Iwan D Innovative product to support JKN Alana 30 Julyi 2016

(1)

Nama: 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)

12. Dewan Pakar Perhimpunan Rumah Sakit Indonesia (PERSI)

Curriculum vitae

(2)

Innovative product to

contribute to the National

Health Insurance

Innovative product to

contribute to the National

Health Insurance

(3)

Diseases

more

prevalent

Diseases

more

prevalent

Community

takes

opportunity

Community

takes

opportunity

Primary care

trust

Primary care

trust

Substandar

d care of

PHC

Substandar

d care of

PHC

Spoil the

patients

Spoil the

patients

Health care

crisis

Health care

crisis

(4)

Generic

medicin

e

Generic

medicin

e

Cheap

drugs

Cheap

drugs

Too much

regulate

clinicians

Too much

regulate

clinicians

Frequently

unavailabl

e

Frequently

unavailabl

e

Low

quality

Low

quality

incompl

ete

incompl

ete

Doesn’t

have to

comply

Doesn’t

have to

comply

Perceptions on National Formulary

(5)

Drug toxic but

NOT beneficial

Drug toxic but

NOT beneficial

Beneficial

BUT toxic

Beneficial

BUT toxic

Drug NOT toxic

& NOT

beneficial

Drug NOT toxic

& NOT

beneficial

Drug NOT

toxic &

Beneficial

Drug NOT

toxic &

Beneficial

Drug Efficacy to

Human

(6)

Medicine and Population

(7)

Demonstrated in a 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial of 400 patients with schizophrenia. Patients received intramuscular (IM) injections of placebo or RISPERDAL CONSTA®₍₂₅

mg, 50 mg, or 75 mg†_{) every 2 weeks. Patients also received oral antipsychotic supplementation for the first 3}

weeks to allow RISPERDAL CONSTA®_{to reach therapeutic levels. The primary measure of efficacy was change in}

PANSS total scores from baseline to endpoint.

Demonstrated in a 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial of 400 patients with schizophrenia. Patients received intramuscular (IM) injections of placebo or RISPERDAL CONSTA®₍₂₅

mg, 50 mg, or 75 mg†_{) every 2 weeks. Patients also received oral antipsychotic supplementation for the first 3}

weeks to allow RISPERDAL CONSTA®_{to reach therapeutic levels. The primary measure of efficacy was change in}

PANSS total scores from baseline to endpoint.

Positive and Negative Syndrome Scale (PANSS) in

patients with Schizophrenia

(8)

Hepatitis C Treatment

(9)

(10)

(11)

(12)

More Drugs, Fewer Patients: Limits of

Precision Medicine

More Drugs, Fewer Patients: Limits of

Precision Medicine

Posted on November 9th, 2015 by Thibault Geoui in Chemistry

(13)

Risiko ESO meningkat pada pemberian CYP2D6

dependant antidepressants seperti fluoxetine,

paroxetine, venlafaxine & mirtazapine

Risiko ESO meningkat pada pemberian CYP2D6

dependant antidepressants seperti fluoxetine,

paroxetine, venlafaxine & mirtazapine

Mengapa perlu Individualisasi Terapi?

(14)

Highly required, Murah, masuk ke dalam

Formularium Nasional, meskipun ketersediaan

menjadi masalah

Highly required, Murah, masuk ke dalam

Formularium Nasional, meskipun ketersediaan

menjadi masalah

Procain benzilpenicilin serb inj 1 miion IU Procain benzilpenicilin serb inj 1 miion IU

Oksitetrasiklin inj 50 mg/ml, inj 250 mg/ 3 ml, dan inj 500 mg/ml, 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 Metenamin mandelat tab sal enterik 500 mg, antiseptik sal kemih Nitrofurantoin tab 50 mg, obat antiseptik saluran kemih

Nitrofurantoin tab 50 mg, obat antiseptik saluran kemih Propranolol tab 40 mg, obat profilaksis antimigren

