PP51 pharmaceutical innovativeness index (PII): a new framework for assessing health technology innovation based on therapeutic and social relevance

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dc.creatorLudmila Peres Gargano
dc.creatorAriane André
dc.creatorIsabela Freitas
dc.creatorFrancisco de Assis Acurcio
dc.creatorJuliana Alvares Teodoro
dc.creatorAugusto Afonso Guerra Júnior
dc.date.accessioned2026-01-16T19:05:30Z
dc.date.issued2025-01-07
dc.descriptionPôster apresentado no HTAi 2024, encontro que ocorreu em Sevilha, na Espanha.
dc.identifier.doihttps://doi.org/10.1017/S0266462324002228
dc.identifier.issn1471-6348
dc.identifier.urihttps://hdl.handle.net/1843/1436
dc.languageeng
dc.publisherUniversidade Federal de Minas Gerais
dc.relation.ispartofInternational Journal of Technology Assessment in Health Care
dc.rightsAcesso aberto
dc.subjectTecnologia farmacêutica
dc.subject.otherInovação farmacêutica
dc.subject.otherInovação tecnológica em saúde
dc.subject.otherRelevância terapêutica
dc.subject.otherRelevância social
dc.titlePP51 pharmaceutical innovativeness index (PII): a new framework for assessing health technology innovation based on therapeutic and social relevance
dc.typeArtigo de periódico
local.description.resumoIntroduction The value of a new pharmaceutical product should rely on its therapeutic benefits while also considering social health needs. Adapting health technology assessment (HTA) tools, we propose a transparent framework, with well-defined criteria and script, to determine the value of innovation (i.e., innovativeness) with clinical and methodological parameters, based on the social relevance and therapeutic value of new medicines. Methods The study was developed by adapting HTA-based methods identified in the literature: the Italian Medicines Agency (AIFA) and the EValuation of pharmaceutical Innovations with regard to Therapeutic Advantage (EVITA) tool. A sample of oncology drugs approved by the U.S. Food and Drug Administration (FDA) between 2011 and 2021 were assessed by researchers trained in HTA tools using those methods. After assessing the sample, researchers discussed the results, difficulties, and issues experienced. Those issues were addressed, resulting in the creation of the new framework, which included the redefinition of domains, definition of classification criteria for each domain, and scores according to relevance. Results The Pharmaceutical Innovativeness Index (PII) was proposed, with a script, domains, criteria, and an algorithm. The evaluation begins defining indication, outcomes, therapeutic alternatives, time perspective, and data sources. Four domains were considered: Therapeutic Need, which evaluates the existence and benefits of alternatives; Added Therapeutic Value, which talks about the incremental clinical benefit when compared to those alternatives (these first two domains were graded into five levels ranging from absent to maximum); Study Design and Methodological Quality, both classified into three levels. Classification criteria for each domain can be adapted according to the indication and relevant outcomes. Conclusions The PII framework considers clinical and social value weighted by methodological limitation of available evidence to determine the value of innovation of pharmaceutical products. It stands out as a transparent, adaptable, and reproducible tool that aims to reduce the subjectivity of analyses and assist with decision-making. PII has the potential to inform decision-making processes involving value-based pricing, reimbursement, and research and development investment.
local.publisher.countryBrasil
local.publisher.departmentFAR - DEPARTAMENTO DE FARMÁCIA SOCIAL
local.publisher.initialsUFMG
local.subject.cnpqCIENCIAS DA SAUDE
local.url.externahttps://www.cambridge.org/core/journals/international-journal-of-technology-assessment-in-health-care/article/pp51-pharmaceutical-innovativeness-index-pii-a-new-framework-for-assessing-health-technology-innovation-based-on-therapeutic-and-social-relevance/0B37C2F23906D66F61C9A9E671034B1A

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