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Proposing Essential Medicines to Treat Cancer: Methodologies, Processes, and Outcomes Lawrence N

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Proposing Essential Medicines to Treat Cancer: Methodologies, Processes, and Outcomes Lawrence N Published Ahead of Print on November 17, 2015 as 10.1200/JCO.2015.61.8736 The latest version is at http://jco.ascopubs.org/cgi/doi/10.1200/JCO.2015.61.8736 JOURNAL OF CLINICAL ONCOLOGY REVIEW ARTICLE Proposing Essential Medicines to Treat Cancer: Methodologies, Processes, and Outcomes Lawrence N. Shulman, Claire M. Wagner, Ronald Barr, Gilberto Lopes, Giuseppe Longo, Jane Robertson, Gilles Forte, Julie Torode, and Nicola Magrini Lawrence N. Shulman and Claire M. Wagner, Dana-Farber Cancer Institute; ABSTRACT Lawrence N. Shulman, Partners In Health, Boston, MA; Claire M. Wagner Purpose and Julie Torode, Union for Interna- A great proportion of the world’s cancer burden resides in low- and middle-income countries tional Cancer Control; Jane Robertson, where cancer care infrastructure is often weak or absent. Although treatment of cancer is Gilles Forte, and Nicola Magrini, World multidisciplinary, involving surgery, radiation, systemic therapies, pathology, radiology, and other Health Organization, Geneva, Switzer- specialties, selection of medicines that have impact and are affordable has been particularly land; Ronald Barr, McMaster University, challenging in resource-constrained settings. In 2014, at the invitation of the WHO, the Union for Hamilton, Ontario, Canada; Gilberto Lopes, Centro Paulista de Oncologia e International Cancer Control convened experts to develop an approach to propose essential cancer Hcor Onco, São Paulo, Brazil; Gilberto medicines to be included in the WHO Model Essential Medicines Lists (EML) for Adults and for Lopes, Johns Hopkins University, Balti- Children, as well as a resulting new list of cancer medicines. more, MD; and Giuseppe Longo, Azienda Ospedaliero-Universitaria Poli- Methods clinico di Modena, Modena, Italy. Experts identified 29 cancer types with potential for maximal treatment impact, on the basis of Published online ahead of print at incidence and benefit of systemic therapies. More than 90 oncology experts from all continents www.jco.org on November 17, 2015. drafted and reviewed disease-based documents outlining epidemiology, diagnostic needs, treat- ment options, and benefits and toxicities. Supported by the Center for Global Health of the National Cancer Institute, Results National Institutes of Health. Briefing documents were created for each disease, along with associated standard treatment Authors’ disclosures of potential regimens, resulting in a list of 52 cancer medicines. A comprehensive application was submitted conflicts of interest are found in the as a revision to the existing cancer medicines on the WHO Model Lists. In May 2015, the WHO article online at www.jco.org. Author announced the addition of 16 medicines to the Adult EML and nine medicines to the Children’s contributions are found at the end of EML. this article. Corresponding author: Lawrence N. Conclusion Shulman, MD, Center for Global Cancer The list of medications proposed, and the ability to link each recommended medicine to specific Medicine, Abramson Cancer Center diseases, should allow public officials to apply resources most effectively in developing and University of Pennsylvania, 3400 Civic supporting nascent or growing cancer treatment programs. Center Blvd, Philadelphia, PA 19104; e-mail: [email protected]. edu. J Clin Oncol 33. © 2015 by American Society of Clinical Oncology © 2015 by American Society of Clinical Oncology medical oncology, nursing oncology, radiology, and INTRODUCTION 0732-183X/15/3399-1/$20.00 radiation oncology are all necessary for optimal DOI: 10.1200/JCO.2015.61.8736 It is now well documented and widely recognized treatment. The public sector in all countries must that the majority of the world’s cancer patients re- develop and nurture all of these disciplines to best side in countries where options for treatment are support cancer care at the same time as they establish limited, are sometimes only affordable by the mechanisms for financing and resource procure- wealthy, or do not exist at all.1,2 Substantial gains ment. Each of these layers of service delivery is elab- have been made over the past four decades in im- orate, and, although more research is needed, there proving outcomes for patients with cancer, but these are a number of important articles delineating the largely benefit patients living in high-income coun- process of overcoming such challenges in resource- tries. An improved understanding of the biology of constrained settings.6-14 cancer that accompanies advances in cancer surgery, When making decisions about establishing or radiation therapy, and systemic therapies has been strengthening a national cancer program, policy