The document discusses health technology assessment (HTA) in Indonesia. It states that HTA is a systematic, patient-oriented evaluation of new and existing health technologies that examines safety, effectiveness, costs, social and economic impacts, legal and ethical issues. The results of HTA studies inform policymakers' health decisions. The document also outlines the HTA process, including evidence analysis, outcomes analysis, cost-effectiveness analysis, and analysis of ethical and legal implications. It discusses the roles of national regulation, facility policies, and HTA at regional and national levels in Indonesia.
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Evidence-Based Analysis of Health Technology Assessment Processes
1. *
Jakarta, December 12th 2013
Ully Adhie Mulyani
Pusat Teknologi Terapan Kesehatan dan Epidemiologi Klinik
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. *
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. *
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
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. * 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. * 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.
*
18. * 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.
*
19. 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.
*
20. *
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
Notas del editor
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.