*
Jakarta, December 12th 2013
Ully Adhie Mulyani
Pusat Teknologi Terapan Kesehatan dan Epidemiologi Klinik
* HTA terdapat beberapa kata kunci, diantaranya
HTA adalah kajian yang bersifat sistematis,
berorientasi pasien, dan melib...
*
1.

evidence analysis—a systematic evaluation of
evidence for a technology and a requirement of good
evidence with EBM p...
*
HTA

NATIONAL
REGULATION

FACILITY POLICY
AND PROCEDURE
(regional)

Perspektif

Masyarakat

Masyarakat

Fasilitas pelaya...
*
*

PUSAT III & IV

PUSAT I & II

NIHRD role
*
Team leader
Secretariat
Peneliti Pusat 2

WORKING GROUPS
Medicines

Medical Devices

Health Care
Procedure
Policy question

HTA QUESTIONS

• Unit utama
Kemkes

• Tim Teknis HTA

SYNTHESIS

HTA REPORT

• Tim Teknis, multi,
stakeho...
* Proposed HTA

NIHRD

development
process and report
mechanism*

Proposal
Proposal

Proposal

Proposals
HTA Technical
Tea...
* Pengumpulan data primer :
* internvention studies (RCT, non RCT, etc)
* Observational studies
* case studies

* Integrat...
REGIONAL HTA

HTA NASIONAL

*
Diambil dari :
http://www.utwente.nl/mb/htsr/research/HTSR%20series%20early%20HTA/HTSR%20series%20early%20HTA.pdf
pada tan...
Levels of EBM applied in assessing HTA in
Medicine
Diambil dari Paparan dr Doddy Firmanda, pada pertemuan Bimtek HTA di Royal Kuningan, 25 – 27 April 2013
*
*RELATIONSHIP OF

EVIDENCE PROCESS
* Method in assessing of HTA varies for Expert

opinions to Systematic review.
* Applicability for HTA from indivual to po...
Luce, B. R., et al. (2010). "EBM, HTA, and CER:
clearing the confusion." Milbank Q 88(2): 256-276.
Eddy, E. (2009). ―Helat...
*
Decision making process is not solely how genius is it, but moreover
derived from good will and the ability to extract b...
Metode hta dan peran balitbangkes
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Metode hta dan peran balitbangkes

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  • Team leader : adviser to the Minister appointed for HTA activitiesSecretariat : National Institute Health Research and DevelopmentLeader of Medicines working group : Director for Pharmaceutical ServiceLeader of Medical Devices working group : Director for Production and distribution of Medical DevicesLeader of Health care procedure working group : Director for referral health care
  • Tim TeknisPenapisanTeknologiKesehatan- Technical Team for Selection Process for HTA reviewTugas : menapisusulan yang masukuntukdilakukankajian HTA, mengeluarkanrekomendasihasilkajianTim TeknisPengkajianTeknologiKesehatanTugas : melakukankajianberdasarkanprinsip –prinsip EBM, EBHP (evidence based health practice inc : nursery, nutrition, pharmacy) , evidence based health policyBelumdilaksanakan, baruberuparancanganpedomandan program kerja.
  • Metode hta dan peran balitbangkes

