Iwan D Innovative product to support JKN Alana 30 Julyi 2016
Nama:
Curriculum vitae
Prof. dr. Iwan Dwiprahasto, MMedSc, PhD
Riwayat pendidikan
Dokter, FK UGM tahun 1987
S-2: MMedSc Newcastle University Australia, 1993
S-3: PhD, London School of Hygiene & Tropical Medicine, England, 2000
Jabatan:
1. Wakil Rektor Bidang Akademik dan Kemahasiswaan UGM
2. Ketua Komite Nasional (KOMNAS) Penyusun Formularium Nasional
3. Ketua, Komite Nasional (KOMNAS) DOEN (Daftar Obat Esensial Nasional)
4. Komite Nasional (KOMNAS) Penilai Obat Jadi Badan POM
5. Komite Nasional (KOMNAS) Informatorium Obat Nasional Indonesia
(IONI)
6. Komite Nasional (KOMNAS) Obat Tradisional dan Suplemen Makanan
7. Komite Nasional (KOMNAS) Penilaian Teknologi Kesehatan, Kemkes RI
8. Komite Nasional (KOMNAS) Keselamatan Pasien Rumah Sakit, Kemkes RI
9. Chairman, Indonesian Clinical Epidmiology & EBM Network
10. Board of Governor, International Clinical Epidemiology Network (INCLEN)
11. Dewan Pakar Asosiasi Rumah Sakit Daerah (ARSADA)
Innovative product to
contribute to the National
Health Insurance
Iwan Dwiprahasto
Faculty of Medicine, UGM
Challenge in Health care in the era of JKN
Health care
crisis
Substandar
d care of
PHC
Diseases
more
prevalent
Community
takes
opportunity
Spoil the
patients
Primary care
trust
incompl
ete
Generic
medicin
e
Cheap
drugs
Too much
regulate
clinicians
Doesn’t
have to
comply
Frequently
unavailabl
e
Low
quality
Perceptions on National Formulary
Drug Efficacy to
Human
Drug toxic but
NOT beneficial
Beneficial
BUT toxic
Drug NOT toxic
& NOT
beneficial
Diagnosis sama,,
Obat yang
diresepkan sama
Drug NOT
toxic &
Beneficial
Medicine and Population
Positive and Negative Syndrome Scale (PANSS) in
patients with Schizophrenia
Demonstrated in a 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial of 400
® (25
patients with schizophrenia. Patients received intramuscular (IM) injections of placebo or RISPERDAL CONSTA ®
††
mg, 50 mg, or 75 mg ) every 2 weeks. Patients also received oral antipsychotic supplementation for the first 3
® to reach therapeutic levels. The primary measure of efficacy was change in
weeks to allow RISPERDAL CONSTA®
PANSS total scores from baseline to endpoint.
Hepatitis C Treatment
More Drugs, Fewer Patients: Limits of
Precision Medicine
Posted on November 9th, 2015 by Thibault Geoui in
Chemistry
https://pharma.elsevier.com/chemistry/more-drugs-fewer-patients-limits-of-precision-medicine/
Mengapa perlu Individualisasi Terapi?
