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Targeted combination therapies in oncology: Challenging regulatory frameworks designed for monotherapies in Europe

Vancoppenolle, Julie M. ; Koole, Simone N. ; O'Mahony, James F. ; Franzen, Nora ; Burgers, Jacobus A. ; Retèl, Valesca P. ; van Harten, Willem H.

Drug discovery today, 2023-08, Vol.28 (8), p.103620-103620, Article 103620 [Periódico revisado por pares]

England: Elsevier Ltd

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  • Título:
    Targeted combination therapies in oncology: Challenging regulatory frameworks designed for monotherapies in Europe
  • Autor: Vancoppenolle, Julie M. ; Koole, Simone N. ; O'Mahony, James F. ; Franzen, Nora ; Burgers, Jacobus A. ; Retèl, Valesca P. ; van Harten, Willem H.
  • Assuntos: access ; Costs and Cost Analysis ; Europe ; Humans ; lung cancer ; Lung Neoplasms ; Medical Oncology ; Melanoma ; pricing and reimbursement ; research and development ; targeted combination therapy
  • É parte de: Drug discovery today, 2023-08, Vol.28 (8), p.103620-103620, Article 103620
  • Notas: ObjectType-Article-1
    SourceType-Scholarly Journals-1
    ObjectType-Feature-2
    content type line 23
  • Descrição: •Inequality in access to targeted combination therapies (TCTs) across EU-countries.•The pharmaceutical value chain tailored to monotherapies presents barriers to TCTs.•We survey access & identify regulatory challenges to TCTs in 9 EU-countries.•The current pharmaceutical environment fails to incentivize financially sustainable development of TCTs.•Recommendations to close regulatory gaps in R&D and P&R process to improve access. The pharmaceutical value chain, including clinical trials, pricing, access, and reimbursement, is designed for classical monotherapies. Although there has been a paradigm shift that increases the relevance of targeted combination therapies (TCTs), regulation and common practice have been slow to adapt. We explored access to 23 TCTs for advanced melanoma and lung cancer as reported by 19 specialists from 17 leading cancer institutions in nine European countries. We find heterogeneous patient access to TCTs between countries, differences in country-specific regulations, and differences in the clinical practice of melanoma and lung cancer. Regulation that is better tailored to the context of combinational therapies can increase equity in access across Europe and promote an evidence-based and authorized use of combinations.
  • Editor: England: Elsevier Ltd
  • Idioma: Inglês
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  • Realização: ABCD-USP USP   Logos de Redes Sociais: Freepik

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