Reducing the price of treatment for multidrug-resistant tuberculosis through the Global Drug Facility

Abstract Problem Many countries have limited experience of securing the best prices for drugs and have little negotiating power. This is particularly true for the complex, lengthy and expensive regimens used to treat multidrug-resistant tuberculosis. Approach The Stop TB Partnership’s Global Drug Facility is dedicated to improving worldwide access to antituberculosis medicines and diagnostic techniques that meet international quality standards. Local setting The Global Drug Facility is able to secure price reductions through competitive tendering among prequalified drug manufacturers and by consolidating orders to achieve large purchase volumes. Consolidating the market in this way increases the incentives for suppliers of quality-assured medicines. Relevant changes In 2013 the Global Drug Facility reduced the price of the second-line drugs it supplies for multidrug-resistant tuberculosis: the overall cost of the longest and most expensive treatment regimen for a patient decreased by 26% – from 7890 United States dollars (US$) in 2011 to US$ 5822 in 2013. Lessons learnt The price of treatment for multidrug-resistant tuberculosis supplied by the Global Drug Facility was reduced by consolidating orders to achieve large purchase volumes, by international, competitive bidding and by the existence of donor-funded medicine stockpiles. The rise in the number of suppliers of internationally quality-assured drugs was also important. The savings achieved from lower drug costs could be used to increase the number of patients on high-quality treatment.


Introduction
Tuberculosis remains a major global public health problem. According to a 2014 report from the World Health Organization (WHO), only 97 000 patients of the estimated 300 000 patients with multidrug-resistant tuberculosis worldwide were receiving treatment. 1 Access to quality medicines for patients in need is restricted by the limited availability of funding, which is often compounded by poor knowledge of drug management (e.g. storage and distribution) and a lack of staff and facilities. To increase cure rates, it is important that antituberculosis medicines are affordable and that systems are in place for providing proper care at all levels.
Many countries have limited experience in securing the best possible prices for drugs and have little negotiating power since they are not able to consolidate purchases into large volumes. This is especially true of the medicines needed for multidrug-resistant tuberculosis, where treatment is complex and can last two years or more. Moreover, these medicines are much more expensive than those for drug-sensitive tuberculosis. 2,3 The Global Plan to Stop Tuberculosis, which was launched by the Stop TB Partnership, identified universal access to high-quality care for all people with the disease as one of its central objectives. 4 Today, access to quality-assured drugs is promoted by key stakeholders such as the WHO Prequalification Programme, 5 the Global Fund to Fight AIDS, Tuberculosis and Malaria, UNITAID and the Global Drug Facility, which was established by the Stop TB Partnership.

Global Drug Facility
The Global Drug Facility is dedicated to improving access worldwide to tuberculosis medicines and diagnostic techniques that meet international quality standards. In practice, the facility provides only internationally quality-assured medicines that are manufactured under stringent conditions so that countries and their governments can be confident they will always receive high-quality medicines. This stringency ensures that risk of developing drug-resistance is minimized. Recent studies show that the substandard and falsified drugs readily available on the private market have probably contributed to the development of antituberculosis drug-resistance in lowand middle-income countries. 6,7 Today a growing number of antituberculosis medicines are able to meet international quality standards, as verified by the WHO Prequalification Programme or other stringent drug regulatory authorities. In this context, the Global Drug Facility has contributed significantly to drug volume consolidation and has, over the years, consistently secured lower prices for quality-assured antituberculosis medicines. 8

