In low- and middle-income countries (LMICs) the problem of high-cost drugs poses a significant threat to the well-being of entire societies.
The GCI team recently published a scientific paper entitled “Improving Access to High-Cost Cancer Drugs in Latin America: Much to Be Done”, led by Dr. Rossana Ruiz. In a previous article, we summarized the key points from the paper regarding the problem of high-cost drugs in Latin America. This follow-up article will highlight potential solutions to these problems.
The right to life is included in constitutions all over the world. But when innovative cancer medicines are priced at rates exponentially higher than what a country can afford, capitalism is prioritized over this right to life. In low- and middle-income countries (LMICs) the problem of high-cost drugs poses a significant threat to the well-being of entire societies. However, a number of opportunities to reduce costs and improve access to cancer medicine have surfaced in the past several years. These strategies have a lot of promise, and should be identified and implemented in LMICs to increase accessibility and affordability of high-cost drugs. Rossana Ruiz and the GCI team have identified 7 of these potential solutions to be particularly promising:
In order to combat the problems of high-cost cancer drugs in LMICs, the effective distribution or redistribution of monetary resources available in LMICs is imperative. This includes not only providing a budget for specific medicinal treatments, but also budgeting in preventative and diagnostic measures as well as allocating money to palliative care efforts. The less money a community has, the more important it is to distribute it in the most efficient way possible.
We previously discussed cost-effectiveness and the ways in which cost-effectiveness can be analyzed. These systems of analysis are important in synthesizing the value of treatment from all angles — that is, factoring in cost, efficacy, and safety of a cancer treatment. The implementation of strategies and tools that analyze cost-effectiveness in LMICs is of growing importance, and can offer valuable information and suggestions regarding the treatment of cancer and the value of specific medicines to patients.
Many Latin American countries have established or are in the process of establishing institutional agencies dedicated to implementing cost-effectiveness analyses programs and guidelines. These regulatory bodies have been reasonably well established in Argentina, Brazil, Mexico, and Uruguay. There are many more countries that could benefit from the institution of similar programs, yet progress is slow-going. A potential solution to the lack of cost-effectiveness analyses programs is simply the adaptation of other countries’ programs, that is, altering said programs to fit the needs of a neighboring nation. There is a need to formally develop a “systematic and transparent arms-length process” for cost-effectiveness programs in Latin America, but national strategies can be adapted to other countries needs from those that have already begun the process.
The regional joint purchasing of high-cost medicines could potentially enhance negotiation power of LMICs and decrease administrative costs, creating lower prices for countries that cannot afford the latest cancer treatments the world has to offer. In this way, countries with less of a voice in the global community can have their needs met through international collaboration for a common objective.
Significant steps towards collective negotiation have already been taken. UNASUR and MERCOSUR, intergovernmental organizations that enable collaboration between all 12 South American countries, recently endorsed the creation of a committee for joint bargaining and purchasing of high-cost medications, specifically for HIV and AIDS treatments. They plan to implement this same system and technique in regards to the purchasing of anticancer drugs. What’s more, the World Health Organization’s Model List of Essential Medicines is utilized as a reference point for which medicines are necessitated and what prices are fair.
In addition to collective negotiation and joint bargaining, resource funds (referring to “International funds that facilitate the acquisition of medicines at lower prices due to large-volume purchases”) pose a significant step forward for LMICs in the fight for reasonably priced anticancer drugs. Resource funds are beneficial to smaller nations that, because of their size, are charged much higher prices for purchasing relatively small quantities of certain anticancer drugs. For example, the Revolving Fund of PAHO pools national resources from participating countries, then negotiates arrangements with the pharmaceutical corporations to procure high-quality vaccines at up to twenty times lower than their original cost.
The newest, most innovative cancer treatments often include medicines that are economically unfeasible for countries purchasing them alone. The collaboration between LMICs in purchasing high-cost drugs has worked to combat these exorbitant prices, allowing Latin American countries to access many more drugs that were previously unavailable.
Differential pricing refers to the act of stratifying the price of certain cancer medicines in relation to both the average national income of a country and said country’s willingness to pay, making products more expensive in high-income countries (HICs) and less so in LMICs. Currently, LMICs are facing the problematic global pricing policies pertaining to most cancer fighting drugs. Implementing the threat of “compulsory licensing”—that is, temporary permission to overlook patents on original medicinal formulas in order
to manufacture of more affordable biosimilar anticancer medications—has given way to tiered pricing on many of them. The increased affordability of anticancer drugs produces higher levels of access as well as the potential increase in money made by pharmaceutical companies.
However, pharmaceutical companies oftentimes cannot be coaxed into stratifying their prices, which can lead to the implementation of said “compulsory licensing” and the creation of generics and biosimilars.
Generics and biosimilar medicines are therapeutic equivalents (not duplicates) of the original patented medication. These equivalent treatments undergo careful examination to ensure the safety, purity, and potency of the drug within clinical studies. For LMICs, these are “cost-saving alternatives with comparable efficacy and safety to innovative new products”. TRIPS (Trade-Related Aspects of Intellectual Property Rights) can issue compulsory licensing of patented products so that generic medicines can be manufactured, exponentially reducing expenses to people in dire need of medicine and providing LMICs with another potential solution to the problem unaffordable cancer treatments.
The pharmaceutical industry has made claims that compulsory licensing in LMICs negatively impacts innovation by limiting economic incentives, and that "high prices granted by patents are indispensable for recouping investment in research and continuing investigation." However, these claims have been largely unfounded as LMICs only account for one-fifth of profit worldwide. With all of this in mind, it is important to recognize the problems that come with granting compulsory licenses on life-saving anticancer therapies, including “pressure by the pharmaceutical industry, loss of investment, and trade frictions with the countries producing these previously patented drugs”. Not to be overlooked, there remain substantial concern regarding health risks associated with manufacturing generic and biosimilar versions of patented products, including anxieties surrounding efficacy and safety.
Generics and biosimilar medicines remind us that many solutions to the problem of high-cost drugs are not without faults of their own. The pursuit of affordable global cancer treatment remains an immense undertaking with no shortage of complexities to be worked through in the coming years.
Furthermore, evidence-based adaptation of treatment regimens—including changes in dosage, frequency, or duration—may be considered as an alternative strategy for LMICs to improve financial feasibility and access to certain treatments. Because of this, it would be possible for certain countries’ budgets to treat more patients with the same or less resources. In many situations, adapting certain schemes of cancer treatment in LMICs has been found to be "less costly and therapeutically optimal," while remaining similar in efficacy. However, breaking with clinical guidelines assumes many risks of its own, and is never the primary recommended course of action for a country. This further complicates the issue of addressing high-cost drugs in LMICs, ethics and all.
Lastly, an increase in LMIC participation in clinical trials could potentially provide a solution to the crisis presented by high-cost drugs. Clinical research participation would allow patients in LA access to drugs that are otherwise not available to them. However, clinical research participation presents many ethical issues, including economic conflicts of interest, adequacy of informed consent, and the insecurity of subsequent availability/affordability of approved therapies in the future.
So, with all of this in mind, what can physicians do?
The authors end this paper by reminding physicians that they are not just “spectators” in a transaction, but are representatives of the underserved populations they treat with a responsibility to the public and to the health of the nation that they serve. The expansion of medical education in LMICs is imperative; physicians must be aware of the economic position of their country in the world and be able to deduce cost-effective ways of creating availability
of high-cost cancer fighting treatments. Lastly, the authors urge the reader to consider the bigger picture of the multifaceted battle with cancer, and that alleviating the economic burden that cancer drugs present to LMICs is only one aspect of this foreboding challenge. There is much more work to be done.