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ACCES AU MEDICAMENT EFFICIENCE ET CRISE ECONOMIQUE Marc Czarka, MD, FBCPM Collaborateur Scientifique Département d’économie de la Santé ESP-ULB.

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Presentation on theme: "ACCES AU MEDICAMENT EFFICIENCE ET CRISE ECONOMIQUE Marc Czarka, MD, FBCPM Collaborateur Scientifique Département d’économie de la Santé ESP-ULB."— Presentation transcript:

1 ACCES AU MEDICAMENT EFFICIENCE ET CRISE ECONOMIQUE Marc Czarka, MD, FBCPM Collaborateur Scientifique Département d’économie de la Santé ESP-ULB

2 AGENDA 1.INTRODUCTION 2.THE FOURTH HURDLE 3.EFFICIENCY AND PHARMACO- ECONOMICS 4.FINANCIAL CRISIS IMPACT ON HEALTHCARE AND MEDICINES 5.CONCLUSION

3 CHANGING HEALTHCARE ENVIRONMENT + Advances in technology + Political forces (growing public expectations vs. budget control) + Economical forces (competition through innovation) + Aging population = Raising health care expenditures

4 THE FOURTH HURDLE To get a marketing authorization, a drug has to show: –Quality –Safety –Efficacy –(Risk/benefit ratio)

5 THE FOURTH HURDLE Four widely accepted “global principles” governing the planning, funding and provision of healthcare services: – fair access, – efficiency, – responsiveness to society and – innovation.

6 EFFICIENCY?

7 HEALTH ECONOMICS Health economics is applying economic principles and economic theories to health and health care Or, the comparative analysis of alternative courses of action in terms of both costs and outcomes

8 PHARMACO-ECONOMICS Pharmaco-economics – Is health economics applied to drugs – Viewed by pharma as the 4 th hurdle to get the product on the market – Now requested by authorities all around the world before granting reimbursement

9 EFFICIENCY The different steps of evidence –Can it work ? = Efficacy (“Efficacité”) –Does it work in reality ? = Effectiveness (“Effectivité”) –Is it worth doing it, compared to other things we could do with the same money = Efficiency (“Efficience”)

10 EFFICIENCY Budgets are limited, needs are unlimited Safety, efficacy and quality are not enough anymore In a world with scare resources, efficiency becomes important

11 EFFICIENCY So authorities – request pharmaco-economic evaluation to be added to reimbursement file – to allocate budgets to interventions that offers most health gain per unit of money

12 EFFICIENCY  “ Give us more evidence that your drug is efficient and leads to savings in real life” Allow us first to the market (reimbursed) and then we will be able to show real life evidence The evidence dilemma… Adapted from Annemans L.

13 EFFICIENCY Other dilemma’s “According to your study, you are cost-effective. Now, lower your price by 20%, and you will even be more cost-effective” “You claim that you can save money elsewhere (hospitals…). But a hospital bed is filled anyway. So, you don’t really save”

14 WHAT IS THE RELATIONSHIP BETWEEN COSTS AND OUTCOMES? Is it worth spending that much money ??? Costs Outcomes ?

15 ECONOMIC EVALUATION Costs Outcomes

16 ECONOMIC EVALUATION Costs Outcomes Type of Costs : Direct medical costs (hospital, drugs, labs, doctors, …) Direct non medical costs (transportation, diet, …) Indirect costs (premature death, time lost from work) Intangible costs (pain, suffering)

17 ECONOMIC EVALUATION Type of outcomes: clinical parameters (reduction in blood pressure, normalization of cholesterol level, …) morbidity / mortality endpoints (events avoided, survival) quality of life improvements patient satisfaction or preferences Costs Outcomes

18 ECONOMIC EVALUATION Outcome is Longer Life Better Life Costs Outcomes

19 WHICH YARDSTICK? Multiple yardsticks: –Perinatal or neonatal mortality –Life expectancy at birth, later –Disease or handicap free years expectancy –Do the best you can with a certain percentage of GDP –Contribution to GDP growth Alphabet soup of LYG, LOS, NNT, NNH, DALY, QALY… Let’s use QALY as an example

20 QUANTITY AND QUALITY OF LIFE AS OUTCOME Basic idea underlying the QALY? (Quality-Adjusted Life Years) Combination of quality of life and length of life into one measure - a kind of index Facilitates comparisons between different kind of treatments and diagnoses

21 QUANTITY AND QUALITY OF LIFE AS OUTCOME The concept of the QALY If the health state “blind” gives a quality weight of 0.4, then one year as blind gives 0.4 QALY …or 0.4 years in full health gives the same number of QALYs (0.4) as 1 year as blind Adapted from Jonsson B.

