Federico Villa1, Michaela Tutone2, Gianluca Altamura3, Sara Antignani3, Agnese Cangini3, Ida Fortino3, Mario Melazzini3, Francesco Trotta3, Giovanni Tafuri3, Claudio Jommi4. 1. Italian Medicines Agency (AIFA), Via del Tritone, 181 - 00187, Rome, Italy; Department of Pharmaceutical Sciences, Università del Piemonte Orientale, Largo Guido Donegani, 2 - 28100, Novara, Italy. Electronic address: federico.villa@uniupo.it. 2. Italian Medicines Agency (AIFA), Via del Tritone, 181 - 00187, Rome, Italy; Utrecht University, Heidelberglaan 8, 3584 CS Utrecht, NL. 3. Italian Medicines Agency (AIFA), Via del Tritone, 181 - 00187, Rome, Italy. 4. Professor of Practice, Government, Health and Not for Profit Division, SDA Bocconi School of Management, Via Bocconi 8, 20136, Milan, Italy.
Abstract
OBJECTIVES: The aim of this paper is to investigate the determinants of the difference between the price proposal submitted by the industry and the final negotiated price. We used Italy as a case-study. METHODS: Data were gathered through the information system used by Italian Medicines Agency. The time-frame for this analysis is 2013-2017. Factors influencing the delta price were analyzed through a regression analysis. RESULTS: 44 orphan drugs and 89 new other molecular entities obtained reimbursement in the last five years. Following the negotiation process, prices were lowered by 25.1% and 28.6% on average for orphan drugs and other molecules respectively. The price reduction was higher for innovative drugs (-32.2%). Statistically significant determinants associated to higher price reduction were: i) the implementation of a product specific monitoring registry, ii) the negotiation of a financial-based Managed Entry Agreement, iii) a target population larger than 20,000 patients, iv) an expected National Health Service expenditure larger than €200 million. DISCUSSION: The impact of some variables on the delta price was predictable (e.g. for drugs with an expected higher budget impact and a larger population target), others were more surprising (e.g. a significant price reduction for "innovative" drugs). The implementation of financial-based agreements, which often rely on confidential arrangements, was one of the determinants with higher impact on price reduction.
OBJECTIVES: The aim of this paper is to investigate the determinants of the difference between the price proposal submitted by the industry and the final negotiated price. We used Italy as a case-study. METHODS: Data were gathered through the information system used by Italian Medicines Agency. The time-frame for this analysis is 2013-2017. Factors influencing the delta price were analyzed through a regression analysis. RESULTS: 44 orphan drugs and 89 new other molecular entities obtained reimbursement in the last five years. Following the negotiation process, prices were lowered by 25.1% and 28.6% on average for orphan drugs and other molecules respectively. The price reduction was higher for innovative drugs (-32.2%). Statistically significant determinants associated to higher price reduction were: i) the implementation of a product specific monitoring registry, ii) the negotiation of a financial-based Managed Entry Agreement, iii) a target population larger than 20,000 patients, iv) an expected National Health Service expenditure larger than €200 million. DISCUSSION: The impact of some variables on the delta price was predictable (e.g. for drugs with an expected higher budget impact and a larger population target), others were more surprising (e.g. a significant price reduction for "innovative" drugs). The implementation of financial-based agreements, which often rely on confidential arrangements, was one of the determinants with higher impact on price reduction.
Authors: Cong Huang; Carolina Oi Lam Ung; Haishaerjiang Wushouer; Lin Bai; Tao Huang; Xinyi Li; Xiaodong Guan; Luwen Shi Journal: Health Res Policy Syst Date: 2022-01-03
Authors: Federico Villa; Aurora Di Filippo; Andrea Pierantozzi; Armando Genazzani; Antonio Addis; Gianluca Trifirò; Agnese Cangini; Giovanni Tafuri; Daniela Settesoldi; Francesco Trotta Journal: Front Med (Lausanne) Date: 2022-02-17