health technology assessments in korea - cde korea 2012... · health technology assessments in...
TRANSCRIPT
HEALTH TECHNOLOGY ASSESSMENTS IN KOREA
July 24, 2012HTA and Coverage Decisions ConferenceTaipei, Taiwan
Jeonghoon Ahn, PhD
Senior Director
National Evidence-based healthcare Collaborating Agency (NECA)
Seoul, Republic of Korea
1. Background2. HTA in Korea3. Introduction of NECA
CONTENTS
Background
BACKGROUND INFORMATION
South Korea Population; 48,580,293 (2010) Social Security Scheme(2009)
National health insurance (NHI); 96.7% Medicaid; 3.3%
Operating Principle of NHI Drug
New drug; positive list system Existing drug; negative list system
Other health technology negative list system
RECENT ISSUES IN HEALTHCARE SYSTEM IN KOREA
Rising total healthcare expenditure Increasing out-of-pocket money Expected financial deficit Rapid adoption of new health technology Irrational use of some technologies Early phase of evidence-based decision
making system (since 2007) Lack of system to deal with uncertainties
Annual growth rate of total expenditure on health per capita, in real terms
-4
-2
0
2
4
6
8
10
12
14
2004-2005 2005-2006 2006-2007 2007-2008 2008-2009
Australia
Korea
Canada
France
Germany
Italy
Japan
United Kingdom
United States
OECD health data, 2011
Total out-of-pocket payment Covered payment
Data from National Health Insurance Corporation
0.0
2.0
4.0
6.0
8.0
10.0
12.0
14.0
16.0
18.0
20.0
2005 2006 2007 2008 2009
Australia
Korea
Canada
France
Germany
Italy
Japan
United Kingdom
United States
Total health expenditure as share of GDP
OECD health data, 2011
0.0
10.0
20.0
30.0
40.0
50.0
60.0
70.0
80.0
90.0
2005 2006 2007 2008 2009
Australia
Korea
Canada
France
Germany
Italy
Japan
United Kingdom
United States
Public expenditure on health, % total expenditure on health, TEH
OECD health data, 2011
0
5
10
15
20
25
30
2005 2006 2007 2008 2009
Australia
Korea
Canada
France
Germany
Italy
Japan
United Kingdom
United States
OECD health data, 2011
Total expenditure on pharmaceuticals and other medical non-durables, % total expenditure on
health, TEH
0.00
200,000.00
400,000.00
600,000.00
800,000.00
1,000,000.00
1,200,000.00
1,400,000.00
1,600,000.00
Expenditure Income
year
(Unit: one hundred million won)
Expected health insurance financial progress from 2012 to 2030
NHIC, 2010 report
65%
Cove
rage
rate
97%, Covered population
Toward universal coverage in Korea
80%; OECD average
Korea OECDaverage
Korea/OECD
average
CT scan 37.1/million 20 1.9 x
MRI 16/million 9.9 1.6 x
ESWL(Extracorporeal shock
wave lithotripsy )12.4/million 2.9 4.3 x
(ranked first)
2009: OECD data
*# of robot surgery units (da Vinci): Top 3rd in the world
Rapid diffusion of high cost, new technology
Early adoption of new technology even before the assessment & appraisal of it’s value in our society
Indication AgentCML imatinibCML dasatinibALL dasatinibCLL rituximabGIST imatinibGIST sunitinibMultiple Myeloma bortezomibNon small cell lung cancer nilotinibNon small cell lung cancer gefitinibBreast cancer lapatinibBreast cancer trastuzumabRenal cell cancer sunitinibRenal cell cancer sorafenibPancreatic cancer nilotinib
SOME COVERED TARGET AGENTS IN KOREA
HTA IN KOREA
EVIDENCE BASED DECISION MAKING IN HEALTH CARE SYSTEM FOR RECENT 5 YEARS
Medical Service Act new health technology assessment committee(2007)
Health Care Technology Enhancing Act NECA (Dec, 2008)
National Health Insurance Act and activities New drug (Dec, 2006 ~) Reevaluation of existing drugs (April, 2007~) the project of enhancing coverage rate for patients with cancer , off
label use anti-cancer drugs( September, 2005) conditional coverage decision for new technology (2008) Activities of Evidence Based Healthcare in HIRA
Korean System of Accommodating New Health Procedures
Reimburse
No Reimburse
Expert Committees for new tech review for reimbursement
Efficacy and Safety • Reimbursement Decision considering cost‐effectiveness
• Fee for service determination
Drug: FDAIntervention: Committee for nHTA
NHI LawMedical Law
Drugs* Medical Devices Diagnostics and Procedures
HTA research National Evidence-based healthcare Collaborating Agency (NECA)
National Evidence-based healthcare Collaborating Agency (NECA)
National Evidence-based healthcare Collaborating Agency (NECA)
Approval Korean Food and Drug Administration (KFDA)
Korean Food and Drug Administration (KFDA)
Committee for New Health Technology Assessment (CNHTA)
Review and Recommendation
Health Insurance Review and Assessment Services (HIRA) / National Health Insurance Corporation (NHIC)
Health Insurance Review and Assessment Services (HIRA)
Health Insurance Review and Assessment Services (HIRA)
Decision Making Ministry Of Health and Welfare (MOHW)
Ministry Of Health and Welfare (MOHW)
Ministry Of Health and Welfare (MOHW)
KOREAN SYSTEM: INSTITUTIONS
*For drugs, HIRA does dossier review and NHIC does price negotiation
KFDA VS CNHTA
KFDA CNHTALaw Pharmacist Law, Medical
Device LawMedical Services Act
Subject Pharmaceuticals, biologic agents, medical devices
New procedure by physician (may use medical devices)
Nature Regulatory approval MOHW memo (public notice)Review Material
Manufacturer submitted clinical trial and pre-clinical trial data
Systematic Review Report by NECA(NHTA)
Results Market Access Necessary step to apply for medical service decision (cover or not cover)
Remarks Because of regulatory nature, post market surveillance and quality control in manufacturing process is also important
Focus on outcomes of medical services. Since most services are performed by licensed provider at a licensed place
Perspective Safety and Efficacy of the product
Safety and Efficacy,Effectiveness(?), Usefulness(?)