responsible for this progress.3-5 makers must have knowledge of the number of pa- The creation of a cancer treatment program is tients with each disease seen in their country and complex and multidisciplinary by nature. Tissue which types of cancer can be affected. This analysis procurement, pathology capacity, cancer surgery, can be time consuming, and a disease-based © 2015 by American Society of Clinical Oncology 1 Information downloaded from jco.ascopubs.org and provided by at Harvard Libraries on November 18, 2015 from Copyright © 2015 American Society128.103.149.52 of Clinical Oncology. All rights reserved. Copyright 2015 by American Society of Clinical Oncology Shulman et al decision-making platform is one way that countries have prioritized medicines for procurement when resources are limited. Nonetheless, Table 1. Diseases Included in the UICC Review and Proposal among the many cancer medicines that have been developed over Type of Cancer the years, there is wide variation in availability and access—a Adult Pediatric variation that that carries its own implications and one that often Acute myelogenous leukemia and acute Acute lymphoblastic follows the fault lines of cost rather than efficacy. promyelocytic leukemia (adult and leukemia Many have begun calling for the narrowing of the gap between pediatric) 15-23 Chronic lymphocytic leukemia Burkitt’s lymphoma the haves and the have-nots in global cancer medicine. Indeed, a Chronic myelogenous leukemia (adult and Ewing sarcoma major development in this area recently was the invitation by the pediatric) WHO to the Union for International Cancer Control to review the Diffuse large B-cell lymphoma Hodgkin lymphoma WHO Model List of Essential Medicines (EML), section 8.2, which Early-stage breast cancer Osteosarcoma recommends chemotherapeutic and hormonal agents for cancer Early-stage cervical cancer Retinoblastoma Early-stage colon cancer Rhabdomyosarcoma treatment. The result of this review has been two-fold: an application Early-stage rectal cancer Wilms tumor to the WHO Essential Medicines Secretariat in December 2014 as well Epithelial ovarian cancer as a proposed methodology for regular revisions over time. Follicular lymphoma The overarching objectives of this exercise were not only to de- GI stromal tumor velop a comprehensive proposal, but also to describe and document Gestational trophoblastic neoplasia guiding principles for the prioritization of systemic therapies that are Locally advanced squamous carcinoma of the head and neck most essential for cancer treatment. This article is not meant to dimin- Hodgkin lymphoma ish the importance of other components of cancer care—pathology, Kaposi’s sarcoma surgery, or radiation—but rather will focus on cancer medicines as Metastatic breast cancer one component of care. Similar analyses for the other aspects of cancer Metastatic colorectal cancer care would be highly complementary. Metastatic prostate cancer Nasopharyngeal carcinoma Non–small-cell lung cancer METHODS Ovarian germ cell tumors (adult and pediatric) Testicular germ cell tumors (adult and pediatric) In January 2014, in response to the WHO invitation, the Union for Interna- Abbreviations: UICC, Union for International Cancer Control. tional Cancer Control convened a group of oncology experts to review the existing pediatric and adult EMLs.24,25 Although more information can be found on the WHO Web site and in the literature cited,26,27 it is relevant to note here that applications for revisions to the Model List are accepted every 2 Traditionally, pediatric cancers have been considered separately from years (usually by agent, not by disease or disease category) and are deliberated adult cancers in the WHO application process. Furthermore, disease-based on by a panel of invited experts in April of the given year. Full reviews of the recommendations already exist within the WHO for some childhood cancers. cancer medicines on the WHO Model List were conducted in 1984,28 1994,29 Thus, for the pediatric cancers that were considered to be a high burden and/or and, most recently, in 1999.30 highly responsive to therapy, recommendations were made for revisions to the This review was part of the regular cycle of applications to the WHO existing WHO Model List for Children and for additions to the Model List. Expert Committee. Between January 2014 and December 2014, more than 90 Adult and pediatric diseases that were addressed are listed in Table 1. individuals from all regions of the world contributed to the development of the Incidence of disease is a major contributor to public health relevance, 29 disease-based applications.31 A working group of expert clinicians from together with other factors, such as age at diagnosis, cure rates, and poten- around the world met at the WHO 1 month before submission to finalize the tial for long-term remission. The data presented in
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