IP11: DECISION-MAKING IN HEALTH CARE BASED ON ECONOMIC EVALUATIONS: REALITY OR JUST WISHFUL THINKING? EXPERIENCES FROM 4 EUROPEAN COUNTRIES

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1 IP11: DECISION-MAKING IN HEALTH CARE BASED ON ECONOMIC EVALUATIONS: REALITY OR JUST WISHFUL THINKING? EXPERIENCES FROM 4 EUROPEAN COUNTRIES Andreas Gerber-Grote Margreet Franken, Emelie Heintz, James P. Raftery Introduction Questions to ask the auditorium Is health economic evaluation mandatory in your country? Are you content with the way health economic evaluation is performed in your country in terms of methods and processes? Are you content with the effect health economic evaluation has on actual decisions in your country? 2 1

2 Comparison Overview over the four countries/systems Germany The Netherlands Sweden England Type of health care system Bismarck Bismarck Beverigde Social health insurance Social health insurance Tax funded Agencies IQWiG ZINL (previously CVZ) TLV SBU, SALAR (NLT), NBHW Beveridge Tax funded NICE NSC, JCVI, HPA Established (1949) 2002 (TLV) 1987 (SBU) 1999 (NICE) HEE as official criterion HEE mandatory No Yes, for specific groups of drugs Yes for pharmaceuticals Who conducts HEE Manufacturer & IQWiG Manufacturer Manufacturers and HTA agencies Margreet Franken, Andreas Gerber-Grote, Emelie Heintz, J. P. Raftery 3 Yes External academic units Scope HEE Mainly drugs Mainly drugs Mainly drugs, but also more general healthcare technologies Mainly drugs, vaccines, public health Implementation (drugs) Negative list Positive list Positive list Negative list Perspective HEE SHI insurees Societal Societal Public health system Outcome measure HEE Disease-specific natural QALY QALY QALY units Threshold No No Informal Yes: (-40) / QALY Perceived impact HEE Not applicable, as rarely Established Clear and explicit role Well established ever done Health economic evaluation in Germany Andreas Gerber-Grote Head of Department Health Economics 2

3 Germany Is economic evaluation mandatory? Hee not mandatory If used at all then in few cases for drugs At present possible on request by manufactuer or association of SHI funds in the process of early benefit assessments if negotiations fail Hee either commissioned by FJC or by Department of Health Hee in the early benefit assessment of drugs not used since 2011 Perspective: SHI insurees, but societal is possible as additional scenario (needs to be commissioned by FJC) 5 Germany How well done is economic evaluation? Controversy over efficiency frontier versus fix threshold Reluctance to use a fix threshold and the QALY especially within Federal Joint Committee 6 3

4 Germany What is the effect on policy? No perceived impact and No actual impact 7 Germany Why not implemented? GE = reference market GE = largest pharmaceutical market in EU Historical reasons (value of life debate) Question of power (intransparent negotiations vs. transparent results of a health economic evaluation) Efficiency frontier is a sharp weapon to perform value based pricing Efficiency frontier is a sharp weapon to sort out inefficient therapeutic regimens 8 4

Decision making in health care based on economic evaluation: Reality or wishful thinking? The Netherlands Margreet Franken franken@imta.eur.nl Netherlands Is economic evaluation mandatory?

5 Decision making in health care based on economic evaluation: Reality or wishful thinking? The Netherlands Margreet Franken Netherlands Is economic evaluation mandatory? Mainly for reimbursement decisions for drugs Outpatients drugs: mandatory since 2005 (initial decision) Drugs with added therapeutic value But many exemptions (65%): orphan drugs, HIV drugs, low budgetary impact Expensive specialist drugs: mandatory since 2006 Initial decision: indication of cost-effectiveness Reassessment after four years: real-world cost-effectiveness 10 5

6 Netherlands How well done is economic evaluation? Economic evaluations are often not consistent with guidelines Although compulsory hardly ever a societal perspective Hoomans et al. (2012): 38% was consistent with guidelines Economic evaluation are often judged to be insufficiently robust January 2005 July 2011: 52% insufficiently robust However: mostly in earlier years of requirement ( ) Policymakers seemed to be embarrassed by the lack of sufficient data for first reassessments of expensive specialist drugs 11 Netherlands What is the effect on policy? Only the robustness of the evidence is assessed by the reimbursement agency January 2005 July 2011: all outpatient drugs that were rejected reimbursement were judged insufficiently robust, but also 21% of the drugs that were accepted for reimbursement Only a few reassessments of expensive specialist drugs have been finalised, most are still queued up Price agreement (2013) for Myozyme for classic Pompe disease (estimated at 300, ,000/ QALY) 12 6