HTA IN KOREAN HEALTHCARE DECISION MAKING SYSTEM
Since 2007, new pharmaceuticals should submit Cost-Effectiveness Analysis (CEA) results to claim their value and to be reimbursed by the National Health Insurance (NHI)Compare to the existing comparator if available In HIRA review process, the selection of
appropriate comparator is important
HTA IN KOREAN HEALTHCARE DECISION MAKING SYSTEM
2008 ~ 2010, re-evaluation of already listed drugs in the NHI reimbursement list (less effective drugs to be disinvested in the NHI budget) Hyperlipidemia drugs and migraine drugs in 2008 Antihypertensives in 2009-2010 Five other classes of drugs studied until mid- 2010 For the major budget impact class of drugs, CEA
was planned Changed to uniform price lowering policy
RESEARCH IN NECA NECA does studies such as
Drug eluting stents vs bare metal stents in acute myocardial infarction - CMA
TCAs vs SSRIs vs NADs for first-line treatment of depression - CEA
Surgical intervention vs non-surgical intervention for treating severely obese patients
And many more - CEA These study topics were selected by the external
expert review committees who ranked topics suggested from the general public to NECA
EXAMPLE 1 : STENT
Drug eluting stents vs bare metal stents in acute myocardial infarction (NECA 09-011)
Systematic review (update) and economic evaluation
International Journal of Technology Assessment in Health Care (IJTAHC 2011)
23
EXAMPLE 1 : STENT
PICO Patient: Patients with acute ST-segment elevation myocardial
infarction (AMI-STEMI)
Intervention: Drug Eluting Stent (DES)sirolimus-eluting stent, paclitaxel-eluting stent, everolimus-eluting stent, zotarolimus-eluting stent
Comparison: Bare Metal Stent (BMS)
Outcomes: 1. Mortality2. Recurrence rate of MI3. Target Vessel/Lesion Revascularization (TVR/TLR)4. Stent Thrombosis (ST)
24
25
Example 1 : Stent
Forest Plot. Mortality in RCT Studies
26
Example 1 : Stent
* Significant at 5% level, ** significant at 1% level
EXAMPLE 1 : STENT
EXAMPLE 2 : ANTIDEPRESSANTS
For Korean patients with depression, which class of AD is most cost-effective to start with? (NA09-008) 1) tricyclic antidepressants (TCAs), 2) selective serotonin
reuptake inhibitors (SSRIs), and 3) new antidepressants (NADs; SNRIs and others).
Only considers cases where these AD classes are substitutable. The results cannot be applied to the patients with anxiety disorder or
with sleep disorder or has a history of prior failure to certain AD type.
EXAMPLE 2 : ANTIDEPRESSANTS
29
EXAMPLE 2 : ANTIDEPRESSANTS
30
SSRI seems to be the most cost-effective first-line treatment
EXAMPLE 2 : ANTIDEPRESSANTS Sensitivity analysis on non-pharmaceutical
treatments showed similar domination results of SSRI
Sub-group analyses by provider settings –Tertiary centers vs smaller hospitals and clinics resulted SSRI is the most cost-effective choice In tertiary center setting, ICER between SSRIs
and NADs were lowest but still 132 million KRW (more than six times of CE threshold in Korea)
31
EXAMPLE 3 : BARIATRIC SURGERY
Bariatric surgery vs conventional therapy for treating severely obese patients (NECA 11-003)
Patients with BMI ≥ 30 with or without bariatric surgeries such as Roux-en Y gastric bypass (RYGB), Laparoscopic Adjustable Gastric Banding (LAGB), and Sleeve Gastrectomy (SG).
Outcomes research and economic evaluation
EXAMPLE 3 : BARIATRIC SURGERY
Decision Tree Model: Change in weight % (CEA)
EXAMPLE 3 : BARIATRIC SURGERY
Markov Model: QALY outcome (CUA)
Initial Path Health States Change
EXAMPLE 3 : BARIATRIC SURGERY
Alternatives Cost (KRW) Cost Difference Effectiveness (QALY)
Effectiveness Difference
ICER (Cost/QALY)
Conventional 16,392,886 15.43
Surgical 17,914,487 1,521,601 16.29 0.86 1,770,535
Alternatives Cost (KRW) Cost Difference Effectiveness Effectiveness Difference
ICER (Cost/%)
Conventional 2,603,159 5.33
Surgical 11,875,676 9,272,517 23.43 18.10 512,280
CEA (Change in weight %)
CUA (QALY)
NEW CEA GUIDELINE IN KOREA
Introduction ofthe National Evidence-based healthcare Collaborating Agency (NECA)
BRIEF HISTORY OF NECA
NECA ORGANIZATION
Current Position of NECA
BIG GROWTH IN NECA 2010
National Strategic Coordinating Center for Clinical Research (NSCR) is newly established by the Ministry of Health and Welfare (MOHW) and is hosted in NECA
Committee for New Health Technology Assessment (CNHTA) and supporting center are moving to NECA from HIRA (Health Insurance Review Agency)
The Future of NECA
NECA
NSCR
MoHW
11 Clinical TrialCenter
NHTAC Supporting
Center NHTAC
