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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 .). Agenda. Slovak Health Care Role of Pharmacoeconomics Strengths of Drug Policies Weaknesses
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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.)
Agenda • Slovak Health Care • Role of Pharmacoeconomics • Strengths of Drug Policies • Weaknesses • Evolution of HTA • Opportunities / Threats • Remarks ISPOR HTAC; Prague, November 2010
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
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) ISPOR HTAC; Prague, November 2010 Source: Tomek, 2010
2 = 26500€/QALY + ΔC I. II. 1 = 18000€/QALY - ΔE + ΔE Dominant Quadrant III. IV: - ΔC 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 ISPOR HTAC; Prague, November 2010 Source: Ilavska et al., 2009
Strengths of Drug Policies 2/2 • 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 ISPOR HTAC; Prague, November 2010 Source: Ilavska et al., 2009
What goes „right“? Avastin Herceptin Glivec Sutent ISPOR HTAC; Prague, November 2010 Source: SUKL and Tomek, 2010
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 ISPOR HTAC; Prague, November 2010 Source: Tomek, 2010
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
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 • Lackof Political Support ISPOR HTAC; Prague, November 2010
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