brazil model of care_margareth

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New Delhi, India - June 2013

TB in India: Challenges and OpportunitiesMSF Internal Workshop Agenda

Prf. Margareth Dalcolmo, MD, PhDFIOCRUZ MoH

Model of management and

interventions for TB control:The Brazilian Experience

FIOCRUZ


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Declaration of conflict of interest

Principal investigator in Brazil of Phase III Clinical Studywith Bedaquiline TMC 207 Janssen

Member of TB MoH Steering Committee

Member of implementation group for the rapidmolecular test Gene Xpert for TB diagnostic - MoH /FAP / Bill & Melinda Gates Foundation

Member of WHO Task Force Group for introduction ofnew TB Treatments


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Brazil: factsheets

Surface: 8.514.877 km (5th largest country)

States: 27

Borders: Argentina, Bolivia, Colombia, FrenchGuyana, Guyana, Paraguay, Peru, Suriname, Uruguay

and Venezuela

Population (2011): 193.917.083 inhab. (5th largest)

Urban population: 84,0%

GNP (2012):

- Total: US$ 2.2 trillons USD (7th)- Per capita: US$ 11.670 (68rd)

- Minimun wage: US$ 339

Social indicators

- HDI (2012): 0.73 (85th)

- Life expectancy: 73.8 years (102nd)

- Child mortality (2010): 19,3/ thousand (106th)- Years of study: 7.2 years (last in South Amrica)

Brazilian Health Systemuniversal access, free of

change (Right of all, duty of the State Federal

Constitution)


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Russia (Ivanovo)

Russia (Tomsk)

Kazakhstan

Russia (Ivanovo)

Lithuania

Estonia

Uzbekistan

Kazakhstan

53.3

12.3

56.4

14.2

58.1

14.2

13.7

13.2

Highest MDR-TB rates> 10% among new cases

> 50% among treated cases

New cases

Previously treated cases

KZN

MDRTB: 500.000 casos

XDRTB: 50.000 casos


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Countries with XDR TB confirmed cases

Czech Republic

Theboun

dariesandnamesshownandthedesignationsusedonthisma

pdonotimplytheexpressionofanyopinion

whatsoev

eronthepartoftheWHOconcerningthelegalstatusofanycountry,territory,cityorareaorofits

authoritie

s,orconcerningthedelimitationofitsfrontiersorboundaries.

Dottedlinesonmapsrepresentapproximate

borderlin

esforwhichtheremaynotyetbefullagreement.WHO200

5.Allrightsreserved

Ecuador

Georgia

Argentina

Bangladesh

Germany

Republic of Korea

Armenia

Russian Federation

South Africa

Portugal

Latvia

Mexico

Peru

USA

Brazil

UKSweden

Thailand

Chile

Based on information provided to WHO Stop TB Department May 2009

Spain

Islamic Republic of Iran

China, Hong Kong SAR

France

Japan

Norway

Canada

Italy

Netherlands

Estonia

Lithuania

Ireland

Romania

Israel

Azerbaijan

Poland

Slovenia


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70 thousand new TB cases reported in 2012

4,6 thousand deaths in 2010 17th country in burden of disease (one of 22 high burdencountries)

111th country in TB incidence rate

4th cause of death among infectious disease

TB is a compulsory reported disease

Treatment is fully provided by government and free ofcharge. Procurement is a federal responsability

Standardized drugs not available in private sector. Noconflict between public and private sector

TB in Brazil: factsheets and context


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Since the introducton of short-course regimen RHZ, in1980 at countrywide level, all revisions andrecommendations are made and published with theagreement with MoH and medical societies.

Drug procurement is a federal level responsability. Treatment is fully provided by government and free ofcharge first line as well as second line

Standardized drugs not available in private sector. No

conflict between public and private sector

DOT adopted as a national policy in different modalities

Quality control of all drugs regularly done

TB in Brazil: Guidelines


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51.8

36.1

0

10

20

30

40

50

60

70

TB incidence rate. Brazil, 1990-2012.*

Per 100 thousand inhab.

Year

Source: MS/Sinan and IBGE. *preliminary data

Decrease = 30,2% (average 1,4% per year)


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Consistent decrease of incidence and mortality ratessince mid 90s

Stability of operational indicators as cure and default

rates in undesirable levels

One fourth of TB patients are enrolled in the UnifiedRegister for government social support programs(Cadastro nico)

14% of TB cases are beneficiaries ofBo lsa Famlia

Epidemiological Antecedents


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TB mortality rate. Brazil, 2000 - 2010

Source: MS/Sinan and IBGE.

Per 100.000 inhab.