7 Netherlands Why not implemented? Access seems to be crucial Postponing difficult decisions Political unacceptability of difficult decisions No sense of urgency: pharmaceutical budget (as share of health care budget) is rather stable over the years due to cost containment policies (e.g., claw-back mechanisms, preferential policy by health insurers) Media attention (identifiable individuals, cancer) 13 IMPACT OF HEALTH ECONOMIC EVALUATIONS IN SWEDEN Emelie Heintz Karl Arnberg, Lars-Åke Levin, Jan Liliemark and Thomas Davidson Swedish Council on Health Technology Assessment (SBU) 7

8 Sweden Healthcare in Sweden Shared responsibility for healthcare: central government, 20 county councils/health authorities 290 municipalities/district councils National reimbursement scheme for pharmaceuticals (TLV) National guidelines (The National Board of Health and Welfare) Health technology assessment (SBU and regional HTA agencies) 15 Sweden Is economic evaluation mandatory? Yes, for reimbursement of outpatient drugs (TLV) Part of recommendations on hospital drugs and medical devices (TLV) New initiative: County council s group on new drug therapies (NLT) One of several factors that influence recommendations in national guidelines (NBHW) Part of HTA reports often in the form of a systematic review (SBU and regional HTA agencies) 16 8

9 Sweden How well done is economic evaluation? Guidelines by TLV (LFNAR 2003:2) Welfarist focus close to economic theory Societal perspective QALY preferences from the patient perspective Discussion about costs of added life years and productivity changes Cost per QALY < euro Low euro Moderate euro High > euro Very high Costs in relation to health benefit (NBHW) 17 Sweden What is the effect on policy? Compliance to TLV:s decisions strong incentives to follow decisions on full reimbursement Difficult to assess the impact of economic evaluations in national guidelines and HTA reports In 30% of the recommendations in national guidelines, economic results are included may influence the recommendation County councils use cost calculations in HTA reports when making investment decisions 18 9

10 Sweden Why not implemented? The ethical platform and ranking of principles Autonomous health authorities (county councils) Budget perspective health authorities may never result in that Cost-effectiveness is something When you say its cost-effective, I get patients worried. that The are dying, long-term principally desirable, since it or severely ill, elderly, have means politicians that the resources do not are understand used that it means dementia, that are we intellectually need in the more best possible resources way and that challenged, have severe functional the resources will benefit more impairments or are in other similar Health economic people competence situations are not receiving care or are offered less qualitative care. 19 Health economic evaluation in England James Raftery PhD Professor of HTA 10

11 England Is economic evaluation mandatory? Yes for some drugs (those referred to NICE), for screening programmes (NSC) and immunisation/vaccination (JCVI). Not for most drugs or treatments Under NHS Constitution (2009) but in fact since late 1990s But big exceptions: drugs for some diseases (cancers, multiple sclerosis, orphan drugs), patients close to end of life. Chlamydia screening, vascular health checks. Exemptions cost about 10% NHS drugs spend 21 England How well done is economic evaluation? NICE Guides detailed and updated 2004/8/13/14 Extra-welfarist (QALY, NHS perspective, discounting), Bayesian (CEAC) Tensions re perspective (value based pricing) Parallel independent academic evaluations for NICE to 2006, then independent assessments of company submissions academic centres claim global lead in methods Exempt from Conflicts of Interest (work for both) 22 11

12 England What is the effect on policy? Rhetoric: Yes. Reality: variable NICE not recommended rate: official 16%, actual 7% due to exemptions (MS, cancer, EOL, PAS) Main effect: price discounts linked to economic evaluation. Confidential, often minor. Language of economics widely adopted, less understood Exemptions: political unacceptability of difficult decisions (in public, denying individual sick patient) Civil servants striving for consistency (Cancer drugs fund review), funding research/evidence 23 England Why not implemented? Cost benefit analysis poorly reflects public preferences and its discords on hot topics Tensions in welfare v extra welfarist economics Tragedy of named individual beats societial prudence Political hot topics drive policy lurches 24 12

13 England Main conclusions Need to look at health system, not just NICE & hidden opportunity cost (who loses?) Economic evaluation has not saved much money but provides a language for price negotiation General price cuts saved more but limited from 2014 Special funds for high priced drugs require governance, reporting and evaluation 25 Conclusion Irrespective of differences between the countries, the results are the same : 26 13

Quality of Health Care and the Design of the Basic Benefit Package Lessons from Overseas

Quality of Health Care and the Design of the Basic Benefit Package Lessons from Overseas Michael Drummond Centre for Health Economics, University of York Outline of Presentation Efficiency and the use