Chagas disease patients without access to treatment

18 December 2015

Chagas disease patients without access to  treatment

While in the United States the potential impact of the FDA’s priority review voucher (PRV) is being dicussed, elusive access to treatment for Chagas disease is highlighted not only for the 300,000 patients in-country, but for the almost 7 million people infected worldwide.

At least 10,000 people die annually because of Chagas disease in the world.  Some estimates indicate that number is far higher. The first-line recommended medicine, benznidazole, was developed back in the 1970s and yet not even 1% of those suffering the disease receives treatment. Whilst the emergence of a new producer willing to provide  benznidazole in the US could have been an important breakthrough, instead KaloBios  just announced their intentions to elevate  drug prices to the level of Hepatitis C treatments, prompting  many calls for concern.  Irrespective of the latest news of their controvertial CEO Martin Shkreli, we must remain vigilant of  the urgent need to scale up access to treatment in the US and other countries.

Today our Global Chagas Disease Coalition calls for affordable pricing of benznidazole, once it is approved by the FDA, as well as appropriate and responsible use of the Priority Review Voucher mechanism (PRVs), an incentive to develop drugs for neglected diseases. We also wish to draw attention to the almost 7 million people infected by the parasite worldwide who already live the reality of having no diagnosis and treatment. Solutions to ensure access are urgently needed.

Today, there are only two producers of benznidazole, but so far neither has registered their products in the US, further complicating access.Instead benznidazole is provided by the US Centers for Disease Control and Prevention (CDC), through clinical trial protocols.

Having more drugs available in the market at affordable prices has been for many years one of the key cornerstones to increase access to treatment.  But it is not the only one.  Currently, a lack of physician awareness of Chagas disease, together with the absence of active disease surveillance, and  knowledge of disease transmission further ensure that  only a small percentage of Chagas disease suffers in the US will be diagnosed and treated.  

Dr. Sheba Meymandi, who leads a Chagas Disease Center of Excellenceat Olive View-UCLA Medical Center in Los Angeles, California, believes  that the consequences of recent acquisition by KaloBio of the rights to benznidazole as reported by the New York Times on “Martin Shkreli’s Latest Plan to Sharply Raise Drug Price Prompts Outcry”, would be disastrous for the affected patients in the US: “Once FDA approved, the CDC would no longer provide the drug which is currently distributed free of charge. If you are uninsured or covered by Medicaid it will be unlikely that benznidazole will be covered - similar to what is happening to patients with Hepatitis C”. Additional recent research findings that transmision of Chagas disease occurs regularly in the State of Texas suggests that lack of access to benznidazole could become ensure that Chagas disease remains a highly prevalent yet neglected health disparity.

The International Federation of People Affected by Chagas Disease (FINDECHAGAS), has also expressed their profound concerns on the current situation of access to treatment for all persons having infection of Chagas in the US.

As called for recently by DNDi, MSF, Sabin Vaccine Institute, and other public health groups in an open letter to the US Senate, a potential solution to avoid misuse of this incentive and abuse of affected people would be to add an access requirement to the PRV mechanism. The Chagas Coalition supports this call in order to preserve the right to access to treatment by those in need.

In addition, we cannot afford to lose track of what is at stake here: the urgent need to scale up access to treatment in all affected countries, especially in Latin America, where access to drugs comes on top of other barriers that  go from the lack of knowledge of the disease by patients and physicians,  to the limited offer of care and the inexistence of a test of cure after treatment. All of this is connected to a sustainable strategy for affordable access to diagnosis and treatment in low and middle income countries – which depends upon stronger political leadership from those same countries.

The Coalition has come together to mobilize efforts to scale-up access to currently available diagnosis and treatment, as well as to stimulate improved models of care delivery and research and development for new drugs and diagnostic tools. Our concern, and that of all the members is how to bridge the gap between those infected and the diagnosis and treatment available. Access to treatment of Chagas disease remain at risk not only for the 300,000 patients the USA, but also for the millions worldwide.

It is time to treat Chagas disease patients now; let’s make sure we all unite efforts to make this happen.