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09/09/2019
1
Strategi Penerapan HTA
di Rumah Sakit
Abdul Khairul Rizki Purba, dr., M.Sc., SpFK
Clinical Pharmacologist – Pharmacoepidemiology & Pharmacoeconomics
Department of Pharmacology and Therapy, Universitas Airlangga
Drug and Therapeutic Committee, Dr. Soetomo Hospital
Khairul Purba 1
Name: Abdul Khairul Rizki Purba, dr., M.Sc., Sp.FK
Affiliations:
◦ Department of Pharmacology and Therapy, Universitas Airlangga, Surabaya
◦ Drug and Therapeutic Committee, Dr. Soetomo Hospital, Surabaya
◦ Ph.D. candidate at University Medical Center Groningen, the Netherlands
◦ WHO consultant for Essential Medicine List (EML), Geneva, Switzerland
S1: FK Universitas Airlangga, Surabaya
S2: FK Universitas Gadjah Mada, Yogyakarta
Sp: Spesialis Farmakologi Klinik, Universitas Indonesia, Jakarta
Ph.D. Candidate in Pharmacoepidemiology and Pharmacoeconomics, UMCG, the Netherlands
Khairul Purba 2
Conflict of interest
Tidak ada conflict of interest dengan
institusi atau pihak industri/farmasi
manapun dalam menyampaikan substansi
keilmuan presentasi ini.
Khairul Purba 3
09/09/2019
2
HTA
A multidisciplinary field
Applied research aimed at providing high-quality information about ◦ the clinical effectiveness or efficacy
◦ cost-effectiveness
Broader impact (including social and ethical implications) of health technologies (drugs, medical technologies and health interventions)
To support and inform: ◦ Decision makers (who responsible for health policy
and purchasing, health services and management, and clinical practices)
Granados A. Int J Technol Assess HealthCare. 1999;15(3):585–92
Khairul Purba 4
Technology & Health technology
Technology: the application of scientific
knowledge for practical purposes
Health technology: all types of
interventions used in the health field for
promotion, prevention, screening, diagnosis,
treatment, rehabilitation, and long-term care.
◦ Drugs
◦ Diagnostics
◦ Biological substances
◦ Medical/surgical procedures
Khairul Purba 5
HEALTH CARE COSTS as % OF GDP
09/09/2019
3
1. Product Mix:
Prescribing of newer more expensive medications:
Omeprazole
Lansoprazole
Esomeprazole
Pantoprazole
Rabeprazole
Pravastatin
Atorvastatin
Simvastatin
2. Volume effect:
Growth in the number of prescription items
The number of eligible GMS patients has fallen by 9.1% from 1.27 million in
1993 to 1.16 million in 2003. However, the 32.3 million items prescribed in 2003
represent an 87% increase over the 10 year period.
(Ryan et al)
10% of GMS expenditure 2003 (€51.3m)
8.3% of GMS expenditure 2003
(€42.9m)
The main reasons driving such growth in
pharmaceutical expenditure:
Khairul Purba 7
Hospital-based HTA
increased pressure to make more efficient
use of scarce resources
Evidence and data should also be
collected and analysed within hospital
context
Use of scientific evidence to support both
clinical practices and management
decision making in hospitals.
Khairul Purba 8
Hospital-based HTA
To inform decisions regarding devices,
drugs and procedures
To provide answers to health authorities
with respect to improving the quality and
efficiency of care delivery in a context of
limited budgets
To improve the rationality of the decision-
making process
Khairul Purba 9
09/09/2019
4
3 level HTA
Khairul Purba 10
Framework of hospital-based HTA models
Cicchetti A et al., Hospital Based Health Technology Assessment
Sub-interest Group. 2008 Khairul Purba 11
1. The ambassador model Dissemination of recommendations generated by a
national authority to hospitals by means of clinicians who are recognized as opinion leaders in their speciality and who play the role of ambassadors of the HTA ‘message’ within health-care organizations.
Initiate and promote efforts at the local and regional levels
The ambassador model does not produce HTA locally, but it promotes use of HTA recommendations made by other entities within the hospital.
Khairul Purba 12
09/09/2019
5
2. The mini-HTA To support decisions related to approval of new health
technologies in that hospital.
Most frequently, a single professional—generally the applicant (a clinician or a surgeon)—performs the miniHTA.
The mini-HTA consists of a questionnaire or a form used to collect data within the health-care organization.
The questions usually cover four themes: the technology, the patients, the organizational consequences and the financial consequences.
The mini-HTA is often the main basis for decision-making in hospital management
Khairul Purba 13
3. The Internal HTA Committee
A multidisciplinary group composed of health-care professionals within the organization is in charge of reviewing evidence related to use of new health technologies.
