PENGANTAR PENAPISAN DAN ADAPTASI

TEKNOLOGI KESEHATAN
(HEALTH TECHNOLOASSESMENT )

bambang udji djoko rianto

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Sekilas tentang HTA

HTA memprediksi:
- pengaruh teknologi baru
- muncul & meluas
- bidang kesehatan & kedokteran
- klinis & sosial

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Dampak:

Safety & efikasi

Faktor ekonomi cost effectiveness
Faktor etik, legalitas, kewajaran
Isue luas terhadap kesehatan & keuntungan
sosial

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 Tujuan HTA:
mempengaruhi & mendukung pembuatan
tata cara keputusan klinik
Idealnya HTA meliputi:
- kerangka kebijakan
- hasil yang potensial dari perkiraan
- penilaian keputusan yang nyata

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 Salah penafsiran Healthcare technology
- pemahaman tradisional
Ruang lingkup HTA lebih luas meliputi:

- Drugs and Pharmaceuticals

- Medical Equipment
- Information Systems
- Clinical Procedures
- Organisational and support system
Bersama untuk pelayanan medik
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 Technology can be extended to include:
- a health improving nutritional product
- a health service and any other tool
- method or structure relevant to health care

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Peran HTA

To support policymaking irrespective of the

environment
Policy formulation can arise in different
settings and for different reasons

For example HTA could be used to support

product development and marketing
Health insurers could use HTA to decide
which technology they will cover.
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 HTA could help government and its agencies
determine the most appropriate ways of
allocating scarce resources

Health care managers could use HTA to

decide upon which technologies are the most
appropriate to adopt or indeed determine
which technologies to decommission
(dihentikan)

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 HTA can be used to educate clinicians and patients
regarding the adoption and proper use of particular
technologies

Regulatory agencies rely upon HTA methodologies

to provide important information, which will help
them to license or support health care technologies

Scope HTA is used today in all health care settings

including Prevention, Screening, Diagnosis,
Treatment and Rehabilitative care.

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1. Identification and priority setting

The first important step is to identify the technologies

that need to be assessed, taking into consideration the
scope of HTA identified above. This may prove to be
relatively straightforward

The requirement for example may be mandatory as:

- in the case of drug regulations and licensing
- the cost of a particular technology may be very high
and consequently unavailable to all patients so
choices have to be made about who gets it

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Identification and priority setting
Sometimes technologies which are unregulated
can give rise to closer scrutiny, as in the case of
herbal remedies, for example the recent public
outcry against regulating the use of St. Johns
Worth.
ideally assessments should be done in phase
with the life cycle of a particular technology:
Future Technology
Emerging Technology (bermunculan)
New Technology
Accepted Technology
Obsolute Technology

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Isu dalam penapisan dan adaptasi
teknologi kesehatan

Inovasi
Pengembangan teknologi
Evaluasi
Penyebarluasan pemakaian
Efisiensi

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 Innovation, development & diffusion
of Medical technology
Established technology
Late adopters

Early adopters Obsolete (tak ter

usang) technolog
Clinical trials
Abandoned/ ditinggalkan
First medical use technology

Innovation Development Diffusion Evaluation

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 Identification and priority setting

Life Cycle Phase Potential Assessments

Future Technology Design Phase Prospective Assessment
Access Societal Effect
Emerging Technology Not Yet Adopted Prospective Assessment
Assess Societal Effect
Pilot Efficacy and Safety
New Technology Being Adopted Economic Analysis
Accepted Technology Widely Adopted Assess Societal Effect
Appropriateness
Resuability
Obsolete Technology Decommission Appropriateness
Resuability
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 Checklist untuk evaluasi
Criterion Description
Burden of Disease
Epidemiological Criteria 1. Pervalence
2. Incidence
3. Mortality
4. Qualitative Description
Quality of Life 5. Generic Questionnaire
6. Diseace-specific Questionnaire
7. Utility Measurement
8. Qualitative Description
Cost of Illness 9. Direct Cost
10. Indirect Costs
11. Qualitative Description
12. Number of Treatments in a period and/or
Frequency of Use
geographic area
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 Checklist untuk evaluasi

