SS-HTA-2015

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    Sudigdo SastroasmoroHTA Committee, MOH RI

    HTA in Indonesia:

    Current progress

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    Selected referencesBanta HD. A global perpective on health technology

    assessment. Available from .!anitadayalitip.org"erreira #. Health technology assessment. $rinciples andpractical issues. Available from .medicaladvisors.co.%a&'las%iou $( #ar CD. )vidence*based practice or!boo!.Blac!ell $ubl. #assachusetts( +,,-.'oodman CS. HTA ,: Introduction to health technology

    assessment. Bethesda( #D. /ational 0ibrary of #edicine12S34 +,5.Health )6uality )urope. 2nderstanding health technologyassessment 1HTA3. 7uly +,,8.Health technology assessment of medical devices. 9H

    #edical device technical series. +,. 7CAH. Health care at the crossroads. Strategy forimproving the medical liability system and preventingpatient in;ury.available from.aacn.nche.edu&media&dpf&7CAH*,+.pdf  

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    Problem in health care

    =esearch: hat e can do

    HTA: hich ones e can do

    Clinical guidelines: hat e should do

    $ractice: doing hat e should do

    Clinical audits: did e do hat e

    should do?

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    Clinical 'overnance

    @A frameor! through hich

    /HS organi%ations areaccountable for continuouslyimproving the 6uality of their

    services and safeguarding highstandards of care( by creating

    an environment in hich

    e>cellence in clinical care ill

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    ClinicalGovernance

    Clinicalaudits

    Education Training

    Ris! 

    management

    Account"abilit#

    Research develo$ment

    ClinicalE%ective"

    ness

    atient safety

    Clinical audits

    E&M' HTA Clinical guideline•

    Clin pathays• Algorithms• $rotocols• $rocedures• Standing orders

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    Search the

    evidence

    Criticallyappraise

    the evidence

    Formulate

    in answerablequestion

    Problem

    in Practice

    Recom-mendation(s)  The)B#Cycle

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    9hat is .

     Technology

    Health technology

    Health technologyassessment

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     Technology

    Health

    technology

    Health TechnologyAssessment

    The application of scienticknowledge for practical purposes

     Any intervention that may be usedto promote health, to prevent,

    diagnose, or treat disease or forrehabilitation or long-term care

    Drugs, biologics, devices, medicalsurgical procedures, support

    systems,organizational/managerial systems A systemic evaluation of

     properties, eects and impacts ofdifusion and use of !T" #t is amultidisciplinary process to

    evaluate safety, e$cacy,eectiveness, social, economic,

    organizational and ethical issues

    Purpose

    Scope

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    $urposes of health

    technology$romotion

    $reventionDiagnosis

     Treatment

    =ehabilitation0ong*term care

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    $hysical nature

    Drugs% beta*bloc!ers( antileu!emia

    &iologics% vaccines( blood products( stem

    cellsDevices% cardiac pacema!ers( CT scanners(#=I

    'edical and surgical procedures: e.g.(psychotherapy( nutrition counseling(coronary angiography

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    Attributes & aspects to beassessed

    Safety

    )Ecacy

    )Fectiveness)conomic

    Socio*cultural

    )thical0egal*Institutional

    =eligious

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    9hat areas can HTAaddress?

      High volume * aFects many

      High ris! * medical( social(ethics

      High cost * unnecessary health

    cost

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    Types of economic analysis*ost-of-illness analysis +*#A% a determination

    of the economic impact of an illness( e.g.(thalassemia( D#.*ost-minimization analysis +*'A% adetermination of the least costly among

    alternative interventions that are assumed toproduce e6uivalent outcomes.*ost-eectiveness analysis +*A% acomparison of costs in monetary units ithoutcomes in 6uantitative non*monetaryunits( e.g.( reduced mortality or morbidity.*ost-benet analysis +*&A% compares costsand benets, both of which are .uantied incommon monetary units"

    *ost-utility analysis +*A% a form of C)A

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    #ethods in HTA

    $rimary data Technical studies 1functionality(

    validation3

    )>pert 1and user3 opinion)pidemiological and observational studiesClinical trials=eal data on cost for economic analysisConsensus development

    Secondary data: Integrative &literature synthesis 1meta*analysis3

    Combined

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    $revious HTA Indonesia:"lo 1+,,*+,,83

     Thorough assessment of literatures1#eta*analysis( =CTs( obs studies( caseseries( etc.3

    Initial draft by HTA StaF $anel of e>perts: 2niversities($rofessional rgani%ations( therInstitutions & Individuals

