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Pharmaceutical Policy Reform in Korea

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Presentation on theme: "Pharmaceutical Policy Reform in Korea"— Presentation transcript:

1 Pharmaceutical Policy Reform in Korea
Tae-Jin Lee, PhD. Seoul National University, Korea

2 Outline Korean Health Care System Policy background
New pharmaceutical policy: PLS Implications Challenges and responses Issues

3 Korean Health Care System
National health insurance (NHI) Universal coverage 96% of population rest 4% covered by Medicaid Single payer system: NHIC Financing by premiums (partially by government general revenue) Limited coverage of services: MRI, Ultrasono, some expensive therapies not covered by NHI Dominant method of payment/reimbursement fee-for-service

4 Mounting Pressure on Financial Sustainability of KNHI
Demand and supply factors Continuous expansion of coverage Population aging New technologies Growing demand for and expectation of quality health care by consumers Structural factor: Fee-for-service

5 NHI Reforms Considered source: Health Insurance Reform Committee (2004)
Triggered by financial instability of NHI system, the following changes were suggested Change in reimbursement method FFS DRG Global Budgeting Design a separate elderly care system Introduction of economic evaluation into health care delivery on device pharmaceuticals procedures

6 Characteristics of pharmaceuticals
Imperfect pharmaceutical market (Drummond et al., 1997; Harris et al., 2001) Asymmetry of information on drugs Decision on utilization of drugs by doctors The third-party payment  Increase in drug expenditures  Regulation on the coverage and price of drugs in most developed countries

7 Objectives of pharmaceutical policy
Supply of quality drugs Ensuring patients’ access to drugs Containment of drug expenditures Encouraging R & D

8 Introduction of Economic Evaluation into Pharmaceutical Reimbursement Decisions and Positive List System

9 Annual increase rate (%)
Background 1-1 Expenditures on drugs have increased rapidly since 2000 Per capita health expenditure and expenditure on prescription drug (US $, PPP) Year 2000 2001 2002 2003 2004 2005 Annual increase rate (%) Prescription drug 107 153 160 181 206 242 17.7 THE 780 932 977 1051 1138 1318 11.1 Source: OECD Health Data 2007

10 Background 1-2 Share of drug expenditure out of total KNHI expenditure (2001~2006) (unit : 100 million KRW, %) 2001 2002 2003 2004 2005 2006 Total exp. 178,195 190,606 (7.0%↑) 205,336 (7.7%↑) 223,559 (8.9%↑) 247,968 (10.9%↑) 285,580 (15.2%↑) Drug exp. 41,804 48,014 (14.9%↑) 55,831 (16.3%↑) 63,535 (13.8%↑) 72,289 84,041 Drug share 23.5 25.2 27.2 28.4 29.2 29.4 Note 1: share of drug expenditure out of total KNHI expenditure has been increasing from 23.5% (2001) to 29.4% (2006) Note 2: nominal drug expenditure increased from 4.2 billion KRW to 8.4 billion KRW in 5 years Note 3: annual increasing rate of 15.0% is compared to 10.6% of KNHI other medical expenditure

11 Background 2 The number of drugs reimbursed in the NHI amounted to over 21,000 in 2006 There were large variations in prices among drugs with same effectiveness Source: HIRA

12 Fast Introduction of New Drugs into KNHI Reimbursement List: 2003-2005
Background 3 Fast Introduction of New Drugs into KNHI Reimbursement List: No. of Countries Adopted 1 2 3 4 5 6 164 New Drugs to Korea Number 7 67 32 20 17 12 9 % 4.3 40.8 19.5 12.2 10.4 7.3 5.5 Note 1: Annually, about 50 new drugs are introduced into Korean NHI Note 2: There were 7 Korean new drugs Note 3: Korean NHI introduced 67 (40.8%) new drugs as 2nd country in the world; 32 products (19.5%) 3rd in the world Source: MOH, Korea

13 Issue with Fast Introduction
Drug pricing done based on A7-country prices as reference A7 countries: US, UK, Switzerland, Japan, France, Germany, Italy With few countries adopting a certain new drug, not enough price and clinical data available to guarantee reasonable pricing in Korea For example, 25 new drugs in 2003, for which Korea reviews as the 2nd country in the world, Korean price to be determined based on only one A7 price as a reference Seen as a problem from health financing perspective