22 New Medical Treatment LET’S COMPARE Quantity of Life (Years) Utility (Weights) 0 1 Existing Medical Treatment QALY gained, adding life to years

23 COMPARING COSTS AND CONSEQUENCES additional costs additional effects

24 COMPARING COSTS AND CONSEQUENCES additional costs additional effects Innovative products most often cost more and do more Innovative products are rarely cost-saving 1% 95% 3%

25 additional costs additional effects IS THIS DRUG COST-EFFECTIVE ? E C D B A Bargain? Unaffordable?

26 THRESHOLD RECOMMENDATIONS CountryThreshold/QALYReference AustraliaAUD 42-76,000George et al CanadaCAD ,000Laupacis NetherlandsEUR 20,000Rutten New ZealandNZD 20,000Pritchard UKGBP 30,000Nice USUSD ,000Earle SwedenSEK 500,000Johannesson

27 QALYs in Decision-Making: Issues and Prospects The use of measures, such as the QALY, relate to social decisions An improvement in health outcomes might not be the only reason to use the QALY Other reasons are –overall improvement of societal welfare –indicator of society’s care and compassion. Smith MD, Drummond M, Brixner D. Moving the QALY Forward: Rationale for Change. Value in Health, 2009; 12,S1-4

28 QALYs in Decision-Making: Issues and Prospects In the conventional concept of QALYs, a health state that is more desirable is more valuable. Value is equated with preference or desirability. A critical question is: desirable to whom, self and/or community? Weinstein MC, Torrance G, McGuire A. QALYs: The Basics. Value in Health, 2009; 12,S5-9

29 QALYs : UNDERLYING ASSUMPTIONS Weinstein MC, Torrance G, McGuire A. QALYs: The Basics. Value in Health, 2009; 12,S5-9

30 MERITS? There are merits in the use of the QALY within the mainstream of decision-making concerned with questions of resource allocation within patient populations To conclude, it is important to recognize that, at either pole, we have to make social decisions -implicit, if not explicit- about resource allocation. In my view, the use of cost-utility models that use the QALY can be a pragmatic and necessary tool to improve these complex decisions often made under conditions of considerable uncertainty and bias. Kind P et al. The Use of QALYs in Clinical and Patient Decision-Making: Issues and Prospects. Value in Health, 2009; 12,S27-30 Garrison LP Jr, Editorial: Using QALYs for Societal Resource Allocation. Value in Health, 2009; 12,S36-37

31 WELL KNOWN MEDICAL THRESHOLDS ReferenceIntervention€/LYG (1999) Lombaert,1997Pneumococcal vaccination 65+ Cost saving Deltenre, 1997H pylori eradication in patients with GD ulcer Cost saving Beutels et al., 1996Universal hepatitis B vaccination 500 €/LYG Lombaert,1997Influenza vaccination 65+ 1,500 €/LYG Muls et al., 1994Secondary prevention of CHD with statins vs. no treatment 9,700-19,700 €/LYG Annemans, 1998Primary prevention of CHD with statins vs. no treatment (hi-risk patients) 21,000-26,000 €/LYG Van Doorslaer, 1994Hepatitis A vaccination of travelers 27,000 €/LYG

32 COST PER LYG WITH VARIOUS INTERVENTIONS Source: J Probstfield, Am J Cardiol 2003: 91 (suppl): 22G – 27G Johannesson et al. N Engl J Med 1997; 336: 332–336; T O Tengs, Risk Analysis 1995: 15, 3, ; Treatment Cost per LYG (USD) Smoking cessation - physician counseling 1,300 – 3,900 B-blocker post-MI, high-risk5,900 Statins (4S)9,800 AIDS drug cocktails15,000-20,000 B-blocker post-MI, low-risk20,200 Driver’s-side air bag27,000 Kidney dialysis50,000

33 COST PER LYG WITH VARIOUS INTERVENTIONS Treatment Cost per LYG (USD) Annual mammography for women aged ,000 Exercise ECG for asymptomatic man aged 40 years 124,000 Cox-2 inhibitors Celebrex or Vioxx for arthritis patients at average risk for ulcers 185,000 Annual helical CT scan of former heavy smokers to detect lung cancer 2,300,000 Source: J Probstfield, Am J Cardiol 2003: 91 (suppl): 22G – 27G Johannesson et al. N Engl J Med 1997; 336: 332–336; T O Tengs, Risk Analysis 1995: 15, 3, ;

