Introduction of new tools has often been associated with a significant delay between global availability and local adoption, and the process of health technology change has presented significant challenges. The TB Alliance has identified eight key focus areas to facilitate regimen change and product introduction in a manner that ensures new TB regimens quickly reach patients who need them.
Before patients can access new regimens, policy-makers at the global and country levels will need to review clinical trial data and assess the suitability of the products for their constituents. The TB Alliance expects that the World Health Organization as well as national TB programs will consider the evidence and make policy recommendations about their TB treatment guidelines. The TB Alliance will supply relevant information, including clinical data and relevant market studies, to help policy-makers with these choices.
A key step in making a drug available is product registration with national drug authorities. The TB Alliance and our partners intend to file for regulatory approval of our regimens with key regulatory authorities, and work with the WHO prequalification program and local regulatory authorities to seek regulatory authorization for countries that choose to adopt the new regimens.
Some countries will want to measure the impact of new regimens on health systems and treatment outcomes in a real-world setting prior to adopting new products. The TB Alliance will work with appropriate stakeholders
The presentation of new TB treatments needs to be carefully considered to maximize both simplicity (for procurement and dispensing) and cost effectiveness. This might include blister packaging, and the use of fixed dose combination tablets and patient kits.
As a PDP, the TB Alliance will not manufacture the products ourselves, but will instead work with our pharmaceutical and other supply partners to ensure that products are made to the highest quality standards.
The TB Alliance will act as a liaison to ensure that adequate financing is in place for procurement of the new regimens. Resources may come from the countries themselves (either government budgets or donor funding such as the Global Fund for AIDS, TB and Malaria), from bilateral donors, or other sources.
The TB Alliance does not intend to be involved directly in product distribution. Our role is to ensure that distribution supply chains are well established to ensure a smooth transition from existing to new regimens with an uninterrupted supply of product available to patients.
Resistance to TB drugs has emerged globally; therefore, rapid diagnosis and drug-sensitivity testing (DST) are essential elements of proper TB care. DST can verify that the patient's TB bacteria are sensitive to the drugs, so that the drugs will work. The TB Alliance believes rapid TB diagnostics must be made available to all TB patients, and that such availability creates the proper environment into which new TB regimens should be introduced.