In 2014, the majority of international health aid was dedicated to HIV. So, one might reasonably assume that this is the largest health problem facing the world. Yet, HIV only constitutes 4% of the global burden of disease. In 2014, noncommunicable diseases (NCDs) made up 50% of the entire disease burden, but only received 2% of all global health funds.
The disease burden of NCDs is fast outpacing that of infectious diseases. Despite this, the proportion of global health financing dedicated to combatting NCDs has remained constant over the past 15 years at 1 to 2%.
Currently, 32.6 million individuals are living with cancer (diagnosed in the last five years). In 1970, 15% of new cases were in low- and middle-income countries. In 2008, 56% were in low- and middle-income countries. By 2030, this proportion is expected to be 70%. So, not only is the burden of NCDs rising globally, but it is also beginning to disproportionately affect countries with the least resources to deal with them.
But, if NCDs have been steadily increasing in low- and middle-income countries, why has global action not followed suit? The HIV epidemic reversed the reduction of infectious disease deaths in children and young adults and, as a result, stunted the epidemiological and demographic transition, particularly in sub-Saharan Africa. Consequently, preventing HIV and other major infectious diseases became the focus of the Millennium Development Goals (MDGs) set in 2000. Likewise, in 2001, the United Nations General Assembly committed all governments to prioritizing the HIV epidemic, shelving the issue of NCDs for the next decade. Accordingly, the World Health Organization (WHO) and UNAIDS updated their “Strategies for the Prevention and Control of Diseases” to reflect this HIV and infectious-disease focused agenda; within this document, NCDs were not mentioned.
This concerted advocacy and mobilization around HIV/ AIDS gave way to an international surge of funding that gave millions of people in low-resource settings access to antiretroviral therapy (ART). Although this global movement to fight AIDS came too late for many, today HIV/AIDS is largely seen as a manageable condition rather than a death sentence.
Analyzing how HIV was internationally addressed offers important lessons on the barriers, and potential points of intervention, for NCD treatment, such as cancer. Although a similar end point needs to be reached in the fight for cancer care—high quality, affordable, accessible, sustainable treatment—there are different pharmaceutical barriers to addressing cancer in low- and middle-resource settings.
Once adequate health systems are in place, medicine is indispensable for treating and managing NCDs. However, the pricing, development, and administration for cancer drugs are markedly different than that of HIV. An important point of divergence between HIV treatment and cancer treatment is the level of generic competition: generics were integral in making ART internationally affordable.
Many cancer treatments are biologics (i.e. a virus, therapeutic serum, toxin, antitoxin, hormone or protein, including monoclonal antibodies or similar products used to diagnose, prevent, treat or cure a disease) rather than small molecules (i.e. small, chemically manufactured active-substance molecules). New cancer medications are increasingly biotechnology products, meaning they are produced using living systems such as plant or animal cells, bacteria, viruses, and yeast. In contrast, the treatment for HIV/AIDS, antiretroviral therapy (ART), is a small molecule drug. This means that the research and development (R&D) process as well as regulatory landscape is different. This has a significant impact on how generic versions of cancer treatment are made and regulated.
For a manufacturer to obtain marketing authorization and WHO prequalification of generic versions of a drug, they must simply demonstrate interchangeability. For small-molecule products, relatively simple bioequivalence studies establish interchangeability, such as testing a compound’s melting point. Approving generics does not require fully repeating efficacy and safety clinical trials. However, the regulatory requirements for biologics are different.
Due to their biological nature, biosimilars are never the exact same molecule. As a result, the repeat tests to demonstrate interchangeability with the originator are much more extensive. For FDA approval, biosimilar companies must repeat clinical trials that may have taken the originator company upwards of five years and hundreds of millions in investment to complete. As a result, biosimilars cost much more to produce than traditional small-molecule generics and require significant investment by the generic producer. The immense cost for biosimilar R&D is a large part of why there is a lack of generic competition and, thus, the high, monopolized prices of cancer therapy.
Reduction of cancer mortality will be suboptimal without treatment. Like HIV drugs, cancer treatment must be affordable and reliable. However, given the biologic nature of many cutting-edge cancer therapies, the current approval process for generic cancer drugs is inadequate. As such, regulatory agencies need to acknowledge that the current approval process is effectively acting as a barrier for generic competition in the cancer drug market. If we envision a future where cancer treatment is as widely accessible as ART, health organizations need to start prioritizing NCDs as much as they do infectious ones—streamlining the biosimilar drug approval process is a necessary first step.
Ashley Andreou is graduate student in the MPH program at Yale University