Disease Prevention and Control / Communicable Diseases / Malaria

Access to Antimalarial Medicines: Improving the Affordability and Financing of Artemisinin-Based Combination Therapies

Antimalarial Drug Combination Therapy

WHO Booklet (33 pp, PDF)
- Discussion & Conclusions

Contents
1. Introduction
2. Current pricing of antimalarial drugs
3. Current financing mechanisms
4. Cost-effectiveness in malaria management
5. Use, quality & costs of antimalarial drugs at the consumer level

- Household management of malaria
- Appropriateness of self-medication with antimalarials
- Quality of antimalarial drugs in developing countries
- Direct & indirect costs of malaria to households
6. Experiences in improving drug financing
- General options to improve affordability & financing
- Decreasing costs of second-line anti-TB drugs in DOTS-Plus programs
- Decreasing costs of antiretroviral drugs: Accelerated Access Initiative
7. Discussion & conclusions
- Drug use practices & behaviours in malaria management
- Selecting the most appropriate ACTs
- Making ACTs more affordable
- Securing sustainable financing for ACTs
- The need for an integrated & collaborative approach
References   |   Annex: Prices of antimalarial drugs from various sources

Antimalarial Drug Combination Therapy: Report of a WHO Consultation
The Use of Antimalarial Drugs: Report of a WHO Informal Consultation

PAHO Malaria Page
WHO Malaria Page: English   |   français

Malaria management is in a state of transition. Chloroquine resistance has increased around the world, and this single drug treatment has become useless in most malaria-endemic areas. Resistance to sulfadoxine-pyrimethamine (SP) is also widespread and its use will soon have to be discontinued. Resistance to other antimalarial drugs, such as amodiaquine, varies, but their useful therapeutic life also appears limited. This is unfortunate since these currently used drugs are all off-patent, with low prices close to production costs.

Options for alternative antimalarial drug policies are limited, especially in the regions facing the highest resource constraints, such as Africa, south of the Sahara. In many cases, a lack of resources has forced countries to continue the use of drugs whose effectiveness is known to be limited due to drug resistance. Although the potential value of drug combinations, particularly artemisinin-based combination therapies (ACTs), is widely acknowledged and accepted, high costs are still a major barrier to their effective use. Because of the increasing role as first or second-line treatment of malaria of these drugs, it is important that their use is secured, that they are not misused to the extent of currently available antimalarials, and that the development of resistance is held back as long as possible.

This paper provides a background for further discussion on affordable and sustainable financing policies for ACTs in the short- and medium-term future. It does not prescribe 'solutions' but instead presents a critical overview of the main policy options to improve affordability and financing. It focuses on the current situation and addresses the challenges in improving access to combination therapies in countries that bear a high malaria burden and suffer the negative consequences of increasing drug resistance.

There are already standard texts, such as Managing Drug Supply (Quick et al, 1997), which describe drug-supply systems suitable for developing countries. These texts lay down the principles of good drug management, including selection, good procurement practices, efficient distribution, rational use, adequate financing, and functional quality assurance. Unfortunately, few of these texts refer to the particular issues faced by malaria control.

Structure of the Report: This paper will build on two sets of knowledge and experience—that of WHO/Essential Drug Management in drug financing and affordability, and of Roll Back Malaria in antimalarial drug supply to countries around the world. Consulted documents are listed in the reference section. Section 2 of this paper discusses current prices of antimalarial drugs, and projections for the future. Section 3 includes information on current antimalarial drug financing mechanisms, and discusses the question of "who will pay for ACTs?". Section 4 shows how much consumers already pay for treating malaria, and provides information on the indirect costs of malaria treatment. Section 5 reviews the experiences of other priority health programmes that have worked to improve financial access to drugs. Based on this information, Section 6 discusses options for improving antimalarial drug policies in the worst malaria-endemic countries, particularly those in Africa, south of the Sahara. An annex giving a price overview of drugs commonly used in malaria control programmes in the regions in the world is included.

