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"The international experience of DOTS-Plus and the Green Light Committee mechanism" Dr Ernesto Jaramillo Medical Officer, WHO/HTM/STB/THD. World Health Organization. DOTS-Plus.

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slide1

"The international experience of DOTS-Plus and the Green Light Committee mechanism" Dr Ernesto JaramilloMedical Officer, WHO/HTM/STB/THD

World Health Organization

WHO/STB/THD

dots plus
DOTS-Plus

The strategy designed to manage MDR-TB using second-line anti-TB drugs within the DOTS strategy in low- and middle-income countries.

DISCLAIMER: DOTS-Plus means DOTS first

WHO/STB/THD

the green light committee mechanism of the stop tb partnership
The ‘Green Light Committee’ mechanism of the Stop TB Partnership

The mechanism of WHO and its partners of the Stop TB Partnership to enabling access to second-line anti-TB drugs in low- and middle-income countries to treat multidrug resistant tuberculosis under programmatic conditions and following specific guidelines (Guidelines for implementing DOTS-Plus projects for the management of MDR-TB).

WHO/STB/THD

the green light committee mechanism of the stop tb partnership1
The ‘Green Light Committee’ mechanism of the Stop TB Partnership
  • DOTS-Plus and the GLC mechanism: a comprehensive response to…
    • Evidence that basic DOTS was not enough to control TB and MDR-TB
    • Global widespread misuse of second-line TB drugs
    • Failure of the market of second-line TB drugs
    • Lack of policy to manage and control MDR-TB

WHO/STB/THD

a market failure management of mdr tb before the creation of the glc mechanism
A market failure: management of MDR-TB before the creation of the GLC mechanism

Situation on low and middle income countries

High Cost of Treatment

Lack of Drug Demand

Insufficient response to demand

Lack of Policy

Lack of evidence on feasibility and cost-effectiveness

WHO/STB/THD

response to mdr tb by linking concepts
Response to MDR-TB by linking concepts

ACCESS

Price & quality

RATIONAL USE OF DRUGS

GLC

mechanism

POLICY FOR TB CONTROL

WHO/STB/THD

advantages of applying to the who glc mechanism
Advantages of applying to the WHO GLC mechanism
  • Access to quality-assured drugs following international accepted standards (including WHO)
  • Access to low-cost drugs
  • Access to a continuous drug supply, essential for treatment success
  • Access to technical assistance to ensure rational drug use

WHO/STB/THD

advantages of applying to the who glc mechanism1
Advantages of applying to the WHO GLC mechanism
  • Access to an external monitoring mechanism
  • Increased rational use of drugs
  • Creation of wide evidence base for national policy development
  • Ensures consolidation of DOTS as the strategy to control TB

WHO/STB/THD

slide9

Scaling-up of DOTS-Plus through the GLC mechanism

April 2005 – 33 projects

WHO/STB/THD

the glc has contributed to a paradigm shift in the management of mdr tb

The GLC has contributed to a paradigm shift in the management of MDR-TB

34 projects

28 countries

10,939 patients

Source: WHO 2002

GLC-approved DOTS-Plus projects

Applications under review by the GLC

Countries preparing application

WHO/STB/THD

the green light committee mechanism
The ‘Green Light Committee’ mechanism
  • …has contributed to demonstrate that:
    • Market of SLDs can be increased and be rationally handled
    • DOTS-Plus is feasible, effective and cost-effective
    • Integration of DOTS-Plus into regular DOTS is feasible and strengthens regular DOTS programmes

WHO/STB/THD

dots plus and the green light committee mechanism a learning experience for all
DOTS-Plus and the ‘Green Light Committee’ mechanism: a learning experience for all!
  • …by creatively sailing in non-chartered waters, the Working Group on DOTS-Plus and its subgroups have contributed to demonstrate that:
    • Market of SLDs can be increased and be rationally handled
    • DOTS-Plus is feasible, effective and cost-effective
    • Integration of DOTS-Plus into regular DOTS is feasible and strengthens regular DOTS programmes

WHO/STB/THD

increased size and quality of the market of second line anti tb drugs
Increased size and quality of the market of second-line anti-TB drugs
  • Eli Lilly transfer of technology and effects on supply
  • Increasing production capacity in some manufacturers
  • Investments in some manufacturers to meet quality standards

WHO/STB/THD

main components of a dots plus project
Main components of a DOTS-Plus project
  • Plan(who will do what, when, how, where?)
  • Locating the project in the NTP structure
  • Case finding strategy
  • Treatment regimen
  • Drug management (including procurement plan)

WHO/STB/THD

main components of a dots plus project1
Main components of a DOTS-Plus project
  • Role of hospital vs ambulatory treatment
  • Management of adverse reactions
  • Data collection and analysis
  • Laboratory functions
  • Training of health care workers

