DOELMATIGHEID: TECHNIEK & PRAKTIJK
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1 DOELMATIGHEID: TECHNIEK & PRAKTIJK MJ Postma Prof in PharmacoEconomics Unit of PharmacoEpidemiology & PharmacoEconomics (PE2) Department of Pharmacy & Director of Institute of Science in Healthy Aging and health care (SHARE) UMCG University of Groningen
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4 4 th HURDLE
5 4 th HURDLE Since 2005 for GVS : 1A vs. 1B Quality Toxicity/Safety Efficacy/Effectiveness Cost-effectiveness Similar interest with GezondheidsRaad in costeffectiveness of vaccines, screening and recently NOACs Member for 8 and 12 years
6 BELEIDSREGEL DURE GENEESMIDDELEN Policy Rule 80% reimbursed beyind hospital budget >0.5% hospital drugs buget (±2.5 mio) Strange incentive to higher prices Timing T=0 T=3 T=4 (infliximab, rituximab) Procedure Indicative cost-effectiveness + design outomes res Strong T=4 dossier Relatively light procedure (in particular T=0)
7 HEALTH CARE COSTS
8 4 th HURDLE IN NATIONAL IMMUNIZATION PROGRAM
9 4 th HURDLE Hepatitis B 2000 not cost-effective 2008 cost-effective Meningococcal Vaccination shots not cost-effective HPV, no full catch-up due to unfavourable costeffectiveness Conjugate pneumococcal vaccination 2001 not cost-effective 2005 cost-effective 2010 not cost-effective
10 4 th HURDLE Hepatitis B 2000 not cost-effective 2008 cost-effective Meningococcal Vaccination shots not cost-effective HPV, no full catch-up due to unfavourable costeffectiveness Conjugate pneumococcal vaccination 2001 not cost-effective 2005 cost-effective 2010 not cost-effective
11 PHARMACOECONOMICS Integration of various types of info Drug costs Other Costs Savings in health care Costs of side effects Life years gained Better quality of life Decreased sickness leave CostEffectiveness = (C S) / QALY QALY = Quality-Adjusted Life Year
12 QALY Complexiteit Zo eenvoudig mogelijk Maar wel alle essenties Soms complex noodzakelijk (diabetes, infectieziekten) Waarom Vertalen van intermediare uitkomsten naar harde Extrapolatie voorbij de tijdshorizon van de klinische studies Typen Beslisboom, meest eenvoudig, korte termijn/acuut Markov model, kan nog in EXCEL, chronisch
13 ISSUES Measure QALYs How to interprete the cost-effectiveness ratio? Types of costs to include: broader societal, production losses, indirect medical Discounting
14 ISSUES Measure QALYs How to interprete the cost-effectiveness ratio? Types of costs to include: broader societal, production losses, indirect medical Discounting
15 Insert Boersma
16 Insert Boersma
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18 ROTAVIRUS VACCINE (KCE-RAPPORT)
19 UK Benchmark for decisions: incremental cost per QALY gained Probability of rejection on grounds of cost ineffectiveness A = < 20,000 per QALY gained: -Considered an efficient use of NHS resources B = > 30,000 per QALY gained -Would need special circumstances to accept Increasing cost/qaly Source: Rawlins and Culyer, BMJ 2005;329:
20 HOW TO CONTINUE In the absence of a threshold? ZorgInstituut NL Guidelines (11 criteria) Some specific, some bit vague Dossiers are evaluated using the guidelines Country-specific guidelines very similar but differ on details ISPOR
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22 Proefsc
23 M Parouty et al, 2011
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25 TAKE HOME Update vergoedingen in NL Geneesmiddelen Farmaco-economische richtlijnen Issues Er is geen afkappunt Streng, maar er is helder loket Commissie Pakket Studies Allicht veel aandacht voor gnm en vaccins (financiering) Enorme groei in aantal Historisch zeker ook interesse in medische hulpmiddelen
26 ISSUES Measure QALYs How to interprete the cost-effectiveness ratio? Types of costs to include: broader societal, production losses, indirect medical Discounting
27 TAKE HOME Update vergoedingen in NL Geneesmiddelen Farmaco-economische richtlijnen Er is geen afkappunt Streng, maar er is helder loket Commissie Pakket Dutch situation Travel and parking costs Production losses during monitoring At least halving of ICER
28 CONCERTA Bron: Hoomans et al 2010 NTvG
29 CONCERTA Bron: Hoomans et al 2010 NTvG
30 CONCERTA Bron: Hoomans et al 2010 NTvG
31 OUTPATIENT PHARMACEUTICAL EXPENDITURE IN MILLIONS OF s: STABILITY!
32 INTERMEDIATE SUMMARY Need for a threshold expressed (Vaccines in HC!) GVS strict Difficult to get on 1B 2013: 11 of 12 denied (ulipristal) Issues Intransparant models, sometimes complex models needed Alignment therapeutic and economic dossiers Hospital drugs (and orphan drugs) mild No threshold No impact of discounting easy models Severity of disease
33 INTERMEDIATE SUMMARY
34 INTERMEDIATE SUMMARY
35 INTERMEDIATE SUMMARY
36 COMPARISON NL WITH SMC
37 2005: CVZ framework in Referenc Quality Toxicity/Safety Efficacy/Effectiveness Cost-effectiveness Extended to ho Source: screenshot NOS-news
38 EXPENSIVE HOSPITAL DRUGS T=0 is a mild assessment, with many oncology drugs Eight T=4 assessments so far Alglucosidase, Omalizumab, Agalsidase, Rituximab, Trastizumab, Voriconazol, Ranibizumab, Natalizumab Only 1 got negative evaluation on adequate use and costeffectiveness based on T=4 Despite Critiques on absence or use of EQ-5D, use UK-tariffs Idem on costs, e.g. often indirect costs missing Limited use of observational data (only dosing) Relatively easy models
39 INTERMEDIATE SUMMARY
40 mm-dd-yy 40 Cost per QALY categorized by severity Cost per QALY NICE Severity RVZ, 2006
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42 not ^ not ^ QALY is a QALY is a QALY I am uneasy about the mantra of a QALY is a QALY is a QALY. It means that an increase in utility from 0.3 to 0.5 is valued the same as an increase from 0.7 to 0.9. I am not sure this is fair. Rawlins. Value in Health 2012;15:568-9
43 mm-dd-yy 43
44 44 mm-dd-yy
45 THRESHOLD(S) One threshold only guarantees maximisation of QALYs Societal values may prefer non-maximal total QALYs though Such preferences are related to Severity Equity Fair innings Proportional shortfall And may translate in, for example, end-of-life criteria/considerations and access schemes
46 SUMMARIZING Specific Dutch approach: societal & discounting Need for harmonization of assessments of outpatient and inpatient drugs Need for threshold Variable Exceptions ZiNL extends to all areas (inclusive vaccines!)
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