34 SELECTED RISK REGULATIONS AND THEIR COST PER LIFE SAVED Regulation (year issued)Cost per life saved (USD) Child-proof lighters (1993)100,000 Respiratory protection (1998)100,000 Logging safety rules (1998)100,000 Electrical safety rules (1990)100,000 Steering-column standard (1967)200,000 Hazardous-waste disposal (1998)1,100,000,000 Hazardous-waste disposal (1994)2,600,000,000 Drinking-water quality (1992)19,000,000,000 Formaldehyde exposure (1987)78,000,000,000 Landfill restrictions (1991)100,000,000,000 The price of prudence, The Economist, January 22, 2004

35 £2,329 £2,695 £2,803 £3,369 £3,017 5,000 10,000 15,000 20,000 25,000 Year 1Year 2Year 3Year 4Year 5 Source: Stolk et al, BMJ 2000:320 Time Horizon Incremental Cost/QALY (GBP) ‘appropriate’ for NHS funding < £25,000 0 VIAGRA CAN BE SHOWN TO BE VERY COST-EFFECTIVE …

36 £2,329 £2,695 £2,803 £3,369 £3,017 5,000 10,000 15,000 20,000 25,000 Year 1Year 2Year 3Year 4Year 5 Source: Stolk et al, BMJ 2000:320 Time Horizon Incremental Cost/QALY (GBP) … BUT WHAT IS THE SOCIAL AND THERAPEUTIC NEED? ‘appropriate’ for NHS funding < £25,000 0 Not Fully Funded

37 So, is it an efficient drug ? Not a Yes / No answer Depends on many factors : – compared to what ? – health care system – cost structure – population considered EFFICIENCY

38 Other factors are also important to consider in resource allocation : – are there alternatives ? – budget impact ? – affordability ? EFFICIENCY

39 PHARMACO-ECONOMIC EVALUATION A tool for efficient resource allocation –Value for money Does not replace decision making Other goals also important

40 CRISIS IMPACT ON HEALTHCARE The drivers of the sector are relatively independent of the wider economy : –prevalence of the disease –unmet medical needs –population growth and aging population Demand –continues to grow over time and –is relatively inelastic compared to demand of other goods like cars, holidays… However, tougher economic conditions will have an impact on society’s ability and willingness to pay Hence, impact will be a collateral damage The Boston Consulting Group : Implications of the Financial Crisis for the Bio-Pharmaceutical Sector. November 2008

41 PRESSURE FACTORS As GDP growth slows, consumer spending will fall and unemployment will rise, leading to –decrease in tax revenues –increase in demand on social services budgets –significant increase in pressure on public finance The cost of various government bailing out the financial sector will exacerbate these pressures. As the gap between growth of health care expenditures and growth of GDP widens, the specific pressure for cut in health care spending will grow. The Boston Consulting Group : Implications of the Financial Crisis for the Bio-Pharmaceutical Sector. November 2008

42 PRICE PRESSURE Increasing use of generic drugs Higher rebates in tender business The Oslo conference « Health in times of global economic crisis: implications for the WHO European Region (February 2009) »: Get all stakeholders ready to rationalize and do better with less money. More specifically, explore options and implement measures to reduce the cost of medicines and medical devices. The Boston Consulting Group : Implications of the Financial Crisis for the Bio-Pharmaceutical Sector. November 2008

43 INCREASING REQUIREMENT FOR EVIDENCE Health Technology Assessment (HTA) Bodies will assess more rigorously efficiency which will likely lead to more restrictive reimbursement Site of Care and Local Payers may require more formal data (« mini HTA ») before paying or covering for a new technology Increasing Importance of Non Clinicians Stakeholders

44 CONSUMERS’ BEHAVIOUR Consumers themselves may limit their access to treatment Patients in the US start skipping doses, cutting pills in half and falling to fill prescription The effect are even more apparent where spending is more discretionary in cosmetic-related medicine and surgery for instance. The Boston Consulting Group : Implications of the Financial Crisis for the Bio-Pharmaceutical Sector. November 2008

45 IMPACT ON HEALTH OUTCOMES? Impact on mortality –Russian Federation in the early 1990s : major increase in adult male mortality –Thailand : increase in adult mortality No Impact on mortality –Data from the US and Europe show that recession have been accompanied by falling mortality rate reduction of smoking Reduction in alcohol use more time available for child care The Financial Crisis and Global Health WHO – 21 January 2009 Report of a high-level Consultation

46 CONCLUSION Substantial uncertainty still exist but some fundamental drivers will remain : –Industry’s innovative drive –Demographic shock –Downward pressure on prices and more restrictive reimbursement decisions : Cost-containment measures Cost-utility evaluations


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