Recently the complete results of the Phase II study of GlaxoSmithKline’s malaria vaccine (Mosquirix™) were published (Olotu et al. 2011) with the headline result being a 46% decrease in risk of infection in children 15 months after vaccination. Clearly a vaccine for malaria, even one with less than the more typical 90% efficacy, is remarkable and welcome progress; “It’s promising and encouraging,” Robert Newman, director of the WHO Global Malaria Program, was quoted (Bloomberg article). Given my interest in the business side of global health, the announcement got me wondering about the economics of Mosquirix’s use, not only how much the vaccine would cost per dose or how it much it would cost to deploy, but, since malaria’s control (or elimination) will involve multiple approaches (e.g., exposure control through bed nets and insecticides, new diagnostics for surveillance, access to existing drugs, new drugs, and vaccines for different stages of the parasite’s lifecycle and with better effectiveness), how it will fit in to an overall strategy, if there is one.
As generally known, malaria is one of the big three most deadly infectious diseases (HIV and TB are the others), infecting more than 300 million people and killing upwards of 1 million (85% of whom are children) each year (CDC Malaria Facts). And while there are only about 1500 annual cases here in the US (mostly due to returning travelers), the potential for infection by one of the four species of Plasmodium exists in more than 100 countries where half of the world’s population lives. Malaria has been a target of international public health efforts for 40 years with a significant boost in attention in 2008 when Bill Gates, whose foundation has put about $2 billion into the cause, said elimination of the disease was possible as early as 2015, a challenge that was echoed by Margaret Chan, WHO Director General, several “world leaders,” and a few experts (Washington Post article). Since the mid-2000s, fighting malaria has been a cause de jour that has inspired many fund-raising efforts (e.g., America Idol’s Idol Gives Back charity specials, Nothing But Nets, Malaria No More, Imagine No Malaria) which compete with the established international actors like the Roll Back Malaria Partnership, the Global Fund to Fight AIDS, TB, and Malaria, and the President’s Malaria Initiative. And modest progress has been made. According to the WHO World Malaria Report 2009 (WHO 2009 Malaria Report), the increase in funding for malaria control (from $300 million in 2003 to $1.7 billion in 2009) has resulted a 50% reduction in cases in 38 malaria-endemic countries (nine in Africa) and a 50% reduction in deaths in Eritrea, Rwanda, Sao Tome and Principe, Zambia and Zanzibar.
So I looked for economic data and found, fortunately, a series of recent publications in the Lancet (Lancet 2010) that included a study of the cost and financial feasibility of controlling compared to eliminating the disease (Sabot et al. 2010). The authors used six case studies (two in China and four in Africa) to explore whether the direct cost savings of elimination will offset initial investment costs; their general conclusion is that it doesn’t. This sobering finding is tempered by several qualifications: there were wide variations in the epidemiology and economic contexts of the cases, variable cost accounting, non-inclusion of costs borne by the health system and individual, and non-inclusion of possible benefits, like increased tourism and business due to a reduced malaria threat. The authors’ take home lesson: malaria control/elimination programs need to be country-specific, planned thoroughly, and financed differently, i.e., “a fundamental shift in the perception of malaria investment from a so-called quick win to a routine expenditure, such as that for immunization, with corresponding changes in financing mechanisms and policies.”
Accompanying the reports were several commentaries which offered for perspective. Das and Horton noted “It would be fair to say that in past years global leadership in malaria control has been absent. Organizations and agencies have tended to work in a fragmented way and often without consensus,“ and “The danger of the Gates call for a new era of elimination is that their immense funding power and influence (witness WHO’s instant support) could cause damaging swings in funding and political priorities … funding for malaria control is falling well behind what it needs to be.” (Das and Horton 2010). So it looks to me as if the attack on malaria has too many organizations, large and small, with their own favorite approaches and without interest in country-by-country rational planning and the funding of broad, integrated control programs. Maybe a better role for these various groups would be to make available the tools for planning and the funding for implementation to individual countries rather than imposing solutions, that is, use the health sector wide approach I wrote about in my post of 1/20/11.
BTW for those of you (like me) who are interested in the costs of development and subsequent pricing of global health vaccines, according to a Lancet editorial (Lancet editorial 2010), the development of Mosquirix started more than about 20 years ago and has cost more than three-quarters of a billion dollars (GSK put in $450 million and the Gates Foundation, $300 million). The Phase III trials began in 2009 in 16000 children in 11 African countries and it may be approved for sale in 2013. Interestingly, the mechanism by which Mosquirix works is unknown though it is suspected it stimulates antibodies that bind up the parasite in the first few minutes after infection and before it gets to the liver. As for pricing, in a speech in January 2010, GSK’s CEO, Andrew Witty, has said the vaccine will be priced to cover its manufacturing cost with a small return (5%) which will be fully reinvested into research and development for second-generation malaria vaccines or vaccines for other neglected tropical diseases (GSK press release and Forbes article). So at a price of $1 per dose and annual use of 400 million doses, GSK gets only $20 million of its $450 million investment back each year. Ouch.