ARV Treatment: Special Focus
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Since it appears we still have the possibility of contributing, here are a few reactions to your summary, Steve. I hope others react also. I agree with you and many participants that this was an interesting experience in itself and also contributed to my understanding of the issues around the economics of ARV therapy (or HAART as it is now being called). I particularly want to thank you for your excellent summaries and for forcing us all to keep our eyes on the objectives of the discussion. You put in a lot of work, and all of us are the beneficiaries. With respect to the question of the economic focus, my reaction is that there are many other discussion groups on the internet for other topics related to AIDS and that we therefore benefit from restricting the discussion to economics. That said, non-economic considerations often influence economic analysis and are therefore pertinent. For example, the economic criterion "equity" refers to fairness to people with different "living standards". But there is room for debate regarding how to decide which of two people has a lower living standard and therefore should be targeted for government transfers by anti-poverty, pro-equity government programs. In the rest of this posting, I will quote your remarks and then add comments of my own preceded by my initials, M.O.. In a few places I have inserted comments into your text by putting my word in caps. Lessons Learned: 1. First, we have learned that we need to determine if there are tenable arguments for the public sector to provide ARVs. A further discussion of the public economics of offering ARVs is useful and should be pursued. M.O. I would put this more into context by phrasing it: "First, we have learned that we need to develop and refine a set of tools that governments can use to decide whether to subsidize new expensive experimental treatments like ARVs for AIDS, chemotherapy for cancer, organ transplants, etc.." Such tools would apply the concepts from public economics but must also consider basic questions of the affordability of the therapy under consideration. And affordability depends on the number of cases, which leads to your second lesson: 2. Next, we have learned that in many countries, we remain in the dark in regards to the current and future prevalence of HIV. Numerous contributors noted that our estimates of people living with HIV and AIDS could be severely over or under-estimated, which in turn would significantly affect the estimates of costs for providing ARVs. It was noted in Tanzania that modelling exercises performed as early as 1988 have turned out to be relatively accurate predictors of the epidemic. Conversely, modelling in Latin America has raised a number of issues about the validity of such exercises. Therefore it can be argued that more accurate mathematical modelling would help countries to better prepare for the future epidemic. M.O. Yes, I agree. But the mathemeatical models are only as good as the basic seroprevalence and behavioral data on which they feed. Such models are extremely sensitive to their inputs regarding: 1) the heterogeneity of sexual behavior and the degree of mixing of people with different amounts of risk behavior; and 2) the current seroprevalence among those with the riskiest behavior. Thus, all countries need to gather such information in order to improve the performance of the models and in order to predict more accurately the future course of the epidemic the consequent cost of any committments it makes to subsidizing ARV therapy. 3. This discussion has exposed the lack of data regarding the potential costs and benefits of ARVs in either developed or developing countries. This lack of data has contributed to the poorly-informed decisionmaking regarding the public purchase of these drugs. Economic research is needed to address this issue, as it is likely to affect the way in which policymakers perceive the costs and benefits of these drugs. Unfortunately it appears that none of this economic research is currently being initiated. M.O. On the benefit side, the developed countries are doing a great deal of research. The question is at what point is it appropriate to do parallel research on the issue of benefits in poor countries. I can think of three reasons that research on the benefits in developing countries might be useful: 1) for biological reasons related to the strain of HIV or the nature of the medical history of AIDS in poor countries, the same treatment may have different benefits in poor than in rich contries; 2) health care systems in poor countries may have more difficulty supporting advanced, technically complex treatments; and 3) compliance may be more difficult to achieve in poor countries. As an economist, I can't conjecture with much confidence about these medical issues, but it seems to me that all three of these sources of difference are likely to make the same treatment less effective in developing than in rich countries and the reason for the research would be to test that hypothesis and to measure the degree to which effectiveness is reduced in the setting of a given developing country. If this is true, then one might not want to start doing these trials until one is pretty sure that the cost-effectiveness would be favorable given the best possible outcomes on the benefit side - namely the outcomes that are achieved in the rich countries. That is, one can start by analyzing the cost side in some detail on a theoretical basis, while assuming the maximum achievable benefits. This is already a substantial research task and, I believe, should precede any effort to set up trials in developing countries. Of course, some trials are currently going on in developing countries and others are planned, so analyses of these should be done as well, is discussed below. 