These committees usually include representatives of
◦ the administrative staff
◦ materials/supply management
◦ medical staff
◦ nursing staff
Khairul Purba 14
4. The HTA unit
The highest degree of structure for hospital-based HTA
Approve an introduction of a new technology, given that final decisions are made by the medical executive committee, the senior management or the hospital governing board
Responsible for ensuring that the collected evidence is relevant to the local context by using primarily local data
Expertise in HTA:
◦ Nurses
◦ Physicians
◦ Other health professionals
◦ Patient representatives
◦ Administrator
◦ Ethicists
◦ Health economists
Khairul Purba 15
09/09/2019
6
Proses HTA di RS
• Agenda settingIdentification
&
Prioritization
• Policy questionsAssessment of evidence analysis and evidence generation
• Decision
• ImplementationDissemination
Khairul Purba 16
Efisiensi dan pemerataan di RS
Efisiensi Pemerataan/Adil
Apakah diperoleh
manfaat yang paling
tinggi dari biaya yang
dikeluarkan?
Apakah semua
mendapat peluang
yang sama dalam
memperoleh obat?
Khairul Purba 17
HTA
CLINICAL ECONOMIC
Safety
Work
productivity
Direct Medical
Costs
Quality of
Life
Bothersomeness,
tolerability
HUMANISTIC
SatisfactionEfficacy
Resources
consumed
Side
effects
Khairul Purba 18
09/09/2019
7
HTA Evaluation
Choice
Intervention A
Intervention BConsequences B
Consequences A
Costs B
Costs A
membandingkan biaya-biaya dan dampak atau
konsekuensi dari dua (atau lebih) intervensi
kesehatan.
Khairul Purba 19
Prinsip BIAYA (COST)
Dalam pengertian awam, “cost” adalah apa yang kita bayar untukmemperoleh atau menikmatibarang atau jasa.
Dalam HTA → Opportunity costs
Khairul Purba 20
Direct cost
Direct cost: biaya yg harusdilkeluarkan/dibayarkan sebagai akibat dariadanya suatu penyakit atau selama intervensitx
◦ Direct medical cost: biaya kebutuhan medis E.g. biaya untuk obat, kamar saat rawat inap, biaya
tambahan yg tidak ditanggung oleh asuransi
◦ Direct non-medical cost: membiayai segalapengeluaran yang diakibatkan oleh suatupenyakit/terapinya E.g. biaya transportasi untuk pergi ke RS, akomodasi,
konsumsi untuk pendamping selama px di RS
Khairul Purba 21
09/09/2019
8
Indirect cost
Indirect cost: biaya yg secara tidak langsung
dikeluarkan sebagai konsekuensi dari adanya
penyakit atau pengobatan e.g. hilangnya
produktivitas
◦ Human capital approach
= jumlah hari masuk kerja * penghasilan per tahun / 365
◦ Friction cost approach
Menghitung produktivitas yang hilang berdasarkan waktu
yang dibutuhkan oleh RS untuk mengganti orang yg
sedang menderita penyakit atau sedang menjalani terapi
dg orang lain yg mempunyai kemampuan setara
Khairul Purba 22
Intangible cost
Biaya yg tidak teraba e.g. rasa sakit, rasa
senang, keterbatasan fisik, qualitas hidup
Cara: SF-36
Khairul Purba 23
Metode analisis health economics
Cost-Minimization analysis
Cost-Effectiveness Analysis
Cost-Utility Analysis
Cost-Benefit Analysis
Khairul Purba 24
09/09/2019
9
Types of costs
and
benefits
Intangible
Indirect Morbidity and Mortality
Direct Non medical
Direct Medical
Point of
view
Society
Patient
Payer
Provider
Type of analysisKhairul Purba 25
Ragam biaya berdasarkan perspektif
Ragam biaya Perspektif
Pasien Dokter Rumah Sakit Pembayar Negara
Biaya medik langsung
Honor dokter
Honor lain
Obat & alkes
Diagnostik & lab.
Biaya medik tak langsung
Administrasi
Fasilitas fisik
Sarana
Transport
Kunjungan rumah
Biaya tak langsung
Waktu kunjung dokter
Istirahat sakit
Pekerjaan rumah tangga
+
-
+
-
-
-
-
+
+
+
+
+
+
+
-
-
-
-
+
-
-
-
-
-
+
+
+
+
+
+
-
-
-
-
-
-
+
+
+
+
+
-
+
-
-
-
-
-
+
+
+
+
+
+
+
+
+
+
+
+ = diperhitungkan ; - = tak diperhitungkan Khairul Purba 26
1. Cost minimization analysis Hanya menilai biaya, tak menilai manfaat.
Digunakan utk menetapkan satu pilihan daribeberapa obat yang sama kemanfaatannya.
Berlaku untuk pengobatan penyakit dengan hasilkeluaran yang sama.
Untuk mengetahui berapa penghematan (saving)
Merupakan analisis ekonomik yg paling sederhana.
