1. NTLP - MoH NEED FOR NEW TB DRUG REGIMEN – PERSPECTIVE FROM TANZANIA A presentation for the TB drug Forum Arlington, Virginia: 6-7 Dec. 2005 Dr. S. M. Egwaga NTLP - Tanzania

2. NTLP - MoH Burden of Tuberculosis  WHO estimated 8.8 million new cases and 1.7 million deaths in 2003 –98% of these in the developing world  80% of all cases in 22 high-burden countries in Africa, South East Asia and Western Pacific regions  12 out of the 15 countries with the highest estimated TB incidence rates per capita are in Africa  Underlying cause of the increase is the HIV/AIDS pandemic  WHO reports indicates that 102 of 109 countries surveyed from 1994-2003 have Multi-drug resistance (MDRTB)

3. NTLP - MoH Policy Environment for TB control  Most countries have responded to the TB epidemic by scaling up the WHO recommended DOTS strategy in an environment of Health Sector Reforms and decentralization  There is often little dialogue between those responsible for health systems policy and those responsible for delivering specific programmes like TB control to ensure ownership and informed decision making  There is an acute shortage of human resource – both in quantity and quality to adequately supervise TB control  TB control may be higher on the political agenda after emergency declaration by African Health Ministers in August 2005  The lost productivity due to prolonged TB treatment may affect the whole family and the country at large

4. NTLP - MoH Health system challenges  TB diagnosis among suspects is often subjected to user-fees charges even after declaring it free of charge  TB treatment is provided free of charge but the cost to patient to access treatment sometimes is equal or more than the cost of the drugs  TB drug logistics demand detailed planning to ensure uninterrupted supply  Pharmacy storage facilities are generally small and often without air conditioning  Adherence to treatment regimens especially after the intensive phase is problematic and requires special support  Follow-up of patients who are out of control is often expensive and often not done

5. NTLP - MoH TB regimen challenges  TB treatment is complicated - depends on a multi-drug treatment regimen not easily understood by the average health worker and majority of patients  TB treatment requires daily monitoring by health workers or treatment supporters  The treatment duration is long: 6-8 months  The number of tablets swallowed a day is big especially if accompanied with ARVs too.

6. NTLP - MoH Meeting the challenges  The Stop TB partnership has established the Global Drug Facility (GDF) to support countries access high quality drugs at an affordable price  WHO with partners has revised TB treatment guidelines to accommodate the HIV/AIDS pandemic to minimize failure and relapses after treatment  New 4-fixed dose combination drugs are now available to patients through GDF grant  The new STOP TB strategy recognises and empowers patients and communities to take active role in supervising treatment and fostering adherence  The Global Alliance for TB drug development is spearheading the development of new treatment regimens which could be shorter and simpler for the patients and service providers.

7. NTLP - MoH Desired characteristics of new TB drugs regimens -1  New TB regimens should have the following characteristics:  More effective – reducing treatment duration to a couple of months or weeks  Ideally should be provided once a day  Ideally effective even for MDR-TB  The number of pills to be swallowed – not more two  They should be compatible with ARVs currently used or to be used in future  Well tolerated even on an empty stomach  Few serious side effects

8. NTLP - MoH Desired characteristics new TB regimen -2  The drugs should not require air-conditioning or a cold chain system  They should have a long shelf life (not less than two years) under room temperature and high humidity  They should be affordable by the government of the country – ideally equal to or below the price of current products (about $10 per patient)  The packaging should be robust, waterproof, light but not bulky  The drugs should also be safe for children use

9. NTLP - MoH Proposed steps to adopt new TB regimens at country level -1  Advocacy at all levels by NTP  Orienting key decision makers at national, regional and district levels on new regimens  Advocacy to include the new regimen into the essential drug list  Ensure new regimen is reflected in government budget  Sensitise key private providers and other stakeholders on the need to change drug regimen

10. NTLP - MoH Proposed steps to adopt new TB regimens at country level - 2  Strengthening public – private mix to improve coverage  Involve faith-based providers and private for profit  Ensure same regimens in private sector as in public to minimise resistance by providing them with drugs  Same TB drug management policy guidelines in public and private sectors  Training health care workers – in public and private sectors  Reinforce prescription of anti-TB regimen by trained personnel

11. NTLP - MoH Proposed steps to adopt new TB regimens at country level - 3  Logistics and drug management issues  Strengthen NTP capacity to estimate drug requirements: running and buffer stocks  Availability of a modern drug procurement, storage and distribution system from national to district levels  Effective clearance and forwarding system to avoid unnecessary delays at port of entry  Decentralised and appropriate storage at district level  Monitoring and accountability at all levels – stocks, ledgers, security

12. NTLP - MoH Proposed steps to adopt new TB regimens at country level - 4  Quality of new regimen  All new drugs have to be registered with the National Drug Regulatory Authority to ensure that the source of drugs is GMP compliant  Checking quality of drugs after entering into the country  Having a mechanism for continuous market surveillance of the circulating products  Having capacity to track information relating to the products - batch number, expiry dates, manufacturer and place of issue  Establish mechanism for surveillance of side effects

13. NTLP - MoH Proposed steps to adopt new TB regimens at country level - 5  Orienting health care providers and patients:  There should be appropriate national policy manuals, guidelines and training manuals for health providers  Updated tools for recording: registers and forms  Training health care workers on new regimens  Establish mechanism for supportive supervision and on-job training on new regimens  Provide opportunity for health workers to share experiences  Document best practices

14. NTLP - MoH Proposed steps to adopt new TB regimens at country level - 6  Patient education and community awareness  Raise community awareness on new regimen through mass media, world TB day, local theatres  Educate patients on change of regimen and advantages – mass media, IEC materials for patients and treatment supporters  Establish peer support groups at community level

15. NTLP - MoH In conclusion  New TB treatment regimens are overdue  The Global Alliance for TB drug development provides a unique opportunity to usher in newer drugs and regimens through public private mix  Resource-limited countries especially in Africa should start creating conducive environment for the proper use of the new TB regimens  Encourage production of generic drugs to reduce prices  There should be mechanism to support local production of new regimens as part of technology transfer

16. NTLP - MoH Thank you all for your attention