Year

3.3 3.13.0 2.8 2.8

2.6 2.6 2.5 2.6 2.5 2.4

0

1

2

3

4

5

2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010


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70.4 70.4 72.4 73.074.7 74.6 74.6 74.5 74.3 73.4 71.6

10.8 9.8 9.5 9.3 9.3 9.2 10.3 10.4 11.2 10.5 9.8

0102030405060

708090

100

2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011

cura abandono

TB cure and default rates. Brazil, 2001- 2011

Source: MS/Sinan and IBGE. *preliminary data

%

Year


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Afrodescendent population: 1,5 times*

Indigenous population: 3 times*

Prisoners: 28 times*

PLHA: 35 times*

Homeless: 67 times**

Vulnerable Populations(RR comparing with general population)

* Source: MS/Sinan and IBGE** Source: Adorno 2010


13/50Source: PNAD, 2008. Minimum Wage = R$678 (US$339)

Relationship between family income (in minimumwages per capita) and TB ocurrence. Brazil, 2008

1.00

0.76 0.74 0.76

0.59

0.10

1.00


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According to Styblo

s rule, to control TB it would be enoughto detect 70% of BK+ cases and cure, at least, 85% of them.

Several respected researches have questioned this rule,pointing that in different scenarios this two programmatic

indicators won`t push down incidence trend until reaches


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Brazilian Social Protection System

Based on three pillars:

National Health System (SUS)

Social Security (National Social Insurance Institute - INSS)

National Social Assistance Policy (SUAS)Brazilian social security system covers the entirepopulation against all basic social risks under the ILOSocial Security (Minimum Standards) Convention(No. 102), 1952.


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Social Security (INSS)

Contributory and requires compulsory affiliation (except for

retirement)

The social insurance system covers individuals in old age,those with disabilities and survivors. In addition, it providesmaternity coverage, involuntary unemployment protection

and others

INSS survey on infectious diseases that most causeinsurance for been away from work in 2012:

Tuberculosis has been the disease among infectiousones that most causes payment of sickness benefitsgranted to formal workers by social security: 12,997cases, representing 31.4% of the number of sicknessbenefits by DIP


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Social Assistence Policy (SUAS)

A non-contributory public policy to provide cash benefitsand services to populations living in poverty, in need, or ina condition of social vulnerability

Social assistance is responsible for ensuring the followingsecurities: income, shelter, coexistence, autonomy andthe survival of circumstantial risks

Currently, there are 19.5 million households (around80 millions people) enrolled in Unified Register forgovernment social support program (Cadnico)


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Instrument to collect data to identify and characterize the poor familiesin Brazil

Target population: families with per capita income of 12 minimumwage (US$170.00) up to three minimum wages (US$1,015.00)

Purpose: identifying the characteristics of poor families and theirindividual members through the Social Identification Number (NIS);

producing socioeconomic diagnosis of low-income families in Brazil,serving as an input for public policies in all levels of government

Types of information about families enrolled: characteristics ofhousehold, family composition, civil identification, educational level,employment status, labor market situation of each family member,

income and total household spending Transparency and control: auditing by crossing administrative

databases of the federal government; biennial review of thesocioeconomic situation of families registered; control by outsideagencies and social control agencies

Cadnico (Unified Registry): key features


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Bolsa Famlia Programme (BFP)

Conditional cash transfer policy focused on poor and extremelypoor families

Immediate relief from poverty

Poor families per capita monthly incomes range from US$ 35to US$ 70; the extremely poor families per capita monthly

income is below US$ 35 (based on World Bank US$1,25/day) Conditionalities as a tool for achieving familie`s commitment

with attendance to health and education services and enforcingthe supply of services for the poor population

Funding of financial benefits: Federal Government budget. Number of beneficiaries of BFP: 13,3 millions

Fiscal Impact of BFP: 0,46% of GDP - US$ 10 billion


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Bolsa Famlia Programme Social Outcomes

Reduction in income inequality 21% of the reduction achieved in income inequality was due to

BFP (2004-2006).

Soares et alii, 2006.

Extreme poverty

BFP explains 18% of the reduction in the poverty gap

Soares and Satyro, 2009.

In 2009, 4.3 million out of 12.4 million beneficiary families havecrossed the extreme poverty line (US$35 per capita monthly)by receiving the financial benefits

Senarc, 2010.


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Bolsa Famlia Programme Health Outcomes

Impacts on health

Increase of child immunization rates (15-25%,according to the vaccine).

