PENGANTAR PENAPISAN DAN ADAPTASI TEKNOLOGI KESEHATAN

bambang udji djoko rianto

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Health Technology Assessment

Pendahuluan

Healthcare Technology Assessment (HTA) first came to prominence in 1972 when the United States Congressional Office of Technology Assessment was established. Up to that time assessments did take place in healthcare. Many western countries have formal HTA programs in place.

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Health Technology Assessment

Pendahuluan

The International Society of Technology Assessment in Health Care (ISTAHC) was founded to promote research, education, co-operation and exchange of information on the clinical and social implications of health technology More recently ISTAHC has been dissolved but Health Technology Assessment International (HTAI) has been launched to continue the work of ISTAHC

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Sekilas tentang HTA

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

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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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Sekilas tentang HTA

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 (mendasarkan) 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 (penelitian cermat), as in the case of herbal remedies, for example ideally assessments should be done in phase with the life cycle of a particular technology:

Future Technology Emerging (bermunculan) Technology New Technology Accepted Technology Obsolete (kuno, tak terpakai) 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 Clinical trials First medical use Abandoned/ ditinggalkan technology

Obsolete technology

Innovation Development Diffusion Evaluation

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Identification and priority setting

Life Cycle Future Technology Emerging Technology Phase Design Phase Not Yet Adopted Potential Assessments Prospective Assessment

Access Societal Effect

Prospective Assessment Assess Societal Effect Pilot Efficacy and Safety

New Technology
Accepted Technology

Being Adopted
Widely Adopted

Economic Analysis
Assess Societal Effect Appropriateness Resuability

Obsolete Technology

Decommission (ditinggalkan)
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Appropriateness Resuability

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Checklist untuk evaluasi

Criterion Burden of Disease Epidemiological Criteria Description 1. Pervalence 2. Incidence 3. Mortality 4. Qualitative Description 5. Generic Questionnaire 6. Diseace-specific Questionnaire 7. Utility Measurement 8. Qualitative Description 9. Direct Cost 10. Indirect Costs 11. Qualitative Description 12. Number of Treatments in a period and/or geographic area
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Quality of Life

Cost of Illness

Frequency of Use
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Checklist untuk evaluasi

Criterion Potential Effects Efficacy 13. Morbidity 14. Mortality 15. Generic Questionnaire 16. Disease-specific Questionnaire 17. Utility - measurement Description

18. Qualitive Description

Potential Costs of the Technology Costs
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19. Costs of Treatment

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Checklist untuk evaluasi

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

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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 (ukuran) 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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2.1 Health Related Quality of Life Indexes

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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2.2 Socio-Economic Evaluations

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 children Both sexes 12 yr-old females

Benefit (millions of $) Prevention of: Acute rubella Congenital rubella Total Cost (millions) Net benefit (millions) Benefit-cost ratio
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5.7 40.3 46 6 40 7.7:1

1.4 72.2 73.6 3 70.6 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 endstage 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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3. Undertaking the Research

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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4. Reviewing the Evidence

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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6. Dissemination

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 (ditinggalkan) technologies which are ineffective, resolve controversies regarding competing treatments and promote the greater usage of proven technologies.
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7. Monitoring the Impact of HTA

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 Synthesis & implementation

Screening & diagnosis Community Effectiveness

Efficiency
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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 daan 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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