DOTS-Plus and the Green Light Committee

What is DOTS-plus?

Based upon DOTS, DOTS-Plus is a comprehensive management strategy under development and testing that includes the five tenets of the DOTS strategy. DOTS-Plus takes into account specific issues (such as the use of second-line anti-TB drugs) that need to be addressed in areas where there is high prevalence of MDR-TB. Thus, DOTS-Plus works as a supplement to the standard DOTS strategy. By definition, it is impossible to conduct DOTS-Plus in an area without having an effective DOTS-based TB control programme in place.

DOTS-Plus is not intended as a universal strategy, and is not required in all settings. DOTS-Plus should be implemented in selected areas with moderate to high levels of MDR-TB in order to combat an emerging epidemic (see The Newsletter of the Global Partnership Movement to Stop TB, Issue 7, 2002). Via the GLC review process, DOTS-Plus is being implemented in Bolivia, Costa Rica, Estonia, Haiti, Karakalpakstan (Uzbekistan), Latvia, Malawi, Mexico, Peru, Philippines and the Russian Federation (Arkhangelsk, Ivanono, Tomsk and Orel Oblasts). More recently, DOTS-Plus projects have also been approved in Georgia, Honduras, Jordan, Kenya, Kyrgyzstan, Lebanon, Nepal, Nicaragua, Romania and Syria.

What is the Green Light Committee?

The Working Group on DOTS-Plus for MDR-TB identified access to second-line anti-TB drugs as one of the major obstacles to the implementation of DOTS-Plus pilot projects. The working group has made arrangements with the pharmaceutical industry to provide concessionally-priced second-line anti-TB drugs to DOTS-Plus pilot projects meeting the standards outlined in the Guidelines for Establishing DOTS-Plus Pilot Projects for the Management of MDR-TB. Currently, prices have been reduced up to 99% compared with the prices in the open market (graph MDR-TB treatment regimen costs [gif 23kb] (see Gupta R, Kim JY, Espinal MA, et al. Responding to Market Failures in Tuberculosis. Science. 2001. 293: 1049-1051). It is the task of the Green Light Committee to review applications from potential DOTS-Plus pilot projects and to determine whether or not they are in compliance with the Guidelines for Establishing DOTS-Plus Pilot Projects for the Management of MDR-TB. Project managers interested in being reviewed by the Green Light Committee should review the document Instructions for Applying to the Green Light Committee for Access to Second-line Anti-Tuberculosis Drugs (WHO/HTM/TB/2006.369) and contact WHO.

In order to ensure timely consideration, the applications for review by the Green Light Committee must be received by WHO in advance of the corresponding meeting date. The following lists give meeting dates and application due dates for 2006.

Application due dates for 2006

• 20 January
• 20 March
• 20 May
• 20 July
• 20 September
• 20 November

Meeting dates for 2006

• mid-February
• mid-April
• mid-June
• mid-August
• mid-October
• mid-December

Strategy and focus

• DOTS prevents the emergence of drug-resistant TB and MDR-TB by ensuring that patients adhere to the full course of treatment.
• DOTS-Plus is designed to cure MDR-TB using second-line anti-TB drugs.
• DOTS-Plus is needed in areas where MDR-TB has emerged due to previous inadequate TB control programmes.
• DOTS-Plus pilot projects are only recommended in settings where the DOTS strategy is fully in place to protect against the creation of further drug resistance.
• It is vital that DOTS-Plus pilot projects are implemented following the recommendations of the Stop TB Working Group on DOTS-Plus for MDR-TB, in order to minimize the risk of creating drug resistance to second-line anti-TB drugs.
• Before launching DOTS-Plus pilot projects, WHO Member States are strongly recommended to consult WHO.
• With the coordination of the Working Group on DOTS-Plus for MDR-TB and a partnership with industry, the price of second-line anti-TB drugs have fallen considerably, making these drugs more accessible to the poor.

Benefits

Strengthening TB control globally will help to reduce TB morbidity, mortality and transmission. Identifying patients with MDR-TB will save direct costs by providing them with effective treatment protocols, rather than having them repeat unnecessary, ineffective treatment. Furthermore, the primary cycle of MDR-TB transmission will be controlled, thereby saving future funds and indirect costs that would otherwise have to be diverted into treatment for both sick individuals and those that they infect.

Meeting reports

Stop TB Working Group on DOTS-Plus for MDR-TB, Paris, France 27-28 October 2003, WHO/HTM/TB/2004.341

DOTS-Plus: preliminary results and emerging issues. Proceedings of the Meeting of the Stop TB Working Group on DOTS-Plus for MDR-TB, Tallinn, Estonia, 10-12 April 2002. WHO/CDS/TB/2002.307 [pdf - 122KB]

Progress in DOTS-Plus and the Management of Multidrug-Resistant Tuberculosis (MDR-TB). Proceedings of the Meeting of the Stop TB Working Group on DOTS-Plus for MDR-TB, Lima, Peru, 25-27 January 2001. WHO/CDS/TB/2001.292 [pdf - 2013.81KB]

For more information regarding DOTS-Plus, contact WHO at dotsplus@who.int

Information resources on the management of MDR-TB