Compassionate use TB treatment with the experimental drug Bedaquiline was introduced by MSF in partnership with the Government of Armenia to expand treatment options available to XDR-TB patients; MSF’s prior experience of compassionate use initiatives in other contexts supported the initiative’s effective implementation and provided an immediate solution to the lack of available treatment options; donor support and a close partnership with the Ministry of Health allowed initial barriers, including the lack of a comprehensive legal framework, to be overcome; closely aligning reforms with ongoing programmes reduced the investment needed in new infrastructure and helped secure greater professional acceptance for activities.
Description of practice
Multidrug-resistant tuberculosis (MDR-TB) has posed a growing public health threat in Armenia, currently among the world’s 27 countries with the highest MDR-TB burden. Extensively drug-resistant tuberculosis (XDR-TB) has also emerged, accounting for approximately 10% of diagnosed MDR-TB patients in 2011. While new TB therapies continue to be advanced, the limited number of approved treatment options for XDR-TB in Armenia restricted care for XDR-TB patients.
After working on MDR-TB control in Armenia for many years, Médecins Sans Frontières (MSF) undertook an initiative, together with the Ministry of Health, to formalize the compassionate use of TB drugs to give patients without other treatment options access to experimental therapies. A committee of experts was convened to develop a compassionate use protocol. In the absence of a formal legal framework for such an initiative, the protocol was approved by a local ethics committee and the Ministry of Health through a humanitarian waiver. In 2012, a confidentiality agreement was signed with the pharmaceutical company (Janssen) developing the drug Bedaquiline, allowing XDR-TB patients meeting strict eligibility criteria to receive this experimental treatment. The drug was made available free of charge through a pharmaceutical company-led programme, supported by MSF. Patients receive a 24-week course of Bedaquiline tablets plus a two-year regimen of supporting antibiotics, such as Linezolid and Imipenem, as well as other standard TB medicines. TB specialists are responsible for selecting potentially eligible patients, but patient approval processes are overseen by independent selection committees. Providers dispensing Bedaquiline received specialized training on topics such as assessing patient eligibility, dispensing Bedaquiline and performing clinical assessments to identify side-effects. TB services continue to be delivered within the existing vertical TB-specialist system, notably the National TB Centre in Abovyan. Aligning the initiative with existing infrastructure and the ongoing National TB Programme has promoted sustainability and helped to ensure the compassionate use programme is appropriately resourced. The Ministry of Health continues to support the initiative as part of the National TB Programme’s policy framework for strengthening Armenia’s response to MDR-TB and XDR-TB.
Implementation of practice
What stage is the practice currently in?
Who was/is responsible for the implementation of the practice?
This initiative was introduced by MSF, drawing from their experience with compassionate use programmes in high-income countries, but working closely with the Government of Armenia to tailor these experiences to the Armenian context. MSF has provided technical support throughout the initiative, including sourcing necessary funding, procuring drugs, training providers and supporting TB service delivery. While MSF took the lead on guiding the initiative’s design, they were “very well supported” by the Ministry of Health, the National TB Centre, external experts and other actors. In particular, the initiative has been supported by the national government’s continuous political commitment to TB control, evidenced by the development and implementation of Armenia’s National TB Programme.
Patients presenting with a TB-related life-threatening condition without alternative treatment options may now be considered for treatment with Bedaquiline. Approximately 62 XDR-TB patients have accessed treatment through the initiative to date. Initial results are promising, however most patients have not yet completed the full two-year treatment. Six-month conversion rates (patients no longer testing positive for TB after six months of treatment) are above 80%, which is higher than seen with previously available treatments.
This case was prepared as part of a larger effort by the WHO Regional Office for Europe and published (2016) in the document, "Lessons from transforming health services delivery: Compendium of initiatives in the WHO European Region".
© Copyright World Health Organization (WHO), 2016
The methodology used for the development of this case is slightly different from the templates used on the IntegratedCare4People web platform, in particular in the analysis of enabling factors and barriers to change.
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- Catherine Hewison
- Médecins Sans Frontières (MSF)