HEALTH TECHNOLOGY ASSESSMENTS IN KOREA

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1 HEALTH TECHNOLOGY ASSESSMENTS IN KOREA July 24, 2012 HTA and Coverage Decisions Conference Taipei, Taiwan Jeonghoon Ahn, PhD Senior Director National Evidence-based healthcare Collaborating Agency (NECA) Seoul, Republic of Korea

2 CONTENTS 1. Background 2. HTA in Korea 3. Introduction of NECA

3 Background

4 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

5 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

6 Annual growth rate of total expenditure on health per capita, in real terms Australia Korea Canada France Germany Italy Japan United Kingdom United States -4 OECD health data, 2011

7 Data from National Health Insurance Corporation Total out-of-pocket payment Covered payment

8 Total health expenditure as share of GDP Australia Korea Canada France Germany Italy Japan United Kingdom United States OECD health data, 2011

9 Public expenditure on health, % total expenditure on health, TEH Australia Korea Canada France Germany Italy Japan United Kingdom United States OECD health data, 2011

10 Total expenditure on pharmaceuticals and other medical non-durables, % total expenditure on health, TEH Australia Korea Canada France Germany Italy Japan United Kingdom United States OECD health data, 2011

11 Expected health insurance financial progress from 2012 to 2030 (Unit: one hundred million won) 1,600, Expenditure Income 1,400, ,200, ,000, , , , , year NHIC, 2010 report

12 Toward universal coverage in Korea 80%; OECD average 65% Coverage rate 97%, Covered population

13 Rapid diffusion of high cost, new technology 2009: OECD data CT scan Korea 37.1/million OECD average Korea/ OECD average x MRI ESWL (Extracorporeal shock wave lithotripsy ) 16/million /million x 4.3 x (ranked first) *# of robot surgery units (da Vinci): Top 3rd in the world Early adoption of new technology even before the assessment & appraisal of it s value in our society

14 SOME COVERED TARGET AGENTS IN KOREA Indication CML CML ALL CLL GIST GIST Multiple Myeloma Non small cell lung cancer Non small cell lung cancer Breast cancer Breast cancer Renal cell cancer Renal cell cancer Pancreatic cancer Agent imatinib dasatinib dasatinib rituximab imatinib sunitinib bortezomib nilotinib gefitinib lapatinib trastuzumab sunitinib sorafenib nilotinib

15 HTA IN KOREA

16 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

17 Korean System of Accommodating New Health Procedures Medical Law NHI Law Drug: FDA Intervention: Committee for nhta Expert Committees for new tech review for reimbursement Reimburse Efficacy and Safety Reimbursement Decision considering cost effectiveness Fee for service determination No Reimburse

18 KOREAN SYSTEM: INSTITUTIONS Drugs* Medical Devices Diagnostics and Procedures HTA research National Evidencebased healthcare Collaborating Agency (NECA) National Evidencebased healthcare Collaborating Agency (NECA) National Evidencebased 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) *For drugs, HIRA does dossier review and NHIC does price negotiation

19 KFDA VS CNHTA Law Subject KFDA Pharmacist Law, Medical Device Law Pharmaceuticals, biologic agents, medical devices Medical Services Act CNHTA 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 Perspective Because of regulatory nature, post market surveillance and quality control in manufacturing process is also important Safety and Efficacy of the product Focus on outcomes of medical services. Since most services are performed by licensed provider at a licensed place Safety and Efficacy, Effectiveness(?), Usefulness(?)

20 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

21 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 Five other classes of drugs studied until mid For the major budget impact class of drugs, CEA was planned Changed to uniform price lowering policy

22 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

23 EXAMPLE 1 : STENT Drug eluting stents vs bare metal stents in acute myocardial infarction (NECA ) Systematic review (update) and economic evaluation International Journal of Technology Assessment in Health Care (IJTAHC 2011) 23

24 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. Mortality 2. Recurrence rate of MI 3. Target Vessel/Lesion Revascularization (TVR/TLR) 4. Stent Thrombosis (ST) 24

25 Example 1 : Stent Forest Plot. Mortality in RCT Studies 25

26 Example 1 : Stent * Significant at 5% level, ** significant at 1% level 26

27 EXAMPLE 1 : STENT

28 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.

29 EXAMPLE 2 : ANTIDEPRESSANTS 29

30 EXAMPLE 2 : ANTIDEPRESSANTS SSRI seems to be the most cost-effective first-line treatment 30

31 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 costeffective 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

32 EXAMPLE 3 : BARIATRIC SURGERY Bariatric surgery vs conventional therapy for treating severely obese patients (NECA ) 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

33 EXAMPLE 3 : BARIATRIC SURGERY Decision Tree Model: Change in weight % (CEA)

34 EXAMPLE 3 : BARIATRIC SURGERY Markov Model: QALY outcome (CUA) Initial Path Health States Change

35 EXAMPLE 3 : BARIATRIC SURGERY CEA (Change in weight %) Alternatives Cost (KRW) Cost Difference Effectiveness Effectiveness Difference ICER (Cost/%) Conventional 2,603, Surgical 11,875,676 9,272, ,280 CUA (QALY) Alternatives Cost (KRW) Cost Difference Effectiveness (QALY) Effectiveness Difference ICER (Cost/QALY) Conventional 16,392, Surgical 17,914,487 1,521, ,770,535

36 NEW CEA GUIDELINE IN KOREA

37 Introduction of the National Evidence-based healthcare Collaborating Agency (NECA)

38 BRIEF HISTORY OF NECA

39 NECA ORGANIZATION

40 Current Position of NECA

48 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)

49 The Future of NECA NECA MoHW NSCR NHTAC Supporting Center NHTAC 11 Clinical Trial Center

51 THANK YOU! 安廷薰 Contact info:

Outline. What HTA Represents in the Reimbursement Review. Principle and HTA Guideline. A Study of HTA PE Dossiers in Taiwan.

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