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
Pediatric Gene Therapy Launches
Gene therapy cures for hereditary genetic conditions are likely to reach the United States market in the coming decades. Several disease areas with potential cures are orphan conditions, which affect … Read More
Patient & Caregiver Themes Survey
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
Incorporation of Value-Based Payment Agreements into the Calculation of Medicaid Drug Rebates
Value-Based Payment (VBP) agreements will play an important role in mitigating uncertainty in durable therapies, where it is unclear whether a large upfront payment is justified based on limited clinical … Read More
Clinical trials and investment trends for novel CAR-T and TCR therapies
Compared to small-molecule therapies, the nature of CAR-T/TCR therapies is such that they can be diversified with lower probability of failure in the clinic. Many companies and academic entities are … Read More
Model Contracts for Innovative Oncology Therapies
When there is substantial uncertainty about a new product’s expected value, stakeholders may have strong reasons to consider performance-based contracts. One of the hardest tasks in crafting such contracts is … Read More