Q&A about the Novartis Foundation’s activities in TB and about the Novartis TB drug donation

What is DOTS?
DOTS (directly observed treatment short-course) is the brand name for the WHO-recommended TB control strategy. It increases cure rates by 20%-50%, reduces deaths due to TB by 10%-30%, and prevents the emergence of multidrug-resistant (MDR) TB.

DOTS has five key components:

• Secure political commitment, with adequate and sustained financing
• Ensure early case detection, and diagnosis through quality-assured bacteriology
• Provide standardized treatment with supervision, and patient support
• Ensure effective drug supply and management
• Monitor and evaluate performance and impact

What are the key elements of the Novartis TB drug donation to Tanzania?
Novartis donated nearly 250,000 TB treatments to Tanzania from 2005 to 2008. Another 250,000 treatments will be delivered from 2009 to 2012. This donation is made available through the Global Drug Facility (GDF) of the Stop TB Partnership, which is hosted by the World Health Organization. Novartis also provides the necessary funds for logistics and independent quality control, to be carried out in addition to the quality control of the Novartis Group.

What is the role of the Novartis Foundation in the donation?
The Novartis Foundation is responsible for the DOTS donation within the Novartis group. The foundation provides additional support through social marketing campaigns and the promotion of the patient-centered treatment (PCT) in Tanzania.

What is patient-centered TB treatment?
Patient-centered TB treatment is an approach whereby a tuberculosis patient can choose where to be supervised for treatment, either at the health facility or at home. Those who choose home-based treatment have to select a supporter (e.g. family member, spouse, neighbor, community health worker) who observes their treatment daily. In Tanzania, the approach is currently being piloted in three districts. The results so far are promising. Around 88% of patients in Tanzania opted for home-based treatment.

What is the role of the Novartis Foundation in patient-centered TB treatment?
The Novartis Foundation, in collaboration with the Tanzanian National TB Programme, the Ifakara Health Institute and the National Institute for Medical Research, carried out a study in 2004 to ascertain the need for and the feasibility of providing PCT in three districts. Most patients and health workers welcomed the possibility of allowing patients to choose where their daily treatment is supervised and by whom. The approach was first introduces in three pilot districts in Tanzania by the National TB Programme, supported by the Novartis Foundation.

Which drugs will be donated?
The DOTS donation comprises the WHO-recommended gold standard TB treatment comprising:

• The 4-drug fixed-dose combination tablets for the two-month phase of intensive treatment (RHZE: rifampicin 150 mg, isoniazid 75 mg, pyrazinamide 400 mg and ethambutol 275 mg) and
• The 2-drug fixed-dose combination tablets for the four-month continuation phase (RH: rifampicin 150 mg, isoniazid 75 mg)

What are the advantages of rifampicin-based fixed-dose combinations
Fixed-dose combinations reduce the risk of resistance by preventing monotherapy and stock-outs of any individual drug and simplify logistics and management for the providers and the system (e.g. prescription errors are minimized). They are also patient-friendly and improve patient compliance as they dramatically reduce the number of tablets patients need to take. Rifampicin-based fixed-dose combinations shorten the duration of treatment by two months to a total of six months.

What are the disadvantages of these fixed-dose combination tablets?
Side effects of any of the individual components of the fixed drug combinations are likely to occur in about three to six per cent of patients. These people will need to be switched to loose drugs, avoiding the drug that causes the side effect. This rate may be higher in patients co-infected with HIV. Therefore, a limited stock of loose drugs must be available in referral centers.

Where are the drugs manufactured?
The fixed-dose combinations are manufactured at the Kolshet plant of Sandoz India (Mumbai). The plant has received GMP certification from the European Health Authorities.

How is the quality of the drugs ensured?
In addition to the standard quality control of the Novartis Group, every batch will undergo independent quality control by an agent appointed by the Global TB drug facility. Novartis covers the costs involved for the quality control.

What is the value of the DOTS donation?
The donation of the second phase (2009 to 2012) is worth USD 6 million. Until the point of delivery in Tanzania, Novartis covers all costs including shipment, insurance and quality control.

What prompted Novartis to make this donation?
The donation is in response to the former United Nations Secretary-General Kofi Annan’s call for support for the fight against HIV/AIDS, TB and malaria. Although TB can be cured with DOTS, it kills almost two million people every year. Rifampicin, a key drug in the fixed-dose combinations, was co-developed in the labs of Novartis. As TB treatment features within the Novartis product portfolio, the DOTS donation was a logical contribution to the fight against TB.

Why was Tanzania chosen as the recipient country?
Novartis has delivered a TB drug donation to Sri Lanka in 2005 but later decided to focus on Tanzania alone. In Tanzania about 60,000 cases are detected every year; the entire country can therefore be covered by the donation for an estimated total of 8 years (first and second phase of donation). Also, Novartis and the foundation have a well established cooperation in Tanzania due to the Multi-Drug Therapy (MDT) drug donation against leprosy which was relevant for the pilot of the patient-centered TB treatment project.

Are there any conditionalities associated with the donation?
Novartis does not impose any conditionalities on the donation. Tanzania has to comply with the conditions of the GDF which include adherence to the internationally accepted DOTS strategy.

Does Novartis support other activities in TB?
Besides the drug donation and the patient-centered treatment program of the Novartis Foundation in Tanzania, the Novartis Institute for Tropical Diseases in Singapore is developing new treatments for TB and multidrug-resistant TB. The products of this research will be made available without any profit.