A Call to Action
Given the momentum and activities of actors to date, there is an opportunity to strengthen, coordinate, and formalize the work around some time-based goals, including:
1. Quickstart: Ensure a minimum of 1000 patients are started on routine regimens, which include BDQ by Jan 2016 , and a minimum of 500 patients started on routine regimens, which include DLM by January 2016
2. Optimal DR-TB treatment: Key repurposed drugs (especially linezolid and clofazimine) should be included on the national Essential Medicines List (EML) in all 50 countries and national TB programmes (NTPs) should be using these drugs as part of the DR-TB regimens. Technical assistance provided for the 27 high DR-TB burden countries3 by 2016 and 50 countries by 2017 for drafting implementation plans for treatment with new and repurposed DR-TB drugs;
implementation plans for DR-TB treatment containing new and repurposed drugs are adopted by 27 countries by 2016 and 50 countries by 2018; and BDQ and DLM are routinely used by 27 countries by end of 2016 and 50 countries by end of 2019. By September 2015 all regional Green Light Committees (rGLCs) are trained and able to provide advice on the use of new and re-purposed drugs for the treatment of DR-TB so that these experts can facilitate optimal use
3. Regulatory status: BDQ and DLM dossiers are submitted by the originator manufacturers for registration in 27 countries by beginning of 2016 and 50 countries by 2017; import waivers are in place in 27 countries by January 2016 while BDQ and DLM are being registered.
4. Pharmacovigilance (PV): Supports a flexible approach for countries implementing BDQ and DLM (such as sentinel PV), proposes a set of standardised data for monitoring and reporting on adverse events, and works towards a supranational body to collect, analyse and disseminate data.
5. Procurement: Forecasting of drugs is completed; procurement strategies are developed for 50 countries by 2018; and, the turnaround time between ordering and drug delivery is reduced.