Apr 26, 2016
In 2014, a group of ASCO member volunteers served on the Union for International Cancer Control (UICC) task force advising the World Health Organization (WHO) on their list of essential cancer medicines. In April 2015, the UICC task force achieved the approval of more than 16 additional drugs for this list.
The WHO Essential Medicines List (EML) provides member countries a list of the most important drugs needed to maintain a basic health care system for all diseases, not just cancer. The list is updated every 2 years, but the last cancer drug had been added in 1999. In 2014, at the invitation of WHO, UICC convened experts to develop an approach to propose essential cancer medicines. These medicines would be included in the WHO Model EML for Adults and for Children, and would result in a new list of cancer medicines.
Lawrence N. Shulman, MD, served as Chair, and Gilberto de Lima Lopes, Jr., MD, MBA, FAMS, served as Co-Chair. Nearly 100 cancer experts hailing from six continents joined Dr. Shulman and Dr. Lopes in the process.
AC: What led to your interest in your field and in global health?
GL: As I was brought up and trained in a middle-income country, when I first moved to the United States I felt like a kid in a candy store. All of those new medications, which in Brazil we could only read about in current books and The New England Journal of Medicine articles, but did not have access to, were actually used in real daily practice for all patients. After nearly 8 years in the United States, I moved to Southeast Asia, working mostly in Singapore but also in Malaysia, lecturing and visiting health care facilities throughout the region. The ability of local populations to be treated with innovative medications quickly became one of my main interests in research, advocacy, and public health practice.
LS: I attended Harvard Medical School, one of the more resource-rich medical environments on the planet, in the early 1970s when President Nixon declared his “war on cancer.” I joined the fight, but the work was confined to academic cancer centers in the developed world, and no attention was paid to the needs in the developing world. In the early 1990s, I had two interns under my supervision on the oncology wards, Drs. Paul Farmer and Jim Kim [who went on to co-found Partners in Health]. We became fast friends, and I helped them with patients with cancer they cared for in Haiti for the next decade. In 2008 they called me and asked me to establish cancer care infrastructures in Rwanda and Haiti, and we got to work. Patients in those environments had little access to cancer care or cancer medications. We now have cancer programs at Butaro Hospital in northern rural Rwanda and at Mirebalais in the central plateau of Haiti. We supplied all of the chemotherapy and ancillary medicines and many other critical medical supplies, and mostly still do today, supported by Dana-Farber Cancer Institute, Brigham and Women’s Hospital, and foundations such as the Jeff Gordon Children’s Foundation and the Breast Cancer Research Foundation.
AC: How did the task force identify the medicines for the WHO EML?
LS and GL: We identified 27 cancer types with potential for maximal treatment impact, on the basis of incidence and benefit of systemic therapies, and drafted and reviewed disease-based documents outlining epidemiology diagnostic needs, treatment options, and benefits and toxicities. We created briefing documents for each disease, along with associated standard treatment regimens, resulting in a list of 52 cancer medicines, 30 from the current list and 22 new medicines. This was the first time that drugs on the list were actually tied to specific diseases and regimens, with detailed analyses of incremental benefit and risk. A comprehensive application was submitted to WHO in December 2014.
The initiative led to the inclusion of several newer cancer agents on the EML. In April 2015, the WHO announced the addition of 16 medicines to the Adult EML and nine medicines to the Children’s EML, bringing the total number of cancer drugs on it to 46 medicines. It also established this new approach to the EML—an approach that is disease-based, with detailed data on diagnostics, dosing and schedule, and risks.
Much work still needs to be done, but the model list now guides health care systems and countries around the world about the most important cancer drugs for the treatment of these diseases.
AC: What did you learn from the process?
LS and GL: The process showed us that with international collaboration we can start to effectively tackle the issue of access to cancer medications in lowresource settings. There remains a gap, though, in what is on the WHO EML and what is available to patients in many countries. Often the drugs are not available at all, and if available, they are often unaffordable for many patients. Defining clear priorities for ministries of health and clear guidance on essential medicines is as critical for cancer as it was for HIV and multidrug-resistant tuberculosis. But the medicines must also be affordable, so pricing and procurement efforts, such as occurred for the HIV drugs, will be necessary to make these medicines more accessible to a greater number of people in need.
AC: What issues must still be considered for optimal global cancer care?
LS and GL: The list is only the beginning. As newer, more expensive drugs, such as the monoclonal antibodies trastuzumab and rituximab, are included, we need to increase the discussion on the use of policy options to increase access to these medications in low- and middle-income countries. Some of these options, each with its upsides and problems, include universal coverage of health care services, tiered pricing and access programs, increased clinical research, use of compulsory licensing, and new innovative public-private partnerships and financing schemes. [Visit Dr. Lopes’ blog to read more about these policy issues.]
There remains a large mortality gap in cancer worldwide. Whereas more than 80% of patients with breast cancer in the United States are long-term survivors, in many countries most women die due to late presentation and lack of access to high-quality cancer care. A child with acute lymphoblastic leukemia has a nearly 90% chance of survival in the United States, but little chance in many countries. We must continue to work to bring the tools we have in countries like the United States to many people around the world who currently have little access to or options for effective care.