4. The discussion has raised the issue of ways to prioritise access to ARVs. When resources are available on only a limited scale, there needs to be a decision regarding the best ways of selecting those who are eligible for care. It was noted, for example, that in Thailand access to ARVs are offered based on the assumed compliance of the patient (which is likely to be associated to their socio-economic status). (ACCORDING TO PROF. BRNET-JAILLY, THIS CRITERION IS ALSO PROPOSED FOR THE CASE IN COTE D'IVOIRE.) In countries where ARVs are only available from the private sector, a decision is implicitly being made to have these drugs available only to the wealthiest members of that society. Other countries offer ARVs only to pregnant women, thereby concluding (IMPLYING?)that saving the child is more cost-effective (OR PERHAPS ONLY MORE AFFORDABLE, OR A HIGHER POLITICAL PRIORITY) than prolonging the life of the mother or the father through longer-term treatment. 5. We have learned that there is no single answer to the question, “Are ARVs cost-effective for developing countries?”. The paper by Katherine Floyd and Charles Gilks made a convincing argument that ARVs are not cost-effective in most developing countries. This conclusion was reinforced by contributors from Tanzania and Vietnam (and at least partially confirmed with data from Colombia). However, data from Costa Rica, Mexico, and other initial analyses from countries in Latin America indicated that ARVs might be cost-effective in wealthier developing countries (especially in Latin America). M.O. I am uncomfortable with the analysis that purports to show that triple-drug therapy could be afforded in many Latin America countries, because the analysis does not compare triple-drug therapy to any other expensive treatment in those countries. Do these Latin American countries fund the latest breakthroughs in cancer therapy as it is practiced in the European and American centers of excellence? Do they fund organ transplants? If the answer is, as I suspect, only partially, what would be the implications for the budgets of these countries if the same generous rules on funding the most expensive available therapies were implemented for all medical conditions, not just AIDS? I would like to know that the percentage of the health budgets going to all of these frontier therapies together is still easily affordable before I am reassured that funding triple-drug therapy in these countries is affordable under current prices and technology. 6. Alternatives to HAART need to be carefully analysed. This includes a review of monotherapy, dual-therapy, or pulse therapy for adults, and the provision of AZT to women during pregnancy. Economists should also consider analysing the cost-effectiveness of non-ARV alternatives, such as home-based care. M.O. Some analysis of home-based care has been done by Eric Van Praag of WHO and Susan Foster of the London School (and is referenced and discussed in Chapter 4 of "Confronting AIDS"), but each such analysis is highly specific to the national setting. I agree that more work needs to be done and that each country should look at alternative options within its own national context. 7. Economic research must consider not only the cost-effectiveness of ARVs currently, but also their potential cost-effectiveness in the future, when the prices (AND EFFECTIVENESS) are likely to be substantially less than current prices. M.O. I agree strongly that we must be aware that technology is changing rapidly. Better to make policies based on principles (such as equal access and subsidy rates for HIV+ and HIV-) than to make definitive rules about specific treatments which either are or are not to be funded. 8. Future economic research needs to consider equity, not just effectiveness. The paper by Professor Brunet-Jailly from Cote D’Ivoire illustrates this issue. It is argued that the well-intentioned desire to create better health care contributed to greater inequities in places like Cote D’Ivoire, and that the provision of ARVs in the future will only further confound this problem. However, it was also argued that the provision of ARVs in developed countries, and the denial of these drugs in developing countries, is itself inequitable. M.O. I believe that part of Prof. Brunet-Jailly's point is that the creation of a pilot program to offer ARV therapy which would otherwise be available only at $10,000 per year per patient might adversely affect the surrounding health care system. If the only effect of such a pilot program is to make this care available to a small portion of the AIDS patients in a country, then it will undeniably worsen the equity of the distribution of health care resources across AIDS patients. As we argue in "Confronting AIDS", this cost might be justifiable if the research gains from such a program are substantial and will eventually benefit all AIDS patients in the country - the argument made by UNAIDS for the pilot programs it proposes launching in five developing countries. However, when such a pilot program is planted in the midst of a health care system with insufficient resources to even provide measles vacinations or maternal and child health care for the general population, it is at least possible that this high-cost, high-prestige pilot program will suck resources away from inexpensive, life-saving preventive and curative care for the poor. (It is also possible, as some have claimed, that the placement of such a pilot