Essential cancer medicines: adding feasibility to the magnitude of clinical benefit value chain

F Roitberg; T Amaral; N I Cherny; R Giuliani; N J Latino; M Galotti; G Bricalli; G Curigliano; G Pentheroudakis; D Trapani

doi:10.1016/j.esmoop.2023.101617

Essential cancer medicines: adding feasibility to the magnitude of clinical benefit value chain

ESMO Open. 2023 Oct;8(5):101617. doi: 10.1016/j.esmoop.2023.101617. Epub 2023 Sep 4.

Authors

F Roitberg¹, T Amaral², N I Cherny³, R Giuliani⁴, N J Latino⁵, M Galotti⁶, G Bricalli⁷, G Curigliano⁸, G Pentheroudakis⁹, D Trapani¹⁰

Affiliations

¹ Hospital Sírio Libanês, São Paulo, Brazil. Electronic address: feliperoit@gmail.com.
² Interdisciplinary Skin Cancer Center, Department of Dermatology, University Medical Centre Tübingen, Tübingen, Germany. Electronic address: https://twitter.com/TeresaSAmaral.
³ Department of Medical Oncology, Shaare Zedek Medical Center, Jerusalem, Israel. Electronic address: https://twitter.com/ChernyNathan.
⁴ Guy's and St Thomas's NHS Foundation Trust, London, UK; European Society for Medical Oncology (ESMO), Lugano, Switzerland. Electronic address: https://twitter.com/RosGiuliani.
⁵ European Society for Medical Oncology (ESMO), Lugano, Switzerland. Electronic address: https://twitter.com/NicolaJaneLatino.
⁶ European Society for Medical Oncology (ESMO), Lugano, Switzerland. Electronic address: https://twitter.com/MartinaGalotti.
⁷ European Society for Medical Oncology (ESMO), Lugano, Switzerland.
⁸ European Institute of Oncology, IRCCS, Milan; Department of Oncology and Hemato-Oncology, University of Milan, Milan, Italy. Electronic address: https://twitter.com/curijoey.
⁹ European Society for Medical Oncology (ESMO), Lugano, Switzerland. Electronic address: https://twitter.com/GPentheroudakis.
¹⁰ European Institute of Oncology, IRCCS, Milan; Department of Oncology and Hemato-Oncology, University of Milan, Milan, Italy. Electronic address: https://twitter.com/darioT_.

Abstract

Background: Cancer is a global public health problem, requiring efficient health system investments to deliver sustainable impact on population health. Access to medicines is a critical component of health systems, having a crucial role in delivering therapeutic benefits. Since 1977, the World Health Organization (WHO) has published a Model List of Essential Medicines (EML) that includes key health interventions for the prevention and control of conditions of public health relevance. Essential medicines are selected for inclusion in the EML based on the evidence of efficacy, safety, therapeutic value, and the potential to impact population health. With the rapid changes in the therapeutic landscape of cancer treatment with new medicine approvals, there is a critical need to select and prioritise specific cancer interventions based on their intrinsic value.

Materials and methods: The European Society for Medical Oncology (ESMO) has developed a decisional methodology based on a threshold with a minimum set of technical specifications and a consensus-based procedure for decisions to select candidate cancer medicines to be submitted to the WHO for consideration for the WHO EML.

Results: ESMO recognises the WHO EML as an important reference guide for medicines that all countries should include in their national EMLs. Cancer medicines on the WHO EML are used in the treatment of the majority of cancers, and are recommended in the evidence-based ESMO Clinical Practice Guidelines that medical oncologists use to treat patients. ESMO's submissions to the WHO EML in 2019 and 2021 and their respective outcomes are presented in the manuscript.

Conclusion: Due to the rising costs associated with newly available therapies, structured, reproducible, and field-tested tools to evaluate the added clinical benefit from these therapies need to be implemented in pre-selecting potential candidate medicines to be included in the WHO EML. ESMO is proud to collaborate closely with WHO on this important global public health initiative.

Keywords: ESMO-MCBS; Global cancer policy; WHO Model List of Essential Medicines; cancer medicines; value in health.

MeSH terms

Delivery of Health Care
Drugs, Essential* / therapeutic use
Feasibility Studies
Humans
Neoplasms* / drug therapy
World Health Organization

Substances

Drugs, Essential