14 Summary of Concerns New drugs are entering into the Korean market very quickly Drugs had been included in the reimbursement list with little consideration of budget impacts and cost-effectiveness Drug expenditure is increasing rapidly, compared to other portions, resulting in higher proportion of NHI expenditures Value for money in drug expenditure needs to be examined at the system level

15 Preparation period A series of studies on drug reimbursement policy
Policy measures to improve drug benefit program (2002) Policy measures to differentiate drug reimbursement by the therapeutic characteristics of drugs (2004) Policy measures to improve drug benefit program with positive list (2005) Health Insurance Review & Assessment Service (HIRA) developed “Guideline for Economic Evaluation of Pharmaceuticals” (2005)

16 Policy changes: PLS As a measure of containing expenditures on drug, the government introduced a “Positive List” system in December 2006, which was characterized as Selective listing of drugs Enhanced importance of cost effectiveness in addition to clinical effectiveness Separation of decision on listing from pricing New procedure for price negotiation

17 Procedure for reimbursement decision
Production or import of a new drug Korea Food & Drug Administration: Evaluation on the safety and effectiveness / approval of marketing HIRA: Decision on listing NHIC: Negotiation on drug price Inclusion of the drug in positive list

18 Procedure for reimbursement decision
Source: Bae et al. (2009)

19 Listing new drugs For new drugs to be reimbursed under the NHI, submission of pharmaco-economic evidence became mandatory from 2008 Criteria for reimbursement decision considered by Drug Reimbursement Evaluation Committee of HIRA Clinical benefits such as severity of disease and potential to replace existing therapies, Cost-effectiveness, Budget impact based on target population, expected sales and substitution effect Whether and at what price the medicine of interest is reimbursed in other countries, and Other impact on health of the population

20 Clinical effectiveness vs. Cost effectiveness
New Drug (X) IQWIG 1. Clinical Effectiveness Benefit assessment A (B, C...) vs. X A (B, C...) vs. X Effectiveness Effectiveness : X > A : X > A Effectiveness Benefit : X = A : X = A Effectiveness Benefit : X > A Benefit : X < A : X < A Benefit : X ? A IQWIG Cost-Effectiveness Cost Minimization 2. Cost - Benefit analysis analysis assessment Potential to get a good price depending on ICER Priced lower than weighted price of comparator drugs Ceiling price Ceiling price Not reimbursable by NHI

21 ICER and Threshold Threshold (λ) of ICER: - No explicit threshold
- May depend on per capita GDP - Decided by taking account of other factors such as severity of disease, burden of disease, impact on quality of life, innovativeness and so on

22 Reimbursement decision and price negotiation on new medicines
Results  2007 (2007.1~2008.4)  2006 2005  Number of products % Listing & pricing completed 10 11.9 79 76.0 31 62.0 Price negotiation under way 26 31.0 -   - Price negotiation broken down 11 13.1 Decision not to list 25 29.8 14 13.5 28.0 To be re-assessed 12 14.3 10.6 5 10.0 Total 84 100.0 104 50 Source: HIRA

23 Reasons for deciding not to reimburse
Source: HIRA, Jirawattanapisal et al. (2009)

24 Pricing new drugs Pricing process was separate from decision making on listing from 2007 Once HIRA decides to reimburse a new drug in the NHI, the manufacturer has to negotiate its price with the National Health Insurance Corporation (NHIC) A price-volume arrangement was introduced to control drug expenditures Considering budget impact, NHIC negotiates price based on the expected sales of new drugs as well as their substitution effect. If actual sales exceed the expected ones during a specified period, the price of the drug should be reduced proportionately

25 Factors considered for price negotiation
Assessment report by DREC of HIRA Budget impact Price of the drug in foreign countries including OECD Patent status Domestic R & D expenditures

26 Price-volume arrangement
Two types of price-volume arrangement Type 1: When actual volume consumed exceeds expected volume by 30+% each year after the drug was included in the reimbursement list Type 2: When consumption volume increases by 30+% for 6 months after adding new indications, compared to volume consumed for the previous 6 months

27 Price-volume arrangement
Baseline price for negotiation for type 1 = 0.9*P0+0.1*{P0*(Ve/Va)} where P0: current drug price Ve: expected volume Va: actual volume consumed Baseline price for negotiation for type 2 Similar to formula for type 1

