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3 January 2023 Ms Heli Laarmann Ministry of Social Affairs Public Health Department Lastekodu 48 10144 Tallinn, Estonia Dear Ms Laarmann, Let me first introduce myself. My name is Joanna Leśniowska and I hold the position of assistant professor in Kozminski University in Poland. At present we are conducting studies with Dr Michał Wojna on the various aspects related to HTA decision-making process. Our study aims to provide a systematic overview and comparison of HTA processes and methods, used in orphan products reimbursement decisions. Despite very extensive literature and research on the assessment of health technology, much remains unknown about its use in drug-reimbursement decision-making processes, especially with regard to orphan drugs. Different approaches are being taken by public payers with respect to main and secondary perspectives used in the economic evaluation (i.e. healthcare payer and wider social perspectives). There is also great methodological heterogeneity in the studies in relation to the measurement and assessment of indirect costs in social perspective (e.g. human capital method and friction cost method). The survey conducted within the framework of our research is designed to gain knowledge on the HTA study “perspective” from which analyses are conducted. Detailed analysis of existing similarities and differences in preferences for economic perspective enables identification of a potential for harmonization and the unification of the European procedures for HTA. In the first phase of our research we aim to focus on orphan drugs reimbursement decisions. Rare diseases represent an economic challenge for every country. Reimbursement decisions for orphan drugs are subject to not only economic and pharmacoeconomic but also social and ethical assessments. Traditional HTA methods seem inadequate in many cases by the very nature of orphan drug and due to the importance of social context (health inequalities). At the same time the class of orphan drugs is reported to be the main driver of the overall spending growth on drugs in developed countries. Some researches argue that there is a need for unification of HTA methodology in orphan drugs reimbursement procedures as a first step to further coordination of national drug policies. Thus, taking into account the above matters, I would like to kindly ask you to provide me with information on methods for economic evaluation of rare diseases treatments in Estonia, i.e.: 1. Perspective – main/primary and secondary perspective (social, third payer/healthcare system/government, patients and families, hospitals/clinicians) 2. Types of costs (medical costs, non-medical costs, productivity losses due to premature death, work absence, or inability to work and informal care costs) 3. Methods of estimating indirect costs due to productivity losses (human-capital, friction-cost) 4. Prevalence/incidence based estimation 5. Types of economic evaluation (cost-minimization analyses, cost-effectiveness analyses, cost- utility analyses, cost-consequences analyses, cost-benefit analyses) Thank you in advance for your answer. I am looking forward to hearing from you soon. Yours sincerely, ………………………….. Joanna Leśniowska, PhD Department of Economics Saatja: Mall Hiet <[email protected]> Saadetud: 04.01.2023 09:12 Adressaat: Mall Hiet <[email protected]> Teema: FW: Request letter - Joanna Leśniowska Manused: Outlook-vkc4gxnx.png; Outlook-3j10xcsp.png; Request letter - Joanna Leśniowska.pdf From: Joanna Leśniowska <[email protected]> Sent: Tuesday, January 3, 2023 11:21 PM To: Heli Laarmann <[email protected]> Cc: Michał Wojna <[email protected]> Subject: Request letter - Joanna Leśniowska Dear Ms Laarmann, I would like to kindly ask you to provide me with some information related to HTA decision- making process. Please find attached the request letter. Yours sincerely, Joanna Leśniowska Joanna Leśniowska, PhD Department of Economics Division of Health Economics and Healthcare Management tel. +48 22 519 53 tel. +48 601 826 001 Kozminski University 57/59 Jagiellonska St., 03-301 Warsaw, POLAND www.kozminski.edu.pl