OBJECTIVES: Advanced Therapy Medicinal Products (ATMPs) offer potential cures for previously untreatable diseases, but their substantial costs and uncertain long-term outcomes present significant affordability challenges for healthcare payers that may not be met through conventional financing models. This study aimed to identify and analyze emerging trends in the adoption of alternative financing models (AFMs) for high-cost ATMPs and characterize factors associated with their use.

METHODS: We conducted a comprehensive scoping review of English-language literature published since January 1, 2019. Articles discussing AFMs and their adoption trends were included. Data were extracted using a standardized form, capturing verbatim extracts from relevant discussions. These extracts were then analyzed to identify descriptive and overarching analytic themes related to AFM adoption.

RESULTS: From 127 identified articles, 34 were included in the review. Most articles focused on the US market, while European perspectives were often limited to individual patient-level outcome-based payment models. The most frequently utilized financial model was stop-loss/reinsurance, aimed at preventing catastrophic spending in response to unforeseen demand. Other models included expanded risk-pooling, patient 'carve-out' to Orphan Reinsurer Benefit Managers, and subscription arrangements with ATMP manufacturers. Key drivers of AFM adoption include the increasing number of approved ATMPs, actuarial risk and surge protection, a desire for predictability in plan costs, familiarity with reinsurance products, and a shift to population-level financing solutions for high-cost medicines. Commonly cited barriers to AFM adoption include costs, administrative burden, regulatory hurdles, and lack of manufacturer engagement.

CONCLUSIONS: Despite the complexities involved, AFMs for high-investment therapies such as ATMPs are likely to become more prevalent as an increasing number of products reach the market and payers struggle to meet healthcare demands. Future research should aim to assess the impact of AFMs on patient access to ATMPs.