WHO/STB/THD

main components of a dots plus project2
Main components of a DOTS-Plus project
  • Role of hospital vs ambulatory treatment
  • Management of adverse reactions
  • Data collection and analysis
  • Laboratory functions
  • Training of health care workers

WHO/STB/THD

lessons learned main barriers to implement dots plus
Lessons learned: main barriers to implement DOTS-Plus
  • Poor integration of the MDR-TB activities in the NTP
  • Lack of drug registration of quality-assured drugs
  • Poor understanding of drug side effects, its prevention and management
  • Poor TB laboratory capacity and/or performance (no quality control system in place, lack of quality assurance for performing DST for first-line TB drugs)

WHO/STB/THD

lessons learned main barriers to implement dots plus1
Lessons learned: main barriers to implement DOTS-Plus
  • Lack of experience in managing second-line drugs to treat MDR-TB under programmatic conditions
  • Inadequate facilities to hospitalize and/or treat MDR-TB patients
  • Absence of social support measures to facilitate adherence to treatment

WHO/STB/THD

lessons learned different ways to implement a single framework
Lessons learned: different ways to implement a single framework
  • MDR-TB burden does not determine the decision to implement DOTS-Plus: from Latvia to Lebanon
  • Country-wide DOTS coverage does not determine the decision to implement DOTS-Plus: from Peru to the Philippines
  • High cost of treatment does not prevent to treat MDR-TB: from El Salvador to Estonia

WHO/STB/THD

lessons learned different ways to implement a single framework1
Lessons learned: different ways to implement a single framework
  • Flexibility to adapt DOTS-Plus to local resources:
    • Control of infection risk: from Estonia to Bolivia
    • Social support: from Peru to Latvia
    • Implementer: from Haiti to Honduras
    • Treatment strategy: from Mexico to Malawi
    • Delivery of treatment: from Nepal to Nicaragua

WHO/STB/THD

lessons learned dots plus preparation takes time
Lessons learned: DOTS-Plus preparation takes time!

DOTS-Plus does not necessarily mean MDR-TB diagnosis and treatment in all regions and all districts from the very beginning !

Slow steps should be taken in order to pilot, adjust and expand a rational and feasible capacity to manage drug resistant TB

WHO/STB/THD

lessons learned dots plus preparation takes time1
Lessons learned: DOTS-Plus preparation takes time!
  • Stepwise implementation of DOTS-Plus includes:
    • Assessment of drug resistance situation (DRS data, risk groups, laboratory capacity, SLD use )
    • Relevance of DOTS-Plus in the context of TB control
    • From pilot phase to country-wide expansion: many scenarios, good to start to with national/provincial centres of excellence

WHO/STB/THD

preliminary results of dots plus projects
Preliminary results of DOTS-Plus projects
  • More than 5,000 patients have been enrolled and 3,100 have completed treatment
  • MDR-TB among new cases in projects assessed range from 1.5-17.1%
  • 57% of the MDR-TB cases treated are resistant to all first line-drugs and also to second-line anti-TB drugs
  • Treatment success rates range from 61-82%
  • Only 2% of patients have stopped treatment due to adverse events

WHO/STB/THD

adverse events 1
Adverse events (1)

Data in 924 patients from Estonia, Latvia, Russia and Philippines show that only 2% (17patients) have stopped treatment due to side effects

WHO/STB/THD

adverse events 2
Adverse events (2)
  • Adverse events are manageable in the treatment of MDR-TB in resource-limited settings provided that standard management strategies are applied including:
      • altering dosages when appropriate
      • ancillary drugs to treat adverse events
      • discontinuation of some drugs if indicated
      • special training on adverse events to second-line drugs
      • standard protocols for registration

WHO/STB/THD

lessons learned one treatment strategy does not fit all

Standardized treatment

No DST done (or DST only done to confirm MDR-TB). All

patients in a patient group or category get the same regimen.

Empiric treatment

No DST done (or DST only done to confirm MDR-TB). Each regimen is individually designed based on patient history.

Individualized treatment

Regimen is designed based on patient history and DST.

Standardized treatmentfollowed by

individualized treatment

Initially all patients in a certain group get the same regimen

and it is then adjusted when DST results become available.

Empiric treatmentfollowed by

individualized treatment

Each regimen is individually designed based on patient

history and then adjusted when DST results become available.