Risiko ESO meningkat pada
pemberian CYP2D6
dependant antidepressants
seperti fluoxetine,
paroxetine, venlafaxine &
Highly required, Murah, masuk ke dalam
Formularium Nasional, meskipun ketersediaan
menjadi
masalah
Procain benzilpenicilin
serb inj 1 miion IU
Oksitetrasiklin inj 50 mg/ml, inj 250 mg/ 3 ml, dan inj 500 mg/ml,
Metenamin mandelat tab sal enterik 500 mg, antiseptik sal kemih
Nitrofurantoin tab 50 mg, obat antiseptik saluran kemih
Propranolol tab 40 mg, obat profilaksis antimigren
Medroksi progesteron asetat inj 50 mg/ml dan inj 150 mg/ml,
Mitomisin serb inj 2 mg, obat sitotoksik
Asam folat tab 5 mg, obat antianemi
Amilorid tab 5 mg, obat diuretik
Hidroklorotiazid tab 12,5 mg, obat diuretik
Hidrokortison tab 10 mg, obat kortikosteroid
Homatropin tts mata 2%, obat midriatik
Suksinilkolin inj 50 mg/ml, dan serb inj 100 mg,
Atropin inj 1 mg/ml, obat antispasmodik
Salbutamol inj 50 mcg/ml, obat antiasma
FORMULARIUM NASIONAL
29 – Therapeutic class
National
Formulary
components
96 - Sub therapeutic
class
573 – drug
items/active
compounds
1018 – preparation/
strength
National Formulary: bottom up
Offer forprocess
proposal: November
2014
Were sent to 812 Institutions
Hospital
Professional
Assoc
District health
Office
Programme
Holder
Until May 2015
Proposal were received from 180
institution (22,16%):
104
Hospital
s
34
Private
hospitals
34
Professio
nal org
4
District
health
office
4
program
me holder
16
Selection Process
Proposal from Hospitals/Professional assoc/Distr
Supported by
Period: 6 months
ReasonHO
to propose
evidence
Eligibility of
institution
Efficacy,
safety
Administrative selections
Reason to propose
Scientific evidence
What
Current
best-to discuss
Approved
indication BPOM
evidence
Price/Cost
component
Panel Decisions
Accepted
Accepted w/
negotiation
Accepted w/
risk sharing
Refused
Challenges
Highly Efficacious
& required
unavailable
amphotericin-B,
hydroxchloroquin,
1. Needs vs
availability
Examples
probenecid,
penisilin-V,
daunorubicin,
ticarcilin, carbeiclin
Small profit margins
Raw materials scanty
Reasons
No longer available
Drugs with similar efficacy
are available
Challenges
2. Expensive & should be taken for
lifes
Antidiabetes
DPP4: linagliptin,
saxagliptin,
vildagliptin
GLP1-receptor
agonist:
liraglutide,
exenetide
Lipid lowering drugs
Statin
Combination
s w/ other
drugs
Complexity of preparations
FDC:
• Metformin +
saxagliptin
• Metformin + linagliptin
• Telmisartan +
amlodipin
• Atorvastatin +
ezetimibe
Complexity of procurement
Elligibility
Much more expensive than
single
Initial tx vs substitutions
Challenges
3. Availability vs use
Listed in e-catalogue, not available in the
market
Registered but no longer produced by
pharma
Listed in e-catalogue, limited stocks
Available, excessively used (parenteral
preparations)
Challenges
4. Marginal efficacy, for chronic use
Never know when to stop
Cost vs adherence
Examples:
• Drugs for OAB: oxybutyrin, fesoterodine,
tolterodine, solifenacin)
• Drugs for dementia
• Drugs for Wet AMD
• Psikhofarmaka
Rivastigmin for Dementia: Clinician's
Interview-Based Impression of
Change
Expensive but highly required
Living with CML: is death no longer the end
(point)?
White & Hughes, Blood 2015 126:2-4
Do we have to pay for this? (NSCLC)
Expensive but not Highly required
Necitumumab + Gemcitabine + Cisplatin
Gemcitabine + Cisplatin
Necitumumab +
Gemcitabine +
Cisplatin
Gemcitabine +
Cisplatin
FDC (single pill) vs Free-drug
combination
Persistence was defined as the percentage of patients meeting a predefined
threshold (depending on the study) during a 12-month follow-up period (Sherrill
2011).
