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

Precision Financing challenges for solid tumor adoptive T-cell therapies

Eric NormanFoCUS, Research Briefs

Durable gene and cell therapies represent a unique challenge to the US healthcare insurer/payer landscape, given the one-time treatment and associated high upfront cost but potentially durable outcomes. Previous research … Read More

Downstream Innovation Part I

Eric NormanLEAPS, Research Briefs

There is a growing recognition of the importance of augmenting product- focused learning with disease-focused learning, incorporating the value of advances in real-world evidence (RWE). In LEAPS, we aim to … Read More

Advancing Healthcare through Innovation and Collaboration

Eric NormanLEAPS, Whitepapers

NEWDIGS is an exciting and innovative approach to developing solutions for systemwide impediments to biomedical innovation and patient care. The noncompetitive, collaborative environment encourages novel and fresh ideas and interactions to … Read More

The Role of Stop-Loss Insurance and Reinsurance in Managing Performance-Based Agreements

Eric NormanFoCUS, Whitepapers

Over the last decade, rising healthcare costs and the availability of expensive new treatment options has led to a substantial increase in the number of patients with large insurance claims. … Read More

Baking the Cake: A decision driven framework for planning fit-forpurpose evidence across stakeholders

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: Baking … Read More

Payer Perspectives Survey

Eric NormanFoCUS, Research Briefs

A survey of 77 payers representing over 280 million lives, completed in April 2019, explored perspectives concerning financing challenges and management strategies associated with durable cell and gene therapies. Download … Read More

Massachusetts Pilot Disease Selection

Eric NormanLEAPS, Research Briefs

Rheumatoid Arthritis (RA) chosen as target for LEAPS Massachusetts (MA) Pilot (RAMA) to demonstrate the feasibility and impact of a sustainable and patient-centered healthcare learning ecosystem to optimize care regimens … Read More

Patient & Caregiver Themes Survey

Eric NormanFoCUS, Research Briefs

Patients and caregivers are key stakeholders in the development of system-wide, implementable precision financing models for durable and curative therapies. Patient and caregiver challenges are generally assumed to be primarily … Read More