Lessons learned: one treatment strategy does not fit all

WHO/STB/THD

evidence of feasibility and effectiveness of dots plus treatment outcomes in some dots plus sites
Evidence of feasibility and effectiveness of DOTS-Plus: Treatment outcomes in some DOTS-Plus sites

WHO/STB/THD

slide33

Evidence of cost-effectiveness:Cost per patient treated under DOTS-plus projects by major line item (health system perspective, 2003 US$)

WHO/STB/THD

evidence of cost effectiveness of dots plus projects
Evidence of cost-effectiveness of DOTS-plus projects

Examples of general benchmarks to compare cost-effectiveness:

  • ≤ GNI per capita
  • ≤ 1-3 times GDP per capita [WHR, 2002].
  • ≤ US$ 565-847 per DALY averted (2003 US$ prices), estimated "limited care" component of essential health package for middle income countries [World Bank, 1993].

WHO/STB/THD

costs effects cost effectiveness of dots plus in the philippines
Costs, effects, cost-effectiveness of DOTS-Plus in the Philippines

Cost per DALY averted

  • < per capita Gross National Income (GNI) (~US$1000)
  • ~ level (US$200 in 2002 prices) considered "attractive" investment in low-income countries by World Bank in 1993
  • < 3x per capita GNI (Commission on Macroeconomics and Health, WHO, 2001)

WHO/STB/THD

preliminary results of dots plus projects1

Preliminary results of DOTS-Plus projects

Strengthened DOTS: quality, consolidation and expansion

Training of human resources for management of drug resistant TB

Laboratory capacity strengthened

Size and quality of market of second-line TB drugs

Commitment of GFATM to fund management of MDR-TB

WHO/STB/THD

preliminary results of dots plus projects2
Preliminary results of DOTS-Plus projects
  • DOTS-Plus is creating, fixing and strengthening DOTS
    • Makes DOTS the default option to control TB: Moldova
    • Ensures political commitment: Estonia
    • Strengthen laboratory capacity: Peru
    • Contributes to a comprehensive TB control policy: the Philippines
    • Highlights the importance of drug management in TB control: all
    • Improves the skills of health care workers: Latvia
    • Improves understanding of local TB and MDR-TB epidemiology: all

WHO/STB/THD

slide38

DOTS-Plus framework

1. Sustained Political commitment

2. Diagnosis of MDR-TB through quality-assured culture and drug

susceptibility testing (DST).

3. Appropriate treatment strategies that utilize second line drugs under

proper management conditions.

4. Uninterrupted supply of quality assured reserve antituberculosis

drugs.

5. Recording and reporting system designed for DOTS-Plus programs

WHO/STB/THD

framework component 1 sustained political commitment
Framework Component 1:Sustained Political commitment
  • Long term investment of resources (human and financial)
  • Addressing the factors leading to the emergence of MDR-TB
  • A well functioning DOTS program !!
  • Procurement of quality-assured drugs and legislation to assure rational use
  • Effective coordination between community, local governments, and international agencies

WHO/STB/THD

slide40
Framework Component 2:Diagnosis of MDR-TB through quality-assured culture and drug susceptibility testing (DST)
  • Proper triage of patients into susceptibility testing and the DOTS-Plus component of the DOTS program.
    • Some programs can do drug susceptibility testing for all patients
    • Most programs will use DST strategies that target MDR risk groups (failures, chronics)
    • Some enrol patients based on representative DRS data (Nepal)
    • But, all programs need access to quality assured drug smear microscopy, culture and susceptibility testing

WHO/STB/THD

slide41
Framework Component 3:Appropriate treatment strategies that utilize second-line drugs under proper management conditions
  • Appropriate regimens
  • Directly observed therapy (DOT) throughout
  • Monitoring and early management of side effects
  • Adequate human resources (both quantity and quality)

WHO/STB/THD

slide42
Framework Component 3:Appropriate treatment strategies that utilize second-line drugs under proper management conditions(continued)
  • Monitoring and management of side effects
    • Management algorithms provided in guidelines
    • Ability to refer when indicated
    • Active monitoring (clinical ! and laboratory)
    • Ancillary medicines at no cost to patient

WHO/STB/THD

framework component 4 uninterrupted supply of quality assured second line anti tuberculosis drugs
Framework Component 4:Uninterrupted supply of quality assured second-line anti-tuberculosis drugs
  • Many challenges of drug procurement
    • Individualized regimens are frequently being adjusted (due to side-effects, drug susceptibility testing results, and lack of treatment response)
    • Short shelf life (18 – 36 months)
    • Global production of quality-assured drugs is limited
    • Drug registration may be lengthy and costly

WHO/STB/THD

framework component 5 recording and reporting system designed for dots plus programs
Framework Component 5:Recording and reporting system designed for DOTS-Plus programs
  • Enables
    • patient registration
    • monitoring (including culture, DST, laboratory tests…etc)
    • interim indicators
    • final outcome analysis
    • comparison of different cohorts

WHO/STB/THD

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