Mahjoub R, Odegaard F, Zaric GS. Health-based agreements on the distribution of risks for performance-based drugs. J Opera Res Soc. 2014;65 (4):588-604. Antonanzas F, Juarez-Castello C, Rodriguez-Ibeas R. Should health authorities offer risk-sharing contracts to pharmaceutical companies? A theoretical approach. Health Econ Policy Law. 2011;6 (3):391-403. Walker S, Sculpher M, Claxton K, Palmer S.
Coverage with evidence development, only in research, risk distribution or patient access scheme? A framework for hedging decisions. Health value. 2012;15(3):570–9. The first agreement between the Commonwealth and a sponsor was held in 1998 to minimize the government`s exposure to the risks associated with the inclusion of a new drug on PBS. Prior to 2003, the agreements were formalized by an exchange of letters. In 2003, the Department entered into agreements to better understand the negotiated terms of these risk-sharing agreements. Kanavos P, Ferrario A, Tafuri G, Siviero P. Manage risks and uncertainty in the introduction of health technology: the role of managed entry agreements. The Glob Directive.
2017;8( S2:84-92. Barros PP. The simple cost-effectiveness of risk-sharing agreements between the NHS and the pharmaceutical industry. Econ Health. 2011;20(4):461–70. Common agreements are required when PBAC recommends the addition of a new drug to the list or an extension of an existing list on PBS for the same intentional population as an existing drug that already has a fact. In this case, the new drug will become a “new drug” for the purposes of the original act and, in most cases, it will become a fact and subject to the same rules as those in effect. Pickin M, Cooper CL, Chater T, O`Hagan A, Abrams KR, Cooper NJ, et al. The multiple sclerosis risk-sharing system monitors the results of studies and lessons for the future. BMC Neurol. 2009;9:1. Launois R, Ethgen O.
Risk-Sharing Agreements: Choice of study design and assessment criteria. Ann Pharm Fr. 2013;71(5):346-57. RSA`s actions were designed to address several types of risks. The most common types of risks are described below. There is a basic action document (annexed to these guidelines) which is then adapted to each specific list to include specific price agreements and risk-sharing agreements. Below is a non-exhaustive list of certain types of general agreements: AIFA Agenzia Italiana del Farmaco. www.aifa.gov.it/content/comunicazioni-managed-entry-agreements-mea. Access 4 m. 2019. Zaric GS, Zhang H, Mahjoub R. Modeling Risk Sharing Agreements and Patient Access Systems.
In: Zaric G, editor. Business research and health policy. International series in operations Research and Management Science, Bd.