Pilihan obat dijatuhkan pada obat yg termurah, tetapi mutu dan suplai terjamin.
Khairul Purba 27
09/09/2019
10
Komponen biaya total penderita osteomyelitis yang dirawat dan
yang pulang awal (dalam ribuan rupiah)
Dirawat Pulang awal Penghematan
Biaya langsung
Sewa kamar
Honor dokter
Obat dan alkes
Pelayanan
tambahan
Asuhan anak
Rumah tangga
Transportasi
Biaya tak langsung
Kehilangan gaji
1748
357
0
0
191
33
72
380
916
231
460
202
102
13
47
300
832
126
-460
-202
89
20
25
80
TOTAL 2781 2271 510Khairul Purba 28
2. Cost-Benefit Analysis
Biaya dan hasil pengobatan dinyatakandalam terminologi yg sama (biasanyadinilai dengan uang).
Untung bersih dapat dinyatakan denganuang,.
Akan tetapi tak semua keluaranpengobatan dapat dinyatakan nilainyadengan uang; atau hasil penilaiannya takseragam.
Khairul Purba 29
3. Cost-effectiveness analysis
Keluaran pengobatan (effectiveness) merupakan‘single outcome’.
Hitung biaya dan manfaat farmakoterapi
Biaya dalam nilai mata uang,
manfaat dinilai dalam satuan alamiah (jumlah yang sembuh, jumlah yang selamat, besarnya penurunantekanan darah, besarnya penurunan kadar guladarah, dll)
Membandingkan biaya-manfaat teknologi baru vs. teknologi standard
Khairul Purba 30
09/09/2019
11
COST-EFFECTIVENESS ANALYSIS (CEA)
CEA includes monetary costs, savings and health gains. Health gains are measured in similar units for several interventions (including non-intervention). Comparison occurs in terms of net costs per unit of health gain.
Health gains
◦ infections averted
◦ cases cured
◦ complications averted
◦ life-years gained (LYG)
Khairul Purba 31
Analisis Biaya - Manfaat
Analisis Peningkatan Biaya – Manfaat:
Biaya1 - Biaya2
Manfaat1 - Manfaat2
Khairul Purba 32
Biaya
A
lebih unggul Analisis selisih
biaya – manfaat
Analisis selisih biaya
– manfaat
B
lebih unggul
A>B
A<B
K
E
M
A
N
F
A
A
T
A
N
A<B A>B
Khairul Purba 33
09/09/2019
12
Contoh: Analisis Biaya - Manfaat
1. Biasa
untuk 1000 penderita
2. Streptokinase (200 ribu)
untuk 1000 penderita
3. TPA (2 juta)
untuk 1000 penderita
Jenis Pengobatan Biaya HasilJumlah jiwa yang
diselamatkan
3,5 M
3,7 M
5,5 M
120†
90†
80†
30
10
40
Khairul Purba 34
Rasio Peningkatan Biaya – Manfaat
(Incremental Cost-Effectiveness Ratio)
Streptokinase vs. Biasa6 juta/1 jiwa yang diselamatkan
TPA vs. Biasa 50 juta/1 jiwa yang diselamatkan
TPA vs. Streptokinase 180 juta/1 jiwa yang diselamatkan
Bila biaya yang tersedia 4 M utk infark akut, maka untukterapi trombolitik tersedia 0,5 M:
1. Dapat diobati 2500 penderita dengan streptokinase dan terselamatkan jiwa sebanyak 75 pasien
2. Dapat diobati 250 penderita dengan TPA danterselamatkan jiwa sebanyak 10 pasien
Yang disediakan adalah streptokinase, karena bilaTPA ygdisediakan social opportunity cost-nya tinggi sekali
Bila pasien memilihTPA, lakukan “cost-sharing”Khairul Purba 35
1
2
3
4
5
6
7
8
9
10
C
TS
Efek
Biaya
1 2 3 4 5 6 7 8 9 10
Analisis peningkatan biaya –
manfaat trombolitik
(streptokinase vs. TPA) pada
infark miokard akut
C = tanpa trombolitik ; S = streptokinase ; T = TPA
(∆CT-S/∆ ET-S)
Khairul Purba 36
09/09/2019
13
Ya
10
Pohon Keputusan (Decision Tree) yang menyatakan
kelebihan biaya pengobatan analsis untung rugi
antibiotika profilaksis pada histerektomi vaginalis
Tidak
34
Ya
44
Ya
3
Tidak
7Infeksi RS
Infeksi luar
RS
Infeksi luar
RS
Ya
2
Tidak
32
0,30
0,70
0,23
0,77
0,05
0,95
Ya
22
Tidak
20
Tidak
42
Ya
2
Tidak
20Infeksi RS
Infeksi luar
RS
Infeksi luar
RS
Ya
2
Tidak
18
0,30
0,70
0,52
0,48
0,05
0,95
Biaya tambahan
(C) tiap
penderita 1877
Proporsi
dari total
Kelebihan
proporsional
biaya
1877 3/44 128
1777 7/44 283
100 2/44 5
0 32/44 0
1877 2/42 90
1777 20/42 846
100 2/42 5
0 18/42 0
TOTAL 1.00 416
TOTAL 1.00 941
0,5
10,4
9
Pro
fila
ksis
Khairul Purba 37
4. Analisis Biaya-Utilitas
(Cost-Utility Analysis) Utk menilai kemanfaatan ganda (lama hidup dan
kualitas hidup).
