Potential Risk-Sharing Agreements for Vaccines

Insurance-based risk-sharing agreements

Stretched healthcare budgets have been tensing up patient access negotiations between healthcare payers and manufacturers. Data and the associated evidence available at registration are often deemed insufficient to accurately estimate the real-life clinical outcomes and budget impact. Payers want to reduce budget uncertainty and manufacturers need to evolve in a competing healthcare environment...

Risk sharing agreements: what lessons from Italy?

Italy is one of the few countries that have matured substantial experience of risk-sharing agreements so far. The first performance-based arrangement was agreed in July 2006, and as of October 2010, eighteen contracts have been in force.The complex management of discount schemes is entirely based on Web registries run by AIFA, the Italian drug agency. The system validates each prescription and ...

Risk-sharing Agreements: Country Experiences and Challenges

Potential Vaccines for Treating Crohn\'s Disease

Crohn's disease (CD) is an inflammatory disease of the gastrointestinal tract (GIT) tract and can affect several parts of the digestive system. There is a relationship between impaired mucosal barrier in the GIT of inflammatory bowel disease patients and the role of bacteria such as Mycobacterium avium paratuberculosis in CD. Apart from different therapeutic approaches for treating CD, developm...

Health-based pharmaceutical pay-for-performance risk-sharing agreements

Many new drugs, such as biologics and cancer drugs, are very costly. However, their effectiveness outside of clinical trial settings is often uncertain at the time they gain market approval. This uncertainty may reflect a lack of real-world outcomes data, as opposed to clinical trials data, for a typical patient population. A risk-sharing agreement is a contract between a drug manufacturer and ...