Access to anti-TB medicines WHO/EDM Technical briefing seminar for international staff active in pharmaceutical support programmes Salle G, WHO HQ 30.

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 STBAcknowledgements 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 high- burden 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

Progress towards targets for TB control

0

1020

30

40

5060

70

80

1990 2000 2010

Year

Cas

es n

oti

fied

un

der

DO

TS

(%

)

average rate of progress: target 2013

accelerated progress:target 2005

DOTS begins

WHO target 70%

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

R- rifampicin, H- isoniazid, E- ethambutol, Z- pyrazinamide, T- thioacetazone

300150

40075150

150150

150300

75150

100

T

5001501501 [RHZ] int.3x w

275400751501 [RHZE]

50Compl. 2 [TH]

15030602 [RHZ] daily

60602 [RH] int. 3x w

30603 [RH]

4001501 [HE]

EZHR

Combination (mg) No. formulations

Essential anti-TB FDCs in WHO Model List

“Securing access to high-quality TB drugs”

Global TB Drug Facility

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

GDF Operations

ApplicationEligibility criteria

Specific conditionsStandard form

Supporting documents

SupplyPooled procurementStandard products

High quality Low cost

ReviewIndependent Committee

12-15 membersmeets 3x/yearCountry visit

MonitoringQuarterly reports

Existing monitoringIndependent verification

Results based

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

Assessment

GDF monitoring

Year 1 Year 2 Year 3

Countrymakes

application

Review by TRC

Country visit

First delivery

Grant agreement

Second delivery

Thirddelivery

Review by TRC

Review by TRC

Review by TRC

Monitoring mission

Monitoring mission

Monitoring mission

Desk audit Desk audit Desk audit

CountriesCountries under consideration for GDF support

Countries approved for regular GDF support

Countries approved for emergency GDF support

0

10000

20000

30000

40000

50000

60000

HR HRES HRESZK

Resistance Pattern

Pe

r P

ati

en

t D

ru

g C

os

t (U

SD

)

Standard Reference Country Cost

High Income Country Average Cost

Low Income Country Average Cost

Green Light Committee Cost

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

Cost of MDR-TB treatment regimens

The Green Light Committee

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

Established in WHO: March 2000

Major obstacle to implementing DOTS-Plus pilot projects is the high costs of SL anti-TB drugs

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

Reasons for price decrease: concessional price with Lilly, increased competition, expired patent, and pooled procurement

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

Contact the GDF

http://www.who.int/gtb/policyrd/DOTSplus.htm

Mailto:[email protected]

mailto:[email protected] http://www.stoptb.org/GDF/default.asp

Contact the MDR-TB/GLC