Access to high-cost drugs for advanced breast cancer in Latin America, particularly trastuzumab

Abstract

Provision of high-level healthcare is a challenge for all low- to middle-income countries (LMICs) since healthcare systems are heterogeneous, face many challenges such as inadequate funding, inequitable distribution of resources and services and usually are not adequately equipped to deal with a huge problem such as breast cancer. The development of anti-HER2 therapies can be considered one of the most important examples of the translation of molecular biology knowledge into clinical benefits for cancer patients. While a variety of novel therapeutic strategies are emerging, current treatment regimens remain focussed on targeted therapy with monoclonal antibodies, mainly trastuzumab, the first agent developed in this field. While these results have revolutionised the outcome of HER2+ patients in clinical trials and in high-income countries where they are widely available, results have not impacted the natural history of this aggressive disease in most of the world. Unfortunately, the availability of these drugs is far from universal in many LMICs, and in Latin America, in particular, patients with HER2+ breast cancer are treated exclusively with standard chemotherapy, a more toxic and less efficient therapy. While the complexity of the situation and the multiple factors that have an impact in this scenario are recognised, we need to map the future and develop feasible strategies to address possible solutions to the problem of drug access. A clear and unbiased diagnosis of the situation is a good starting point. Defining healthcare priorities and a clear strategy for the allocation of resources is difficult but mandatory. In this article, we will discuss current and future challenges regarding access (and lack of access) to high-cost cancer drugs in Latin America, with a focus on anti-HER2 therapies.

Lack of access to CDK4/6 inhibitors for premenopausal patients with metastatic breast cancer in Brazil: estimation of the number of premature deaths

“…In this context, the introduction of costly new technologies represents a particular challenge. This problem can be identified in both the public and private health care scenarios [2].…”

“…Limited access to timely diagnosis, affordable and effective treatment and high-quality care are just some of the factors that result in observed disparities in cancer survival between countries and within countries [22]. While the complexity of the situation and the multiple factors involved are recognised, the oncology community needs actively participate in the development of feasible strategies to address possible solutions to the problem of access to innovative cancer therapies [2]. A clear and unbiased diagnosis of the situation is a good starting point.…”

“…A clear and unbiased diagnosis of the situation is a good starting point. Potential strategies to address the access problem have been discussed elsewhere and include approaches to decreasing cancer medicine costs, optimising regulation and improving clinical research initiatives [ 2 , 22 , 28 , 29 ]. Research participation, with all its caveats, is a practical solution that helps speeding drug development, fostering access and lowering the cost of drug development.…”

“…However, the access to these advances and the provision of high-level healthcare remains a significant challenge, particularly for LMIC. Within this scenario, it should be acknowledged that health care systems and policies are heterogeneous, and especially in LMIC, are not adequately prepared to deal with a complex problem, such as cancer [2].…”

The Office of Innovation: As Core Initiative to Bolster Novel Pharmaceutical Products-The Cuban Approach

“…The Pan-American Health Organization (PAHO) has defined that possibility or impossibility of ensuring access to medicines as one of the most tangible indicators of disparities and inequities that may exist between countries of the region, and among populations segments within the Latin American countries18 . In essence, the financial determinants of access to medicines, including the price of a drug and its impact on household budgets or the financing of the health care system is becoming of considerable importance and concern across the Region19,20 . Interestinglyenough, Latin America has a positive outlook for innovation, despite a scarcity of resources with low indexes for research & development (R&D) activities and related investment.…”