1. HTA and Health Care Decisions in Slovakia. PharmDr. Martin Višňanský, MBA, PhD. President - ISPOR Local Chapter, Slovakia Slovak Agency for Health Technology Assessment (SLOVAHTA, n.g.o.)

2. Agenda Slovak Health Care Role of Pharmacoeconomics Strengths of Drug Policies Weaknesses Evolution of HTA Opportunities / Threats Remarks ISPOR HTAC; Prague, November 2010

3. Slovak Health Care System Overview Social Insurance (Bismark´s Model) & “Free Market” (US-like) Mix:  Compulsory Public Health Insurance (with complementary opportunity)  3 HICs; join-stock companies (population coverage: 2/3 state, 1/3 private)  Operational Expense max. 3,5% (profit has to be reinvested into HC purchasing)  Risk-Redistribution Formula (age, sex, economic activity)  Capitation / Fee-for-Service (DRG in development)  Health Insurance Surveillance Authority, Quality Indicators (to “oversight the system”)  Minimum Public Network, Technical and HR Standards (issues: capacity, access, costs) ISPOR HTAC; Prague, November 2010

4. The Role of Pharmacoeconomics Aims & Goals: Transparency and predictability Access and affordability (avoid social inequities) Price-Volume Caps, Reimbursement with evidence-development, Co-payment shield (€10 resp €15 per month, disable resp 65+) More rational spending Reference pricing effective (“PIIGS countries” impact !?!) HTA effective (part pharmacoeconomics) Demonstrate outcomes to the payers (e.g. patient registries, RCT Ph.IV, local HTA studies) Source: Tomek, 2010 ISPOR HTAC; Prague, November 2010

5. Strengths of Drug Policies 1/2 Pharmacoeconomy Analysis Mandatory part of reimbursement submission from 2006 Recommendation for Pharmacoeconomy Analysis by Slovak MoH Prefered analysis Cost-Minimization Analysis Cost-Effectivness Analysis Cost-Utility Analysis Not preferred analysis Cost-Benefit Analysis Cost of Illness Budget Impact Analysis + ΔC - ΔC + ΔE - ΔE 2 = 26500€/QALY 1 = 18000€/QALY III. IV: I.II. Dominant Quadrant Source: Ilavska et al., 2009 ISPOR HTAC; Prague, November 2010

6. Costs – Direct costs Health care costs Non-health care costs – Indirect costs – Each cost type in extra list with chosen perspective Payer (Health Insurance Companies) perspective is preferred Societal perspective is accepted Discounting – 5% for outcomes – 5% for inputs, costs Sensitivity analysis Pharmacoeconomy modeling is accepted – Transparent model description (inputs, outputs, methods) – Science information have to be included in model – Sensitivity analysis for uncertain parameter Source: Ilavska et al., 2009 Strengths of Drug Policies 2/2 ISPOR HTAC; Prague, November 2010

7. What goes „right“? Herceptin Avastin Glivec Sutent Source: SUKL and Tomek, 2010 ISPOR HTAC; Prague, November 2010

8. Weaknesses liberal „pro oncology“ political willingness – 20 x increase for oncology drugs cca €10 mil in 2000 to € 200 mil euro in 2010) – QALY threshold doesn’ t help too much – Lack of data for biologicals and orphans direct non medical, indirect, intangible costs, ect. not included services, hospitals, diagnostic procedures, CT, MRI, ect. not included Source: Tomek, 2010 ISPOR HTAC; Prague, November 2010

9. Evolution of the HTA Committee for drug policy (MoH) Committee for economics and pricing (MoH & MoF)) Committee for pharmacoeconomics and clinical outcomes (MoH) Rules for including /excluding a drug to list (Law & Degree, MoH) Generic substitution, Tender business (central purchasing, HICs) Degressive margin Databases of reference pricing in EU-27 + Switzerland + US Medical Devices and Medical Dietary Products not assessed SLOVAHTA ( Slovak Agency for Health Technology Assesment, 02/2010) ISPOR HTAC; Prague, November 2010

10. Opportunities / Threats Regulators and payers are still not aware of HTA (not mentioning „other stakeholders“) All relevant stakeholders should be involved Limited HR capacities Limited know-how (in terms of „pure-HTA“) Limited networking capabilities Lack of recognition / acknowledgement Lack of Political Support ISPOR HTAC; Prague, November 2010

11. Remarks EUnetHTA & EUnetHTA JA – Core Model Awareness – Active participation in WPs – Monitoring of Activities HTAi cross-border co-operation (V-4; CZ, PL, HU, A) Formal Education / Training Political / Legal & Financial Support ISPOR HTAC; Prague, November 2010