and better outcomes.
The value-based care model has also emerged as an alternative and potential replacement for the volume-based or fee-for-service reimbursement model. This model provides individuals better care, improves population health, and reduces healthcare costs. Utilizing real-world data in a value-based care model where pay-for-value is prioritized helps prove whether the medicine delivers the same patient outcomes as demonstrated in randomized controlled trials.
The CMS introduced an array of value-based care models, such as the Medicare Shared Savings Program, patient-centered medical homes, and the pioneer Accountable Care Organization (ACO) model. In turn, private payers have adopted similar accountable, value-based care models. The FDA recognizes that real-world evidence can make America’s healthcare system more competitive & efficient as validated outcome measures based on real-world data are incorporated into value-based payment contracts. Value-based payment arrangements rely on a mix of objective and measurable patient outcomes associated with product use and cost data. Historically, payers have had very little information beyond cost and utilization data from their claims systems and the results of clinical trials—many of which do not measure meaningful long-term outcomes and resource use—to inform decision-making on payment for novel drugs and biologics.
Apart from the U.S., Europe, and other developed countries, many developing countries are also exploring the global paradigm shift towards a value-based healthcare model. Several discussions, events, and conferences are being held on value-based care worldwide to check its feasibility, promote its advantages, formulate policies, and discuss the opportunities and challenges. Some of the major summits held in recent years include the 5th Annual Value-Based Care Summit 2020 (Boston, October 2020), Value-Based Care Summit (Chicago, June 2017), 3M’s Value-based Care Conference (Chicago, September 2016), and Value-Based Healthcare in Europe (London, March 2016).
Value-based care is a challenging transformational journey but rapidly gaining traction globally. The value-based mindset helps R&D to design trials, including measurement of cost-effectiveness. The trials also help evaluate the burden of illness during the preliminary stages of drug development and develop value propositions based on real-world data outcomes, such as quality of life, productivity, absenteeism, and frequency of clinical events. Using real-world data and its evidence is a key element for transitioning to value-based care. Thus, increasing focus on personalized and value-based healthcare will drive real-world data market growth during the forecast period. Thus, the global real-world data market is projected to grow at a CAGR of 7.4% to reach $1.66 billion by 2029, according to Meticulous Research®.
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