Price regulation and competition among on-patent anticancer drugs in Italy

IF 3.6 3区医学 Q1 HEALTH CARE SCIENCES & SERVICES

Health Policy Pub Date : 2025-05-08 DOI:10.1016/j.healthpol.2025.105348

Michele Caimmi , Beatrice Canali , Laura Candelora , Alessandra Di Costanzo , Francesca Fiorentino , Chiara Vassallo , Maria Luisa Mancusi

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Abstract

In recent years, the Italian Medicines Agency has adopted several measures aimed at curbing public pharmaceutical expenditure, including temporary and confidential price reductions, and Managed Entry Agreements. Besides, the Agency plays a pivotal role in price negotiations, serving as a tool for cost containment and financial sustainability for the Italian NHS. Our study aims at testing one potentially relevant channel for pursuing this objective and analyze if the Agency anchors the treatment cost of on-patent market entrants with those of on-patent therapeutic alternatives that previously obtained reimbursement in a given market. Our sample includes 86 anticancer indications which obtained reimbursement in Italy between March 2017 and May 2022, whose marketing authorization was granted under the centralized procedure at European level. Gathering data from multiple sources (drugs Summary of Product Characteristics, their pivotal clinical trials, and an IQVIA database on Italian negotiation dynamics), we identify competing indications within cancer site and treatment line, and then evaluate treatment costs based on median exposure to treatment in pivotal clinical trials. We retrieve prices from hospital expenditure data, which reflect discount negotiated with the regulator, tender, and commercial discounts. Our findings suggest that both the market average and the last reimbursed treatment cost significantly correlate with newly negotiated treatment costs, indicating that earlier negotiation outcomes serve as benchmarks for new ones.

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意大利非专利抗癌药的价格调控与竞争

近年来，意大利药品管理局采取了几项旨在控制公共药品支出的措施，包括临时和保密的降价以及管理准入协议。此外，该机构在价格谈判中发挥关键作用，作为意大利国民保健服务的成本控制和财务可持续性的工具。我们的研究旨在测试实现这一目标的一个潜在相关渠道，并分析fda是否将非专利市场进入者的治疗成本与之前在给定市场上获得报销的非专利治疗替代方案的治疗成本挂钩。我们的样本包括2017年3月至2022年5月期间在意大利获得报销的86种抗癌适应症，其上市许可是根据欧洲一级的集中程序授予的。从多个来源收集数据（药物产品特性摘要、关键临床试验和意大利谈判动态的IQVIA数据库），我们确定癌症部位和治疗线的竞争适应症，然后根据关键临床试验中治疗的中位数暴露来评估治疗成本。我们从医院支出数据中检索价格，这些数据反映了与监管机构谈判的折扣、投标和商业折扣。我们的研究结果表明，市场平均和最后报销的治疗费用与新谈判的治疗费用显著相关，表明早期的谈判结果可以作为新谈判的基准。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Health Policy 医学-卫生保健

CiteScore

6.40

自引率

6.10%

发文量

157

审稿时长

3-8 weeks

期刊介绍： Health Policy is intended to be a vehicle for the exploration and discussion of health policy and health system issues and is aimed in particular at enhancing communication between health policy and system researchers, legislators, decision-makers and professionals concerned with developing, implementing, and analysing health policy, health systems and health care reforms, primarily in high-income countries outside the U.S.A.