Discussion and Conclusions

Drug treatment is vital to any strategy to roll back malaria. Protection and prevention are important, but the morbidity and mortality of malaria in Africa cannot be significantly reduced without effective curative measures.

To date, antimalarial drugs have been cheap, and very affordable to low-income populations. While stock-outs in public health facilities are unfortunate, they are often accepted because cheap antimalarials are readily available in the private sector—even though their quality is often substandard and their use likely to induce resistance. New, effective drugs now exist, but they are expensive and governments are unlikely to be able to finance adequate supplies for their health-delivery systems. Private sector prices will be out of the reach of low-income populations.

Increasing rates of resistance mean that continuing efforts to control malaria with the lowcost drugs currently available is no longer an option. ACTs will have to be made widely available in both public and private sectors in malaria-endemic regions of the world. To do this, affordability and financing issues will have to be appropriately addressed. Improving affordability raises some important questions including which ACTs should be recommended. Costs and drug use practices must be considered as well as the pharmacotherapeutic viewpoint. Then there is the question of improving affordability and increasing available financing for ACTs in developing countries.

The questions can only be answered by an integrated and collaborative approach, involving ministries of health, NGOs, donors, international agencies and consumers.

Drug-Use Practices and Behaviors in Malaria Management

Current behaviour patterns in the use of antimalarials by consumers and caregivers must be taken into account when considering treatment policies. The affordability and financing of drugs is also directly related to the ways in which drugs are used and should be an integral part of any discussions on selecting treatments. Unaffordable antimalarials may result in poor treatment practices, which contribute to the development of resistance and shorten the useful treatment life of the drug(s).

A major finding of this survey has been that only a limited amount of data is available on the various factors that influence the use of antimalarials. There are large gaps in our knowledge and this document can only "scratch the surface" of the problem. Much more research, involving the global research community, is needed.

Selecting the Most Appropriate ACTs

Three available ACT combinations have been evaluated for safety and efficacy and are recommended for deployment (WHO 2001c):

  1. artemether-lumefantrine (Coartem);
  2. artesunate (3 days) plus amodiaquine; and
  3. artesunate (3 days) plus SP in areas where SP efficacy remains high.

Selecting the most appropriate ACT involves technical discussion, but also raises financing and affordability questions. WHO has reached an agreement with Novartis for differential pricing of Coartem (artemether-lumefantrine) for use by public sectors in malaria-endemic countries. The cost of Coartem to developing countries is US$ 2.40 per adult treatment. This is much lower than in industrialized countries (US$ 40), but still high for low-income countries, especially when the scale on which the drug needs to be deployed is considered.

Prices of other ACTs may decrease in the next few years, as demand, production and competition increases. MSF (Kindermans et al, 2002) investigated prices from artesunate manufacturers in various countries, and found that they ranged from US$ 0.63 to US$ 1.50 for the 600 mg artesunate dose. The cost of the artesunate plus amodiaquine combination was estimated at around US$ 1.30 per adult treatment today, but was expected to fall to just US$ 0.60 by 2004.

A study conducted in Burundi, Kenya, Rwanda, the United Republic of Tanzania, and Uganda provides an example of the considerable financial implications of antimalarial drug selection (Kindermans et al, 2002). Costs involved in switching drug choices to artesunate plus amodiaquine-based combination protocols were estimated in these countries. Based on current drug prices, it was calculated that the supplementary cost of implementing the artesunate plus amodiaquine combination (rather than the intermediate solution of amodiaquine plus SP) would be US$ 1.05 per adult treatment. As prices of the amodiaquine plus artesunate combination are expected to fall, the incremental costs per treatment are expected to decrease to US$ 0.35 by 2004.

With an estimated 1.2 million cases of malaria per year, the additional cost for Rwanda would therefore be US$ 945 000 per year, while in the United Republic of Tanzania, with an estimated 8.6 million cases per year, the additional annual cost would be US$ 6.4 million. The total number of annual malaria cases in the five countries was estimated at 25.3 million and the combined additional cost of deploying the amodiaquine plus artesunate combination in these five countries would be US$ 19.1 million per year at 2003 prices.

