EML Phase 1

Improving access to medicines for cancer treatment through the WHO Model List of Essential Medicines (EML)

Only 2 generations ago, there were very few medicines available to treat cancer. Most patients succumbed to their disease, and a cancer diagnosis was rarely coupled with hope. But our understanding of cancer biology has advanced significantly, and therapeutic options have diversified tremendously since.

Today, our toolkit to treat cancer patients is vast – from conventional chemotherapies, to immunotherapies, hormone treatment, and other targeted therapies. We now understand more about the ways in which systemic medicines can be beneficial on their own, or in combination with surgery, radiotherapy, transplant, and other interventions. As a result of this progress, most cancer patients today can expect to improve with clinical intervention – whether achieving long-term remission, cure, or palliation.

However, this enormous progress in treating cancer, and patients’ expectations of benefit from medicines is predicated on the assumption that patients can access such medicines. What happens when these essential cancer medicines are out of reach?

Global Access to Medicines

It is estimated that there are 14 million new cancer cases around the world each year, and 8 million cancer-related deaths. Not surprisingly, the burden of both morbidity and mortality falls largely on the developing world. Countries that have the weakest cancer care infrastructure and access to systemic therapies are often those most heavily encumbered by poverty and a high burden of infectious diseases.

In recent years, the global health community has begun to turn its attention toward cancer and other non-communicable diseases (NCDs). Following the UN High Level Meeting on NCDs in 2011, the World Health Organization (WHO) developed its Global Access Plan on the Prevention and Control of NCDs. This Plan calls for – among other targets – an 80% availability of affordable, basic technologies and essential medicines by 2025, including those for cancer.

The WHO has developed a toolbox designed to support countries in decision-making for developing national formularies and cancer control planning, available by clicking here.

The UICC Response

When new effective medicines emerge to safely treat serious and widespread diseases, it is vital to ensure that everyone who needs them can obtain them. Placing them on the WHO Essential Medicines List is a first step in that direction - Margaret Chan, WHO Director General (WHO EML Press release, 8 May 2015)

In 2014, the UICC responded to an invitation by the WHO to lead a full review of the medicines included on the WHO Model List of Essential Medicines (EML). In undertaking this Review, the UICC defined essential cancer medicines as those that are vital for the care and wellbeing for patients, focusing on those for which the potential impact of systemic medicines is clinically significant.

Engaging with more than 100 cancer specialists from across the globe, the UICC led a review to establish a new, up-to-date model list of essential medicines for cancer treatment that would be proposed for the bi-annual essential medicines policy update undertaken by the WHO.

Reviewers and collaborators, including our partners at the WHO, identified cancers where anti-neoplastic therapies could have the largest impact, developed disease-based regimen recommendations, and delineated a new list that not only recommended new medicines but also recommended both a new format for the list itself and a novel way to conduct regular reviews to keep the list up to date.

On Oct 21 2015, WHO published the full report of the 20th Expert Committee on the Selection and Use of Essential Medicines, with its new WHO Model EML and including a dedicated cancer chapter. Sixteen new systemic therapies were added to the list, bringing the total number of cancer medicines to 46. These medicines were derived from regimens used to treat 29 types of cancer on which we can make a significant clinical impact, including both pediatric and adult cancers.

The UICC continues to provide guidance and expertise on which cancer medicines should be considered essential, and how to bridge the delivery gap between the developed and the developing world. The aim is not only to shed light on the barriers to accessing medicines many countries face and resulting disparities in health outcomes, but also to help steer global dialogue, policies, and programs toward equitable access to cancer treatment. We envision the outcome of these efforts to be immediate and long-term gains in breaking down those barriers.

Methods / Approach

Alongside our partners at the WHO, we have aimed to shift the mindset toward cancer treatment from individual medicines to disease-based regimens. With this goal, we work to identify and keep up-to-date on cancers for which anti-neoplastic therapy can lead to cure or long-term palliation. These diseases were divided into 3 categories:

  • Substantial chance for cure with systemic medicines alone in a moderate-incidence disease (e.g. diffuse large B-cell lymphoma)
  • Incremental increase in cure rate with systemic therapy over surgery alone in a high-incidence disease (e.g. arly stage breast cancer)
  • Chance for substantial long-term palliation in a low-incidence disease (e.g. chronic myeloid leukemia)
  • Modest palliation and extension of life in a high-incidence disease (e.g. non-small cell lung cancer)

The broader implication of these efforts has been the reshaping of the architecture of the List itself – each of the 46 medicines correspond to 29 types of cancer, 11 of which could not have been treated prior to the 16-medicine addition. Disease-based briefings were developed for each of these 29 cancers, and included disease-specific sections on epidemiology, diagnostic and administration requirements, regimens, incremental benefits based on systematic reviews, and ultimately the medicines themselves required in treatment.

What is the impact?

It is our intention that the product of this work will be useful to ministries of health toward decision-making for cancer program development by providing a list of specific medicines that could be considered for a national formulary. We believe that the disease-based briefings provide a transparent summary of where investments can make the biggest difference is a critical part of our mission.

We hope that by demonstrating the magnitude of benefit of treatment regimens for individual diseases, policy-makers will have the information needed to determine national approaches to the development of cancer treatment programs and the purchase of anti-neoplastic agents.

We envision our efforts to enable public procurement agencies to be better equipped with decision-making tools, and also to be able to easily reference information on the reasoning underpinning the inclusion of individual agents.

We believe that if all patients have access to these medicines as components of high-quality cancer treatment programs in the many places where cancer care is currently minimal or not accessible, there will be a substantial reduction in world-wide cancer mortality.

How can you get involved?

We invite all cancer specialists to join us in these efforts to expand access. Some specific areas of engagement where we welcome input are: bi-annual review process to keep the List updated; effecting change at the national levels especially in resource-limited settings; and working with private and public sector partners to overcome obstacles to market expansion and improving access for the world’s cancer patients.

For more information and to access the online release:

Click here to view Professor Larry Shulman from the Dana-Faber Cancer Institute present the 2014 UICC review of WHO Essential Medicines for Cancer.

Last update: 
Friday 29 January 2016