Jakarta, December 12th 2013

Ully Adhie Mulyani

Pusat Teknologi Terapan Kesehatan dan Epidemiologi Klinik

*METHODS IN ASSESSING HEALTH TECHNOLOGY & THE ROLE OF NIHRD

*A brief about HTA

*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.

*Stages in HTA according to ISPOR

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.

*Ruang lingkup HTAkarakteristik

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 kemanfaatan dan efektivitas klinik dan cost

Prevent harm Keseragaman pelayanan kesehatan

Metode EfficacyEffectivenessAppropriatenessHealth economic

Safety & efficacySystematic review Meta analysisEconomic, legal & ethics

Efficacy & individual safety

Levels of evidence Evidence Based Health Policy/EBHP & EBM

EBHP EBM

*HTA IN NIHRD

*Dimana ranah HTA?

NIHRD role

PUSAT III & IV PUSAT I & II

*Tim Teknis Pengkajian dan Penapisan Teknologi

KesehatanTeam leader

Medicines Medical Devices

Health Care Procedure

SecretariatPeneliti Pusat 2

WORKING GROUPS

* LANGKAH PELAKSANAAN HTA DI TINGKAT KEMENTERIAN KESEHATAN

cq Tim Teknis PEngkajian Penapisan Teknologi Kesehatan

Policy question• Unit utama

Kemkes

HTA QUESTIONS• Tim Teknis HTA

EVIDENCE ANALYSIS• Badan

Litbangkes

SYNTHESIS• Tim Teknis,

multi, stakeholder & Pakar

HTA REPORT• Tim teknis &

Pengusul PERMENKES

* Adopted from international HTA process

Assessment

HTA Report

Screening

Proposal

Proposal

Proposal

HTA Technical Team

Ad hoc Technical Team

Proposals

*Proposed HTA development process and report mechanism*

Ministry of

Health

Disseminating/

Publishing

approval

result

Evidence analysis

NIHRD

*METODE HTA

*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.

*HTA DAN EBMREGIONAL

HTAHTA NASIONAL

Diambil dari : http://www.utwente.nl/mb/htsr/research/HTSR%20series%20early%20HTA/HTSR%20series%20early%20HTA.pdf pada tanggal 11 Des 2013

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

*Cross Cutting of HTA

* RELATIONSHIP OF EVIDENCE PROCESS

*CONCLUSION

*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.

*literature

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.

*TERIMA KASIHDecision 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