Miquel Serra-Burriel, Nicolau Martin-Bassols, Gellért Perényi, Kerstin N Vokinger
{"title":"Drug Prices After Patent Expirations in High-Income Countries and Implications for Cost-Effectiveness Analyses.","authors":"Miquel Serra-Burriel, Nicolau Martin-Bassols, Gellért Perényi, Kerstin N Vokinger","doi":"10.1001/jamahealthforum.2024.2530","DOIUrl":null,"url":null,"abstract":"<p><strong>Importance: </strong>Understanding how patent expirations affect drug prices is crucial because price changes directly inform accurate cost-effectiveness assessments. This study investigates the association between patent expirations and drug prices in 8 high-income countries and evaluates how the changes affect cost-effectiveness assessments.</p><p><strong>Objective: </strong>To analyze how the expiration of drug patents is associated with drug price changes and to assess the implications of these price changes for cost-effectiveness evaluations.</p><p><strong>Design, setting, and participants: </strong>This cohort study performed an event study design using data from 8 high-income countries to assess the association between patent expiration and drug prices, and created a simulation model to understand the implications for cost-effectiveness analyses. The simulation cost-effectiveness model analyzed the implications of including or ignoring postpatent price dynamics.</p><p><strong>Exposure: </strong>Drug patent expiration.</p><p><strong>Main outcomes and measures: </strong>Change in drug prices and differences in incremental cost-effectiveness ratios when considering vs ignoring postpatent price dynamics.</p><p><strong>Results: </strong>The sample comprised 505 drugs undergoing patent expiration in Australia, Canada, France, Germany, Japan, Switzerland, UK, and US. Price decreases were statistically significant over the 8 years after patent expiration, with the fastest price declines observed in the US: 32% (95% CI, 24%-39%) in year 1 after patent expiration and 82% (95% CI, 71%-89%) in the 8 years after patent expiration. Estimates for other nations ranged from a decrease of 64% in Australia to 18% in Switzerland in the 8 years after expiration. The cost-effectiveness simulation model indicated that not accounting for generic entry into the market may produce biased incremental cost-effectiveness ratios of 40% to -40%, depending on the scenario.</p><p><strong>Conclusions and relevance: </strong>The findings of this cohort study demonstrate that drug prices were reduced substantially after patent expirations in high-income countries. Therefore, incorporating information on patent status and pricing dynamics in cost-effectiveness assessment analyses is necessary for producing accurate economic evaluations of new drugs.</p>","PeriodicalId":53180,"journal":{"name":"JAMA Health Forum","volume":null,"pages":null},"PeriodicalIF":9.5000,"publicationDate":"2024-08-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11329876/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"JAMA Health Forum","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1001/jamahealthforum.2024.2530","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"HEALTH CARE SCIENCES & SERVICES","Score":null,"Total":0}
引用次数: 0
Abstract
Importance: Understanding how patent expirations affect drug prices is crucial because price changes directly inform accurate cost-effectiveness assessments. This study investigates the association between patent expirations and drug prices in 8 high-income countries and evaluates how the changes affect cost-effectiveness assessments.
Objective: To analyze how the expiration of drug patents is associated with drug price changes and to assess the implications of these price changes for cost-effectiveness evaluations.
Design, setting, and participants: This cohort study performed an event study design using data from 8 high-income countries to assess the association between patent expiration and drug prices, and created a simulation model to understand the implications for cost-effectiveness analyses. The simulation cost-effectiveness model analyzed the implications of including or ignoring postpatent price dynamics.
Exposure: Drug patent expiration.
Main outcomes and measures: Change in drug prices and differences in incremental cost-effectiveness ratios when considering vs ignoring postpatent price dynamics.
Results: The sample comprised 505 drugs undergoing patent expiration in Australia, Canada, France, Germany, Japan, Switzerland, UK, and US. Price decreases were statistically significant over the 8 years after patent expiration, with the fastest price declines observed in the US: 32% (95% CI, 24%-39%) in year 1 after patent expiration and 82% (95% CI, 71%-89%) in the 8 years after patent expiration. Estimates for other nations ranged from a decrease of 64% in Australia to 18% in Switzerland in the 8 years after expiration. The cost-effectiveness simulation model indicated that not accounting for generic entry into the market may produce biased incremental cost-effectiveness ratios of 40% to -40%, depending on the scenario.
Conclusions and relevance: The findings of this cohort study demonstrate that drug prices were reduced substantially after patent expirations in high-income countries. Therefore, incorporating information on patent status and pricing dynamics in cost-effectiveness assessment analyses is necessary for producing accurate economic evaluations of new drugs.
期刊介绍:
JAMA Health Forum is an international, peer-reviewed, online, open access journal that addresses health policy and strategies affecting medicine, health, and health care. The journal publishes original research, evidence-based reports, and opinion about national and global health policy. It covers innovative approaches to health care delivery and health care economics, access, quality, safety, equity, and reform.
In addition to publishing articles, JAMA Health Forum also features commentary from health policy leaders on the JAMA Forum. It covers news briefs on major reports released by government agencies, foundations, health policy think tanks, and other policy-focused organizations.
JAMA Health Forum is a member of the JAMA Network, which is a consortium of peer-reviewed, general medical and specialty publications. The journal presents curated health policy content from across the JAMA Network, including journals such as JAMA and JAMA Internal Medicine.