Propranolol tab 40 mg, obat profilaksis antimigren

Medroksi progesteron asetat inj 50 mg/ml dan inj 150 mg/ml, Medroksi progesteron asetat inj 50 mg/ml dan inj 150 mg/ml, Mitomisin serb inj 2 mg, obat sitotoksik

Mitomisin serb inj 2 mg, obat sitotoksik Asam folat tab 5 mg, obat antianemi Asam folat tab 5 mg, obat antianemi Amilorid tab 5 mg, obat diuretik

Amilorid tab 5 mg, obat diuretik

Hidroklorotiazid tab 12,5 mg, obat diuretik Hidroklorotiazid tab 12,5 mg, obat diuretik Hidrokortison tab 10 mg, obat kortikosteroid Hidrokortison tab 10 mg, obat kortikosteroid Homatropin tts mata 2%, obat midriatik

Homatropin tts mata 2%, obat midriatik

Suksinilkolin inj 50 mg/ml, dan serb inj 100 mg, Suksinilkolin inj 50 mg/ml, dan serb inj 100 mg, Atropin inj 1 mg/ml, obat antispasmodik

(15)

FORMULARIUM NASIONAL

National

Formulary

components

National

Formulary

components

29 – Therapeutic class

96 - Sub therapeutic

class

96 - Sub therapeutic

class

573 – drug

items/active

compounds

573 – drug

items/active

compounds

1018 – preparation/

strength

(16)

Were sent to 812 Institutions

Hospital Professional _Assoc District health _Office Programme _Holder

Offer for proposal: November

2014

Offer for proposal: November

2014

16

National Formulary: bottom up

process

National Formulary: bottom up

process

Until May 2015

Proposal were received from 180

institution (22,16%):

(17)

Selection Process

Panel Decisions

Accepted

Accepted w/

negotiation

Accepted w/

risk sharing

Refused

What to discuss

Efficacy,

safety

Current best-

evidence

indication BPOM

Approved

component

Price/Cost

Administrative selections

Eligibility of

institution

Reason to propose

Scientific evidence

Proposal from Hospitals/Professional assoc/Distr

HO

Proposal from Hospitals/Professional assoc/Distr

HO

(18)

Challenges

1. Needs vs

availability

1. Needs vs

availability

Highly Efficacious

& required

Highly Efficacious

& required

unavailable

Examples

amphotericin-B,

hydroxchloroquin,

probenecid,

penisilin-V,

daunorubicin,

ticarcilin, carbeiclin

Reasons

Small profit margins Small profit margins

Raw materials scanty Raw materials scanty

No longer available No longer available

Drugs with similar efficacy are available

(19)

Challenges

2. Expensive & should be taken for

lifes

2. Expensive & should be taken for

lifes

Antidiabetes

DPP4: linagliptin, saxagliptin, vildagliptin DPP4: linagliptin, saxagliptin, vildagliptin GLP1-receptor agonist: liraglutide, exenetide GLP1-receptor agonist: liraglutide, exenetide

Lipid lowering drugs

Statin

Combination

s w/ other

drugs

Combination

s w/ other

drugs

FDC:

•

Metformin +

saxagliptin

•

Metformin + linagliptin

•

Telmisartan +

amlodipin

•

Atorvastatin +

ezetimibe

•

Metformin +

saxagliptin

•

Metformin + linagliptin

•

Telmisartan +

amlodipin

•

Atorvastatin +

ezetimibe

Complexity of preparations Complexity of preparations

Complexity of procurement Complexity of procurement

Elligibility Elligibility

Much more expensive than single

(20)

3

.

Availability vs use

3

.

