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

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

doi:10.1016/j.drudis.2023.103620

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

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

^*Corresponding author for this work

Health Technology Assessment (HTA)

Netherlands Cancer Institute
University of Twente
Centre for Health Policy and Management, Trinity College Dublin
Organization of European Cancer Institutes, Brussels
The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Organisation of European Cancer Institutes (OECI)
Organization of European Cancer Institutes (OECI)

Research output: Contribution to journal › Short survey › Academic › peer-review

5 Citations (Scopus)

94 Downloads (Pure)

Abstract

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.

Original language	English
Article number	103620
Pages (from-to)	1-5
Number of pages	5
Journal	Drug Discovery Today
Volume	28
Issue number	8
DOIs	https://doi.org/10.1016/j.drudis.2023.103620
Publication status	Published - Aug 2023

Bibliographical note

Funding Information:
We are sincerely grateful to all participating oncologists, the European Fair Pricing Network (EFPN), and the Organisation of European Cancer Institutes. The project was funded by the EFPN. J.F.O'M. is supported by Ireland's Health Research Board (EIA-2017-054). The project has been funded by the EFPN. JFOM is supported by Ireland's Health Research Board (EIA-2017-054).

Publisher Copyright:
© 2023 The Authors

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This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

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1-s2.0-S1359644623001368-mainFinal published version, 444 KBLicence: CC BY-NC-ND

Cite this

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title = "Targeted combination therapies in oncology: Challenging regulatory frameworks designed for monotherapies in Europe",

abstract = "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.",

author = "Vancoppenolle, \{Julie M.\} and Koole, \{Simone N.\} and O'Mahony, \{James F.\} and Nora Franzen and Burgers, \{Jacobus A.\} and Ret{\`e}l, \{Valesca P.\} and \{van Harten\}, \{Willem H.\}",

note = "Funding Information: We are sincerely grateful to all participating oncologists, the European Fair Pricing Network (EFPN), and the Organisation of European Cancer Institutes. The project was funded by the EFPN. J.F.O'M. is supported by Ireland's Health Research Board (EIA-2017-054). The project has been funded by the EFPN. JFOM is supported by Ireland's Health Research Board (EIA-2017-054). Publisher Copyright: {\textcopyright} 2023 The Authors",

year = "2023",

month = aug,

doi = "10.1016/j.drudis.2023.103620",

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AU - Vancoppenolle, Julie M.

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AU - O'Mahony, James F.

AU - Franzen, Nora

AU - Burgers, Jacobus A.

AU - Retèl, Valesca P.

AU - van Harten, Willem H.

N1 - Funding Information: We are sincerely grateful to all participating oncologists, the European Fair Pricing Network (EFPN), and the Organisation of European Cancer Institutes. The project was funded by the EFPN. J.F.O'M. is supported by Ireland's Health Research Board (EIA-2017-054). The project has been funded by the EFPN. JFOM is supported by Ireland's Health Research Board (EIA-2017-054). Publisher Copyright: © 2023 The Authors

PY - 2023/8

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N2 - 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.

AB - 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.

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SN - 1359-6446

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ER -

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

Abstract

Bibliographical note

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