Global Alliance for TB drug development (TB Alliance) Speeding Treatments to End Paediatric Tuberculosis (STEP-TB) End of Project Evaluation

Background

The challenge addressed by the project was the lack of child-friendly formulations in the correct dosages aligned to the WHO 2010 revised guidelines. To fill this gap, in December 2012, the UNITAID Executive Board committed up to USD 16.7 million to the Global Alliance for TB Drug Development (TB Alliance) over three years to support the development and production of appropriate new paediatric formulations. The present end-of-project evaluation was to provide UNITAID with an assessment of the implementation of the project with a particular focus on the project’s overall market and public health impact.

Evaluation Approach

The evaluation team reviewed the project documentation, collected data and information through interviews with key stakeholders, conducted an online survey covering all 22 project countries, searched for additional external documentation as needed and finally synthesized information from these various sources to address the different objectives of the present evaluation.

Findings

Using the UNITAID grant evaluation framework, the evaluators rated the various criteria as following:

Relevance is rated as high:

1. The project targeted several gaps in the TB paediatric market, contributing to much better and reliable estimates of the burden of childhood TB. The new estimate is that there are around 1 million TB patients in children, whereas the previous 2013 estimates were about half of that.
2. The project resulted in two new correctly dosed fixed dose combinations of first line drugs. The new formulations have an ERP review for time limited procurement and are today globally available through the GDF mechanism of supply.
3. The project contributed to two of UNITAID’s six strategic objectives in a short term: objective 2 to increase access to affordable paediatric medicines for tuberculosis, and objective 6 to increase access to products for the prevention of TB. It also contributed to objective 5 in a longer term from additional paediatric development activities around Moxifloxacin, PA-824 and Bedaquiline.

Effectiveness: rated medium to high

1. The outputs of the grant were consistent with the objectives and expected outcomes as described in the project plan. All activities were developed as per project plan and most deliverables were completed.
2. UNITAID was regularly informed about the progress of the project through regular updates sent on a semi- and annual basis, regular quarterly meetings and email or calls if needed, and has been involved in discussions and decision making on the changes. One major change has been the integration of the Bedaquiline study under output 4 from reallocation of unused fund initially dedicated to engage the manufacturers.
3. The outputs of the project were largely achieved within the timeframe specified in the project plan and even ahead for some activities. Two main activities could not be completed within the overall project timeframe or as expected: 1- The pharmacokinetic study in infants under output 2 that needed further investigation of Rifampicin dosing. A follow-up study was initiated during the NCE phase and is ongoing. 2- Announcement on the readiness of dispersible Ethambutol from MacLeods and of the two FDCs from Lupin’s was expected early 2017, but this has not been done yet.

4. Efforts were made throughout the project to ensure that the overall goal is achieved. A weakness we can see is that it might have been good to anticipate certain steps earlier, especially steps for implementation of the formulations.