Beneficiary pregnant women have 1.5 as manypre-natal doctor attendances as non-beneficiarieswith the same social and economic profile

Probability of being born full term is 14.1% higherfor children in families that receive the benefit

Source: (Bolsa Familia Impact Evaluation Research, 2010)


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Political

Commitment


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Brazilian federal budget (US$) for TB, 2000-2012*

Source: NTP Brazil

US$

$ 0.00$ 10,000,000.00

$ 20,000,000.00

$ 30,000,000.00

$ 40,000,000.00

$ 50,000,000.00

$ 60,000,000.00

$ 70,000,000.00

$ 80,000,000.00

$ 90,000,000.00


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Over the last few years, there was a significative reduction of thepopulation living under conditions of poverty. Poverty in Brazildecreased 67% and 35 million people left the poverty line since2004

This outcome was the result of the economic growth and politicaldecisions

Highlights: the increase of the number of jobs and it s formalizations,the real valuation of the minimum wage, the extention and

consolidation of conditioned income transfers programs (Bolsa Famlia,Benefcio de Prestao Continuada) and credit expantion

However, in spite of this recognized effort, 16,2 million people stilllive under conditions of extreme poverty

Improvement of social indicators in Brazil inrecent years


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Policies in the Ministry ofHealth & advances


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Participation at National Health Council(the highest health forum in country)

Recommendation # 003 of March 17th 2011National Health Council

"It is recommended that the Ministry of Health: joinedwith other areas of the Federal Government, with theparticipation and support of social movements, theNational Congress and institutions from other sectors,the creation and maintenance of social benefits forpeople with tuberculosis, so as to increase treatmentadherence and reduce abandon rates. "


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Decided:(...)11. Develop actions and strategies that consider the needs ofimpoverished communities, the afrodescendent population, thehomeless people, prisoners and indigenous population and

people living with HIV/AIDS in order to improve TB control amongthese populations.12. To establish an intersectoral committee with the participationof civil society, to develop joint actions in order to addresssocial determinants related to TB, especially those who have

direct relationship with poverty and poor access.()I ratify the National Health Council resolution # 444 of July 6th, 2011.

Alexandre Rocha Santos PadilhaMinister of Health

Resolution # 444 of the National HealthCouncil, July 6th, 2011


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1. Creation of the Parliamentary Front against TB, at the National

Congress, to promote the discussion on TB control in the Brazilianparliament

2. Supply of social incentives for TB patients by 85% of States andmunicipalities (food packages, travel vouchers, free of charge to

community restaurants)

3. Research funding and development in social protection and TB inpartnership with universities (UFBA, UFES, UFRJ, UNB, Fiocruz)

4. Creation of the special committee at the National Congress tostudy and produce reports in diseases of poverty

5. Linkage between TB information system (Sinan-TB) and theUnified Register for government social support programs (Cadnico)

Important achievements of 2012


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Social Determinants

Linkage between Sinan (2011) x Cadnico:

Out of 73.833 TB new cases 25.1% live in poverty

13.9% (10,278) of new TB cases receive Bolsa Famlia


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Among cases beneficiaries of BF only 17.8 had more thaneight years of education

And only 36.1% had any kind of work in the previous year

before enrollment in Cadastro nico For those who worked the amount received during thisperiod (one year) had a median of US$900 (min US$1 andmax of US$21,000)

Cure rate in cases recipients of BF was 6% greaterthan in the all other cases

First general outcomes and TB impact

Source: MS/Sinan and Cad.nico


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Treatment outcome of TB new casesacording to receipt of benefit. Brazil, 2011*

77.7

7.73.8

71.8

9.5 9.2

0

10

20

30

40

50

6070

80

90

Cure Defoult Death

BF Not BF


%

Default


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TB new cases under DOTS accordingto receipt of benefit. Brazil, 2011*


49.5

44.1

41

4243

44

45

46

4748

49

50

BF Not BF

%


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Systematic revision

Justification

Rationale of changes ofTB guidelines done in

Brazil in 2009

MoH, Medical societies, nursecouncil, and civil society

TB T t t S t i B il Ch d i 2009


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TB Treatment System in Brazil Changes done in 2009

2RHZE/4RH

Culture, ID &DST at end of 2nd

month when

smear +

Retreatment

post cure orabandon

All cases withculture and

DST

2RHZE/4RH

FAILURE

6SZELvf/TZAM

alternativeto SM

18 - 24 moduration

Failed or

TBXDRindivi-dualizedregimenwith 5drugs

CMETHCLZPAS

Treatment only inreferences

Pediatric regimen2RHZ/4RHDispersible tablets

Until FDCs 4For meningitis 2RHZE/7RH

+ steroids

TB B il N ti l G id li 2010


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TB Brazil National Guidelines 2010

