Implementing the new short course regimen for the treatment of drug-resistant Tuberculosis in South Africa

South Africa has the third-highest Tuberculosis (TB) burden and the second-highest drug-resistant TB (DR-TB) burden globally. TB is a curable and preventable disease caused by bacteria spread from person to person through the air. Resistant forms of the disease pose a significant threat to preventing and treating further transmissions. Innovative approaches to expand the use of existing methods of diagnosis together with the introduction of new treatment products, such as shorter, more effective drug regimens, are key to effective control of the disease in the country.

South Africa is a global leader in adopting new diagnostic and treatment options recently completing the national scale-up of the GeneXpert diagnostic device – a rapid, automated molecular test for both drug-sensitive and drug-resistant TB.  South Africa has also embraced the introduction of key new drugs such as bedaquiline, linezolid, and clofazimine.

However, there are still significant gaps which must be overcome to improve treatment outcomes and reduce mortality from TB. A recent study showed that despite the availability of free TB diagnosis and care in South Africa, patients often don’t seek care or are lost along the treatment pathway due to income loss, high transportation costs, and the frequent clinic visits associated with accessing treatment. This is especially true in cases of DR-TB for which the treatment can last up to 24 months and severe side-effects make adherence to treatment difficult. DR-TB also poses a significant cost burden not only to patients but also to the entire health system: while it comprises only 7% of the country’s incident TB cases, it accounts for approximately 47% of the national TB budget, thus limiting resources for the system as a whole.

In May 2016, the World Health Organization (WHO) issued a conditional recommendation on a new shorter regimen for the treatment of DR-TB that decreases treatment duration from 24 months to 9-12 months. Although the randomized clinical trials for this regimen have not been completed, various observational studies have shown promising results, with increased treatment success rates of 82-89%, compared to 42% with the conventional regimen. This new treatment regimen is therefore well poised to significantly impact South Africa’s TB program.

In anticipation of new WHO guidelines, the Clinton Health Access Initiative, Inc. (CHAI) saw an opportunity to gauge interest and prime TB program decision-makers on the benefits and potential considerations for roll-out of the new shorter treatment regimen. In February 2016, CHAI presented a business case on the benefits of a regimen switch to the National Tuberculosis Control Programme (NTCP) in South Africa that outlined the potential to not only deliver considerable savings for programmatic budgets, but also to improve patient adherence and treatment outcomes.

Since the official release of the WHO recommendation, the NTCP undertook to update the current diagnostic and treatment protocols, and implement the shortened regimen for the treatment of DR-TB at the national level. A number of activities have taken place since then, including meetings with key stakeholders, systems strengthening initiatives, and training of healthcare workers on the roll-out. The national treatment guidelines are currently being reviewed and new tools are being made available to manage the spread of TB. The national scale-up of the shortened regimens is expected to begin in April 2017 and will be announced  today on World TB Day.

CHAI has provided key support functions to expedite the roll-out of the new short course regimen. CHAI developed and presented a pharmacoeconomics model to the Essential Drugs Programme to expand upon the potential benefits of the new regimen, such as cost-effectiveness and improved quality of life and lives saved, to encourage its introduction.

CHAI also developed costing analyses which estimated potential savings from the introduction of the new regimen and ensured its inclusion in planning and budgeting activities at both the national and provincial levels. Key to these activities was the development of multiple scenarios for implementation, and forecasting the procurement volumes which would be required in each case. The forecast estimates are being used to support efforts to ensure supply security of key medicines for DR-TB patients.

The commitment of South Africa to prioritize combatting and ending TB is clearly highlighted in the National Department of Health’s commitment to raise awareness of TB testing and treatment this World TB Day. The theme “Unite to end TB and HIV: South African Leaders taking Action” highlights the need for urgent action within all levels of government. The coming year will be a critical and exciting time as the new regimen is expanded nationally, and CHAI will continue to support this goal.