    1. 1. * Jakarta, December 12th 2013 Ully Adhie Mulyani Pusat Teknologi Terapan Kesehatan dan Epidemiologi Klinik
    2. 2. * HTA terdapat beberapa kata kunci, diantaranya HTA adalah kajian yang bersifat sistematis, berorientasi pasien, dan melibatkan multidisiplin terhadap aplikasi teknologi kesehatan yang baru maupun yang sudah ada. * Ruang lingkup : Keamanan, keefektifan, biaya, aspek sosial ekonomi, hukum, dan etika * Hasil kajian tersebut menjadi masukan bagi para penentu kebijakan dalam pengambilan keputusan kesehatan. *
    3. 3. * 1. evidence analysis—a systematic evaluation of evidence for a technology and a requirement of good evidence with EBM principles 2. Outcomes analysis  In this stage there is an estimation of the magnitude of the effects of the technology on the desired clinical outcomes (the ―benefits‖) and on potential harms such as side effects and risks (the ―risks‖). 3. analyses of costs and cost-effectiveness; here the researcher estimates the effect of the technology on costs and compares the clinical effects against the costs to determine if the ratio is sufficiently high. 4. The last stage is the analysis of the ethical and legal implications of the technology.
    4. 4. * HTA NATIONAL REGULATION FACILITY POLICY AND PROCEDURE (regional) Perspektif Masyarakat Masyarakat Fasilitas pelayanan kesehatan Orientasi Populasi (kesehatan masyarakat) Industri/manufaktur Pasien dan asuransi kesehatan Peran Memaksimalkan Prevent harm kemanfaatan dan efektivitas klinik dan cost Keseragaman pelayanan kesehatan Metode Efficacy Effectiveness Appropriateness Health economic Safety & efficacy Systematic review Meta analysis Economic, legal & ethics Efficacy & individual safety Levels of evidence Evidence Based Health Policy/EBHP & EBM EBHP EBM karakteristik
    5. 5. *
    6. 6. * PUSAT III & IV PUSAT I & II NIHRD role
    7. 7. * Team leader Secretariat Peneliti Pusat 2 WORKING GROUPS Medicines Medical Devices Health Care Procedure
    8. 8. Policy question HTA QUESTIONS • Unit utama Kemkes • Tim Teknis HTA SYNTHESIS HTA REPORT • Tim Teknis, multi, stakeholder & Pakar • Tim teknis & Pengusul * EVIDENCE ANALYSIS • Badan Litbangkes PERMENKES
    9. 9. * Proposed HTA NIHRD development process and report mechanism* Proposal Proposal Proposal Proposals HTA Technical Team result Ministry of Health approval Ad hoc Technical Team Screening Assessment Evidence analysis Disseminating /Publishing HTA Report * Adopted from international HTA process
    10. 10. * Pengumpulan data primer : * internvention studies (RCT, non RCT, etc) * Observational studies * case studies * Integrative methods * peer-reviewed published literature of primary data studies. * These can range from quantitative, structured approaches such as meta-analyses or systematic literature reviews to informal, unstructured literature reviews. * Cost analysis methods can involve either or both primary data methods and integrative methods. *
    11. 11. REGIONAL HTA HTA NASIONAL *
    12. 12. Diambil dari : http://www.utwente.nl/mb/htsr/research/HTSR%20series%20early%20HTA/HTSR%20series%20early%20HTA.pdf pada tanggal 11 Des 2013
    13. 13. Levels of EBM applied in assessing HTA in Medicine
    14. 14. Diambil dari Paparan dr Doddy Firmanda, pada pertemuan Bimtek HTA di Royal Kuningan, 25 – 27 April 2013
    15. 15. *
    16. 16. *RELATIONSHIP OF EVIDENCE PROCESS
    17. 17. * Method in assessing of HTA varies for Expert opinions to Systematic review. * Applicability for HTA from indivual to population * The most important is that HTA should address questions: ―can it works‖, ―does it works‖ and ―is it worth it‖ and give the best to the population. * NIHRD role in HTA is by providing evidence in assessing a health technology. * MOH should established the HTA team, independent and have an authority and coordinate with other Eselon I/Unit utama. *
    18. 18. Luce, B. R., et al. (2010). "EBM, HTA, and CER: clearing the confusion." Milbank Q 88(2): 256-276. Eddy, E. (2009). ―Helath technology Assessment and Evidence Based Medicine: What Are We Talking About?‖. Value in Helath (12): 56 – 57 Firmanda, D. ―Pelaksanaan Penilaian Teknologi Kesehatan (HTA) dalam Rangka Kendali Mutu dan Biaya Bagi Pengambil Kebijakan‖ disampaikan pada 25 – 27 April 2013. *
    19. 19. * Decision making process is not solely how genius is it, but moreover derived from good will and the ability to extract black and white from grey area
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