OBJECTIVES: Outcome-based agreements (OBAs) have gained prominence as a pricing and reimbursement strategy for innovative pharmaceuticals. These agreements link reimbursement to real-world clinical outcomes, aiming to align financial risk with therapeutic value. However, the impact of OBAs on time to patient access remains an area of debate. Our study aimed to assess whether OBAs influence time to market access for novel therapies across key Health Technology Assessment (HTA) countries in the European Union (EU) and Canada.

METHODS: We conducted a comprehensive analysis on OBAs by linking the Lyfegen Agreements Library with NAVLIN Pricing & Market Access Databases. Our study focused on:

• Agreement Identification: Identified recent launches or new indications with OBAs that can be linked between databases.
• Geographic Scope: Key HTA countries in the EU and Canada.
• Case Study Drugs: Selected a pool of drugs that are reimbursed through OBAs in certain countries and non-OBA reimbursement in others to compare time to access.
• Type of OBA: Stratified results by type of OBA
• Exclusion Criteria: Assets in the Cell & Gene Therapy

RESULTS: Preliminary findings indicate that OBAs impact time to access in several ways. In countries where OBAs are implemented, time to patient access is often expedited. These agreements facilitate early access by providing conditional reimbursement based on real-world evidence. Negotiating and implementing OBAs can be time-consuming, and this has resulted in a blend of OBA types being employed by different countries (e.g., Fixed Discount/Rebate, Coverage with Evidence Development, Budget Cap, Outcome Guarantees). Early access pathways vary by country, impacting the utilization of OBAs between countries.

CONCLUSIONS: Our study sheds light on the role of OBAs in shaping time to access novel therapies on Key HTA countries in the EU and Canada. Understanding the interplay between OBAs, HTA processes, and time to access is crucial for optimizing patient access while ensuring sustainability.