Share

This is a joint post with Heather Lanthorn.

This week the Global Fund Board will determine whether to “expand, accelerate, terminate or suspend the Affordable Medicines Facility – malaria (AMFm).” Ideally, the Board would make an evidence-based decision. However, both the sufficiency and the relevance of available technical evidence have been questioned (see here and here). The role of political and process evidence is also not very transparent. Below, we lay out our understanding of the potential options and the factors the Board should consider.

The AMFm was designed to expand the supply and demand for the most effective treatment for malaria – artemisinin-based combination therapies (ACTs), and is comprised of three prongs:

1.       negotiated global price reductions – convincing private pharmaceutical  manufacturers to sell ACTs to private importers at the prices at which they usually sold to public importers, with speculations of a large market at this price;

2.       a ‘high-level’ subsidy and distinguishing logo – the centerpiece of the initial IOM report, this ‘factory-gate’ subsidy is paid to the manufacturer, in order to further lower the price of the approved ACT to become more affordable compared to less-effective malaria drugs with large market share (i.e. chloroquine and SP,as well as artemisinin monotherapies (AMT)); and

3.       country-specific supporting interventions – to support the regulatory infrastructure to ensure quality, affordable supply, and to increase demand for the new supply of ACTs.

Each of the prongs could hypothetically move forward along with or without the others in a re-configured AMFm.

Options

To proceed, the Board has to decide whether to terminate or continue AMFm as currently designed. Any decision will carry both benefits and costs – human, financial, political, and otherwise. Fundamentally, the Board must answer two key questions – Is a lack of evidence reason enough to continue or halt AMFm? And, is that lack of evidence reason enough to continue or halt AMFm, given that the delivery strategies for many other Global Fund programs also lack such a high standard of evidence?

If the Board opts to ‘continue’, they need to plan how to ‘expand’ or ‘modify’ it. The ability of AMFm to be funded by the Global Fund in its 3-pronged form – the only form for which evidence exists – has been questioned, including by the USG, which has strong legal leverage in this case. Realistic options are on the table which attempt to increase access to - and appropriate use of - ACTs wherever treatment for fever is sought. The options below are not necessarily mutually exclusive, but each has controversial elements hinging upon real politik.

Maintain the negotiated price reductions by manufacturers (Prong 1). Having seen the sales volumes from AMFm, manufacturers might be willing to maintain the negotiated lowered prices, even in the absence of a subsidy by donors, to capitalize on this revealed market for ACTs. Yet the same manufacturers may also decrease their production capacity or halt their capacity expansion plans if they don’t see a stable market in the future. Some of the decisions of manufacturers are likely out of the Board’s hands.

Continue to finance AMFm efforts (All 3 Prongs). In the pilot, prices on ACTs were kept low both through negotiations and subsidies. Funding for the subsidy came from a variety of global donors, who paid into a ring-fenced cache housed at the Global Fund. Funds for supporting persuasion and monitoring efforts came from re-programmed Global Fund grants. Moving forward, there are two key financing options for the range of AMFm expenses.

  • Integrated Global Fund process: AMFm activities and funding could be completely integrated into the Global Fund’s regular proposal process.
  • Matched fund: To fund AMFm-like activities, implementing countries could choose to allocate some funds for AMFm which are then matched by global donors (e.g. the Global Fund or bilateral donors). Countries could potentially pay from their Global Fund grants or out of their own health budget. It is unclear where this would be housed.

Direct funds towards AMFm subsidies and interventions (Prongs 2 and 3). With either financing option, it is not yet clear how the funds would be directed toward private sector activities.

