Call to action: Accelerate access to DR-TB drugs
• Bedaquiline (BDQ) was conditionally approved by the US FDA 26 months ago and delamanid (DLM) was approved 10 months ago by the European Medicines Agency (EMA)
• WHO issued interim guidance recommending the programmatic use of bedaquiline 20 months ago and delamanid 4 months ago
• Janssen, the manufacturer of bedaquiline, announced a donation of bedaquiline through USAID, but nearly three months later, the details are unknown and there is no mechanism established for accessing this programme
At the end of 2014, little more than 600 people had received bedaquiline through expanded access programmes, and fewer than 10 had received delamanid outside clinical trial settings.
The sign on letter calls for accelerated action to ensure access to new and re-purposed DR-TB drugs, in particular for people experiencing treatment failure who are now left without any treatment options.
Mr. Donal Brown, Head, Global Funds Department, U.K. DfID
Amb. Deborah Birx, U.S. Global AIDS Coordinator
Dr. Patrizia Carlevaro, Managing Director, Otsuka
Dr. Charles Daley, Chair, Global Drug-Resistant TB Initiative (GDI)
Dr. Lucica Ditiu, Executive Secretary, Stop TB Partnership
Mr. Philippe Douste-Blazy, Chair, UNITAID
Dr. Mark Dybul, Executive Director, Global Fund to Fight AIDS, TB and Malaria
Dr. Eric Goosby, UN Secretary-General’s Special Envoy for TB
Dr. Gilla Kaplan, Director, Tuberculosis, Bill and Melinda Gates Foundation
Dr. Petra Keil, Head of Global Public Policy, Novartis
Dr. Joel Keravec, Manager, Global Drug Facility, Stop TB Partnership
Dr. Susan Maloney, Global TB coordinator, U.S. CDC
Mr. Lelio Marmora, Executive Director, UNITAID
Mr. Greg Perry, Executive Director, MPP
Dr. Yogan Pillay, Deputy Director General, National Department of Health, South Africa
Dr. Mario Raviglione, Director, Global TB Program, WHO
Dr. Thomas Shinnick, Chair, Global Laboratory Initiative
Dr. Adrian Thomas, VP of Global Market Access & Commercial Strategy Operations and Head of Global Public Health, Janssen
Ms. Cheri Vincent, Chief, Infectious Diseases Division, USAID
Mr. David Wilson, Global AIDS Program Director, World Bank
Mr. Hiroyuki Yamaya, Director, Global Health Policy Division, International Cooperation Bureau, Ministry of Foreign Affairs
10 March 2015
We are deeply concerned by the delay in the introduction of new and repurposed drugs to treat drug-resistant tuberculosis (DR-TB) in high-prevalence settings for people who need better, more effective treatment.
We call upon your agencies and organisations to accelerate and strengthen activities to ensure access to new and repurposed DR-TB drugs in 52 countries. We propose an informal consortium, convened by the World Health Organisation (WHO), which will operate in the spirit of greater coordination and towards agreed-upon responsibilities and time-bound goals.
New drugs to treat DR-TB have finally been developed; yet long after their approval, they are only available to a small number of those who need them. New drugs delamanid (DLM) and bedaquiline (BDQ) have been granted accelerated or conditional approval by stringent drug regulatory authorities; delamanid in April 2014 by the European Medicines Agency (EMA), and bedaquiline by the US FDA in December 2012.
WHO issued interim guidance recommending the programmatic use of bedaquiline in June 2013 and delamanid in October 2014. However, at the end of 2014, a little more than 600 people have received BDQ through expanded access programmes, and fewer than 10 have received DLM outside clinical trial settings.
Janssen, the manufacturer of bedaquiline, issued a press release in December 2014 announcing a donation of 30,000 courses of bedaquiline through USAID, but nearly three months later, the details are unknown and there is no mechanism established for accessing this programme.
We call upon you to work together with in-country partners to urgently make these drugs available to patients to both save their lives and stop ongoing transmission of highly resistant strains in the community.
Towards this end, we request that you develop a consortium and create a framework for action and provide necessary support to enable national governments to have the information, technical assistance (TA), and resources they need to rapidly make new and repurposed DR-TB drugs available to patients.
This includes supporting governments to develop implementation plans; establish fast-track registration or import waiver processes and compassionate use (CU), or a similar mechanism, as an interim strategy; establish pharmacovigilance (PV) as required; and update guidelines, and procure drugs in order to start providing treatment with these drugs to people in need.
Drug companies also must meet their responsibilities. They must allow broad early access to these drugs through compassionate use-like mechanisms, and rapidly register their products widely (especially in countries where clinical trials have been conducted and in countries with a high TB burden). Companies should have transparent and fair policies for pricing, registration and licensing, particularly for low-and middle-income countries.
We encourage actors in the proposed consortium to address the numerous barriers to accessing BDQ and DLM and other DR-TB drugs, and seize the opportunities that exist to overcome them.
These barriers include a lack of technical assistance and capacity support to countries, regulatory hurdles, and the heavy resource requirements of pharmacovigilance (PV) and cohort event monitoring (CEM). The consortium actors should take advantage of opportunities to implement better treatment for DR-TB, such as reprogramming funding from the Global Fund to Fight AIDS, TB, and Malaria, and establishing compassionate use, or similar pre-approval access programmes, as an interim strategy in advance of regulatory approval.
We urge the consortium to commit to the following goals:
Quickstart: Ensure 500 patients are started on routine regimens which include BDQ by July 2015, and 500 patients started on routine regimens which include DLM by January 2016.
Optimal DR-TB treatment: Technical assistance provided for 25 countries by 2016 and 52 countries by 2017 for drafting implementation plans; implementation plans are adopted by 25 countries by 2016 and 52 countries by 2018; and BDQ and DLM are routinely used by 20 countries by end of 2016 and 52 countries by end of 2019. Key repurposed drugs (especially linezolid and clofazimine) should be on the national Essential Medicines List (EML), and countries and national TB programmes (NTPs) should be using these drugs.
Regulatory status: BDQ and DLM dossiers are submitted for registration in 25 countries by beginning of 2016 and 52 countries by 2017; and drugs are registered, or import waivers are in place, by 2016.
Pharmacovigilance (PV): The consortium supports a flexible approach for countries implementing BDQ (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 and analyse data.
Procurement: Forecasting of drugs is completed; procurement strategies are developed for 52 countries by 2018; and, the turnaround time between ordering and drug delivery is reduced.
- 1) USAID and Janssen ensure the donation agreement for bedaquiline is finalised and the details made public by World TB Day, 24 March 2015, and that it reflects input from treatment implementers and affected communities;
- 2) The recipients of this letter express willingness and agreement to participate in such a consortium by World TB Day on 24 March 2015; and
- 3) WHO convene the consortium and develop a framework for action in April 2015.