Failed MDR orTBXDR

Individual regimen with5 drugs

CapreomyicinEthionamideClofazimine

PAS+ 1

Failure and MDR regimen

6 S Z E Lvf / TZ

AM alternative to SM18 - 24 months duration


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Example of Brazil

Developing andimplementing a fullplatform for DR-TB

program management with

a comprehensive patientfollow-up moduleintegrated with a second-

line drug management

systemOn line

Helio Fraga MDR-TB Clinic


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DR TB Diagnosis and Information


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DR-TB Diagnosis and Information

Suspected cases in primary health facilities or hospitals

Culture and drug susceptibility test

Confirmed or probable cases

National Reference Levelfor DR-TB control (MoH)

Regional DR-TB Reference Center

Case Reporting System

Case validation


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Innovative TB Care

Rapid diagnosis of TB includinguniversal drug-susceptibilitytesting ; systematic screening ofcontacts and high-risk groups

Treatment of all forms of TBincluding drug -resistant TB withpatient support

Collaborative TB/HIV activitiesand management of co-morbidities

Preventive treatment for high-risk groups and vaccination ofchildren

Bold policies and supportivesystems

Government stewardship ,commitment, and adequateresources for TB care and controlwith monitoring and evaluation

Engagement of communities , civil

society organizations, and all publicand private care providers

Regulatory framework for vitalregistration, case notification, drugquality and rational use, and infectioncontrol

Universal Health Coverage, socialprotection and other measures toaddress social determinants of TB

Intensified Research

Discovery, development andrapid uptake of new diagnostics,drugs and vaccines

Operational research to optimizeimplementation and adoptinnovations

Enhanced TB Strategy Post-2015

Targets (draft) : 75% reduction of deaths(and 40% reduction in incidence by 2025)

Ad i TB


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Guidelines, clinical studies, new

drugs perspectives

After 40 y post Rifampin .....

Advances in TBtreatmentWhere are we ?


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Approved drugs for TB in 70 years

1940-9 SM, PAS1950-9 INH, PZA, CS, ETH

1960-9 CM, EMB, RIF

1970-9

1980-9 Rifabutina, Ciprofloxacin*

1990-9 Rifapentine2000-9 Momentum*not approved for TB


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TB drugs: state of the art for clinical use2012

Drug Class Producer Status

Rifapentine Rifamycin Sanofi-Aventis Fase 3

Moxifloxacin Fluoroquinolone Bayer/GA Fase 3

Gatifloxacin Fluoroquinolone BMS Fase 3TMC-207 Diarylquinolone Janssen Fase 2b

OPC-67683 Imidazooxazole Otsuka Fase 2b

PA-824 Imidazooxazine GATB Fase 2a

SQ-109 Ethylene Diamine Sequella Fase 1

PNU-100480 Oxazolidinone Pfizer Fase 1

AZD-5847 Oxazolidinone AstraZeneca Fase 1

How we are participating in research studies in Brazil ?


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How we are participating in research studies in Brazil ?

BASIC RESEARCH

DESCOBERTANOVO FRMACO

CLINICAFASE III

PRE CLINICALEVALUATION

CLINICAFASE I

CLINICAFASE II

REGISTRO

ACESSO AO

PACIENTE

NITROIMIDAZOLIC and OXAZOLIDINONES

DIARYLQUINOLIN

FLUOROQUINOLONES

EBA studies

Post marketing study

Phase IV Terizidon

Bedaquilin

Rifapentin / Moxifloxacin

New roots to isoniazid and ethambutol


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In conclusion: Next steps in socialdeterminants

To evaluate the impact of Bolsa Famlia Programme in TBtreatment outcome

To uphold the special committee for study in diseases ofpoverty, at the National Congress

To increase research partnership in social protection and TB

To strengthen the intersectoral actions both at state and

municipality levelsSocial income transfer for TB patients living under social

vulnerability linked to adherence to the treatment.


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In conclusion: Next steps in TB control

To implemment rapid molecular diagnostic using Gene

X-pert in all municipalities with > 200 cases / yearTo provide culture , ID and DST to ALL retreatment cases

To go on with transference of tecnology for FDCproduction (Lupin and Farmanguinhos)

To implement farmacovigilance in all reference units

To assure more civil society participation

To obtain the part of the second line drugs through GDF

To start compassionate use for Bedaquiline for XDRcases


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Acknowledgements

FIOCRUZ - Brazil and Ministry of Health

Dr Draurio Barreira NTP Coordinator

and staff

Dr. Joel Keravec and Project MSH - Brazil

WHO/Stop TB Department - Task ForceExpert Group


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