  • With AMFm funds fully integrated with malaria allocations by the Global Fund, the public sector representatives that generally act as the Principal Recipient in applying for Global Fund grants may be less motivated to pursue private-sector subsidization or intervention. If this is the case, integration might begin the slow death of AMFm-style private sector delivery strategies aimed at increasing access to quality treatment wherever the population usually treats fever. But, it might also help to protect the public sector's ACT supply, which allegedly experienced shortages from AMFm. On the other hand, some argue that integration would not, necessarily, prompt the slow decline of private sector strategies. For example, past Global Fund grants in several countries have included private sector delivery strategies despite public sector PRs, and without explicit guidance or incentives to do so -- although we do not know how effective those strategies have been compared to AMFm.
  • With a matched fund that could complement the integrated process, there might be more scope to direct money towards private sector activities because each dollar the principal recipient chooses to allocate to AMFm-like activities would be matched by a donor. Recognizing that in the integration option the public-sector principal recipients may not be incentivized to support the distribution in the private sector, this matching fund attempts to increase uptake of AMFm-like activities that under the integration option will likely be low. For those that support increasing private-sector access to ACTs, this might be a promising complement to full integration.
  • In both the pure integration option and the matching fund option, the Global Fund’s Technical Review Panel (TRP) could be mandated to provide be clear guidance on the role of the public and private sector in a malaria treatment plan. If treatment patterns in a given country suggest that the private sector is heavily used, TRP could strongly encourage incorporating private-sector mechanisms into that country’s proposals. The TRP should also assess the extent to which ACTs are used appropriately in both sectors.

Continue and strengthen supporting interventions (Prong 3). While the AMFm pilot increased ACT awareness and use, there are loud (and valid) criticisms that it did not promote appropriate use and hence may be accelerating drug resistance. In response, the Board will have to address how funds and technical support would be made available to continue and strengthen regulation, persuasion, and evaluation activities. This will include facilitating fever diagnosis, treatment protocols, proper dosing, and means of encouraging the timely completion of full doses of ACTs. 

The Board will further have to grapple with if and how these activities can specifically be promoted in the private sector and how to direct funds andsupport toward these activities. We note that it is not known whether the public sector treats febrile illnesses more or less appropriately than the private sector. We also note that there are several expansion paths to scaling-up appropriate use of ACTs, requiring both requires both expanded access (of varying quality) and expanded appropriate use (see figure below).

 

Making a decision 

The Board should not focus exclusively on funding and applying the subsidy, thereby sidelining issues of supporting interventions to improve the use of ACTs, e.g. diagnostics. Getting drugs to the private sector and getting people to use the right ones in the right way are two different problems: both need to be fully addressed both in terms of funding and implementation.

All combinations of the above options present trade-offs. No doubt the Board is carefully analyzing the risks and benefits of each. Whatever the Board decision, it should be clear what technical criteria are used to weigh benefits and costs of different options: people reached, lives saved, cost of drugs, overall costs, and the spread of drug resistance. The Board must consider not only the benefit and cost criteria of pursing an option, but also the opportunity costs of not pursuing that option.

There are also broader and practical criteria, including the ability of an intervention to more broadly strengthen supply and regulatory systems and how decisions will affect the reputation andtrustworthiness of a range of stakeholders. Moreover, the Board must consider several logistical and political issues around how changes to (or elimination of) AMFm will impact the in-country response to malaria:

  • Will supply-chains be disrupted if AMFm is abruptly suspended, and what steps can be taken to mitigate this?
  • Have consumer expectations about ACT pricing and logos changed? How can demand for ACTs be sustained if prices change?
  • How can goodwill and partnerships between the implementers, politicians, and business sectors generated by AMFm be based maintained and strengthened? Where this trust is tenuous, a negative decision by the Board may well generate a negativereaction in the pilot countries. These concerns were clearly stated by country representatives at the recent IOM/CDDEP meeting.

In closing

The Board faces difficult decisions. Both the substance and process of how they are made will set an important precedent in the use of evidence in policy decision-making. Good luck and god speed to the Global Fund Board.

The authors thank Amanda Glassman, April Harding, Rachel Silverman, Jenny Ottenhoff, and several others for helpful comments.