Global Health Policy
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June 07, 2007
Adopting ACTs for Malaria: Kenya's Experience
Posted by Jessica Pickett at 09:46 AM
Artemisinin-based combination therapies (ACTs) for malaria are the textbook case of demand forecasting gone wrong, in part because of wildly optimistic assumptions about uptake in developing countries. While the recent CGD report A Risky Business: Saving Money and Improving Global Health through Better Demand Forecasts discusses the underlying incentives - and the resulting health and financial consequences - it does not not explain why it took so long for countries to switch to Coartem in the first place. Now, a new article in the Malaria Journal addresses this critical question head-on by providing a detailed look at Kenya's experience changing and implementing their national malaria drug policy, which highlights the need for more and better evidence to inform decision-making at every level and draws out key lessons for the future.
I strongly recommend reading the paper in its entirety, as it makes far too many excellent points and historical facts to summarize here. But the big takeaway is that the poor availability and quality of data delayed a decision of which product to use in place of the former first-line drug treatment protocol, sulphadoxine/sulphalene-pyrimethamine, and that even after settling on artemether-lumefantrine (AL) - under the Coartem fixed dose brand - it took over two and half years before it was actually available to patients:
The factors that resulted in a paralysis from policy decision to policy implementation included: (1) concerns and government procurement difficulties with a single-sourced product; (2) timely access to external funds provided by the [Global Fund to Fight AIDS, Tuberculosis and Malaria]; (3) lack of agreement on whether there was a long-term, sustainable financing plan; and (4) competing local and international interests for alternatives to AL. The GFATM was in its nascent stages and experience needed to be built in putting up structures that would ensure its monies were spent in a transparent way. Nonetheless, alternative mechanisms of financing drug procurement require further attention and the issue of long-term financing remains unresolved.
The paper also addresses the opposition from local manufacturers, who were left holding huge stocks of the old products, and the legislative implications of allowing over-the-counter access in the future. Finally, the authors point towards the "complexities of harmonizing various national treatment guidelines, developing effective in-service training, ensuring adequate drug supply and educating the patient population" inherent in any change of national drug policies:
Each of these activities consume huge amounts of ministry staff time and demand inputs from many other partners [and] must be carefully managed to avoid health workers being confronted with new drugs without information on how to prescribe and dispense them, trained health workers without the resources to implement the new policy or a patient population told that old medicines don't work but who cannot access new medicines.
There are many more hurdles ahead, as Kenya seeks to sustain regular drug supplies and manage the new systems in place. While better demand forecasts will both contribute to and result from these ongoing efforts, there is much more that needs to be done, and like the authors, I hope that the government, donors and others will continue to support the uptake of ACTs - both in Kenya and elsewhere - as well as the credible operational research that should inform each of the steps along the way.
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Comments
I enjoyed reading the article a lot since it strongly reiterates many of the things we have found and stated in the ACT study. Below are my comments:
1. If you study our risk map, in the column for the national buyer, we say that their biggest risk is sustainability of funding and grant timing and disbursement risk. The article clearly reflects that was true for the Kenya case.
2. This then raises a broader question. Multilateral donors like the GFATM who in turn depend upon other donors and hence will always be at a disadvantage to provide predictable funding streams whereas bilateral donors like DFID may be able to provide the 10–year conditionality based commitment. Thus, studies that do a comparative evaluation (retrospective) of how each donor agency is performing on its grants will have a clear self-selection bias. Going forward, countries may increasingly use different funding streams for different activities (drug procurement, other commodity procurement, and health systems etc.) by assessing the impact of sustainability of funding risk on that activity. They will seek grants from the least predictable funding source for the activities with the least impact from funding sustainability risk. Multilaterals may thus lose some of the portfolio/uncertainty pooling advantage that comes from funding various activities within each grant.
3. The article clearly shows how a country can reduce its risk of excess inventory (which we anyways had assessed as low) by arranging to receive staggered shipments every quarter. Also, by using "pull" arrangements downstream like they mention Kenya did they can further reduce the risk of wasted product and leakages in the supply chain.
4. We were correct in our assessment that the safety of approved products is at best a moderate risk for the countries. Kenya moved to AL based on some basic research but then will wait for some more safety data and studies before making it an OTC drug.
5. It shows that we were right in our assessment of a moderate risk of price (decrease) being faced by the countries. The expectation that the price of HIB vaccine will decrease and the fact that it did not made the MoH consider what the price will be and is it likely to come down or not. They may postpone making a change in the national treatment policy if they are anticipating a price decrease in the future.
6. We missed the part that the lack of approved drugs is a risk for the country. Not having any other approved drug is causing Kenya all kinds of problems with its sole drug law, monopoly concerns and its media and communications campaign. In the revised version I want to change the risk map and incentive map to reflect that.
Posted by: Prashant Yadav at June 27, 2007 05:06 PM
It reiterates the need for detailed country SWOT /5-Forces (Michael Porter) analysis prior to any launch. Such analysis would help identify all stakeholders, and ensure engagement, buy-in and ownership. Potential conflict of interest (e.g. government interest in local manufacturing firms) would also be identified and possibly negotiated. Excellent initiatives that do not build these dynamics into the plan can eventually be politicized, slowed and sometimes even abandoned. It is interesting to contrast SP's rapid adoption (1998) vs. AL hesitant embrace. Such analysis would not only be useful for developing new initiatives, but would also be more effective.
Posted by: May Ongola at June 27, 2007 05:07 PM
I strongly advocate a transition to local production of ACTs to reduce cost & expedite the availability of life saving malaria treatments.
There are already several raw material producers for artemisinin in East Africa; a major extraction and purification plant was commissioned in Kenya in Jan 2007; and many of the local pharmaceutical companies are already producing ACTs at competitive costs - without significant financial or technical support, and without regulatory bodies to ensure quality.
I support a rapid transition to production of ACTs in Africa - to bridge the supply chain, bring down cost, create jobs thru investment....the subsidies aren't sustainable. Investment in Africa to fight malaria ... local production of ACTs, bednet companies, etc. is sustainable - and it is empowering - and not all the bureaucratic waste, red tape...
Posted by: Lisa Amenya at July 12, 2007 03:56 PM
Have you had the opportunity to look at Plasmox being promoted by AQ+Plc as an effective alternate cure for malaria and further providing immunity up to 2 years!
Posted by: SENTIBA GORDON at August 2, 2007 11:59 AM