Implementation Brief: Innovative contracting 101

Eric NormanFoCUS, Implementation Briefs

This brief provides an introduction to innovative contracts, or value-based contracts, which may be used to facilitate access to innovative, high-cost treatments. These contracts can address uncertainty around treatments and … Read More

Implementation Brief: Access considerations for innovative treatments

Eric NormanFoCUS, Implementation Briefs

This brief offers a checklist of key steps that different stakeholders should consider to ensure patients have access to innovative treatments. These therapies present unique challenges for different stakeholders and … Read More

Implementation Brief: Key terms for payment innovation

Eric NormanFoCUS, Implementation Briefs

This brief provides definitions of key terms that are often used in discussions about designing and implementing innovative payment solutions. It offers an overview of solution models, types of risk, … Read More

Implementation Brief: Considerations for developers in applying the Multiple Best Price (MBP) rule to improve access to novel therapies

Eric NormanFoCUS, Implementation Briefs

This brief highlights some key steps and considerations for biopharmaceutical developers of novel, high-value therapies seeking to successfully implement CMS’s Multiple Best Price rule. The rule, which went into effect … Read More

Implementation Brief: Understanding access issues for new therapies

Eric NormanFoCUS, Implementation Briefs

Our first implementation brief outlines several major barriers to patient access for novel cell and gene therapies. It also describes how providers, payers, and developers may overcome these barriers, with … Read More

Are Cell and Gene Therapy programs a better bet?

Eric NormanFoCUS, Research Briefs

Compared to traditional drug development programs, do durable cell and gene therapy (CGT) programs experience higher or lower clinical success rates? Estimating the Probability of Technical and Regulatory Success (PTRS) … 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

How can self-insured employers prepare for the portfolio impact of highcost gene therapies coming to market?

Eric NormanFoCUS, Research Briefs

Self-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 rare diseases, … 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