Hasil pengobatan biasanya dinyatakan dalamquality adjusted life years (QALYs) atau disability adjusted life years (DALYs).
Utility didefinisikan sbg tingkat kesejahteraanfisik dan mental (wellbeing) yg secara subyektifdinyatakan dalam skor
Masih ada ketaksamaan pendapat tentangpengukuran utilitas.
Khairul Purba 38
Measuring QOL
Happy Miserable
How are you feeling today?
Khairul Purba 39
09/09/2019
14
Overall Health Rating Item
Overall, how would you rate your current health?
(Circle One Number)
0 1 2 3 4 5 6 7 8 9 10
Worst possible
health (as bad or
worse than
being dead)
Half-way
between worst
and best
Best
possible
health
Khairul Purba 40
EQ-5D
Khairul Purba 41
Preference for generic measurement of QALY (EQ-5D)
Khairul Purba 42
09/09/2019
15
Perhitungan utility (QALY)
Khairul Purba 43
Cost per QALYs of health interventions
Hutton J et al., PharmacoEconomics 1997Khairul Purba 44
Physical health and functioning
Mental Health and functioning
Social and role functioning
HRQOL Domain*
Perceptions of general well-being
* Schron and Scumaker; Patrick and Erickson
Khairul Purba 45
09/09/2019
16
Types of HRQOL Measures
Generic instruments
➢Health profiles
➢Preference-based measures
Specific instruments
➢Disease specific (e.g. diabetes)
➢Population specific (older)
➢Function specific (sexual)
➢Condition/problem specific (pain)
Khairul Purba 46
Generic instruments (health profiles)
SF-36/SF-12 scales and number of items per scale
◦ Physical functioning (10)
◦ Role limitations attributed to physical problems (4)
◦ Bodily pain (2)
◦ General health perceptions (5)
◦ Emotional well being (5)
◦ Role limitations/emotional (3 items)
◦ Energy/fatigue (4 items)
◦ Social functioning (2 items)
Khairul Purba 47
Biaya, mortalitas, mobiditas pengobatan
penyakit X dengan dua cara pengobatan
Cara
pengobatan
Biaya
pengobatan
Mortalitas
(lama hidup)
Morbiditas
(kualitas
hidup)
Litilitas
(QALY)
A
B
200 juta
100 juta
4.5 tahun
3.5 tahun
0.8
0.9
3.6 QALY
3.15 QALY
Ratio Biaya – Utilitas :
Rerata A = 200 juta/3.6 QALY = 55.5 juta/1 QALY
Rerata B = 100 juta/3.15 QALY = 31.7 juta/1 QALY
Selisih A-B = 200-100 juta = 22.2 juta/1 QALY
3.6-3.15
Khairul Purba 48
09/09/2019
17
• Estimated survival 10 years
• Estimated quality of life
(relative to ‘perfect health’)
= 0.7
• QALY = 10* 0.7 = 7.0
QALY gained 4.5
With Treatment
• Estimated survival 5 years
• Estimated quality of life
(relative to ‘perfect health’)
= 0.5
• QALY = 5* 0.5 = 2.5
Without treatment
If the costs treatment A $18,000, then the cost per QALY is
18,000/4.5 = $4000/QALY
Khairul Purba 49
Source Advantages Disadvantages
RCT Measure efficacy
Well controlled
Powered to detect statistically
significant differences
Offer sufficient sample size
Collect prospective data
Do not reflect “usual care”
Results may be difficult to
generalize
Not usually comparative
Not usually powered to detect
QoL or Economic differences
Time-consuming & expensive
Database
studies
Have large sample size potential
Can provide data quickly
Are reflective of “usual care”
Differ in quality of databases
Use on inconsistent coding
Expert
opinions
Are inexpensive
Can provide missing data quickly
Are reflective of usual care
Can adjust to protocol-driven
resource use
Have potential for bias
Are controversial
Potential for large variations
HTA Data Sources
Khairul Purba 50
What is your conclusion?
Khairul Purba 51
09/09/2019
18
COST-EFFECTIVENESS PLANE
Khairul Purba 52
Any comments?
Khairul Purba 53
Applications for HTA
Khairul Purba 54
Conclusions