Criterion Description
Potential Effects
Efficacy 13. Morbidity
14. Mortality
15. Generic Questionnaire
16. Disease-specific Questionnaire
17. Utility - measurement
18. Qualitive Description
Potential Costs of the
Technology
Costs 19. Costs of Treatment

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 Checklist untuk evaluasi

Criterion Description
Uncertainty of Applying
the Technology
Controversy 20. Different Judgements in a Profession
Susceptibility of
Physicians to new 21. Differences between Physicians
knowledge
Indication Region 22. Defination
Ethical and Social
23. Initial Questions
Implications
24. Applications Questions
25. Regulation Questions

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 2. Determine the Nature of the
Assessment Problem
This stage is all about coming to terms with the
exact nature of the problem and why it needs to be
investigated. In reality, researchers or indeed
anyone setting out to undertake an investigation will
want to find out in advance the parameters or scope
of the problem. Who are the target population?
What is the environment? Can the users be
identified? What are the economic perspectives
which should be taken into consideration? All of
these are important. The most important one,
however, is associated with scoping the problem.

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2.1 Health Related Quality of Life Indexes

It is also important to consider at this stage the

type(s) of analysis which will have be undertaken in
order to draw conclusions from the work. The
yardstick by which the effectiveness, safety, efficacy
and often appropriateness of health care technology
are measured is through health outcomes. Although
the common method of expressing outcomes might
be in terms of morbidity and mortality, other
measures may also be considered. A particular
health care technology application might, for
example have a social impact or may result in either
a loss or gain from a health or societal perspective.

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 A more appropriate means of measuring such
impacts could be achieved by using Health Related
Quality of Life (HRQL) indexes or measures.
Goodman includes the following examples of
general HRQL indexes: Sickness Impact Profile,
Nottingham Health Profile, Quality of Well-being
Scale, Functional Independence Measure, Short
Form ( SF)-36, Euro-Qol Descriptive System, Katz
Activities of Daily Living. Examples of disease
specific HRQL indexes include the New York Heart
Association Functional Classification, Arthritis
Impact Measurement Scales and the Visual
Functioning (VF)-14 Index.

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2.2 Socio-Economic Evaluations

Cost Benefit Analysis: - The costs and

outcomes or benefits of particular technology
are expressed purely in monetary terms
Cost Effectiveness Analysis: - In this case the
costs associated with a particular technology
are measured in monetary terms while the
outcome is measured in its natural units
Cost Utility Analysis: - To overcome the
shortcomings in CEA, the value or quality of
years of life (called utility) is measured
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 Cost Minimization Analysis: - In situations where the
outcome of using particular technologies might be
the same or relatively close then netting off the
direct costs relating to the intervention may be
appropriate. This method is referred to as Cost
Minimisation Analysis.
Cost of Illness Analysis: - In certain circumstances
one might wish to determine the impact of a disease
or condition like drinking, drug abuse or smoking
solely in economic terms.

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Cost-efectiveness analysis

Comparison of the cost of different ways to

achieve a common outcome
Result: Cost per unit outcome, Units of
outcome per dollar spent
Example: Dollars per life saved

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Cost-benefit analysis

Comparison of an interventions cost and

benefit in the same units (misal Rupiah)
Result: Net benefit or cost, Ratio benefit to
costs
Example: Saving from the cost of a
prevention program

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 Prophylaxis of Urinary Tract Infection
(CBA)
Cost:
Cost per year of prophylaxis $85
(trimetoprim-sulfamethoxazole)
Cost per infection $126
Expected frequency (women with two or more
episodes in prior year)
Placebo: 3.0 infection/year
Treatment: 0.15 infection/year
Cost-benefit
Cost: $85
Benefit: (3-0.15) X ($126) = $ 359
Annals of Internal Medicine, 1981: 94:251-255

