1. Dr Joanna Lis President-Elect Polish Society of Pfarmacoeconomics

3. Source: OECD Health Data 2009: data from 2007 year Expenditure [Exch. rate, million US$] Expenditure as % GDP

4. * 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 Expenditure [Exch. rate, million US$] Expenditure as % GDP

5. Source: National Health Found, Report 2008

6. ◦ corelation between level of health care expenditure vs quality of diabetics health care ◦ 0,74 (p<0,05) Wydatki na ochronę zdrowia (OECD Health Data, 12.2008)

7.  Strong corelation between level of health care expenditure vs quality of health care in cardiology  0,84 (p<0,05) Wydatki na ochronę zdrowia (OECD Health Data, 12.2008)

9. PRICE CONTROL x VOLUMEN CONTROL = SPENDING CONTROL SUPPLYSUPPLYSUPPLYSUPPLY PRICE REGULATIONSj, (freezing, lowering, …) CUT TING COSTS FOR MARKETING RSS NATIONAL REFERENCE PRICING International Price Comparisons PRODUCT VOLUME CAPS REVENUE CONTROL "Cost-effectiveness pricing" PROFIT CONTROL REBATES PRODUCT RENEVUE CAPS VBP DEMANDDEMANDDEMANDDEMAND PATIENT’S COPAYMENT FOLUMULARIES PATIENT/DISEASE BUDGET REGISTRATION & MARKET AUTHORISATION RULES POSITIVE/NEGATIVE REIMBURSEMENT LISTS PHYSICIAN RX BUDGET INSURANCE SYSTEM CONTROL PRESCRIPTION PHUSICIAN HEALTH CARE BUDGET GENERIC SUBSTITIUTION TRATMENT GUIDELINES TAXES PARALLEL TRADE

10. 10 NameMeritsAdvance Pharma Law Amendment implementing EU Dir Important: introduction of 8+2+1 RDP regime Consulted in 2009 Clinical trials Assumptions of new Law ( single act) Important: - New (obligatory) insurance for each participant - 1 trials at a time by one investigator Consulted in Jan’10 Registra- tion New law on Regulatory Office Important: MA issued by President of Reg. Office (not MoH) Consulted in 2009 Reimbur- sement New reimbursement law : expected important changes:  Individual decisions  Fixed margins and prices  Risk-sharing agreements  Tax on pharma activities (Garattini tax) Not Consulted yet Doctors Draft law on New types of specializationsConsulted Jan 2010 Clinical hospitals New regime of clinical hospitals (erected by Medical Universities) n/a

11. 11 Company MoH risk- sharing agreem. conditional reimbursement Health outcome Financial outcom population based individual patient based pay for performance Coverage with clinical evidence development Payment for treatment continuation only Payment for treatment outcome Upfront payment refunded in case of no treatment outcome Defined market share and overspendings’ pay-back Defined volume and overspendings’ pay-back Limited no of treatment Natural rebate DRAFT!

13.  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

14. 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

15. ◦ 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

16. DAILY INSULIN DOSES (IU) InsulinRCTObservational studiesMarket research study Lantus3923,127,9 NPH373723,128,3 Premixed insulin46,53541,2 Proportions of use between Lantus and other insulin InsulinRCTObservational studiesMarket research study NPH0,941,001,01 Premixed insulin1,191,591,48 HTA Consulting, 2010

17.  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

18.  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  Data on consumption of different types of insulin, together with the characteristics that describe the dynamics of the consumption trends (for the sample country (Greece)) HTA Consulting, 2010 Insulin utilization and trends used in the prognosis in Greece

19. HTA Consulting, 2010

21. ECONOMIC SOCIAL NEGOTIATION in RSS ORGANIZATION ETHICS

22.  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

23.  In case of lack of head to head trials comparing directly an assessed and an alternative technology, it is recommended to conduct an indirect comparison.  Indirect comparisons can be performed and presented independently of direct comparisons. In the case of mixed comparisons involving both direct and indirect comparisons, the results of direct comparisons alone should be presented separately and independently from the results of the mixed comparison. Health Technology Assessment Evidence Based Medicine EFFICACyEFFICACy Does it Work? For whom? Comparative Cost EFFECTIVENESSEFFECTIVENESS

24. Health Technology Assessment Evidence Based Medicine EFFICACyEFFICACy Does it Work? For whom? Comparative Cost EFFECTIVENESSEFFECTIVENESS

25.  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

26. CHANGES IN HEALTH CARE SYSTEM WHICH ALLOW TO GET BETTER ACCESS WITHIN LIMITED RESOURCES Let’s do together!