The activities of payers, patients, providers, and developers are inherently interrelated in delivering access to CGTs.

• Providers must be credentialed to deliver care, contracted to participate in the network. They must also define payment terms and maintain or acquire patients.
• Payers must establish networks of care, contract with providers, define patient benefits, determine their own financial solutions, and potentially monitor outcomes even after patient disenrollment.
• Patients must seek approved providers, adjust to limitations of benefit terms, and potentially participate in outcomes monitoring, even after disenrolling from a payer’s coverage.
• Developers must determine safe administration requirements of providers, potentially establish Centers of Excellence, and potentially define outcome measures with payers as well as patient supports.

FoCUS discussions have highlighted additional considerations for the stakeholders as they think through complete solutions to enable sustainable patient access to these therapies.

This section provides an overview of several key issues.