Opportunities and challenges surrounding financial models for high-investment medications: A survey of access decision-makers and employers

BACKGROUND: As an increasing number of cell and gene therapies are US Food and Drug Administration approved, health care stakeholders are attempting to strike a balance between patient access to innovative treatments and overall affordability. Access decision-makers and employers are evaluating how implementation of innovative financial models can support coverage of high-investment medications. OBJECTIVE: To understand how access decision-makers and employers are using innovative financial models for highinvestment medications. METHODS: A survey was conducted with access and employer decision-makers recruited from a proprietary database of market access decision-makers from April 1 to August 29, 2022. Respondents were asked about their experiences using innovative financing models for high-investment medications. RESULTS: Across both stakeholder segments, stop-loss/reinsurance was the most utilized financial model, with 65% of access decision-makers and 50% of employers currently using this financial model. More than half (55%) of access decision-makers and nearly one-third of employers (30%) currently use a provider contract negotiation strategy, with similar percentages of access decision-makers (20%) and employers (25%) planning to implement this strategy in the future. Aside from stop-loss/reinsurance and provider contract negotiation, no other financial models exceeded 25% penetration in the employer market. Subscription models and warranties were the least common models currently used by access decision-makers (10% and 5%, respectively). The greatest growth for access decision-makers is expected for annuities, amortization or installment strategies, outcomes-based annuities, and warranties, with 55% of access decision-makers planning to implement each. Few employers are seeking to implement new financial models in the next 18 months. Both segments prioritized financial models that can address the actuarial or financial risk arising from uncertainty in the number of patients likely to be treated with a durable cell or gene therapy. Many access decision-makers cited a lack of opportunities from manufacturers as a reason for not using a model, whereas employers also identified lack of information and financial viability as reasons for not using a model. In most cases, both stakeholder segments prefer to work with current partners as opposed to a third party when executing an innovative model. CONCLUSIONS: Access decision-makers and employers are adopting innovative financial models as traditional management techniques are insufficient to manage the financial risk associated with highinvestment medications. Although both stakeholder segments see a need for alternative payment models, they also recognize the challenges and complexity associated with their implementation and execution of these types of partnerships.