Incorporating New Societal Perspectives for Health Economic Evaluations of Orphan Drugs in Czech Republic

Published Feb 23, 2022

Jiri Klimes, Tomas Mlcoch, Tomas Dolezal

Health economic assessment has been an integral part of the methodology and a comprehensive Health Technology Assessment (HTA) system in the Czech Republic since 2008. As of January 1, 2022, new legislation enters into force in the Czech Republic, which regulates the setting of prices and reimbursement for medicinal products, the major changes redefine the new reimbursement process for orphan drugs. A fundamental change is the separation of the assessment and appraisal process, which will be in the hands of the commission at the Ministry of Health. There are a number of criteria assessed in this process, but a fundamental change is the wider societal perspective to be applied in the evaluation of these orphan drugs.                                 

The ISPOR Czech chapter, as the major driver of the methodology changes in the field of HTA, is organizing several seminars, lectures and discussion sessions engaging local and international experts, like Prof. Susan Griffin, Senior Research Fellow at Centre for Health Economics of University of York, together with other key stakeholders and policy makers. The core of the ongoing discussion is the definition of terms and types of costs and benefits that are applied in such perspective. There are two major views (in addition to the standard health care payer’s perspective and medical costs): 1) The entire governmental perspective; calculating social care costs - disability pensions, sickness, care allowances or other social care costs; 2) The whole societal perspective; mainly includes opportunity costs, including productivity costs/losses - absenteeism, presenteeism, premature deaths, caregiver disutilities for both patients and their caregivers.

In line with general recommendations, productivity costs can be calculated using two basic methods (friction costs approach (FCA), human capital approach (HCA)), the preferred method seems to be the HCA method in the Czech Republic, which takes into account the lifelong productivity loss of the patient or his/her surroundings.

The ongoing discussion and especially the consensus will need to be adopted, especially with regards to the following aspects: 1) Definition of costs vs. transfers with regards to the type of perspective (governmental vs. societal); 2) The emergence of a uniform methodology and recommendations, ideally with the creation of uniform tariff tables, which will clearly guide each author of the analysis, carried out from a broader perspective, so that the methodology is uniform and comparable across different analyzes and diseases.

The impact on caregivers will always have to be taken into account, however with respect and avoiding to double counting (QoL vs opportunity costs). ISPOR Czech Chapter aims to bring such methodology and recommendations as part of the research objectives in 2022.

Your browser is out-of-date

ISPOR recommends that you update your browser for more security, speed and the best experience on Update my browser now