Price reductions
In 2013, as in previous years, the Global Drug Facility reduced the price of the second-line drugs it supplies for the treatment of multidrug-resistant tuberculosis. This has resulted in a significant decrease in the overall cost of treatment. Fig. 1 illustrates the change between 2011 and 2013 in the cost of the longest and most expensive regimen for treating multidrug-resistant tuberculosis, one of many regimens available worldwide. For a 24-month treatment course, the cost of Problem Many countries have limited experience of securing the best prices for drugs and have little negotiating power. This is particularly true for the complex, lengthy and expensive regimens used to treat multidrug-resistant tuberculosis. Approach The Stop TB Partnership's Global Drug Facility is dedicated to improving worldwide access to antituberculosis medicines and diagnostic techniques that meet international quality standards. Local setting The Global Drug Facility is able to secure price reductions through competitive tendering among prequalified drug manufacturers and by consolidating orders to achieve large purchase volumes. Consolidating the market in this way increases the incentives for suppliers of quality-assured medicines. Relevant changes In 2013 the Global Drug Facility reduced the price of the second-line drugs it supplies for multidrug-resistant tuberculosis: the overall cost of the longest and most expensive treatment regimen for a patient decreased by 26% -from 7890 United States dollars (US$) in 2011 to US$ 5822 in 2013. Lessons learnt The price of treatment for multidrug-resistant tuberculosis supplied by the Global Drug Facility was reduced by consolidating orders to achieve large purchase volumes, by international, competitive bidding and by the existence of donor-funded medicine stockpiles. The rise in the number of suppliers of internationally quality-assured drugs was also important. The savings achieved from lower drug costs could be used to increase the number of patients on high-quality treatment.
Lessons from the field Global Drug Facility and multidrug-resistant tuberculosis Kaspars Lunte et al.
treating one patient decreased by up to 26% -from 7890 United States dollars (US$) to US$ 5822 -over this period.
In calculating costs, we used nominal prices obtained from the Global Drug Facility and did not adjust for either inflation or exchange rates. The price reductions obtained by the Global Drug Facility were secured through a competitive and transparent tendering process among the manufacturers of prequalified, antituberculosis drugs and by the facility's continuing efforts to consolidate orders. During this time, the number of suppliers of quality-assured drugs for multidrugresistant tuberculosis has increased. In 2012, a capacity assessment carried out by the Global Drug Facility found that a greater number of manufacturers were now able to supply internationally quality-assured, second-line drugs for multidrug-resistant tuberculosis and that, as a result, production capacity could, if required, be rapidly expanded to satisfy twice the current demand.
The actions of the Global Drug Facility have also led to an increase in the number of courses of treatment for multidrug-resistant tuberculosis delivered. In 2013, the facility delivered a sufficient quantity of various drug combinations to provide 32 000 courses of treatment, compared with 19 600 courses in 2011.

Discussion
A summary of the main lessons learnt from the operation of the Global Drug Facility is given in Box 1. First, the expansion of the supplier base for internationally quality-assured, second-line drugs for multidrug-resistant tuberculosis ensures competition in the drug market that enabled the Global Drug Facility to consistently secure low prices. Second, the ability of the Global Drug Facility to increase the volume of drug purchases by consolidating orders from different purchasers also contributed to lower costs, as did the system of competitive bidding involving long-term agreements and the existence of the donor-funded rotating stockpile. The stockpile also helped decrease delivery times. Third, the resulting drug cost savings led to an increase in the number of courses of treatment delivered. In the future, these savings could be used by governments and donors to further increase the number of patients treated, which could, in turn, contribute to even greater consolidation of orders and, hence, to additional reductions in the cost of quality-assured drugs. ■  Lessons from the field

Reducir el precio del tratamiento para la tuberculosis multirresistente mediante el Servicio Farmacéutico Mundial
Situación Muchos países tienen una experiencia limitada en garantizar los mejores precios de medicamentos y poco poder de negociación, lo cual es particularmente cierto en el caso de los regímenes complejos, largos y costosos utilizados para tratar la tuberculosis multirresistente. Enfoque La asociación Stop TB del Servicio Farmacéutico Mundial se dedica a mejorar el acceso a nivel mundial a los medicamentos antituberculosos y las técnicas de diagnóstico que cumplen con los estándares internacionales de calidad. Marco regional El Servicio Farmacéutico Mundial es capaz de lograr reducciones de precios mediante la licitación competitiva entre fabricantes de medicamentos precalificados y la consolidación de pedidos para lograr grandes volúmenes de compra. Consolidar el mercado de esta manera aumenta los incentivos para los proveedores de medicamentos con garantía de calidad.