Efficacy
Appropriate
use
Acceptabilit
y
Safety
Determinant
s of
medicine for
health care
Accessibilit
y
Quality
Availability
Affordabilit
y
Factors Affecting Treatment Cost in Patients with Early
Breast Cancer Receiving Chemotherapy and antiHER2
at RSUP DR Sardjito 2007-2014
Variable
Radiotherapy
N
Mean cost
(Rp)
Yes
48
290.166.455
No
35
250.296.626
13
35
244.128.225
301.791.254
71
276.707.307
9
282.856.735
12
35
253.043.260
298.745.083
Surgery to Radiotherapy
210 days
Surgery to
Chemotherapy
120 days
Chemotherapy to radiotx
180 days
AP to antiHER2
Different in
cost
(+ Rp per
pats)
P
value
SD
87.685.03
9
98.862.98
0
66.062.565
86.511.300
0,056
40.000.000
0,035
91.125.962
112.297.76
8
85.543.088
83.552.955
0,853
57.000.000
7.000.000
Rukmi et45.000.000
al., 2016
0,111
Availability of
Medicines
Lack of
sustainable
financing
Shortages of
Medicines
Geographycall
y problematics
Problems
in the
sustainabl
e supply
Uninformed
government
procurement
s
Limited
number of
Quality
Distributor
Accessibility to Medicines
Access failures in national health systems
Barriers to access to health services
Lack of diagnosis, lack of treatment
Structural health system problems
Limited HR
Limited infrastructure
Limited access to information
Acceptability and Use of
Medicines
Cultural and behavioral determinants
Prescription of branded medicines which may
not be accessible
Patients’ perception about effectiveness, safety
and accessibility of medicines
Misuse of medicines by patients
Lack of health literacy
Safety and Quality of Medicines
Limited capacity of quality assurance
Weak pharmacovigilance
Inadequate regulatory framework for the
private sector
Insufficient regulatory authority capacity
Lack of public awareness
UU No 40/2004 Pasal 25 & 26
• Daftar dan harga obat serta BMHP
yang dijamin BPJS ditetapkan
pemerintah
• Jenis pelayanan yang tdk dijamin
ditetapkan pemerintah
Peraturan Presiden Republik Indonesia Nomor
12 Tahun 2013 Tentang Jaminan Kesehatan
(Pasal 32)
(1) Pelayanan obat dan bahan medis habis pakai
untuk Peserta Jaminan Kesehatan pada Fasilitas
Kesehatan berpedoman pada daftar dan harga obat,
dan bahan medis habis pakai yang ditetapkan oleh
Menteri.
(2) Daftar dan harga obat dan bahan medis habis
pakai sebagaimana dimaksud pada ayat (1) ditinjau
kembali paling lambat 2 (dua) tahun sekali
Ina CBGs and how to safe hospital
budget
Ina CBGs tariffs
Diagnosis
Medic
ine
Might be
saved
BMHP
Treat
ment
Room
Fixed cost
Cons
ultati
on
Curriculum vitae
Prof. dr. Iwan Dwiprahasto, MMedSc, PhD
Riwayat pendidikan
Dokter, FK UGM tahun 1987
S-2: MMedSc Newcastle University Australia, 1993
S-3: PhD, London School of Hygiene & Tropical Medicine, England, 2000
Jabatan:
1. Wakil Rektor Bidang Akademik dan Kemahasiswaan UGM
2. Ketua Komite Nasional (KOMNAS) Penyusun Formularium Nasional
3. Ketua, Komite Nasional (KOMNAS) DOEN (Daftar Obat Esensial Nasional)
4. Komite Nasional (KOMNAS) Penilai Obat Jadi Badan POM
5. Komite Nasional (KOMNAS) Informatorium Obat Nasional Indonesia
(IONI)
6. Komite Nasional (KOMNAS) Obat Tradisional dan Suplemen Makanan
7. Komite Nasional (KOMNAS) Penilaian Teknologi Kesehatan, Kemkes RI
8. Komite Nasional (KOMNAS) Keselamatan Pasien Rumah Sakit, Kemkes RI
9. Chairman, Indonesian Clinical Epidmiology & EBM Network
10. Board of Governor, International Clinical Epidemiology Network (INCLEN)
11. Dewan Pakar Asosiasi Rumah Sakit Daerah (ARSADA)
Innovative product to
contribute to the National
Health Insurance
Iwan Dwiprahasto
Faculty of Medicine, UGM
Challenge in Health care in the era of JKN
Health care
crisis
Substandar
d care of
PHC
Diseases
more
prevalent
Community
takes
opportunity
Spoil the
patients
Primary care
trust
incompl
ete
Generic
medicin
e
Cheap
drugs
Too much
regulate
clinicians
Doesn’t
have to
comply
Frequently
unavailabl
e
Low
quality
Perceptions on National Formulary
Drug Efficacy to
Human
Drug toxic but
NOT beneficial
Beneficial
BUT toxic
Drug NOT toxic
& NOT
beneficial
Diagnosis sama,,
Obat yang
diresepkan sama
Drug NOT
toxic &
Beneficial
Medicine and Population
Positive and Negative Syndrome Scale (PANSS) in
patients with Schizophrenia
Demonstrated in a 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial of 400
® (25
patients with schizophrenia. Patients received intramuscular (IM) injections of placebo or RISPERDAL CONSTA ®
††
mg, 50 mg, or 75 mg ) every 2 weeks. Patients also received oral antipsychotic supplementation for the first 3
® to reach therapeutic levels. The primary measure of efficacy was change in
weeks to allow RISPERDAL CONSTA®
PANSS total scores from baseline to endpoint.