    Inputs and revisions via e*mail

    full*team discussions( revisions

    "inal draft and recommendations

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    HTA Indonesia( +,,*+,,J

    /o clear organi%ation

    /o clear staF 

    /o e>perience

    /o guidelines

    Budget allocation 1?3

     et K 5, HTA topics erecompleted

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    )>amples

    Lit < prophyla>is

    Blood transfusion

    $reoperativepreparation

    Immunomodulator

    sInuen%a vaccine

     Tonsillo*

    adenoidectomy

    Ciproo>acin

    )S90

    Hormone replacementtherapy

    #anagement of

    sinusitisC$D

    0iposuction

    Hearing screening

    HTA I/D/)SIA +,,*+,,J

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    Hospital*based HTA

    HTA M International & /ational level

    0ocal & Hospital*based:=ecommended

    SpeciNc hospitals High technology SpeciNc mode of care

    ther hospitals SpeciNc conditions #ay diFer from national HTA

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     Types of Hospital*based HTA

    Ambassador #odel rgani%ation * Individual "ocus of action * Clinical practice

    #ini*HTA #odel

    rgani%ation * Individual "ocus of action * #anagerial decision

    ma!ing

    Internal Committee #odel rgani%ation * 'roup( Team( 2nit "ocus of action * Clinical practice

    HTA 2nit #odel

    rgani%ation * 2nit "ocus of action * #ana erial decision

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    Managerialdecision

    ma!ing

       O  r  g  a  n   i  (

      a   t   i  o  n  a   l

      c  o  m  $   l  e  )   i   t  #

    *o+Individual-

    HighTeam,

    .nit-

    Ambassador

    Model

    Mini HTAModel

    InternalCommittee

    Model

    HTA.nit

    Model

    Clinical$ractice

      #odels in local & hospital*based

    HTA

    /ocus o0 action

    C# Hospital Hospital based

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    C# Hospital: Hospital*basedHTA

    #odern dressing and s!in grafting in the

    management of diabetic footChallenges to establish a HTA unit inCipto Hospital

    ral presentation in HTA M Intl Congress( 9ashington(+,5

    Cochlear implant in children

    #egaprosthesis implant'amma !nife stereotactic radiosurgery0ong*acting antipsychotic in;ections

    ral prest. HTA M Int Congress( slo( 7une( +,O

    )chocardiography and the length of stay of congestiveheart failure 1Taian( +,53

    +

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    /ational HTA Committee

    #H Decree( + April +,5)Fective August +,5

    rgani%ational structure Chairman Secretary #embers

    Secretariat

    2nder the Secretary 'eneral & Centerfor Health "inancing and Security

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     7ob description

    Developing concept and activities

    Developing HTA 'uidelines

    Accepting proposals fromsta!eholders

    $riority setting the proposals

    Developing ad hoc 0anel to e>ecuteHTA process

    $roviding recommendations to the#H

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    bstacles and ay*out

    Currently e have no full*time staF All are part*timers ta!en from severaldirectorates in the #H( including

    from /H=C 1e call them $ICs Mpersons*in*charge3

    9or!shops on )B#( HTA( medical

    riting- of the $ICs attended + ee! on*the*

     ;ob training in HITA$( Bang!o!

    1"ebruary +,O3

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    Ad hoc $anel

    Ad hoc $anel is supposed to beestablished for each topic

    Consists of: #ember1s3 of HTA Committee )>perts of $rofessional organi%ations Academia ther relevant personnel

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    HTA Indonesia: "lo

     Topic selection 1HTAC3$re*proposal $IC3Ad*hoc $anel HTAC #ember1s3

    Academia $rofessionals thers

    $roposal 1$IC P $anel3"irst draft $IC3Discuss and revisions by email 1$anel3#onthly plenary meetings 1$anel3

    "inali%e in *5 meetings 1$anel3

    Person-in-Charge: Member of 

    Secretariat who has attended

    EBM, HTA, Medical Writing worsho!s

    HTA Committee

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    To!ic "HTAC#

    Edit HTAC

    Member"s# of HTAC Academia

    Professionals

    $thers

    Panel

    P%C"s#&irst draft

    Emails, monthl'

    meetingsPanel

    &inal draft

    Pre-!ro!osal

    "P%C#Pro!osal

    "Panel#

    (o e)ternal

    re*iewers

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    $re*proposal1P&* + pages3

     Title

    Submitted by ..