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 CBA Rubella Vaccination
2 yr-old 12 yr-old
children females
Both
sexes

Benefit (millions of $)
Prevention of:
Acute rubella 5.7 1.4
Congenital rubella 40.3 72.2
Total 46 73.6
Cost (millions) 6 3
Net benefit (millions) 40 70.6
Benefit-cost ratio 7.7:1 24.5:1
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CBA & CEA of Lead Screening

FEP screening costs $2890 per case of

learning disability averted and $19,380 per
case of mental retardation averted
In communities where the prevalence of lead
poisoning is greater than 7%, FEP screening
also saved money
NEJM 1982, 306:1392-8

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Economic analysis

CBA/CBU enable decision maker to compare

the returns on investing resources in services
designed to treat different health problem
CEA enables decision maker to compare the
costs of different ways of tackling the same
health problem

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Example of CBA & CEA

CBA would help decision maker asses the

return on investing $500,000 additional
resources in either renal transplantation
program or cardiac surgery program
CEA would help the decision maker asses
the relative cost-effectiveness of dialysis and
of transplantation as methods of treating end-
stage renal failure

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3. Undertaking the Research

This stage is not difficult to understand and follows

the norms usually employed in research and
investigation. The first task is to determine if similar
research has been undertaken elsewhere. The
usual sources of secondary data are examined,
including published literature, Government Reports,
Journals, Databases and so forth. New fieldwork
should only be commissioned when it becomes
clear that secondary studies cannot provide the
necessary evidence.

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 The basic rules for quality research should
apply to new studies. In other words
preference should be given for prospective,
controlled, randomised, blinded studies
where the cohort is as large as possible.
What is lacking, however, in HTA Studies to
date is the shortage of real live situations
where the technology is actually in use. New
studies should seek to try and redress this
imbalance.

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 4. Reviewing the Evidence

Once the body of evidence or fieldwork has been

done the next stage is to critically analyse the
results. This is called synthesis as we are trying
synthesis or determine the outcome of the
investigation. Literature Reviews, Systemetic
Reviews, Group decision making methods, Outcome
analysis, Impact Analysis, Secondary Analysis and
other types of quantitative research may all be used
or combined depending upon the circumstances.

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 In HTA however it is preferable also to use
methodologies which are formal, structured, quantifiable
and well documented. Both Meta Analysis and Decision
Analysis are commonly used. Meta Analysis involves the
application of statistical techniques to findings from
research reports. Basically Meta Analysis regards the
findings from one study as a single piece of data. The
results or findings from multiple studies on the same
topic therefore can be merged to yield a data set that
can be analysed in a manner similar to that obtained
from individual subjects . Careful selection and
organisation of material can help reduce bias, which is
often a prominent feature of Meta Analysis

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 5. Evidence Grading

It has become accepted practice that the quality of

research should be clearly benchmarked so that the
reader knows the strengths of the findings. These
benchmarks are sometimes referred to as Evidence
Grading. Two common schemes include Evidence
Grading for Practice Guidelines published by the
Agency for Healthcare Policy and Research, and
Evidence Grading for Clinical Preventative Services
published by the US Preventative Services Task
Force

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 6. Dissemination

Once the evidence has been reviewed, the analysis

completed and the conclusions reached, the next
stage is to report the findings. Traditionally, medical
literature and scientific meetings have been the
main vehicles for getting the message across.
However, this mode of transport has not always
been kind to HTA. Basically, scientific literature is
geared towards research and there is little or no
interest in work which addresses benefits realisation
or social issues.

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 Another factor is the time lag before studies
are actually published and of course not
everyone keeps up to date with the literature.
Indeed, there is so much material being
circulated that it is hard to prioritise what is
really important. All these factors sometimes
mitigate against getting the kind of exposure
in the literature that good quality research in
HTA often deserves.

