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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

安廷薰 Contact info: jahn@neca.re.kr

THANK YOU!