HTA and Health Care Decisions HTA and Health Care Decisions in Slovakia.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 OverviewSocial 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)

Source: Tomek, 2010ISPOR HTAC; Prague, November 2010

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 AnalysisCost-Effectivness AnalysisCost-Utility Analysis

• Not preferred analysisCost-Benefit AnalysisCost of IllnessBudget Impact Analysis

+ ΔC

- ΔC

+ ΔE

- ΔE

2 = 26500€/QALY

1 = 18000€/QALY

III. IV:

I. II.

Dominant Quadrant

Source: Ilavska et al., 2009ISPOR HTAC; Prague, November 2010

• 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

What goes „right“?

Herceptin Avastin

Glivec Sutent

Source: SUKL and Tomek, 2010ISPOR HTAC; Prague, November 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

Source: Tomek, 2010ISPOR HTAC; Prague, November 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

• Lack of 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