Country/Region: Poland
Submission Guidelines

Guidelines for conducting Health Technology Assessment (Part 4 & 5) (2009) (Polish Version 2007)
PDF in English (page 25-43); PDF in Polish(page 21-37)

Submission Guidelines Source:

Poland Agency for Health Technology Assessment

Additional Information:

Polish Guidelines for Conducting Pharmacoeconomic Evaluations (2010)
PDF in English

Information up to date as of Thursday, May 19, 2011

Submission Guidelines Key Features:

Key Features:  
Title and year of the document
Guidelines for conducting Health Technology Assessment (Part 4 & 5) (2009) (Polish Version 2007)  
Affiliation of authors
AHTAPol, universities, authors of HTA analysis 
Purpose of the document
Provide methodological and reporting guidelines for HTA evaluations of medical technologies (drugs, devices, procedures) 
Standard reporting format included
Target audience of funding/ author's interests
Decision makers, researchers, pharmaceutical companies 
The first perspective of the analysis is the payers ‘perspective, i.e. one of the entity financing health care services (public payer, patient, other payers). However, it is advised to adopt a social perspective as well, to highlight the indirect costs. 
Usually approved indication, sometimes HTA analysis is done for indication which are not registered yet for example for non-standard therapy in oncology area. 
Target population
Relevant groups or sub-groups need to be defined. 
Subgroup analysis
Choice of comparator
It is advisable to use comparators that are: a) frequently used; b) cheapest; c) most effective; and d) compliant, to the practical guidelines. 
Time horizon
Time horizon of the economic analysis should be long enough to allow proper assessment of differences in health outcomes and costs between the assessed health technology and the comparators. 
Assumptions required
Preferred analytical technique
A standard economic analysis should be composed of: a) cost-consequences analysis; b)· cost-effectiveness analysis or c) cost-utility analysis. 
Costs to be included
a) direct medical costs; b) direct non-medical costs; c) indirect costs within the health care services sector; d) indirect costs outside the health care services sector; and e) incommensurable costs. 
Source of costs
The identification, measurement and valuation of costs should be consistent with the perspective of the Polish health care payer. 
Yes, based on data from trials comparing the study medication and the comparator, observational databases and literature. It is important that the compared alternative technology correspond to Polish conditions. 
Systematic review of evidences
Yes, systematic review of the existing clinical and economic studies on the technology, 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
Preferred outcome measure
Preferred method to derive utility
In order to examine preferences for the utility assessment, it is possible to use direct and indirect preferences measurement methods. It is also advised to use indirect methods of preferences measurement, easy to make, compare and interpret using validated questionnairesin Polish language. While measuring preferences with EQ-5D questionnaire, it is advised to use the European Value Set obtained by means of the visual analogue scale 
Equity issues stated
Discounting costs
The assumed rate of discount is equal to: 5% for costs and 3.5% for health care results – in the basic analysis; 5% for costs and health care results, 0% for health care results and 5% for costs – in sensitivity analyses. 
Discounting outcomes
The assumed rate of discount is equal to: 5% for costs and 3.5% for health care results – in the basic analysis; 5% for costs and health care results, 0% for health care results and 5% for costs – in sensitivity analyses. 
Sensitivity analysis-parameters and range
The scope of parameter variability should be determined on the basis of a review of publications, experts' opinions or on the basis of confidence intervals around the average value. The variable distribution implemented in the assessment of uncertainty of input parameters should be defined and justified in probabilistic analyses. 
Sensitivity analysis-methods
Presenting results
The results of the economic analysis should be presented in the following form: a) total clinical results and, separately, total costs of compared technologies; and b) incremental cost-effectiveness ratio (in the case of domination or extended domination). The presentation method should be clear enough to ensure proper interpretation of the analysis and the possibility of data recovery and utilization in the future. The results of the analysis of particular population sub-groups should also be presented if such analysis has been carried out. It should indicate whether and how much can the examined technology be more cost-effective in the sub-groups, than in the entire analyzed population. 
Incremental analysis
Total costs vs effectiveness (cost/effectiveness ratio)
Portability of results (Generalizability)
The patient population to which the economic evaluation applies should be consistent with the patient population defined in the clinical part of the reimbursement request submission. 
Financial impact analysis
YES - see the whole point 5. The budget impact analysis determines the financial consequences of the introduction of the assessed health technology in the Polish health care system. 
Mandatory or recommended or voluntary
For reimbursement process of drugs it is mandatory to enclose 3 types of HTA analysis: clinical effectiveness analysis, economic analysis and budget impact analysis; methodology of these analysis (described in AHTAPol guidelines) is recommended 

Acknowledgement: ISPOR Poland Chapter highly contributed to the key feature form.

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