Ask PAM: “How many?”

Eric NormanFoCUS

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

Innovating methods for planning, producing, and using real-world evidence

Eric NormanLEAPS, Research Briefs

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

Eric NormanLEAPS, Whitepapers

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

Emerging market solutions for financing and reimbursement of durable cell and gene therapies

Eric NormanFoCUS, Whitepapers

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)

Eric NormanFoCUS, Research Briefs

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

Eric NormanFoCUS, Whitepapers

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

Eric NormanFoCUS, Research Briefs

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

Transforming Real-World Evidence in Biomedical Innovation: Advancing the Design of Collaborative Disease-Focused Learning Ecosystems

Eric NormanLEAPS, Research Briefs

The LEAPS methodology begins by answering two structured questions – WHAT evidence to produce, and HOW to produce it, as outlined in this two-part Research Brief series: • Part I: … Read More