program would IMPROVE the surrounding health care system.) Thus, in places where such pilot programs are being set up, it would be useful to monitor not only the program itself, but also the access to and quality of care in the surrounding health care system to to measure the degree of any positive or negative effects of the pilot program on the surrounding system. Future Economic Research Agenda Finally, the issue that was not discussed in great detail was the idea of developing a research agenda for the economic aspects of ARVs. As the moderator, I’d like to propose such an agenda based on our lessons learned so far. I would like to emphasise again that I’m only focusing on the economic research here, and that obviously there would be a larger research agenda that would need to be developed. Also this agenda narrowly focuses on the issue of ARVs, even though this should be considered within the wider concept of all care for people living with HIV and AIDS. M.O. And, I would argue, within the larger framework of all expensive, experimental, frontier medical technology, current and future. After all, other new and expensive treatments are in the pipeline and will soon be available in the rich countries. Research on the economics of ARVs whould help developing country governments to respond more quickly and appropriately to these new advances as they filter down from the north to the south. 1. In general, it appears that there needs to be further economic consideration given to the rationale for spending public funds on ARVs in developing countries. Such an economic analysis should consider the context of health sector reform that countries are currently going through, as well as addressing the equity and effectiveness issues that have been discussed during this conference. M.O. As I have discussed above, I think the research should be done with in the larger context of all expensive, experimental, frontier medical technology, current and future. 2. Next, for the poorest developing countries where ARVs are currently not available, it appears that a medical and economic research agenda should focus on therapy that would be less expensive than HAART. This could include monotherapy, dual therapy and pulse therapy. In addition, such countries need to consider the possible cost-effectiveness of offering AZT to pregnant women to limit vertical transmission. M.O. Yes, I agree. 3. For the wealthier developing countries where ARVs are currently not available, consideration should be considered as to the willingness and ability of PWAs to pay for such therapy. Economic methodologies such as contingent valuation could be incorporated to assess how much and for how long PWAs can pay for therapy. There should also be an attempt to identify those who are able to pay for such care, so that any public provision of ARVs could be focused specifically on the poor who are unable to pay for such drugs. In addition, these countries should assess the cost-effectiveness of offering a short-course of AZT for the limitation of vertical transmission. M.O. Let's not limit this topic to "the wealthier countries where ARV is currently not available." One of the poorest countries in the world is India. Yet they have a nascent and rapidly burgeoning private market for triple-drug therapy. My guess is that there will be a small proportion of wealthy or well-connected AIDS patients who are willing and able to acquire triple-drug therapy in almost any country, no matter how poor. I agree that governments should consider this fact when they are making policy on subsidies to expensive care, in an attempt to channel larger subsidies to the poorer patients. Indeed in the worst case scenario, a country could insittute a public subsidy for ARV but only give it to those who would have bought it anyway, achieving a zero health gain at enormous public cost. M.O. The existence of the private market for ARVs raises another interesting issue. While patients who comply with ARV therapy may reduce their viral loads and therefore become less infectious, those who are unable to fully comply will be carrying a new variety of the HIV which is resistant to the triple-drugs they were taking. If some of these non-complying patients then infect others with this new variety of HIV, they will be spreading a disease which is even harder to treat than the form of HIV currently prevalent in the country. If these biological ideas are correct, the implication is that the public has an interest in regulating the quality of ARV therapy delivered in the private sector, such as to assure the maximum degree of compliance of private patients. This is an issue which is potentially very controversial, since those who benefit from the unfettered growth of private sector ARV therapy include the wealthier (and therefore more influential) patients, the wealthiest physicians and the wealthy pharmaceutical retailers. However, until the potential danger of spreading drug-resistant strains of HIV can be shown to be minimimal in a given country, this is an issue of intense importance to the country's public health and deserves the attention of both medical and economic researchers. 4. For the wealthier developing countries where ARVs are currently available, there should be economic impact assessments to monitor how these drugs are affecting the economic productivity and health care utilisation of those who have access. M.O. And, as I argue above, the impacts of the programs on the surrounding health care systems should also be assessed. Again, thanks for your expert guidance in this discussion. I look forward to the next one! 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