Dr Joanna Lis President-Elect Polish Society of Pfarmacoeconomics Expenditure Expenditure as % GDP [Exch. rate, million US$] 300,000 15.0% 250,000 12.0% 8.7% 200,000 8.2% 8.0% 7.7% 9.0% 7.4% 6.7% 6.1% 6.1% 6.1% 150,000 5.8% 5.8% 5.2% 5.2% 6.0% 4.6% 100,000 3.0% 50,000 0.0% 0 Finland Ireland Italy France Slovak Republic Spain Czech Republic Poland Hungary Austria Greece Germany Denmark Sweden Source: OECD Health Data 2009: data from 2007 year Expenditure Expenditure as % GDP [Exch. rate, million US$] 1.9% 40,000 2.0% 1.8% 35,000 1.5% 1.6% 1.4% 30,000 1.3% 1.4% 1.2% 1.2% 25,000 1.2% 1.0% 0.9% 20,000 1.0% 0.8% 0.7% 0.8% 0.6% 0.6% 15,000 0.5% 0.6% 10,000 0.4% 5,000 0.2% 0 0.0% * expenditure on pharmaceuticals and other medical non-durables comprises pharmaceuticals such as medicinal preparations, branded and generic medicines, drugs, patent medicines, serums and vaccines, vitamins and minerals and oral contraceptives. Source: OECD Health Data 2009, data from 2007 year Respiratory system; Musculo-skeletal system; 1,42% 3,99% Nervous system; n/a ; VARIA; 1,55% 16,02% Alimentary tract and 7,92% metabolism ; 15,52% Respiratory system 14,28% Antiparasitic products, Blood and blood forming insecticides and repellents; organs; 0,08% 5,02% Antiinfectives for systemic use; Cardiovascular 7,35% Antineoplastic and system; 14,68% immunomodulating agents; 6,27% ; Dermatologicals Genito-urinary system and Systemic hormonal 0,71% sex hormones ; preparations, excluding sex 3,98% hormones and insulins; 1,23% Source: National Health Found, Report 2008 ◦ corelation between level of health care Wydatki na ochronę zdrowia 2006 r. (USD, ppp) a ocena systemu opieki nad pacjentami z cukrzycą expenditure vs quality 900 of diabetics health care RANKING SYSTEMÓW OPIEKI NAD PACJENTAMI Z ◦ 0,74 (p<0,05) 850 UK DAN HOL FRA BEL 800 NOR WŁO NIE 750 IRL SZWC SZWE AUS CUKRZYCĄ LIT FIN LUX 700 ŁOT HISZ SLO WĘG MAL 650 GRE EST CZE 600 SK 550 POL RUM CYP POR 500 BŁG 450 0 500 1000 1500 2000 2500 3000 3500 4000 4500 w ydatki na ochronę zdrow ia per capita 2006 (USD, ppp) Wydatki na ochronę zdrowia (OECD Health Data, 12.2008) Strong corelation between level of health care expenditure vs quality of Wydatki na ochronę zdrowia per capita w 2006 r. (USD, ppp) a ocena systemu opieki nad pacjentami z chorobami serca health care in cardiology 900 0,84 (p<0,05) RANKING SYSTEMÓW OPIEKI NAD PACJENTAMI Z 850 FRA LUX 800 HOL AUS CHOROBAMI SERCA 750 SZW SLO WŁO FIN UK DAN 700 BEL NIE MAL HISZ IRL 650 CYP EST SK CZE 600 POR GRE WĘG 550 LIT POL 500 ŁOT 450 0 500 1000 1500 2000 2500 3000 3500 4000 4500 WYDATKI NA OCHRONĘ ZDROWIA PER CAPITA 2006 (USD, PPP) Wydatki na ochronę zdrowia (OECD Health Data, 12.2008) PRICE CONTROL x VOLUMEN CONTROL = SPENDING CONTROL PRICE REGULATIONSj, CUT TING COSTS FOR RSS (freezing, lowering, …) MARKETING S NATIONAL REFERENCE U PRODUCT VOLUME PRICING REVENUE CONTROL P CAPS P L International Price Comparisons Y "Cost-effectiveness pricing" PROFIT CONTROL REBATES PRODUCT RENEVUE CAPS VBP PATIENT’S COPAYMENT FOLUMULARIES PATIENT/DISEASE BUDGET D REGISTRATION & MARKET POSITIVE/NEGATIVE PHYSICIAN RX BUDGET E AUTHORISATION RULES REIMBURSEMENT LISTS M A CONTROL PHUSICIAN HEALTH CARE N INSURANCE SYSTEM PRESCRIPTION BUDGET D GENERIC SUBSTITIUTION TRATMENT GUIDELINES TAXES PARALLEL TRADE Name Merits Advance Pharma Amendment implementing EU Dir Consulted in Important: introduction of 8+2+1 RDP regime 2009 Law Clinical Assumptions of new Law ( single act) Important: Consulted in - New (obligatory) insurance for each participant Jan’10 trials - 1 trials at a time by one investigator Registra- New law on Regulatory Office Important: Consulted in MA issued by President of Reg. Office (not MoH) 2009 tion Reimbur- New reimbursement law : expected important changes: Not Individual decisions Consulted sement Fixed margins and prices yet Risk-sharing agreements Tax on pharma activities (Garattini tax) Doctors Draft law on New types of specializations Consulted Jan 2010 Clinical New regime of clinical hospitals (erected by Medical n/a Universities) hospitals 10 DRAFT! Coverage with clinical evidence conditional development re imbursement Payment for treatment continuation only He alth C ompany o utcome p ay for Payment for treatment outcome MoH p erformance risk- Upfront payment refunded in case of sharing no treatment outcome ag reem. Defined market share and population overspendings’ pay-back Financial based o utcom Defined volume and overspendings’ pay-back Limited no of treatment individual patient based Natural rebate 11 A complete assessment of health technology comprises the following analyses: 1) Analysis of decision problem 2) Clinical effectiveness analysis 3) Economic analysis 4) Analysis of impact on health care system Analysis of impact on health care system covers ◦ the budget impact analysis and ◦ the assessment of organizational consequences for the heath care system, and possibly the assessment of possible ethical and social implications ◦ Lantus utilization after reimbursement decision Future expenditures on Lantus after its reimbursement are calculated based on predicted use of Lantus given in international units (IU). Share of estimated consumption of Lantus within basal insulin market was estimated on