Country/Region: Slovak Republic
PE Guidelines

Guidelines for Economic Evaluation of Health Care Interventions (December 2011)
http://www.zakonypreludi.sk/zz/2011-422 (December 2011)

PE Guidelines Source:

Ministry of Health of the Slovak Republic
http://www.health.gov.sk/?farmako-ekonomicky-rozbor-lieku

Additional Information:
Last Webpage Update: Tuesday, April 3, 2018

PE Guidelines Key Features:

Key Features:  
Title and year of the document
Guidelines for Economic Evaluation of Health Care Interventions (December 2011) 
Affiliation of authors
MoH, ISPOR  
Purpose of the document
Provide methodological and reporting guidelines for PE evaluations and evaluation of medical devices. 
Standard reporting format included
Yes 
Disclosure
Yes 
Target audience of funding/ author's interests
Decision makers, researchers, pharmaceutical companies 
Perspective
Costs: Health care payer; Outcomes: society (for health-related quality of life: health state descriptions by patients, valuations from general public). 
Indication
Approved indication 
Target population
Relevant groups or sub-groups need to be defined. 
Subgroup analysis
Yes 
Choice of comparator
The most relevant alternative treatment which is either the the treatment that is most likely to be replaced by the new treatment or, in case of add-on treatments, the current treatment without the add-on product. 
Time horizon
Lifetime (chronic conditions or acute conditions with long term sequelae), duration of the treatment or disease and its consequences (acute conditions without long term effects) or 5 years. 
Assumptions required
Yes 
Preferred analytical technique
Cost-utility analysis (CUA) if the treatment has an impact on health-related QoL that is significant to the patient or if there are multiple patient-relevant clinical outcome parameters expressed in different units. 
Costs to be included
Direct health care costs should be included. These encompass costs directly related to the treatment of the disease as well as direct health care costs related to the disease in life years gained. 
Source of costs
The identification, measurement and valuation of costs should be consistent with the perspective of the Slovak health care payer. Relevant sources should be used for unit costs. 
Modeling
Yes, based on observational data from trials comparing the study medication and the comparator, observational databases and literature. 
Systematic review of evidences
Yes, systematic review of the existing clinical and economic studies on the intervention, including unpublished studies and studies with negative results. The search strategy should be reproducible and selection criteria and procedures clearly presented. 
Preference for effectiveness over efficacy
Yes 
Preferred outcome measure
Final outcome parameters: life years gained (CEA) or QALYs gained (CUA) for chronic conditions or other relevant outcome variable, as in the clinical file, for acute conditions. 
Preferred method to derive utility
TTO or SG (VAS). 
Equity issues stated
A QALY is a QALY, no matter to whom it accrues. 
Discounting costs
Future costs should be discounted at a rate of 5 %.  
Discounting outcomes
Future benefits should be discounted at a rate of 5 %.  
Sensitivity analysis-parameters and range
Interval estimates should be presented for each parameter in the economic evaluation. All different aspects of uncertainty in the evaluation should be addressed. Confidence interval around the ICER; Cost-effectiveness plane; cost-effectiveness acceptability curve; Tornado diagrams. 
Sensitivity analysis-methods
Probabilistic sensitivity analyses should be performed on all uncertain parameters in a model. 
Presenting results
Results should be presented in a defined form, it should contain the discounted costs, outcomes, incremental costs and incremental outcomes in a disaggregated form and separately for the study intervention and the comparator. 
Incremental analysis
Yes 
Total costs vs effectiveness (cost/effectiveness ratio)
Yes 
Portability of results (Generalizability)
The patient population to which the pharmaco-economic evaluation applies should be consistent with the patient population defined in the clinical part of the reimbursement request submission. 
Financial impact analysis
It is required for 5 years period under different scenarios. 
Mandatory or recommended or voluntary
Mandatory 

Acknowledgement: Dr. Tomas Tesar highly contributed to the key feature form (Tesar Tomas, PharmD, PhD, MBA, Union Health Insurance Fund, Bratislava, Slovakia)

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