Transcript Benefits and Barriers of HTA / Pharmacoeconomics

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
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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
ISPOR costs)
HTAC; Prague, November 2010
(issues: capacity, access,
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
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
I.
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ΔC
2 = 26500€/QALY
II.
1 = 18000€/QALY
ΔE
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ΔE
Dominant
Quadrant
IV:
ISPOR HTAC; Prague, November 2010
III.
ΔC
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“?
Herceptin
Glivec
Avastin
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
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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
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SLOVAHTA
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(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
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HTAi
cross-border co-operation (V-4; CZ, PL, HU, A)
Formal Education / Training
Political / Legal & Financial Support
ISPOR HTAC; Prague, November 2010