Document Library

TitleContentCategoriesLink
Barriers and Enablers for Outcomes-based Agreements: An International ReviewA summary of international experience with the implementation of outcomes-based agreements.View
Innovative Funding Models for Reimbursement of Advanced Therapy Medicinal Products (ATMPs)A reference for payers and manufacturers who are considering entering negotiations for ATMP reimbursement.View
Risk Assessment FrameworkA risk assessment framework for the identification of innovative therapeutics that may require an innovative …View
Outcomes-Based Managed Access Agreement ContractAn outcomes-based managed access agreement contract template that can be customized and tailored.View
Patient Information and Consent FormSample patient information and consent form for a managed access agreement.View
Physician Liability Under Managed Access AgreementsOverview of legal and ethical considerations for physicians providing care for patients under managed access …View
Manual for Developing Real-World Evidence (RWE)Practical guidance on developing a comprehensive and integrated real-world evidence (RWE) generation program.View