Establishment of a New Approach to Defining Essential Medicines for Cancer: Implications of the 2014-2015 UICC Review of the WHO Model List

Abstract

Abstract 4 Background: In 2013, there were more than 8 million deaths attributed to cancer, and nearly 15 million new cancer cases worldwide. The majority of this burden falls on countries that are often already triply burdened by infectious diseases, under-resourced systems, and inadequate numbers of health professionals. Access to medicines is a critical component of addressing gaps in cancer care outcomes, and has been prioritized by the United Nations in the post-2015 development agenda. Since 1977, the World Health Organization (WHO) has published a Model List of Essential Medicines bi-annually as a tool for policy-makers and procurement agencies. Approach: In January 2014, the WHO invited the Union for International Cancer Control (UICC) to convene a task team to review the cancer therapies on the WHO's Model List. UICC, and leadership from Dana-Farber Cancer Institute identified 27 diseases for consideration. Approximately 100 oncology experts from around the world participated. Disease-based documents were produced by at least 3 experts each, resulting in recommended treatment regimens which defined the medicines proposed for addition to the EML. This process was driven by the guiding principle of the magnitude of benefit of systemic therapies – for which the focus was on first-line options – and prevalence of disease, as in the case of lung cancer, for example. Further, the UICC task team recommended the establishment of a regular evaluation of cancers to be included for review, and anti-neoplastic agents indicated for treatment. Results: The new approach led to 16 new cancer medicines being added to the List, from a total of 22 proposed, including all of those recommended for children, and a method for periodic review and evaluation. Implications: Establishment of a disease-based approach to defining where cancer medicines can have the largest impact has been critical, as has the establishment of a scheduled re-evaluation of the list based on new data. The UICC and partners are beginning efforts to utilize the new list of cancer medicines with policy-makers in low-income settings with the goal of narrowing the gap to essential therapies for cancer patients in low and middle income countries. AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST: Lawrence Shulman No relationship to disclose Claire Wagner Consulting or Advisory Role: Silver Creek Pharmaceuticals Ronald Barr No relationship to disclose Gilberto Lopes Honoraria: AstraZeneca, Roche/Genentech, Merck Serono, Merck Sharp & Dohme, Fresenius Kabi, Novartis, Bristol-Myers Squibb, Janssen-Cilag Consulting or Advisory Role: Pfizer, Bristol-Myers Squibb, Lilly/ImClone Research Funding: Lilly/ImClone, Pfizer, AstraZeneca, Merck Sharp & Dohme, Eisai Expert Testimony: Sanofi Giuseppe Longo No relationship to disclose Jane Robertson No relationship to disclose Gilles Forte No relationship to disclose Julie Torode No relationship to disclose Nicola Magrini No relationship to disclose