Access to cancer medicines in low- and middle-income countries

Major breakthroughs have been realised in controlling cancer in the past five decades; however, for patients in low- and middle-income countries, many of these advances are nothing but an aspiration and hope for the future

Approximately 80% of global cancer-related deaths occur in low and middle-income countries (LMICs), which might reflect poor access to oncology therapies, including drugs. These countries can drive down the costs of drugs by, for example, buying generic or biosimilar drugs, expanding their involvement in clinical trials and implementing universal health-care schemes to pool resources. Compulsory licensing schemes, sanctioned by the World Trade Organization, can be put in place to permit the production of generic medications while intellectual property rights are still in effect. Furthermore, multiple-stakeholder public–private partnerships can be leveraged to finance drug distribution schemes. Those are key points suggested by Dr Gilberto de Lima Lopes Jr of the Johns Hopkins Singapore International Medical Centre, Johns Hopkins University School of Medicine in Singapore and colleagues in review article, published as an advance online publication in the Nature Reviews Clinical Oncology on 9 April 2013.

Major breakthroughs have been realized in controlling cancer in the past five decades. However, for patients in LMICs, many of these advances are nothing but an aspiration and hope for the future. For example, marked improvements in the management of childhood cancer have improved typical 5-year survival rates to approximately 80% from less than 50% in the 1970s. Moreover, since the 1990s, adjusted cancer death rates have decreased in developed countries because of expansive screening programmes (especially for prostate cancer and breast cancer), preventative measures and improved diagnostic accuracy, as well as treatment developments in specific malignancies, such as those of the breast, colon and lung. Even patients with non-curable metastatic diseases have benefited from considerable improvements in survival durations and quality of life with the introduction of systemic treatments with chemotherapeutic, hormonal and other targeted agents. For example, patients with colorectal and lung cancer now have median survivals of ≥1–2 years rather than just a few months.

New therapies are certainly one of the explanations for such improved results. However, monoclonal antibodies and tyrosine kinase inhibitors have been reported to cost 5,000–10,000 USD per month of treatment. Given that LMICs bear the largest proportional burden of cancer mortality, how these nations address the burgeoning cost of cancer treatment is important.

In their article, the authors discuss how emerging economies are attempting to address the increasingly important issue of access to cancer medicines. They focused on how to reconcile small, incremental, but significant improvements in the management of cancer with the exponentially increasing costs of new agents. Basically, they examined how LMICs are using generic and biosimilar drugs, expanding participation in clinical trials, implementing universal health-care schemes to pool resources, and using compulsory licensing schemes as well as increasing multiple-stakeholder public–private partnerships to increase access to cancer medications for their citizens.

LMICs face a dual challenge: while they must address long-term issues such as implementing preventive care and health education programmes for their populations, which are characteristic challenges of underdeveloped societies, they must also address how to finance and provide their population with increasingly expensive cancer therapies, which is a problem of the developed countries. Limited data have been reported on the prevalence of the use of newer, innovative cancer medications in emerging markets.

In this news we focus on few problems addressed by the authors in their review article.

Universal coverage for health care in LMICs

With the goal of improving access to health care, universal insurance coverage—the fundamental element of functional health-care systems that pools resources and provides financial protection from the costs of illness—is increasingly common in emerging Asian and Latin American countries. For example, Brazil, Chile, Colombia, Costa Rica, Mexico, Malaysia, South Korea, Taiwan, Thailand and others have enacted legislation creating comprehensive insurance systems over the past few decades. Notably, the definitions of universal coverage vary widely between countries and, even when enacted, systems struggle to increase the breadth of coverage, the proportion of a population that is insured, the extent of benefits that are offered and the proportion of expenses that are covered. The majority of LMICs, many of which are in Africa, still lack a universal coverage programme.

Drug development in emerging markets

A number of pharmaceutical companies in emerging markets have started to develop drugs that are not intended, at least initially, to be sold in high-income economies. Although these developments go some way to driving down the costs of medications, several caveats must be raised. Firstly, scrutiny of new medications in LMICs seems to be less rigorous than in the USA and Europe, which raises the possibility of safety and efficacy concerns. For example, clinical trials that led to some drugs approval in China and India have not yet been published in peer-reviewed journals. Secondly, as companies take these drugs to larger and more lucrative markets in high-income countries, their development costs will likely increase in the future. Finally, that a significant number of new drugs will come through this route is unlikely because pharmaceutical and biotech companies in developed nations are still more likely to generate the largest number of new clinically significant compounds.

Involvement in clinical research

Although the positive effect of increasing clinical trial participation is evident in emerging markets, many challenges must be addressed. These issues include ethical matters—such as the adequacy of informed consent, financial compensation and potential conflicts of interest for all involved in the trial—as well as potential lack of adequate oversight from regulatory authorities and potential ethnic differences in treatment results. Another issue is cost; for example, the cost per trial case in India can be 90% lower than that in academic centres in the USA, for reasons that might include cheaper labour and less-restrictive regulations. However, whether a decrease in the cost of running clinical trials eventually translates into lower costs for drugs in LMICs remains to be seen. Furthermore, the issue of incentives for academic centres in LMICs must be addressed: the active participation in the development of certain drugs does not guarantee that those drugs will be available to the large majority of patients that seek care in the same institution once approval is granted because of a lack of insurance coverage.

New payment systems

LMICs can also gain access to expensive drugs through price discrimination, which is an important concept in economics and business that consists of charging different prices for the same product in different markets or segments of a market. This discrimination is usually based on consumers' ability to pay and on the elasticity of demand. Also called differential, tiered or equity pricing, price discrimination is common practice in most industries outside health care, in which discounts and rebates are common place, and enables companies to expand the number of customers who are able to afford its products.

Health technology assessments

Just as in Canada and Western Europe, LMICs that implemented a policy of universal health-care coverage have struggled with rising health-care and medication costs. This stress has led to the creation of agencies or groups that provide formal and informal health technology assessments, one dimension of which is cost-effectiveness. In the past two decades, Malaysia, Indonesia, Taiwan, South Korea, Vietnam, Argentina, Brazil, Chile and others have conducted economic evaluations of new health interventions (for example, drugs, diagnostic methods and medical devices), which have become an integral part of coverage decisions in national health-care and other-payer systems. Although the main reasons for establishing these agencies or groups are similar around the world—that is, the creation of an objective and transparent means of assessing alternative interventions in the setting of limited resources, aiming to improve health-care quality—LMICs struggle more with a lack of resources, human capital and knowledge of the subject.

Many new drugs in oncology improve median overall survival by just a few months at a cost of thousands or tens of thousands of dollars. Value-based insurance design and pricing schemes use the basic premise that an intervention's cost should be linked to the benefit it provides, which could potentially bring the cost of new medications closer to thresholds that would be considered cost-effective because medications that are not considered value-for-money would not be covered. This scheme would also avoid rationing of more-effective and life-saving medications because of high costs. Importantly, value-based insurance programmes can also help industry and payers establish price discrimination policies as cost-effectiveness thresholds vary according to national per capita income.

According to the authors of this article, any truly effective programme will require multiple stakeholder involvement—including governments, industry and civil society—to address the issue of access to medication. They suggest that only with the creation of a global entity to fight cancer that is supported by a global fund it will be possible to improve cancer care in LMICs and drive down the high mortality rates in these regions.