Use of Real-World Data to Support US Regulatory Submissions In July 2024, the Food and Drug Administration (FDA) finalized recommendations on using real-world data (RWD) and real-world evidence (RWE) in regulatory submissions. The FDA has increasingly recognized the importance of RWE in enhancing the regulatory process for drugs and medical devices. RWE refers to data…
Understanding New Technology Add-On Payment (NTAP) NTAP is a mechanism introduced by the Centers for Medicare and Medicaid Services (CMS) to support the adoption of innovative medical technologies. It is significant for manufacturers because it provides additional financial incentives for hospitals to use new technologies, addressing the constraints of Medicare Severity Diagnosis Related Groups (MS-DRG)…
Demystifying the Markov Model A Markov model is a type of model which leverages an analytic framework designed to model pseudo-randomly changing systems. To accomplish this, Markov models represent the scenario as a series of mutually exclusive states with transition probabilities determining the transition between any two states over a certain time period. The probability…
What Is Cost-Effectiveness Analysis? Broadly speaking, cost-effectiveness research, also known as cost-effectiveness analysis, is a method of health care economic analysis that assesses and compares the difference in costs and outcomes associated with different courses of action. In the pharmaceutical industry, these analyses are typically performed to compare treatment intervention and analyze a new intervention…
Population modeling is transforming the way we leverage real-world data (RWD) to make informed decisions in healthcare. By simulating population dynamics and predicting the impact of interventions, these models help uncover actionable insights into treatment outcomes, healthcare utilization, and cost-effectiveness—offering a deeper understanding of how therapies perform in diverse, real-world settings. Population models are critical…
Our ability to generate data has, and continues to, undergo exponential growth over the course of our lives. As our data universe expands, we seek new and innovative ways to improve our everyday lives. One industry of focus includes healthcare, where researchers, pharmaceutical companies, payers, physicians, and more are constantly working to improve patient outcomes…
Artificial intelligence (AI) is rapidly transforming the healthcare industry, ushering in a new era of precision, efficiency, and personalized care. From enhancing diagnostics to optimizing treatment plans and streamlining administrative tasks, AI technologies are being integrated across various aspects of healthcare. With its ability to process vast amounts of data and deliver insights in real…
In today’s fast-paced healthcare landscape, the importance of gathering insights from diverse perspectives cannot be overstated. Healthcare advisory boards play a pivotal role in this process, serving as a bridge between industry stakeholders and the invaluable expertise of thought leaders, clinicians, and patient advocates. These boards provide a platform for discussion, collaboration, and strategic thinking,…
Health insurance in the US varies significantly in cost, coverage, care sites, provider networks, eligibility, and governing policies. To understand this complex landscape, it’s helpful to categorize insurance as either publicly or privately funded. Publicly funded plans include: Privately funded plans are also referred to as commercial plans. These can be: Employer-Sponsored Insurance Employer-sponsored insurance…
Gross to Net (GTN) is the income from all sales compared to revenue after discounts on the sales. When considering the gross to net for drugs, the calculation of the net revenue includes several components, courtesy of the complex outpatient drug distribution and reimbursement systems. The following are included in the calculation of net price: …