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
How can self-insured employers prepare for the portfolio impact of highcost gene therapies coming to market?
Share the researchSelf-insured employers (SIEs) currently rely on traditional stop-loss insurance to protect against unexpected high-cost claims, including those for cell and gene therapies. Given that current approvals are in … Read More
Precision for Whom? Partnering with patients to ensure that Precision Medicine targets what matters
Despite decades of growth and adaptation in patient engagement, knowing or being able to find guidance for whichmodel or approach will be most impactful in which healthcare or research context … 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
The resource navigation challenges for patients and caregivers
Share the researchWhile the problem of finding system-wide, implementable precision financing models for curative and durable therapies involves all stakeholders, patients and caregivers are directly affected by many different elements … Read More
Updated projection of US durable cell and gene therapies product-indication approvals based on December 2019 development pipeline
Ongoing pipeline modeling by the MIT NEWDIGS FoCUS team projects 10X growth from July 2020 levels, but with large uncertainties. Download FoCUS Research Brief 2020F207v51Share the research
Downstream Innovation Part II
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