28 Results from price negotiation
Year Application Agreement on price Negotiation broken Under negotiation 2007 24 12 - 2008 72 57 15 2009 21 6 1 14 Total 117 75 (72.8%) 28 (27.2%) Note: As of April 30, 2009 Source: NHIC

29 Re-assessment of listed drugs
Drugs reimbursed under the previous “Negative List” system were allowed to remain in the new “Positive List” Starting from 2007, 5-year-long re-assessment of 49 therapeutic groups of the listed drugs was planned. In 2007, two therapeutic groups of drugs, migraine and hyperlipidemia, were re-assessed In March 2010, re-assessment of drugs for hypertension was completed Currently, re-assessment of 5 therapeutic groups of drugs is under way The main criterion for decision on whether to keep them in the list or out of the list is cost-effectiveness in addition to clinical effectiveness

30 Delisting unproduced drugs
Timeline for re-assessment of listed drugs Category Number of therapeutic groups to be re-assessed 2007 2008 2009 2010 2011 16,529 drugs Delisting unproduced drugs Pilot project Main project 2 6 10 15 16 * Sweden: started re-assessment in 2002, completed 7 therapeutic groups 30

31 Variation in daily cost of hypertension drugs
Daily cost (KW) Ingredient - Lowest daily cost: KW 30, Highest daily cost: KW 977 Source: Kim et al. (2010)

32 Results from re-assessment
Anti-migraine drugs Pharmaco-economic study carried out for 3 expensive triptans (Suma-, Nara-, Zolmi-) Naratriptan and Zolmitriptan dominated by Sumatriptan Two drugs remain in the List after voluntary price cut Lipid modifying agents Pharmaco-economic study carried out for all statins No statistically significant difference in effectiveness among statins Compared to no treatment, treatment with statin found very expensive (ICER: >$70,000/QALY for 55-year-old patients, >$40,000/QALY for high risk) Verdict of 30% price cut resulted in resistance

33 Implications of recent policy
Economic effects Possible to utilize drugs with similar therapeutic effects at lower costs Price cut as a byproduct of re-assessment of the listed drugs Access to new drugs Delayed due to the fourth hurdle and two-tier process for listing and pricing Enhanced access to cost-effective quality drugs Dynamic efficiency R & D may shrink Need to look at incentive compatible pricing

34 Some challenges Question on usefulness of PE
Suspicion about reimbursement decision made regardless of submitting PE Complaints of no incentive for carrying out PE Re-assessment of listed drugs delayed Aversion to the re-assessment Lack of government’s willingness to make a step forward Weak infrastructure to carry it out within HIRA

35 Response to challenges
Rationalization of process Preliminary consultation introduced to avoid unnecessary PE Application of CEA to a minimal level for the listed drugs Enhancing the expertise for review and appraisal Economic sub-committee established Training manpower within HIRA

36 Issues Close coordination between HIRA and NHIC Threshold ICER
In case of price negotiation being broken, had to go back to HIRA, now don’t have to Threshold ICER Better to be flexible depending on severity of diseases Incorporating other criteria into decision making Severity, availability of other treatments, equity, budget impact, innovation, and so on Value-based pricing Good price for cost-effective innovative drugs

37 Issues Harmonization of evidence requirement: from Korean perspective
The issue of transferability of clinical data remains as an important HTA issue in Korea Measurement of Preference Tools such as EQ-5D and HUI developed in Europe and North America, when used as they are, may fail to reflect preference of Asian cultural aspects, even after reliability and validity of them for certain Asian populations are tested

38 Threshold ICER Definition Examples of threshold ICER
A society’s maximum willingness-to-pay for one unit of effectiveness (usually, 1 QALY) Ranges for threshold ICER are preferred to point estimates Examples of threshold ICER England & Wales (NICE): £20,000~£30,000 / QALY Australia (PBAC): Aus$ 42,000~76,000/LYG New Zealand (PHARMAC): NZ$20,000/QALY US (MCOs): US$ 50,000~100,000/QALY Canada: CAN$20,000~100,000/QALY

39 Criteria considered for drug reimbursement in NHS
Source: NICE

40 Concluding Comments No system can be perfect from the beginning
Under many constraints, Korea’s PLS policy started We expect refinements and improvements of the system over the years as it goes


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