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 There are, of course, other routes. Special
Conference, such as Consensus Conferences, for
example, could be arranged among expert analysts
to disseminate important research findings. Annual
Meetings and Seminars arranged by professional
bodies are also another forum. In the case of
licensing requirements or in the event of a
technology, which impacts upon the entire
community, then either the appropriate regulatory
bodies or the relevant Government Agencies will
usually take a leading role in making the research
findings available.

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7. Monitoring the Impact of HTA

The final stage in the HTA process is to monitor

what impact, if any the HTA research has made
Remember we said at the outset that one of the
primary goals of HTA is to influence policy makers
and ensure that resources are allocated more
effectively. We can now expand upon these goals.
HTA should also help to decommission technologies
which are ineffective, resolve controversies
regarding competing treatments and promote the
greater usage of proven technologies.

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 Another important role, which HTA should have, is
to help the consumer choose the most appropriate
healthcare technology for them. Nowadays,
consumers are bombarded with advertisements that
are presented in all sorts of shapes and forms. Chat
show programmes devote a lot of air time to health
and medical matters while the power of the web
delivers the ultimate in direct marketing and the best
or worst is yet to come! HTA can take a lead role in
putting technologies into perspective for consumers.

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 The technology assessment
iterative loop
Burden of illness

Efficacy
Monitoring &
reassessment
Screening & diagnosis
Synthesis &
implementation Community Effectiveness

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Health Technology Assessment 41
Teknologi kesehatan yg baru

Disambut dg antusias oleh dokter dan

pasien, dg menaruh kepercayaan besar akan
hasil gunanya.
Jarang dievaluasi sebelum pemakaiannya scr
luas
Kekecewaan muncul manakala pengalaman
klinik tidak sesuai dg yang diiklankan,
ditambah kenaikan biaya

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Dasar penilaian teknologi kesehatan

Teknologi baru versus teknologi yang sudah

ada.
Manfaat vs risiko
Accuracy, reproducibility ?
Apakah bisa diterapkan dalam prosedur
pengobatan
Biaya.

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Dasar penilaian teknologi kesehatan

Kalau ada apakah akan dipakai

Apakah perlu operator khusus
Pemeliharaan apakah mudah atau sulit
Kondisi lingkungan yang mendukung
Suku cadang
Biaya operasional

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Penilaian dalam penapisan dan
adaptasi teknologi kesehatan

Penilaian hasil guna scr klinis

Penilaian ekonomik dan kualitas hidup
Adopsi dan pemakaian scr luas

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Mengapa teknologi kesehatan yg baru
banyak dipakai sebelum dilakukan
penilaian?

Pengaruh pihak ketiga penyandang dana

Ketersediaan standar evaluasi kritis dalam
program pendidikan dokter
Insentif

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Number needed to treat (NNT)
One measure of treatment effectiveness.
The number of people you would need to
treat with specific intervention for a given
period of time to prevent one additional
adverse outcome or achieve one additional
beneficial outcome.
NNT = 1/ARR

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 Efikasi berbagai AINS berdasarkan nilai NNT
(Number Needed to Treat)

Diklofenak 50 mg
Naproksen 440 mg
Ketorolak 10 mg
Ibuprofen 400 mg
Morfin 10 mg IM
Parasetamol 650 mg + kodein 60 mg
Aspirin 650 mg
Parasetamol 1000 mg
Parasetamol 650 mg
Tramadol 75mg

0 1 2 3 4 5 6

Number Needed to Treat (NNT)

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Number needed to harm (NNH)

One measure of treatment harm.

The number of people you would need to
treat with specific intervention for a given
period of time to cause one additional
adverse outcome.
NNH = 1/ARI

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Pokok Bahasan

Teknologi Diagnosis
Teknologi terapi
Teknologi Pencegahan
Teknologi Bedah
Dampak adopsi teknologi
Evaluasi ekonomi teknologi kesehatan

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