Country/Region: Czech Republic
Submission Guidelines

Cost-effectiveness Guidelines (May 2017) and Budget Impact Guidelinies published by State Institute for Drug Control (SUKL) (Czech official HTA agency for drug regulation)

Submission Guidelines Source:

Cost-effectiveness guidelines
PDF in Czech

Budget impact guidelines
PDF in Czech

Additional Information:

Health economics guidelines (cost-effectiveness and budget impact) in Czech Republic by Czech Pharmacoeconomic Society (CFES, October 2016)
http://farmakoekonomika.cz/wp-content/uploads/2016/10/DP_CFES_13-10-2016_final.pdf

Last Webpage Update: Wednesday, January 31, 2018

Submission Guidelines Key Features:

Key Features:  
Title and year of the document
Cost-effectiveness Guidelines (May 2017)  
Affiliation of authors
State Institute for Drug Control (http://www.sukl.eu/)  
Purpose of the document
To establish both methodology and ideal modelling instruments for the assessment of cost-effectiveness and budget impact analyses submitted to SUKL  
Standard reporting format included
Yes, the report should consist of generally recommended chapters (i.e. purpose of the study, comparator, target population, perspective, clinical inputs, costing etc.)  
Disclosure
Yes, however some parts of the dossier can be classified as confidential except the main results of clinical evidence and the pharmacoeconomic evaluation (i.e. ICER, net budget impact)  
Target audience of funding/ author's interests
State Institute of Drug Control and Health insurance companies  
Perspective
Public healthcare system (i.e. health insurance companies)  
Indication
Yes. Detailed indication criteria following pivotal randomized clinical trial should be included (not as stated in summary of product characteristics). Indication criteria have to be in line with target population in the pharmacoeconomic model.  
Target population
Target population must be clearly described and be fully in line with the terms of reimbursement/indication criteria  
Subgroup analysis
Yes, if it is meaningful, possible to construct and makes it statistical sense.  
Choice of comparator
Therapeutic procedures that are accepted as commonly used in the target population and, at the same time, are currently permanently (not temporarily or exceptionally) covered/reimbursed by health insurance companies  
Time horizon
The time horizon should be long enough to allow a reliable and reasonable conclusions of the difference in costs and health benefits/outcomes (QALYs) based on available evidence  
Assumptions required
Yes 
Preferred analytical technique
Cost-utility analysis (CUA) with QALY as final outcome measure is preferred. In some justified cases (non-inferiority/superiority), cost-minimization (CMA) can be used. If QALY is not possible to estimate, reasonable surrogate outcomes (such as life-years (LY)) can be used in CEA.  
Costs to be included
All relevant direct costs covered from health insurance companies perspective (medical and non-medical) to the disease should be identified.  
Source of costs
List of Reimbursed medicinal products (www.sukl.eu), Current version of Regulation No. 134/1998 Coll. and decree setting out the list of medical services (reimbursement + restrictions), official list of reimbursed medical devices (published by Health insurance companies) and list of DRG  
Modeling
Yes 
Systematic review of evidences
Yes 
Preference for effectiveness over efficacy
Yes, if the study is robust and quality.  
Preferred outcome measure
Quality-adjusted life-year (QALY) is preffered outcomes. In cases where this outcome is not possible to use, life-years gained (LYG) or other surrogate outcomes can be used  
Preferred method to derive utility
EQ-5D or specific questionnaire that can be converted into EQ-5D by a mapping algorithm. If EQ-5D is not available, other sources can be used but have to be discussed.  
Equity issues stated
No 
Discounting costs
Basecase: 3%; Sensitivity analysis: 0% and 5%  
Discounting outcomes
Basecase: 3%; Sensitivity analysis: 0% and 5%  
Sensitivity analysis-parameters and range
Sensitivity analysis should include all input parameters and estimate their impact on basecase result. Ranges should be based on standard errors (SE) or 95% confidence intervals. If assumptions about ranges are made (e.g. ±20%), these have to be justified and discussed.  
Sensitivity analysis-methods
One-way sensitivity analysis (OWSA), scenario analysis and probabilistic sensitivity analysis (PSA)  
Presenting results
OWSA: Table or tornado diagramme, PSA: Cost-effectiveness plane/scatter plot, cost-effectiveness acceptability curve (CEAC) with probability that an intervention is cost-effective at given willignness to pay threshold (WTP; equal to 1,2 million CZK (approx. €47000/QALY)  
Incremental analysis
Yes 
Total costs vs effectiveness (cost/effectiveness ratio)
Yes 
Portability of results (Generalizability)
Only for Czech Republic  
Financial impact analysis
Yes. These include detailed estimation of the number of treated patients (based on required indication criteria) and consequent costs (drug costs but also others - complications, costly procedures etc.)  
Mandatory or recommended or voluntary
Mandatory by Law (both cost-effectiveness and budget/financial impact analysis)  

Acknowledgement: The following people helped contribute to the key features form: Monika Sebestianova, MSc, Market Access Specialist, Value Outcomes, Prague, Czech Republic; Tomas Mlcoch, MSc, Health Economy Analyst, Institute for Health Economics and Technology Assessment (iHETA) and Value Outcomes, Prague, Czech Republic; Tomas Dolezal, MD, PhD, Scientific Director, Institute for Health Economics and Technology Assessment (iHETA) and Value Outcomes, Prague, Czech Republic

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