    b;ectiveSynopsisly evidence

    =eferences

    Appendices Suggestion of Ad hoc

    panel

    ther relevant issues

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    $oposal

    Development of preproposal by $ICand Ad Hoc $anel

    Include methods of Nnding primarydata especially for the purpose ofeconomic analyses

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    "ormat of early draft

     Title

    $roposed by ..Chapter * Introduction 9hy HTA is needed =esearch 6uestion1s3

    b;ectives: general( speiNc#ethods: Search strategy Critical appraisals 0evels of evidence 'rades of

    recommendations $rimary data collection

    =esults and discussion

    =eferences

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    "inal =eport Title0ists of Tables( glossary( abbreviations(

    foreords( etc)>ecutive summaryIntroduction:   7ustiNcation for HTA =esearch 6uestions $urpose: general( speciNc

    #ethods:  Search strategy Statement on critical appraisals 0evels of evidence 'rades of recommendations $rimary data collection

    =esults and discussionConclusions and recommendations=eferencesAppendices. Incl. Statement of conict of

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    SS/E!/"#$-%&"P-'

    Hierarchy of evidence

    #eta*analysis of =CT

    0arge =CT

    Small =CT

    /on*=andomi%ed trials

    bservational studies

    Case series & reports

    Anecdotes( e>pert(

    consensus

    0evel

    0evel +

    0evel

    0evel 5

    A

    B

    C

    =ec

    1eight o0 Scienti2cScrutin#

    "or complete description see .cebm.net

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    0aporan a!hir

    Sedapat mung!in berupa scienticdocument 

    $enulisan sesuai !aidah ilmiah:ring!as( ;elas( leng!ap 1BCC * brief,clear, complete3

    Hindar!an plagiarisme

    $usta!a muta!hir

    $erhati!an e;aan( frasa( !alimat(paragraf 

    $enulisan sitasi dan daftar usta!a

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    Berapa lama per topi!?

    Denmar! Topi! besar : +,, halaman( (O M +(O

    tahun Sedang: ,, halaman( * (O tahun

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    Biayanya?

    Dr. Charles Sha M /IC): ;uta 2SD &topi!

    Dr. ot 1HITA$ M Thailand3: ;uta2SD & tahun( untu! 5, topi!( l!. ,, ;uta & topi!

    =SC# 1Hospital*based HTA3: 5,, ;uta & 5 topi!

    2nit HTA 1+,,*+,,83 * Q, ;uta &

    topi!

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    Info tambahan

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    Initial HTA topics

    9e are no conducting HTA on +topics:

    SildenaNl for the treatment of

    pulmonary hypertension 1$H3 $roposed by patient association

    )conomic analysis of continuousambulatory peritoneal dialysis 1CA$D3vs. hemodialysis $roposed by professional organi%ation #ore than 8, of patients ith )S=D are

    managed by hemodialysis

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    $roblems encountered

    "or )S=D treatment: collection ofprimary data needed for economicanalysis

    )S=D treatment can only done in largerhospitals /ot available in many provinces &

    districts( esp. in remote area Calculation of indirect costs etc. may be

    confusing

    "or sildenaNl:

     The drug is oF*label for the treatment of

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    $ICs meeting to discuss the progress1ee!ly3

    $lenary meeting ith $anel 1monthly3

     The + topics are e>pected to be Nnali%edin 7uly

    August M December +,O M 5 topics

    +,R M , topics

    Capacity building: attendinginternational or!shops( conferences

    rgani%ational aspects: recruitment for

    full*staF and appropriate funding plans

    =ecent activities and plans

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    "inal =eport

    So much as possible as a scienticdocument 

    $rinciples of scientiNc riting: BCC M1brief, clear, complete3

    Avoid plagiarism

    =ecent references

    9ords( spelling( phrases( sentences(paragraphs

    Citation and references

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    International collaboration andsupports

    PATH 1$rogram for Appropriate Technologyin Health3 * Seattle

    3ICE 1/ational Institute for Health andCare )>cellence3 International * 0ondon

    HITAP 1Health Intervention and Technology Assessment $rogram3 *Bang!o!

    1HOAIPHSS 1Australia*Indonesia $artnershipfor Health System Strengthening3

    HTAi 1Health Technology Assessment

    International3

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    "orms of supports

    Discussions

    Consultations

    9or!shops

    n*the*;ob training for $ICs inBang!o! 1$ATH and HITA$3

    Invitations to ;oin internationalconferences

    Study tour to /IC)

    StaEng and administrative issues

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    e are not the Nrst

    But ill be one of the best