{"title":"Factors influencing the reimbursement of cancer drugs in Europe: A scoping review.","authors":"Pelayo Nieto-Gómez, Celia Castaño-Amores","doi":"10.1111/jep.14080","DOIUrl":null,"url":null,"abstract":"<p><strong>Rationale: </strong>Reimbursement process of oncology drugs in Europe occurs within a complex decision-making process that varies between Member States. Distinctions between the States trigger societal debates since it is necessary to balance access to medicines and health systems sustainability.</p><p><strong>Aims and objectives: </strong>We aimed to review the evidence concerning factors associated with the reimbursement decision or Health Technology Agency recommendation of oncology drugs in Europe.</p><p><strong>Methods: </strong>A systematic literature search was performed in two databases from inception to august 2023. Screening and data extraction were performed by pairs.</p><p><strong>Results: </strong>Thirteen articles were included and encompassed data from 11 nations. Seven articles showed that cost-effective (C-E) drugs and lower Incremental Cost-Effectiveness Ratios (ICERs) had higher likelihood of reimbursement. Disease severity might influence the reimbursement decision with financial agreements. Improvement in clinical outcomes, substantial clinical benefit (p < 0.01) or overall survival gains (p < 0.05) were positively associated. Orphan drug designation impact varies between countries but positive decisions are usually achieved under specific conditions. Clinical and C-E uncertainty frequently led to reimbursement with financial agreements or outcomes-based conditions. Sociodemographic factors as: social health insurance system, higher Gross Domestic Product and larger elderly population were positively associated with reimbursement (p < 0.01).</p><p><strong>Conclusion: </strong>There is a need for further research into key determinants of reimbursement decisions in Europe and the development of drug access models that can effectively address and overcome costs and effectiveness uncertainties.</p>","PeriodicalId":15997,"journal":{"name":"Journal of evaluation in clinical practice","volume":null,"pages":null},"PeriodicalIF":2.1000,"publicationDate":"2024-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of evaluation in clinical practice","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1111/jep.14080","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"HEALTH CARE SCIENCES & SERVICES","Score":null,"Total":0}
引用次数: 0
Abstract
Rationale: Reimbursement process of oncology drugs in Europe occurs within a complex decision-making process that varies between Member States. Distinctions between the States trigger societal debates since it is necessary to balance access to medicines and health systems sustainability.
Aims and objectives: We aimed to review the evidence concerning factors associated with the reimbursement decision or Health Technology Agency recommendation of oncology drugs in Europe.
Methods: A systematic literature search was performed in two databases from inception to august 2023. Screening and data extraction were performed by pairs.
Results: Thirteen articles were included and encompassed data from 11 nations. Seven articles showed that cost-effective (C-E) drugs and lower Incremental Cost-Effectiveness Ratios (ICERs) had higher likelihood of reimbursement. Disease severity might influence the reimbursement decision with financial agreements. Improvement in clinical outcomes, substantial clinical benefit (p < 0.01) or overall survival gains (p < 0.05) were positively associated. Orphan drug designation impact varies between countries but positive decisions are usually achieved under specific conditions. Clinical and C-E uncertainty frequently led to reimbursement with financial agreements or outcomes-based conditions. Sociodemographic factors as: social health insurance system, higher Gross Domestic Product and larger elderly population were positively associated with reimbursement (p < 0.01).
Conclusion: There is a need for further research into key determinants of reimbursement decisions in Europe and the development of drug access models that can effectively address and overcome costs and effectiveness uncertainties.
期刊介绍:
The Journal of Evaluation in Clinical Practice aims to promote the evaluation and development of clinical practice across medicine, nursing and the allied health professions. All aspects of health services research and public health policy analysis and debate are of interest to the Journal whether studied from a population-based or individual patient-centred perspective. Of particular interest to the Journal are submissions on all aspects of clinical effectiveness and efficiency including evidence-based medicine, clinical practice guidelines, clinical decision making, clinical services organisation, implementation and delivery, health economic evaluation, health process and outcome measurement and new or improved methods (conceptual and statistical) for systematic inquiry into clinical practice. Papers may take a classical quantitative or qualitative approach to investigation (or may utilise both techniques) or may take the form of learned essays, structured/systematic reviews and critiques.