Financial tools and policy

The reimbursement of cell and gene therapies (CGTs) is challenging the US healthcare market. Considering the pricing of CGTs approved thus far, the acute cost of the numerous pipeline products likely to launch soon may be substantial for payers. This cost, in addition to the lack of long-term clinical durability data, could mean that payers will be reluctant to fund these types of therapies, which could have serious negative consequences for patients.

The FoCUS project has examined issues that relate to the launch of cell and gene therapies. FoCUS stakeholders have identified precision financing tools with unique properties that make them more or less appropriate for use in different situations associated with this new class of drugs. Preferred financial solutions vary depending on specific case factors, including cure characteristics, treatment indication and the type of payers (“precision financing”). Most solutions relate to issues that arise between payers, developers and sometimes providers, with the need at times for performance-related payments.

This toolkit is organized to first help your organization become knowledgeable about the CGT pipeline , the Precision Financing Solutions,  and the solution implementation challenges. Government policy and regulations in five key areas further define potential challenges. With this background you can evaluate your needs, customize your precision financing options, consider your implementation challenges and arrive at a preferred solution design for your situation.