This Expert Opinion outlines some pre-conditions that are considered to be essential at the national level prior to the use of new drugs for the treatment of tuberculosis, as well as specific conditions needed in order to successfully implement new TB drugs/regimens.
The aim of this document is to provide expert opinions on the introduction of new TB drugs in Member States of the EU/EEA. Similar principles can be applied to the introduction of repurposed drugs that are already in use for treating other diseases but show potential in curing TB, or introduction of new regimens with existing drugs. The main focus of the expert opinion document is on MDR TB treatment but the same principles are also applicable to drug-susceptible TB and latent TB infection.
This expert opinion outlines some pre-conditions that are considered to be essential at the national level before starting to use new drugs, as well as specific aspects that are needed in order to successfully implement new TB drugs/regimens.
Target audiences for the document are national policymakers, regulatory authorities, parties responsible for drug management and procurement, civil society organisations (CSOs) with an interest in TB, as well as those involved in national TB programmes.
This expert opinion does not substitute any international or national guidelines or clinical/risk management protocols for the treatment and management of TB. It should be read in the context of wider guidance documents for all forms of TB, including MDR and XDR TB. In this context, the World Health Organization (WHO) has developed a global roadmap which reviews evidence, has developed recommendations for the rational introduction of new and repurposed drugs for TB, and published a policy implementation package for new TB drug introduction. WHO has also published specific interim guidance with very specific considerations for the use of Bedaquiline and Delamanide.
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