the basis of data from European countries where Lantus is reimbursed. ◦ Lantus utilization without reimbursement decision Values for this forecast was obtained based on the dynamics of the consumption of Lantus in Poland (IMS Health data) ◦ Insulin dosage Calculator gives the opportunity to use input data on insulin dosage from RCTs, observational studies or market research studies * HTA Consulting, 2010 DAILY INSULIN DOSES (IU) Insulin RCT Observational studies Market research study Lantus 39 23,1 27,9 NPH 37 23,1 28,3 Premixed insulin 46,5 35 41,2 Proportions of use between Lantus and other insulin Insulin RCT Observational studies Market research study NPH 0,94 1,00 1,01 Premixed insulin 1,19 1,59 1,48 HTA Consulting, 2010 Utilization of insulin glycaemic test strips Comparison of use of test strips in addition to insulin therapy indicates differences between patients on Lantus, NPH and premixes. Compared to NPH/Premixes Lantus requires less strips. ◦ The difference is 20 less strips a month for new patients starting therapy and ◦ 13 strips a month for patients using insulin for before Insulin prices Perspective of the analysis: The analysis was conducted from public payer (NHF) and patient perspective. Time horizon The analysis was conducted in 5 years perspective. HTA Consulting, 2010 Replacement (switching) of insulin (NPH and premixes) by Lantus Based on the insulin utilization from European countries (analysis of the structure of insulin market relating to replacement of NPH and premixes after Lantus reimbursement) User can choose: ◦ Selected country (choice between different European countries can be made) ◦ European mean calculated as arithmetic mean ◦ European mean calculated as mean weighted by population size ◦ European mean calculated as mean weighted by insulin utilization ◦ User prognosis – user can choose the degree of share between NPH and Premixes which are replaced by Lantus Insulin utilization and trends used in the Data on consumption of different types of prognosis in Greece insulin, together with the characteristics that describe the dynamics of the consumption trends (for the sample country (Greece)) HTA Consulting, 2010 Reimbursement by payer – scenario with OADs 20 15 10 Refundacja NFZ [mln PLN] 5 Lantus 0 NPH Mieszanki Metformina -5 Glimepiryd Paski glikemiczne -10 -15 -20 2010 2011 2012 2013 2014 YEAR HTA Consulting, 2010 Insulins usage 250 200 150 Lantus Zużycie insulin [mln IU] 100 50 NPH 0 -50 -100 Mix -150 -200 2010 2011 2012 2013 2014 Rok Reimbursement by payer – scenario without OADs 20 15 Refundacja NFZ [mln PLN] 10 5 Lantus 0 NPH -5 Mieszanki -10 Metformina -15 Glimepiryd Paski glikemiczne -20 -25 2010 2011 2012 2013 2014 Rok HTA Consulting, 2010 ECONOMIC SOCIAL ETHICS ORGANIZATION NEGOTIATION in RSS Individual decisions: changes to administrative procedures leading to full implementation of EU Transparency Directive No 105. Decisions are to be taken in the individual form Drugs reimbursement lists will be often updated and published in form of internal MoH order/ not as legal Act published in Official Journal. New bodies will be introduced: Transparency Council and Economic Committee which will conduct negotiations with pharmaceutical companies Fixe margins and prices Rebates will be forbidden as well as all kinds of commercial practices concerning decreasing of ex-factory official price. Pharmacy margins will be accounted from reimbursement limit/ not from the price. Risk-sharing agreements Arrangements between a payer and a pharmaceutical, device, or diagnostic manufacturer Tax on pharma activities („Garattini tax”) 3% of reimbursed drugs sales paid by Pharmaceutical Companies to the state budget. This money are going to be spent on independent clinical trials and registers (CER) Others: Limits will be based on the cheapest drug with 15% market share level in therapeutic group. Constant cost-reevaluation under reference price system E In case of lack of head to head trials F E Health Technology comparing directly an assessed and an F alternative technology, it is F Assessment E recommended to conduct an indirect comparison. F C Does it Work? Comparative For whom? I T Cost Indirect comparisons can be performed I and presented independently of direct C V comparisons. In the case of mixed comparisons involving both direct and A E indirect comparisons, the results of C N direct comparisons alone should be E presented separately and Evidence Based y Medicine independently from the results of the S mixed comparison. S E Health Technology F Assessment E F E F C F Does it Work? T Comparative For whom? I I Cost C V E A N C E y S Evidence Based Medicine S Comparative Effectiveness is the conduct and synthesis of research comparing the benefits and harms of different interventions in a „real world” settings. The purpose of this research is to improve health outcomes by developing and disseminating evidence – based information to patients, clinicians and other decision makers, responding to their expressed needs, about which interventions are most effective for which patients under specific circumstances” Additional taxes for financing CER CHANGES IN HEALTH CARE SYSTEM WHICH ALLOW TO GET BETTER ACCESS WITHIN LIMITED RESOURCES Let’s do together!