Dr Joanna Lis President-Elect Polish Society of Pfarmacoeconomics

1. How to provide the proper access for innovative treatment to the patientsin Poland?Let’sdiscussaboutnewtrends and plannedchanges… Dr Joanna Lis President-ElectPolishSociety of Pfarmacoeconomics

2. Expentitures on health carein Poland are not to high as…

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

4. PUBLIC EXPENDITURE ON PHARMACEUTICALS AND OTHER MEDICAL NON-DURABLES*[Exch. rate, million US$] Expenditure [Exch. rate, million US$] Expenditure as % GDP * 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

5. State expenditures on therapeutics groups – 2007 Source: National Health Found, Report 2008

6. Level of health care expenditure vs quality of diabetic health care • corelationbetweenlevel of health careexpenditurevsquality of diabetics health care • 0,74 (p<0,05) Wydatki na ochronę zdrowia (OECD Health Data, 12.2008)

7. Level of health careexpenditurevsquality of health careincardiovacular • Strongcorelationbetweenlevel of health careexpenditurevsquality of health careincardiology • 0,84 (p<0,05) Wydatki na ochronę zdrowia (OECD Health Data, 12.2008)

8. Payerperspective: Necessity to control of the HC expenditures …

10. MoHLegislativeroadmap in Poland

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

12. Tools for newplannedsolutionsin health care system in Poland areneeded…

13. Guidelines for conducting Health Technology Assessment (HTA) • A complete assessment of health technology comprises the following analyses: • 1)Analysis of decisionproblem • 2) Clinical effectiveness analysis • 3) Economic analysis • 4) Analysis of impact on health care system

14. Guidelines for conducting Health Technology Assessment (HTA) - BIA 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. EXAMPLE: DESCRIPTION OF THE MODEL* indiabetes for LAA • 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. EXAMPLE: DESCRIPTION OF THE MODEL* in diabetes HTA Consulting, 2010

17. EXAMPLE: DESCRIPTION OF THE MODEL* in diabetes • 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. EXAMPLE: DESCRIPTION OF THE MODEL* in diabetes • 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)) Insulin utilization and trends used in the prognosis in Greece HTA Consulting, 2010

19. HTA Consulting, 2010

20. HTA Consulting, 2010

21. Analysis of impact on health care system ECONOMIC SOCIAL ETHICS ORGANIZATION NEGOTIATION in RSS

22. New Changes to ReimbursementLawin Poland isplannedsoon … • Individual decisions: changes to administrative procedures leading to full implementation of EU TransparencyDirective 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: TransparencyCounciland 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 Companiesto 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. Guidelines for conducting Health Technology Assessment (HTA)in Poland – RelativeEffectiveness Health Technology Assessment • 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. E F F I C A C y E F F E C T I V E N E S S For whom? Cost Does it Work? Comparative EvidenceBasedMedicine

24. The structure remain but the setting changes ! Health Technology Assessment E F F E C T I V E N E S S E F F I C A C y For whom? Cost Does it Work? Comparative Evidence Based Medicine

25. CER in Poland • 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. How to provide the proper access for innovative treatment to the patients in Poland? CHANGES IN HEALTH CARE SYSTEM WHICH ALLOW TO GET BETTER ACCESS WITHIN LIMITED RESOURCES Let’s do together!