Availability vs use

Listed in e-catalogue, not available in the

market

Listed in e-catalogue, not available in the

market

Registered but no longer produced by

pharma

Registered but no longer produced by

pharma

Listed in e-catalogue, limited stocks

Available, excessively used (parenteral

preparations)

Available, excessively used (parenteral

preparations)

Challenges

(21)

4. Marginal efficacy, for chronic use

Never know when to stop

Cost vs adherence

•

Drugs for OAB: oxybutyrin, fesoterodine,

tolterodine, solifenacin)

•

Drugs for dementia

•

Drugs for Wet AMD

•

Psikhofarmaka

•

Drugs for OAB: oxybutyrin, fesoterodine,

tolterodine, solifenacin)

•

Drugs for dementia

•

Drugs for Wet AMD

•

Psikhofarmaka

Examples:

Challenges

(22)

Rivastigmin for Dementia: Clinician's

Interview-Based Impression of

Change

Rivastigmin for Dementia: Clinician's

Interview-Based Impression of

(23)

White & Hughes, Blood 2015 126:2-4

Living with CML: is death no longer the end

(point)?

Living with CML: is death no longer the end

(point)?

(24)

Do we have to pay for this? (NSCLC)

Necitumumab + Gemcitabine + Cisplatin Gemcitabine + Cisplatin

Necitumumab + Gemcitabine + Cisplatin

Gemcitabine + Cisplatin

Expensive but not Highly required

(25)

(26)

FDC (single pill) vs Free-drug

combination

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).

(27)

(28)

(29)

Factors Affecting Treatment Cost in Patients with Early

Breast Cancer Receiving Chemotherapy and antiHER2

at RSUP DR Sardjito 2007-2014

Factors Affecting Treatment Cost in Patients with Early

Breast Cancer Receiving Chemotherapy and antiHER2

at RSUP DR Sardjito 2007-2014

Variable N Mean cost

(Rp) SD

P value

Different in cost (+ Rp per

pats)

Radiotherapy

 Yes 48 290.166.455 87.685.03

9 0,056 40.000.000

 No 35 250.296.626 98.862.98

0

Surgery to Radiotherapy

 <= 210 days 13 244.128.225 66.062.565 0,035 57.000.000

 > 210 days 35 301.791.254 86.511.300 Surgery to

Chemotherapy

 <= 120 days 71 276.707.307 91.125.962 0,853 7.000.000

 > 120 days 9 282.856.735 112.297.76

8

Chemotherapy to radiotx

 <= 180 days 12 253.043.260 85.543.088 0,111 45.000.000

 > 180 days 35 298.745.083 83.552.955

AP to antiHER2

 <= 100 days 12 224.093.177 79.749.877 0,046 58.000.000

 > 100 days 70 282.675.762 94.556.289

Rukmi et al., 2016

(30)

(31)

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

(32)

(33)

Acceptability and Use of

Medicines

Lack of health literacy

Misuse of medicines by patients

Patients’ perception about effectiveness, safety

and accessibility of medicines

Patients’ perception about effectiveness, safety

and accessibility of medicines

Prescription of branded medicines which may

not be accessible

Prescription of branded medicines which may

not be accessible

C

ultural and behavioral determinants

(34)

Safety and Quality of Medicines

Limited capacity of quality assurance

Weak pharmacovigilance

Inadequate regulatory framework for the

private sector

Insufficient regulatory authority capacity

(35)

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

•

Daftar dan harga obat serta BMHP

yang dijamin BPJS ditetapkan

pemerintah

•

Jenis pelayanan yang tdk dijamin 

(36)

Peraturan Presiden Republik Indonesia Nomor

12 Tahun 2013 Tentang Jaminan Kesehatan

(Pasal 32)

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.

(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

(2) Daftar dan harga obat dan bahan medis habis

pakai sebagaimana dimaksud pada ayat (1) ditinjau

(37)

Ina CBGs and how to safe hospital

budget

Ina CBGs and how to safe hospital

budget

Ina CBGs tariffs

Diag-nosis

Medic

ine

BMHP

ment

Treat

Room

Cons

ultati

on

Might be

(38)