Transcript Access to anti-TB drugs - WHO archives

Access to anti-TB medicines
WHO/EDM Technical briefing seminar
for international staff active in pharmaceutical support programmes
Salle G, WHO HQ
30 Sept - 4 Oct 2002
Dr S. Phanouvong
Focal point for access to TB drugs
EDM and STB
Acknowledgements to Drs I. Smith and L. Blanc
STB for the materials used in this presentation
Presentation outline
 The Global targets in TB control
 The constraints in DOTS expansion
 The Global TB Drug Facility (GDF)
 Operations
 to date achievements
 The Green Light Committee
DOTS case detection and cure

In 2002
• Smear+ cases ave. cure rate of 80% in all DOTS
programmes (70% in African region)
• 148 countries adopted DOTS strategy (incl. 22 highburden ones which bear 80% of est. incidents cases)
• 55% of global pop had access to DOTS
• 27% of infectious cases were detected and treated
under DOTS

TB remains as global health problems
•  2 billion of the world pop. is infected with TB bacillus
• 75% of cases in economically productive age group
• About 8.7 million develop active TB every year
• About 2 million deaths annually
Cases notified under DOTS
(%)
Progress towards targets for TB
control
80
70
60
50
40
30
20
10
0
WHO target 70%
accelerated
progress:
target 2005
DOTS
begins
1990
average rate of
progress: target 2013
2000
Year
2010
Constraints in DOTS expansion

Some political/programmatic constraints
• Lack of or weak political will and commitment
• Lack of institutional/infra. to provide services
• inadequate supply of good quality TB drugs
 shortages of 1 or 2 drugs

Emergence of MDR-TB
 >3% of new cases 1996-1999

HIV-AIDS epidemic
Constraints in DOTS expansion (c.)

Operational and managerial
• TB treatment is seen as complicated&takes time
 many tablets/capsules to be taken
 too many drug formulations (different dosage
strengths- esp. the FDCs)
 requires DOT for potential success in treatment.
DOT is not strictly applied in drug taking
• Lack of effective co-ordination in a decentralised
system
 for drug procurement, distribution and use
Essential anti-TB FDCs in WHO Model List
No. formulations
Combination (mg)
R
1 [HE]
3 [RH]
H
Z
150
30
150
75
300
150
60
60
150
150
60
30
150
150
75
400
1 [RHZ] int.3x w
150
150
500
1 [RHZE]
150
75
2 [RHZ] daily
Compl. 2 [TH]
T
400
60
2 [RH] int. 3x w
E
400 275
50
100
150
300
R- rifampicin, H- isoniazid, E- ethambutol, Z- pyrazinamide, T- thioacetazone
Global TB Drug Facility
“Securing access to
high-quality TB
drugs”
What is the GDF?
• A global initiative to secure access to high
quality drugs to accelerate DOTS expansion,
addressing four needs:
–
–
–
–
The need for more resources for TB drugs
The need for high quality TB drugs
The need for efficient procurement systems
The need for standardised products
What does the GDF offer?
• Now
– Grants of first line drugs, to support DOTS expansion
– A direct procurement mechanism for countries and
NGOs, for use in DOTS programmes
– A web-based tool for placing orders and tracking
shipments
• Future
– A list of ‘prequalified’ manufacturers of quality TB
medicines
– Diagnostics and second line medicines
Application
Eligibility criteria
Specific conditions
Standard form
Supporting documents
Monitoring
Review
Quarterly reports
Existing monitoring
Independent verification
Results based
Independent Committee
12-15 members
meets 3x/year
Country visit
Supply
Pooled procurement
Standard products
High quality
Low cost
GDF Operations
Applications & Review
• Eligibility for grants of first line drugs
– Annual per capita GNP under $3,000 (low and lower middle income countries)
– Priority for countries with a per capita GNP under $1,000
• Documents needed to support application
–
–
–
–
National plan & budget for DOTS expansion to meet global targets
Technical guidelines demonstrating commitment to principles of DOTS
Annual report on DOTS performance (WHO TB database collection form)
Recent external review
• Review
– Technical review committee of independent experts
– Continuous application and review process, with TRC meetings at least 3
times a year
– Emergency applications can be reviewed urgently
– Support provided in principle for three years (renewable)
Who are the donors of GDF?
• An initiative of the Global Partnership to Stop
TB aiming to provide free drugs for 10 million
people with TB by 2005
• Needs $250 million over the next 5 years
• Initial funding from Canada, Netherlands &
US
To date achievements
• Processed applications from 43 countries; 33 countries
approved for support, and 1 pending
• Drugs ordered for 21 countries and delivered to 11 countries
• Drugs committed for almost 1,600,000 patients
• New funds received from donors (CIDA, US & Dutch) ~
$11m
• Drug prices down ~30%
• Average drug cost per patient: ~$11.2
• Catalyst for introduction and expansion of DOTS
• Catalyst for standardisation - FDCs
GDF monitoring
Country
makes
application
Review
by TRC
Review
by TRC
Country visit
Grant
agreement
Assessment
First
delivery
Monitoring
mission
Review
by TRC
Monitoring
mission
Desk audit
Year 1
Monitoring
mission
Desk audit
Year 2
Second
delivery
Review
by TRC
Desk audit
Year 3
Third
delivery
Countries approved for regular GDF support
Countries approved for emergency GDF support
Countries under consideration for GDF support
Countries
Cost of MDR-TB treatment regimens
Standard Reference Country Cost
High Income Country Average Cost
Low Income Country Average Cost
Green Light Committee Cost
Per Patient Drug Cost (USD)
60000
50000
40000
30000
20000
10000
0
HR
HRES
HRESZK
Resistance Pattern
Source: Rajesh Gupta et al. Responding to market failures in tuberculosis control. Policy Forum: Public Health. Science’s
Compass, Science, vol. 293 10 Aug 2001. www.sciencemag.org
The Green Light Committee
Established in WHO: March 2000
Major obstacle to implementing DOTS-Plus pilot projects is the high costs of SL
anti-TB drugs
Members:
Centers for Disease Control and Prevention, Harvard Medical School, Médecins
Sans Frontières, National TB Programme - Peru, The Royal Netherlands
Tuberculosis Association, and World Health Organization
Examples of GLC drug prices
 Capreomycin: monopoly,non-patent - Eli Lilly&Com.
• Open market unit price: $22.00 - $31.00
• GLC unit price: $1.00 - $1.75
 Cycloserine: monopoly, non-patent - Eli Lilly&Com.
•Open market unit price: $2.99 - $3.99
•GLC unit price: $0.13 - $0.75
 Ofloxacin: monopoly, patent - Aventis
•Open market unit price: $1.27
•GLC unit price: $0.40 - $0.45
Reasons for price decrease: concessional price with Lilly, increased
competition, expired patent, and pooled procurement
Contact the GDF
mailto:[email protected]
http://www.stoptb.org/GDF/default.asp
Contact the MDR-TB/GLC
Mailto:[email protected]
http://www.who.int/gtb/policyrd/DOTSplus.htm