New article in Health Affairs Forefront Transformative new pharmaceutical treatments hold the promise of changing patients’ lives by slowing and curing disease, improving well-being, and advancing quality of life. Yet, … Read More
Ask PAM: “How many?”
Individual Indication Workbook in actionHow many treatment-eligible people are in my population?The Pipeline Analysis and Modeling (PAM) in the NEWDIGS Paying for Cures Toolkit maintaints a unique, detailed, indication-by-indication analysis … Read More
Extending the vision of adaptive point-of-care platform trials to improve targeted use of drug therapy regimens: An agile approach in the learning healthcare system toolkit
Publication in Contemporary Clinical Trials To improve drug regimen use, we propose an adaptive point-of-care (APoC) platform trial for robust real-world evidence (RWE) production, addressing uncertainties post-market. Using rheumatoid arthritis … Read More
Innovating methods for planning, producing, and using real-world evidence
Real-world data (RWD) are a critical element of the evidence needed to help reach this goal, potentially informing a new drug’s development or providing insight for its use after it … Read More
A practical approach for defining outcomes and thresholds for predictive healthcare algorithm development using real-world dataOut
As the healthcare system evolves towards value-based care, predictive algorithms can play a critical role, but their findings must be perceived as meaningful, substantial, and actionable by those outside the … Read More
Precision Reimbursement for Precision Medicine: Using Real-World Evidence to Evolve From Trial-and-Project to Track-and-Pay to Learn-and-Predict
Basic scientists and drug developers are accelerating innovations toward the goal of precision medicine. Regulators create pathways for timely patient access to precision medicines, including individualized therapies. Healthcare payors acknowledge … Read More
Emerging market solutions for financing and reimbursement of durable cell and gene therapies
The FoCUS project was launched in 2016 with the aim of developing precision financing solutions that address the challenges and financial impact created by durable cell and gene therapies entering … Read More
Payer perspectives on outcomes tracking for value-based payment arrangements (VBPs)
Share the researchWith the new CMS rule changing Medicaid Best Price reporting to encourage VBPs, many options are available for which healthcare system players will collect, protect and adjudicate the … Read More
Warranty Model: A potential precision financing solution for durable cell and gene therapies
Durable cell and gene therapies are poised for rapid growth – potentially providing transformative benefits for patients and exacerbating financial challenges for payers, providers, patients, and therapeutic developers. With five … Read More
Impact of FDA Guidelines on Communication between Developers and Payers on Metrics in Performance-Based Agreements
The FDA regulates communications from pharmaceutical developers to ensure that statements about products are appropriately supported by evidence. In this Research Brief, we explore the possible impacts of these regulations … Read More