Hepatitis C Treatment
More Drugs, Fewer Patients: Limits of
Precision Medicine
Posted on November 9th, 2015 by Thibault Geoui in
Chemistry
https://pharma.elsevier.com/chemistry/more-drugs-fewer-patients-limits-of-precision-medicine/
Mengapa perlu Individualisasi Terapi?
Risiko ESO meningkat pada
pemberian CYP2D6
dependant antidepressants
seperti fluoxetine,
paroxetine, venlafaxine &
Highly required, Murah, masuk ke dalam
Formularium Nasional, meskipun ketersediaan
menjadi
masalah
Procain benzilpenicilin
serb inj 1 miion IU
Oksitetrasiklin inj 50 mg/ml, inj 250 mg/ 3 ml, dan inj 500 mg/ml,
Metenamin mandelat tab sal enterik 500 mg, antiseptik sal kemih
Nitrofurantoin tab 50 mg, obat antiseptik saluran kemih
Propranolol tab 40 mg, obat profilaksis antimigren
Medroksi progesteron asetat inj 50 mg/ml dan inj 150 mg/ml,
Mitomisin serb inj 2 mg, obat sitotoksik
Asam folat tab 5 mg, obat antianemi
Amilorid tab 5 mg, obat diuretik
Hidroklorotiazid tab 12,5 mg, obat diuretik
Hidrokortison tab 10 mg, obat kortikosteroid
Homatropin tts mata 2%, obat midriatik
Suksinilkolin inj 50 mg/ml, dan serb inj 100 mg,
Atropin inj 1 mg/ml, obat antispasmodik
Salbutamol inj 50 mcg/ml, obat antiasma
FORMULARIUM NASIONAL
29 – Therapeutic class
National
Formulary
components
96 - Sub therapeutic
class
573 – drug
items/active
compounds
1018 – preparation/
strength
National Formulary: bottom up
Offer forprocess
proposal: November
2014
Were sent to 812 Institutions
Hospital
Professional
Assoc
District health
Office
Programme
Holder
Until May 2015
Proposal were received from 180
institution (22,16%):
104
Hospital
s
34
Private
hospitals
34
Professio
nal org
4
District
health
office
4
program
me holder
16
Selection Process
Proposal from Hospitals/Professional assoc/Distr
Supported by
Period: 6 months
ReasonHO
to propose
evidence
Eligibility of
institution
Efficacy,
safety
Administrative selections
Reason to propose
Scientific evidence
What
Current
best-to discuss
Approved
indication BPOM
evidence
Price/Cost
component
Panel Decisions
Accepted
Accepted w/
negotiation
Accepted w/
risk sharing
Refused
Challenges
Highly Efficacious
& required
unavailable
amphotericin-B,
hydroxchloroquin,
1. Needs vs
availability
Examples
probenecid,
penisilin-V,
daunorubicin,
ticarcilin, carbeiclin
Small profit margins
Raw materials scanty
Reasons
No longer available
Drugs with similar efficacy
are available
Challenges
2. Expensive & should be taken for
lifes
Antidiabetes
DPP4: linagliptin,
saxagliptin,
vildagliptin
GLP1-receptor
agonist:
liraglutide,
exenetide
Lipid lowering drugs
Statin
Combination
s w/ other
drugs
Complexity of preparations
FDC:
• Metformin +
saxagliptin
• Metformin + linagliptin
• Telmisartan +
amlodipin
• Atorvastatin +
ezetimibe
Complexity of procurement
Elligibility
Much more expensive than
single
Initial tx vs substitutions
Challenges
3. Availability vs use
Listed in e-catalogue, not available in the
market
Registered but no longer produced by
pharma
Listed in e-catalogue, limited stocks
Available, excessively used (parenteral
preparations)
Challenges
4. Marginal efficacy, for chronic use
Never know when to stop
Cost vs adherence
Examples:
• Drugs for OAB: oxybutyrin, fesoterodine,
tolterodine, solifenacin)
• Drugs for dementia
• Drugs for Wet AMD
• Psikhofarmaka
Rivastigmin for Dementia: Clinician's
Interview-Based Impression of
Change
Expensive but highly required
Living with CML: is death no longer the end
(point)?
