December 2019 marked the transition from the LEAPS two-year design and feasibility assessment phase to the rollout of the rheumatoid arthritis in Massachusetts (RA MA) Pilot. Some important themes surrounding … 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
Precision Financing challenges for solid tumor adoptive T-cell therapies
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
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
Tracking Medicaid Coverage of Durable Cell and Gene Therapies
Durable cell and gene 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. This study … Read More
Transforming Real-World Evidence in Biomedical Innovation: Advancing the Design of Collaborative Disease-Focused Learning Ecosystems
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
State Insurance Regulations Regarding Benefit Design (Deductible and Co-Pay Waivers)
FoCUS has identified an issue that may be a barrier to timely patient access to durable therapies. The advent of expensive, one-time durable therapies will require changes in private payer … Read More
Baking the Cake: A decision driven framework for planning fit-forpurpose evidence across stakeholders
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
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
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