This figure would go down by two-thirds if prices fall as expected over the next few years. Changing to Coartem, priced at US$ 2.40 per adult dose, would result in a supplementary cost of US$ 39.2 million for the five countries combined. Coartem is patented until 2010 and prices may not fall as quickly as for other ACT options.

However, the real costs of the continued use of failing antimalarial drugs, including management of treatment failures, management of severe malaria, and transmission control expenses, are not included in these figures, nor is the inestimable cost of poverty and human suffering caused by malaria-related deaths and disability.

Making ACTs More Affordable

No single strategy is likely to solve the problem of ACT availability. A pluralistic approach using several strategies to serve different needs and different groups is likely to achieve the best results. Options need to be evaluated and a careful mix of strategies selected.

When health systems are not able to provide ACTs at little or no cost, consumers may have to purchase them in the private sector. Private-sector marketing of ACTs may result in unaffordable prices, which may result in use of suboptimal doses, ineffective treatments, partial sales of course-of-treatment packages, poor patient information, increased chances of developing resistance, and perhaps ultimately to increased malaria deaths. The public sector will, therefore, have to take the lead in ensuring access to ACTs. It may also be necessary to regulate the private sector to make ACTs more available and affordable to populations.

Securing Sustainable Financing for ACTs

Although Ministries of Health rarely make clear how antimalarial drugs are being financed (Goodman et al, 1999) optimizing government subsidies and avoiding the major part of them going to urban centres and better-off populations is a first strategy for ensuring equal access to antimalarial drugs, including ACTs. However, government subsidies are still unlikely to be sufficient for effective malaria control, and donor consortia will be needed to help finance antimalarial drug supplies. New ways of working together will be required. In Kenya for example, a large number of donors fund a great variety of programme activities with limited coordination (Malaria Consortium, 2001) but this traditional 'patchwork' funding for malaria control will have to be replaced with more effective cooperation.

Integrated drug-financing programmes will have to be designed; collaborations set up between ministries of health, NGOs, and donors; and joint financing mechanisms will have to be designed so that volume purchases can be made and markets forced to provide favourable prices.

One option may be to set up a malaria drug facility, possibly integrated with existing mechanisms such as the Global Drug Facility. This would allow global projections of malaria drug needs to be based on the requirements of endemic countries; drug manufacturers to be pre-qualified to assure manufacturing and production quality; and pharmaceutical prices negotiated with suppliers on the basis of pooled market demands. An integrated and collaborative approach by all stakeholders and the availability of an effective operational budget would be key in setting up such a malaria drug facility.

The Need for an Integrated and Collaborative Approach

Reducing the global burden of malaria disease and death, which is most suffered in African countries, south of the Sahara requires a major and concerted effort. A significant component of that effort must be to make effective antimalarial drugs accessible to people at risk. This is an uphill task since many of the conventional, affordable drugs are no longer effective. The new recommended ACTs are only just beginning to be used in countries, particularly in Africa, and their availability is limited, and costs high.

To make these drugs generally available will require a committed market, plans to scale up the availability and growth of the natural source plant, as well as production of the artemisinin derivatives. In the longer-term, it will require the chemical synthesis of artemisinin analogues. Currently, one of the most limiting factors in achieving these is inadequate financial investment. It is clear that in the short and medium-term at least, considerable donor investments, in the range of billions of US dollars will be required (Sachs, 2002) to ensure that effective quality antimalarial treatments are available where they are most needed.

International and partner cooperation is needed to prime a dormant market and increase the availability of ACTs. Collaboration is required to estimate market size, and pooled procurement mechanisms must be entered into to lower prices. Increased financial support for improving access to antimalarial treatment must be a part of a comprehensive strategy that addresses all of the health systems issues identified in this paper, ranging from national regulatory systems and health financing to education of mothers to improve their adherence to treatment schedules.