White & Hughes, Blood 2015 126:2-4
Do we have to pay for this? (NSCLC)
Expensive but not Highly required
Necitumumab + Gemcitabine + Cisplatin
Gemcitabine + Cisplatin
Necitumumab +
Gemcitabine +
Cisplatin
Gemcitabine +
Cisplatin
FDC (single pill) vs Free-drug
combination
Persistence was defined as the percentage of patients meeting a predefined
threshold (depending on the study) during a 12-month follow-up period (Sherrill
2011).
Efficacy
Appropriate
use
Acceptabilit
y
Safety
Determinant
s of
medicine for
health care
Accessibilit
y
Quality
Availability
Affordabilit
y
Factors Affecting Treatment Cost in Patients with Early
Breast Cancer Receiving Chemotherapy and antiHER2
at RSUP DR Sardjito 2007-2014
Variable
Radiotherapy
N
Mean cost
(Rp)
Yes
48
290.166.455
No
35
250.296.626
13
35
244.128.225
301.791.254
71
276.707.307
9
282.856.735
12
35
253.043.260
298.745.083
Surgery to Radiotherapy
210 days
Surgery to
Chemotherapy
120 days
Chemotherapy to radiotx
180 days
AP to antiHER2
Different in
cost
(+ Rp per
pats)
P
value
SD
87.685.03
9
98.862.98
0
66.062.565
86.511.300
0,056
40.000.000
0,035
91.125.962
112.297.76
8
85.543.088
83.552.955
0,853
57.000.000
7.000.000
Rukmi et45.000.000
al., 2016
0,111
Availability of
Medicines
Lack of
sustainable
financing
Shortages of
Medicines
Geographycall
y problematics
Problems
in the
sustainabl
e supply
Uninformed
government
procurement
s
Limited
number of
Quality
Distributor
Accessibility to Medicines
Access failures in national health systems
Barriers to access to health services
Lack of diagnosis, lack of treatment
Structural health system problems
Limited HR
Limited infrastructure
Limited access to information
Acceptability and Use of
Medicines
Cultural and behavioral determinants
Prescription of branded medicines which may
not be accessible
Patients’ perception about effectiveness, safety
and accessibility of medicines
Misuse of medicines by patients
Lack of health literacy
Safety and Quality of Medicines
Limited capacity of quality assurance
Weak pharmacovigilance
Inadequate regulatory framework for the
private sector
Insufficient regulatory authority capacity
Lack of public awareness
UU No 40/2004 Pasal 25 & 26
• Daftar dan harga obat serta BMHP
yang dijamin BPJS ditetapkan
pemerintah
• Jenis pelayanan yang tdk dijamin
ditetapkan pemerintah
Peraturan Presiden Republik Indonesia Nomor
12 Tahun 2013 Tentang Jaminan Kesehatan
(Pasal 32)
(1) Pelayanan obat dan bahan medis habis pakai
untuk Peserta Jaminan Kesehatan pada Fasilitas
Kesehatan berpedoman pada daftar dan harga obat,
dan bahan medis habis pakai yang ditetapkan oleh
Menteri.
(2) Daftar dan harga obat dan bahan medis habis
pakai sebagaimana dimaksud pada ayat (1) ditinjau
kembali paling lambat 2 (dua) tahun sekali
Ina CBGs and how to safe hospital
budget
Ina CBGs tariffs
Diagnosis
Medic
ine
Might be
saved
BMHP
Treat
ment
Room
Fixed cost
Cons
ultati
on