Working around the issues

Payer considerations in providing access to cell and gene therapy (CGT) roughly fall into two categories: those related to administration and management of a therapy, and those related to implementing precision financing solutions.

Key therapy administration and management topics to consider:

Treatment facility requirements
Center of Excellence requirements
Geographic coordination challenges
Provider reimbursement development and contracting
Pre- and post-treatment clinical care requirements

Key financing solution topics to consider:

Actuarial capabilities and risk acceptance
Developer performance-based contracts
Identification of performance metrics
Collection of performance data
Patient tracking over time
Patient mobility management
Comparing collected data to performance criteria
Collection of any performance-based rebates and/or payments

Payers should identify solution design requirements in advance and lay out general internal expectations and policy principles to enable operational preparation and resource availability.

Below are operational elements FoCUS participants have identified for consideration.

Element	Sub-elements
Performance contract design	How will we track outcomes over time? How will we handle patient mobility?
Delivery networks and policies	Will we require provider certification? Will COEs be used or needed? Will out-of-state networks be needed?
Provider reimbursement	Do we need to adapt any provider reimbursement elements? Will we need to clarify reimbursement coding? How do we want to handle these therapies as part of any buy-and-bill reimbursement we have?
Benefit design and coding	Do we need to adapt our benefit design? How will we handle patient copays and other patient financial implications?

An illustration of access issues and efforts to overcome the barriers is outlined in the Catalyst Implementation Brief: Understanding access issues for new therapies.

Market solutions for access

It may not be efficient for all insurers to build capabilities internally to serve CGT patients or establish their own contracts with providers and manufacturers. Market solutions are emerging to efficiently address the required capabilities. This white paper shares results from a survey of currently known market solution providers, published in June 2021.

The list below shares multiple commercial product categories that are available to support CGT access. When payers are unable to support financial solutions without external resources, developers may wish to consider contract terms that support the efficient execution of finance solutions with developing suppliers.

Category	Characteristics of the products
Payer reinsurance/stop loss/ risk carve-out solutions	Specified CGT or other high-cost therapies are carved out of financial responsibility or risk. May or may not have financial attachment points; carve-out is specific to the covered therapy and not total patient medical and drug costs. Do not offer performance guarantees, but assume all actuarial/financial risk
Contract negotiation and data management services for payers and pharmaceutical companies	Act as third parties to negotiate contracts for CGTs. Provide data/outcomes tracking services Contracts may include performance guarantees, but the service companies themselves do not assume financial risk
Provider contract negotiation services	Oriented towards providers and patient care pathways Multiple services offered, including COE network creation and contracting, data analytics, and cost containment Performance guarantees are oriented towards clinical services and outcomes rather than financial guarantees
Financial and pharmaceutical company warranty services	Includes payment plans, with or without performance guarantees. Warranties for purchase by pharmaceutical companies that can provide protection to payers for suboptimal product performance.